Froben 50mg Tablets

1. Name Of The Medicinal Product

Froben Tablets 50 mg

2. Qualitative And Quantitative Composition

Froben Tablets 50mg contain 50 mg Flurbiprofen BP.

3. Pharmaceutical Form

The tablets are sugar-coated and yellow in colour. They may be either unprinted or printed in black with an identifying motif.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of rheumatoid disease, osteoarthritis, ankylosing spondylitis, musculoskeletal disorders and trauma such as periarthritis, frozen shoulder, bursitis, tendinitis, tenosynovitis, low back pain, sprains and strains.

Froben is also indicated for its analgesic effect in the relief of mild to moderate pain in conditions such as dental pain, post-operative pain, dysmenorrhoea and migraine.

4.2 Posology And Method Of Administration

For oral administration. To be taken preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.4).

Adults:

150 to 200 mg daily in two, three or four divided doses. In patients with severe symptoms or disease of recent origin, or during acute exacerbations, the total daily dosage may be increased to 300 mg in divided doses.

For dysmenorrhoea, a dosage of 100 mg may be administered at the start of symptoms followed by 50 or 100 mg given at four- to six-hour intervals. The maximum total daily dosage should not exceed 300 mg.

Children:

Not recommended for use in children under 12 years.

Elderly:

The elderly are at increased risk of the serious consequences of adverse reactions. Although flurbiprofen is generally well tolerated in the elderly, some patients, especially those with impaired renal function, may eliminate NSAIDs more slowly than normal. In these cases, flurbiprofen should be used with caution and dosage should be assessed individually.

If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

4.3 Contraindications

Froben is contraindicated in patients with hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the inactive ingredients.

Froben is contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to flurbiprofen, aspirin or other NSAIDs.

Froben is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Froben should not be used in patients with active, or history of, ulcerative colitis, Crohn's disease, recurrent peptic ulceration or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding).

Froben is contraindicated in patients with severe heart failure, hepatic failure and renal failure (see section 4.4).

Froben is contraindicated during the last trimester of pregnancy (see section 4.6).

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.2 and GI and cardiovascular risks below).

Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactose deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take this medication.

The use of Froben with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the potential for additive effects (see section 4.5).

Elderly

The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2).

Gastrointestinal bleeding, ulceration and perforation

GI bleeding, ulceration or perforation has been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and may occur with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Froben, the treatment should be withdrawn.

Respiratory disorders

Caution is required if Froben is administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Cardiovascular, renal and hepatic impairment

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients (see also section 4.3).

Froben should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with flurbiprofen administration.

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with flurbiprofen administration and NSAID therapy.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events such as myocardial infarction or stroke. There are insufficient data to exclude such a risk for flurbiprofen.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with flurbiprofen after careful consideration.Similar consideration should be made before initating longer-term treatment of patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Renal effects

Caution should be used when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration.

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8).

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy. In the majority of cases, the onset of the reaction occurs within the first month of treatment. Froben should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

Haematological effects

Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Froben should be used with caution in patients with a potential for abnormal bleeding.

Impaired female fertility

The use of Froben may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Froben should be considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Care should be taken in patients treated with any of the following drugs as interactions have been reported in some patients.

Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking flurbiprofen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.

Anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin (see section 4.4).

Aspirin: As with other products containing NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended because of the potential of increased adverse effects.

Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4).

Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding with NSAIDs (see section 4.4).

Lithium salts: Decreased elimination of lithium.

Methotrexate: Caution is advised in the concomitant administration of flurbiprofen and methotrexate since NSAIDs may increase methotrexate levels.

Ciclosporin: Increased risk of nephrotoxicity.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding with NSAIDs (see section 4.4).

Other analgesics and cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs, including Cox-2 inhibitors, as this may increase the risk of adverse effects (see section 4.4).

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and other NSAIDs.

Studies have failed to show any interaction between flurbiprofen and tolbutamide or antacids. There is no evidence so far that flurbiprofen interferes with standard laboratory tests.

4.6 Pregnancy And Lactation

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, flurbiprofen should not be given unless clearly necessary. If flurbiprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

• renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

• possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

• inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy.

Lactation

In the limited studies so far available, NSAIDs can appear in the breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

See section 4.4 Special warnings and precautions for use, regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

4.8 Undesirable Effects

Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, dyspepsia, flatulence, constipation, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.3 and 4.4) have been reported following flurbiprofen administration. Less frequently, gastritis, has been observed. Pancreatitis has been reported very rarely.

Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including toxic epidermal necrolysis and erythema multiforme).

Cardiac disorders and Vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Respiratory, thoracic and mediastinal disorders: Respiratory tract reactivity (asthma, bronchospasm, dyspnoea).

Other adverse events reported less commonly and for which causality has not necessarily been established include:

Blood and lymphatic system disorders: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Psychiatric disorders: Depression, confusional state, hallucination

Nervous system disorders: Cerebrovascular accident, optic neuritis, headache, paraesthesia, dizziness, and somnolence.

Aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation) (see section 4.4).

Eye disorders: Visual disturbance

Ear and labyrinth disorders: Tinnitus, vertigo

Hepatobiliary disorders: Abnormal liver function, hepatitis and jaundice.

Skin and subcutaneous tissue disorders: Skin disorders including rash, pruritis, urticaria, purpura and very rarely, bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme) and photosensitivity reaction.

Renal and urinary disorders: Toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

General disorders and administration site conditions: Malaise, fatigue

4.9 Overdose

Symptoms

Symptoms of overdosage may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Flurbiprofen has analgesic, anti-inflammatory and antipyretic properties. These are thought to result from the drug's ability to inhibit prostaglandin synthesis.

5.2 Pharmacokinetic Properties

Flurbiprofen is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring about 90 minutes after ingestion. It is about 99% protein-bound and has an elimination half-life of about three to four hours.

The rate of urinary excretion of flurbiprofen and its two major metabolites ([2-(2-fluoro-4′-hydroxy-4-biphenylyl) propionic acid] and [2-(2-fluoro-3′-hydroxy-4′-methoxy-4-biphenylyl) propionic acid]) in both free and conjugated states is similar for both the oral and rectal routes of administration. Metabolic patterns are quantitatively similar for both routes of administration.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize starch powder EP, lactose NF anhydrous, povidone BPC, industrial alcohol FRP, magnesium stearate EP, stearic acid PDR BPC, *sandarac BPC 49 tablet varnish WMR, isopropyl alcohol, sucrose, purified water

Coat

Liquid glucose BPC 63, French chalk for tablets HSE, titanium dioxide BP, colloidal silicon dioxide NF, opalux yellow ASF 2230 HSE, carnauba wax PDR BP, **opacode S-1-8152HV black HSE

* Alternatively sandarac tablet varnish BPC 49

** Alternatively fine black ink markem

6.2 Incompatibilities

None known.

6.3 Shelf Life

Blister pack: 36 months (unopened)

Bulk pack: 12 months (unopened)

6.4 Special Precautions For Storage

None for the blister pack.

Store in a cool, dry place for the bulk pack.

6.5 Nature And Contents Of Container

A blister pack consisting of a PVC blister heat sealed to hard temper aluminium foil packed in a cardboard carton. Each blister contains 10 tablets.

Pack sizes: 10, 20, 30, 100 and 500 tablets. Also a sample pack of 5 tablets in a blister.

A bulk pack of a low density polyethylene bag in a rectangular white plastic tub having a snap-on lid.

Pack sizes: Approx. 25,000 or 50,000 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Abbott Laboratories Limited

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

UK.

8. Marketing Authorisation Number(S)

Froben Tablets 50 mg: PL 00037/0349

9. Date Of First Authorisation/Renewal Of The Authorisation

31 December 2001

10. Date Of Revision Of The Text

02 January 2010

Fosamax Once Weekly 70 mg Tablet

FOSAMAX Once Weekly 70 mg Tablets

Alendronic acid as alendronate sodium trihydrate

Read all of this leaflet carefully before you start taking this medicine, even if this is a repeat prescription.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


• It is particularly important to understand the information in section 3. HOW TO TAKE FOSAMAX, before taking this medicine.

In this leaflet:

1. What FOSAMAX is and what it is used for

2. Before you take FOSAMAX

3. How to take FOSAMAX

4. Possible side effects

5 How to store FOSAMAX

6. Further information

What Fosamax Is And What It Is Used For

What is FOSAMAX?

Fosamax belongs to a group of non-hormonal medicines called bisphosphonates. FOSAMAX prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.

What is FOSAMAX used for?

Your doctor has prescribed Fosamax to treat your osteoporosis. FOSAMAX reduces the risk of spine and hip fractures.

FOSAMAX is a once weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to begin treatment. FOSAMAX not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.

As well as your treatment with FOSAMAX, your doctor may suggest you make changes to your lifestyle to help your condition, such as:

Stopping smoking: Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.

Exercise: Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.

Eating a balanced diet: Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and Vitamin D).

Before You Take Fosamax

Do not take FOSAMAX

(1) if you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients

(2) if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing

(3) if you cannot stand or sit upright for at least 30 minutes

(4) if your doctor has told you that you have low blood calcium

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Take special care with FOSAMAX

It is important to tell your doctor before taking FOSAMAX if:

• you suffer from kidney problems


• you have any allergies


• you have any swallowing or digestive problems


• your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus)


• you have low blood calcium levels


• you have gum disease


• you have a planned dental extraction

A dental examination should be considered before you start treatment with FOSAMAX if you have any of the conditions below.

• you have cancer


• you are undergoing chemotherapy or radiotherapy


• you are taking steroids


• you don’t receive routine dental care


• you have gum disease

Appropriate preventive dental care, as recommended by the dentist, should be followed during treatment.

Irritation, inflammation or ulceration of the gullet (oesophagus – the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking FOSAMAX. These side effects may worsen if patients continue to take FOSAMAX after developing these symptoms.

Taking other medicines

It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of FOSAMAX if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAMAX.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking FOSAMAX with food and drink

It is likely that food and beverages (including mineral water) will make FOSAMAX less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAMAX.

Children and adolescents

FOSAMAX should not be given to children and adolescents.

Pregnancy and breast-feeding

FOSAMAX is only intended for use in postmenopausal women. You should not take FOSAMAX if you are or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with FOSAMAX that may affect your ability to drive or operate machinery. Individual responses to FOSAMAX may vary (See POSSIBLE SIDE EFFECTS.)

Important information about some of the ingredients of FOSAMAX

FOSAMAX contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How To Take Fosamax

Take one FOSAMAX tablet once a week.

Follow these instructions carefully to make sure you will benefit from FOSAMAX.

• 1) Choose the day of the week that best fits your schedule. Every week, take one FOSAMAX tablet on your chosen day.

It is very important to follow instructions 2), 3), 4) and 5) to help the FOSAMAX tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).

• 2) After getting up for the day and before taking any food, drink, or other medicine, swallow your FOSAMAX tablet whole with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.).

• Do not take with mineral water (still or sparkling).


• Do not take with coffee or tea.


• Do not take with juice or milk.

Do not crush or chew the tablet or allow it to dissolve in your mouth.

• 3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.


• 4) Do not take FOSAMAX at bedtime or before getting up for the day.


• 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAMAX and contact your doctor.


• 6) After swallowing your FOSAMAX tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. FOSAMAX is effective only if taken when your stomach is empty.

If you take more FOSAMAX than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

If you forget to take FOSAMAX

If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

If you stop taking FOSAMAX

It is important that you continue taking FOSAMAX for as long as your doctor prescribes the medicine. FOSAMAX can treat your osteoporosis only if you continue to take the tablets.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, FOSAMAX can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported.

Very Common (occurring in at least 1 of 10 patients treated)

Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated)

Uncommon (occurring in at least 1 of 1000 and less than 1 of 100 patients treated)

Rare (occurring in at least 1 of 10000 and less than 1 of 1000 patients treated)

Very rare (occurring in less than 1 of 10,000 patients treated)

Common:

• heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing


• bone, muscle and/or joint pain


• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence;


• headache

Uncommon:

• nausea; vomiting


• irritation or inflammation of the gullet (oesophagus – the tube that connects your mouth with your stomach) or stomach


• black or tar-like stools


• rash; itching; redness of the skin

Rare:

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing


• symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth


• stomach or peptic ulcers (sometimes severe or with bleeding)


• narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach)


• jaw problems associated with delayed healing and infection, often following tooth extraction


• blurred vision, pain or redness in the eye


• rash made worse by sunlight


• severe bone, muscle and/or joint pain


• mouth ulcers when the tablets have been chewed or sucked


• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment

Very rare:

• severe skin reactions

During post-marketing experience the following side effects have been reported (frequency unknown):

• dizziness, changed sense of taste


• hair loss


• joint swelling, fracture of the thigh bone in patients on long-term treatment with FOSAMAX.
  
  Thigh pain, weakness or discomfort may be an early indication of a possible fracture of the thigh bone


• tiredness, swelling in the hands or legs

Laboratory test findings:

Very common: mild and transient decreases in blood calcium and phosphate levels, generally within the normal range.

Tell your doctor or pharmacist promptly about these or any other unusual symptoms.

It will help if you make a note of what you experienced, when it started and how long it lasted.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Fosamax

Keep out of the reach and sight of children.

Do not use FOSAMAX after the expiry date which is stated on the carton and the wallet after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Do not remove the tablets from the blister pack until you are ready to take the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What FOSAMAX contains

Active substance

The active substance is alendronate sodium trihydrate. Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate.

Other ingredients

Microcrystalline cellulose (E460), lactose anhydrous, croscarmellose sodium and magnesium stearate (E572).

What FOSAMAX looks like and contents of the pack

FOSAMAX tablets are available as oval, white tablets marked with an outline of a bone image on one side and ‘31’ on the other.

The tablets are supplied in wallets with sealed aluminium blisters in cartons in the following pack sizes

• 2 tablets (1 wallet containing 2 tablets in aluminium blisters).


• 4 tablets (1 wallet containing 4 tablets in aluminium blisters).


• 8 tablets (2 wallets each containing 4 tablets in aluminium blisters).


• 12 tablets (3 wallets each containing 4 tablets in aluminium blisters).


• 40 tablets (10 wallets each containing 4 tablets in aluminium blisters).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

United Kingdom

The manufacturer is

Merck Sharp & Dohme (Italia) SpA

Via Emilia 21

27100 Pavia

Italy

This medicinal product is authorized in the Member States of the EEA under the following names:

Austria: FOSAMAX einmal wöchentlich 70mg Tabletten

Belgium: FOSAMAX 70 mg Hebdomadaire, comprimés

Denmark: Fosamax Ugetablet

Finland: FOSAMAX 70 mg tabletit

France: FOSAMAX 70 mg comprimé

Germany: FOSAMAX einmal wöchentlich 70 mg Tabletten

Greece: FOSAMAX 70 mg εβδομαδιαίο δισκίο

Iceland: Fosamax vikutafla 70 mg

Ireland: Fosamax Once Weekly 70 mg Tablets

Italy: FOSAMAX 70 mg compresse

Luxembourg: FOSAMAX 70 mg Hebdomadaire, comprimés

Netherlands: FOSAMAX 70 mg één tablet per week

Norway: FOSAMAX 70 mg

Portugal: FOSAMAX 70 mg

Spain: FOSAMAX Semanal 70 mg comprimidos

Sweden: FOSAMAX Veckotablett 70 mg

UK: FOSAMAX Once Weekly 70 mg Tablets

This leaflet was last approved in February 2010

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘FOSAMAX’?

This leaflet gives you the most important patient information about ‘Fosamax’. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information.

For more information about osteoporosis, contact (in UK)_The National Osteoporosis Society, Camerton, Bath BA2 0PJ. Telephone (01761) 471771; Fax (01761) 471104; Helpline 0845 4500230 or (in RoI) The Irish Osteoporosis Society, 33 Pearse Street, Dublin 2, Telephone (01) 6774267.

The National Osteoporosis Society and the Irish Osteoporosis Society are independent charities not connected with Merck Sharp & Dohme Limited.

denotes registered trademark of

Merck Sharp & Dohme Corp.

a division of Merck & Co., Inc.

Whitehouse Station

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USA

© Merck Sharp & Dohme Limited 2010. All rights reserved.

PIL.FSM70.10.UK.3231 – II-027

Fostair 100 / 6 inhalation solution

Fostair 100/6 micrograms per actuation pressurised inhalation solution

beclometasone dipropionate/formoterol fumarate dihydrate.

For use in adults.

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor, or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.


• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Fostair is and what it is used for

2. Before you use Fostair

3. How to use Fostair

4. Possible side effects

5. How to store Fostair

6. Further information

What Fostair is and what it is used for

Fostair is a pressurised inhalation solution containing two active substances which are inhaled through your mouth and delivered directly into your lungs.

The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids which are often referred to simply as steroids and have an anti-inflammatory action reducing the swelling and irritation in the walls of the small air passages in the lungs. Steroids are used in asthma to help treat symptoms and prevent symptoms.

Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators which relax the muscles in your airways and by doing this widen the airways which makes it easier for you to breathe air in and out of your lungs.

Together these two active substances make breathing easier, by providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma and also help to prevent the symptoms of asthma.

Fostair is indicated in the regular treatment of people with asthma in whom:

• asthma is not adequately controlled by using inhaled corticosteroids and ‘as needed’ short-acting bronchodilators.

or

• asthma is responding well to treatment with both corticosteroids and long-acting bronchodilators.

Before you use Fostair

Do not use Fostair:

• 
  do NOT use this medicine to treat sudden symptoms of asthma such as shortness of breath, wheezing and cough or for asthma which is getting worse or for sudden acute asthma attacks. It will not help you and it will not provide immediate relief of your symptoms. To relieve your symptoms use your quick acting ‘reliever’ inhaler which you must carry with you at all times. (Your ‘reliever’ inhaler is a quick acting bronchodilator which should provide rapid relief
  of acute asthma symptoms).


• if you are allergic or think you are allergic to one or other of the active ingredients of Fostair or if you are allergic to other medicines or inhalers used to treat asthma or to any of the other ingredients of Fostair (see section 6: Further Information), contact your doctor for advice.

Take special care with Fostair

Always tell your doctor before using Fostair:

• if you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary heart disease), valvular heart disease or any other known abnormalities of your heart or if you have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal).


• if you have a narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you know that you have an aneurysm (an abnormal bulging of the blood vessel wall).


• if you have disorders of your heart rhythm such as increased or irregular heart rate, a fast pulse rate or palpitations or if you have been told that your heart trace is abnormal.


• if you have an overactive thyroid gland


• if you have low blood levels of potassium


• if you have any disease of your liver or kidneys


• if you have diabetes (if you inhale high doses of formoterol your blood glucose may increase and therefore you may need to have some additional blood tests to check your blood sugar when you start using this inhaler and from time to time during treatment).


• if you have a tumour of the adrenal gland (known as phaeochromocytoma).


• if you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop taking Fostair at least 12 hours before the anaesthesia.


• if you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral or fungal infection of your chest.


• if you must avoid alcohol for any reason.

If any of the above apply to you, always inform your doctor before you use Fostair.

If you have or have had any medical problems or any allergies or if you are not sure as to whether you can use Fostair talk to your doctor, asthma nurse or pharmacist before using the inhaler.

Treatment with a beta-2-agonist like the formoterol contained in Fostair can cause a sharp fall in your serum potassium level (hypokalaemia).

If you have severe asthma, you must take special care. This is because a lack of oxygen in the blood and some other treatments you may be taking together with Fostair, such as medicines for treating heart disease or high blood pressure, known as diuretics or ‘water tablets’ or other medicines used to treat asthma can make the fall in potassium level worse. For this reason your doctor may wish to measure the potassium levels in your blood from time to time.

If you take higher doses of inhaled corticosteroids over long periods, you may have more of a need for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an accident, having a serious injury or before an operation. In this case, the doctor treating you will decide whether you need to increase your dose of corticosteroids and may prescribe some steroid tablets or a steroid injection.

Should you need to go to the hospital, remember to take all of your medicines and inhalers with you, including Fostair and any medicines or tablets bought without a prescription, in their original package, if possible.

Using Fostair with other medicines:

Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any other inhalers and including medicines obtained without a prescription.

Do not use beta blockers with this medicine. Beta blockers such as atenolol, propranolol and sotalol are used to treat a number of conditions including high blood pressure and heart conditions such as abnormal heart rhythms and heart failure; timolol is used to treat glaucoma. If you need to use beta blockers, and including beta blockers in eye-drops, the effect of formoterol may be reduced or formoterol may not work at all. On the other hand, using other beta adrenergic drugs (drugs which work in the same way as formoterol) may increase the effects of formoterol.

Using Fostair together with:

• medicines for treating abnormal heart rhythms (quinidine, disopyramide, procainamide), medicines used to treat allergic reactions (antihistamines), medicines for treating symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitryptiline and imipramine), phenothiazines, can cause some changes in the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias).


• medicines for treating Parkinson’s Disease (L-dopa), to treat an underactive thyroid gland (L-thyroxine), medicines containing oxytocin (which causes uterine contractions) and alcohol can lower your heart’s tolerance to beta-2-agonists, such as formoterol.


• monoamine oxidase inhibitors (MAOIs), including drugs with similar properties like furazolidone and procarbazine, used to treat mental disorders, can cause a rise in blood pressure.


• medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level. This may increase the likelihood of abnormal heart rhythms.


• other medicines used to treat asthma (theophylline, aminophylline or steroids) and diuretics (water tablets) may cause a fall in your potassium level.


• some anaesthetics can increase the risk of abnormal heart rhythms.

Pregnancy and breast-feeding:

There are no clinical data on the use of Fostair during pregnancy.

Fostair must not be used if you are pregnant, think that you might be pregnant or are planning to become pregnant, or if you are breast-feeding, unless you are advised to do so by your doctor.

Driving and using machines:

Fostair is unlikely to affect your ability to drive and use machines.

Important information about some of the ingredients of Fostair:

Fostair contains a small amount of alcohol. Each actuation (puff) from your inhaler contains 7mg of ethanol.

How to use Fostair

Fostair is for inhalation use. Fostair should be inhaled via your mouth into your lungs.

Always use Fostair exactly as your doctor has told you to. You must check with your doctor or pharmacist if you are not sure. The pharmacist’s label will tell you how many puffs to take and how often they must be taken.

Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Fostair. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms. Under no circumstances must you change the dose without first speaking to your doctor.

Adults and the elderly:

The usual dose of this medicine is one or two puffs twice daily.

The maximum daily dose is 4 puffs.

Children and adolescents less than 18 years of age:

Children and adolescents aged less than 18 years must NOT take this medicine.

At-risk patients:

Older people do not need to have their dose adjusted. No information is avaliable regarding the use of Fostair in people with liver or kidney problems.

Fostair is effective for the treatment of asthma in a dose of beclometasone dipropionate which may be lower than that of some other inhalers containing beclometasone dipropionate. If you have been using a different inhaler containing beclometasone dipropionate previously, your doctor will advise you on the exact dose of Fostair you should take for your asthma.

Remember: you must always have your quick-acting ‘reliever’ inhaler with you at all times to treat worsening symptoms of asthma or a sudden asthma attack.

Do not increase the dose

If you feel that the medicine is not very effective, always talk to your doctor before increasing the dose.

If you use more Fostair than you should:

• Taking more formoterol than you should can have the following effects: feeling sick, being sick, heart racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace), headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of glucose in the blood. Your doctor may wish to carry out some blood tests to check your blood potassium and blood glucose levels.


• Taking too much beclometasone dipropionate can lead to short term problems with your adrenal glands. This will get better within a few days however, your doctor may need to carry out some blood tests to check your serum cortisol levels.

Tell your doctor if you have any of the above symptoms.

If you forget to use Fostair:

Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time. Do not double the dose.

If you stop using Fostair:

Do not lower the dose or stop using your medication.

Even if you are feeling better, do not stop using Fostair or lower the dose. If you want to do this, talk to your doctor. It is very important for you to use Fostair regularly even though you may have no symptoms.

If your breathing gets worse:

If you develop worsening shortness of breath or wheezing (breathing with an audible whistling sound), straight after inhaling your medicine, stop using your Fostair inhaler immediately and use your quick acting ‘reliever’ inhaler straightaway. You should contact your doctor straightaway. Your doctor will assess your symptoms and if necessary may start you on a different course of treatment. You may be told that you should not use Fostair again. You should always carry your ‘reliever’ inhaler with you at all times.

Shortness of breath and wheezing which occurs immediately after using your inhaler is caused by acute narrowing of the airways in your lungs and is known as paradoxical bronchospasm. See also section 4: Possible side effects.

If your asthma gets worse:

If your symptoms get worse or are difficult to control (e.g. if you are using your ‘reliever’ inhaler more frequently or if your ‘reliever’ inhaler does not improve your symptoms), see your doctor immediately. Your asthma may be getting worse and your doctor may need to increase your dose of Fostair or prescribe alternative treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Instructions for use:

Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, release one puff into the air to make sure the inhaler is working properly. Whenever possible, stand or sit in an upright position when inhaling.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.

2. Breathe out as slowly and deeply as possible.

3. Hold the canister vertically with its body upwards and put your lips around the mouthpiece. Do not bite the mouthpiece.

4. Breathe in slowly and deeply through your mouth and, just after starting to breathe in press down on the top of the inhaler to release one puff.

5. Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not breathe into the inhaler. After use, close with the protective cap.

If you need to take another puff, keep the inhaler in the vertical position for about half a minute, then repeat steps 2 to 5.

Important: Do not perform steps 2 to 5 too quickly.

If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, this means that Fostair will not be getting into your lungs as it should. Take another puff, carefully following the instructions from Step 2 onwards.

If you have weak hands, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.

To lower the risk of a fungal infection in the mouth and throat, rinse your mouth or gargle with water or brush your teeth each time you use the inhaler.

If you think the effect of Fostair is too much or not enough, tell your doctor or pharmacist.

If you find it difficult to operate the inhaler while starting to breathe in you may use the Aero-Chamber Plus spacer device. Ask your doctor, pharmacist or a nurse about this device.

Cleaning:

Remove the cap from the mouthpiece and regularly (once a week) wipe the outside and inside of the mouthpiece with a dry cloth. Do not use water or other liquids to clean the mouthpiece.

It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you follow the instructions on how to use the AeroChamber Plus spacer device and how to clean it carefully.

Possible side effects

Like all medicines Fostair can cause side effects although not everybody gets them. Possible side effects are listed below according to their frequency.

As with other inhaler treatments there is a risk of worsening shortness of breath and wheezing immediately after using Fostair and this is known as paradoxical bronchospasm. If this occurs you must STOP using Fostair immediately and use your quick acting ‘reliever’ inhaler straightaway to treat the symptoms of shortness of breath and wheezing. You must contact your doctor straight away. Your doctor is likely to assess your asthma and if necessary may start you on another course of treatment. You may be told that you must not use Fostair again.

Common (affecting less than 1 in 10 people):

• Headache, hoarseness, sore throat.

Uncommon (affecting less than 1 in 100 people):

• palpitations


• unusual fast heart beat and disorders of heart rhythm


• some changes in the electrocardiogram (ECG)


• flu symptoms


• fungal infections of the mouth and throat


• fungal infections of the vagina


• inflammation of the sinuses


• rhinitis


• inflammation of the ear


• throat irritation


• asthma attack


• cough and productive cough


• nausea


• abnormal or impaired sense of taste


• burning of the lips


• dry mouth


• swallowing difficulties


• indigestion


• upset stomach


• diarrhoea


• pain in muscle and muscle cramps


• reddening of the face


• increased blood flow to some tissues in the body


• excessive sweating


• trembling


• restlessness


• dizziness

Alterations of some constituents of the blood:

• fall in the number of white blood cells


• increase in the number of blood platelets


• a fall in the level of potassium in the blood


• increase in blood sugar level


• increase in the blood level of insulin, free fatty acid and ketones

Rare (affecting less than 1 in 1,000 people):

• tightness in the chest


• sensation of a missed heartbeat


• increase or decrease in blood pressure


• inflammation of the kidney


• nettle rash or hives


• swelling of the skin and mucous membrane persisting for several days

Very rare (affecting less than 1 in 10,000 people):

• irregular heartbeat


• shortness of breath


• worsening of asthma


• abnormal behaviour


• sleep disorders and hallucinations


• a fall in the number of blood platelets


• swelling of the hands and feet

Using high-dose inhaled corticosteroids over a long time can cause, in very rare cases, systemic effects. These include:

• problems with how your adrenal glands work (adrenosuppression)


• decrease in bone mineral density (thinning of the bones)


• growth retardation (slowing of growth) in children and adolescents


• increased pressure in your eyes (glaucoma)


• cataracts

• Hypersensitivity reactions like skin allergies, skin itching, skin rash, reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat

If you experience any of the above side effects and they cause you distress, are severe or last for several days, or if you feel unwell or notice anything unusual or a side effect which is not mentioned in this leaflet, or if you are worried in any way or if there is anything you do not understand, you should contact your doctor or pharmacist immediately.

How to store Fostair

• Keep out of the reach and sight of children.


• Do not use Fostair beyond five months from the date you get the inhaler from your pharmacist and never use after the expiry date which is stated on the carton and label.


• Do not store the inhaler above 25°C.


• If the inhaler has been exposed to severe cold, take the canister out of the mouthpiece and warm it with your hands for a few minutes before using. Never warm it by artificial means.


• 
  Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures higher than 50°C. Do not pierce the canister.


• Medicines should not be disposed of via waste water or household waste. Return all used, partially used and unused inhalers to your pharmacist to be disposed of.
  
  These measures will help to protect the environment.

Further information

What Fostair contains:

The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.

Each actuation/metered dose from the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.

This corresponds to a delivered dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.

The other ingredients are: ethanol anhydrous, hydrochloric acid and the CFC-free propellant - Norflurane (HFA-134a). To help protect the environment, the inhaler contains the CFC-free propellant, HFA-134a, which replaces completely the chlorofluorocarbon (CFC) propellants present in some other inhalers and appears to have a less damaging effect on the ozone layer. Fostair does not contain CFCs.

What Fostair looks like and contents of the pack:

Fostair is a pressurised solution contained in an aluminium canister with a metering valve, fitted in a polypropylene plastic actuator with a plastic protective cap.

Each pack contains one canister which provides 120 or 180 actuations (puffs).

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Chiesi Limited

Cheadle Royal Business Park

Highfield

Cheadle

SK8 3GY

Manufacturer:

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

I-43100 Parma

Italy

This medicinal product is authorised in the member states of the EEA under the following names:

Austria FOSTER

France FOSTAIR

Germany KANTOS

Greece FOSTER

Hungary FOSTER

Italy FOSTER

Spain FOSTER

Belgium FOSTER

Czech Republic COMBAIR

Slovakia FOSTER

Poland FOSTEX

Portugal FOSTER

Slovenia FOSTER

The Netherlands FOSTER

UK FOSTAIR

Luxembourg FOSTER

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.

This leaflet was last approved in: 07/2010

CP0029/4

87R78.02/01

Fybogel Lemon

1. Name Of The Medicinal Product

Fybogel Lemon.

2. Qualitative And Quantitative Composition

A sachet contains 3.5 g ispaghula husk BP.

3. Pharmaceutical Form

Granules.

4. Clinical Particulars

4.1 Therapeutic Indications

Clinical Indication: for the treatment of patients requiring a high fibre regimen: for example, for the relief of constipation, including constipation in pregnancy and the maintenance of regularity; for the management of bowel function in patients with colostomy, ileostomy, haemorrhoids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel syndrome and ulcerative colitis.

4.2 Posology And Method Of Administration

Fybogel Lemon is intended for oral administration in a suspension in a drink of water. The granules should be stirred into a glass of water and taken as soon as possible, preferably after meals.

Adults and children over 12 years:	One sachet morning and evening.
Elderly:	There is no indication that dosage needs to be modified for the elderly.
Children aged 6 to 12 years:	Half to one level 5 ml spoonful depending on size and age, morning and evening. If there has been no bowel movement after three days of treatment the doctor should be consulted.
Children under 6 years:	To be taken only when prescribed by a doctor, half to one level 5 ml spoonful depending on age and size, morning and evening.

4.3 Contraindications

Fybogel Lemon is contra-indicated in cases of intestinal obstruction, faecal impaction and colonic atony such as senile mega-colon.

4.4 Special Warnings And Precautions For Use

Due to its aspartame content Fybogel Lemon should not be given to patients with phenylketonuria.

If symptoms persist consult a doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Fybogel Lemon may be used during pregnancy and lactation since the ispaghula husk is not absorbed from the gastrointestinal tract.

4.7 Effects On Ability To Drive And Use Machines

Not applicable in view of its physical mode of action

4.8 Undesirable Effects

A small amount of abdominal distension and flatulence may sometimes occur.

4.9 Overdose

In the event of overdosage conservative measures should be taken. The patient may notice abdominal discomfort and flatulence, and attention should be paid to maintaining an adequate fluid intake.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ispaghula husk is capable of absorbing up to 40 times its own weight in water in vitro, and part of its activity can be attributed to its action as a simple bulking agent. In addition, colonic bacteria are believed to use the hydrated material as a metabolic substrate. This results in an increase in the bacterial cell mass with consequent softening of the faeces.

5.2 Pharmacokinetic Properties

The mode of action of Fybogel Lemon is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

No preclinical findings relevant to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Potassium bicarbonate	USP
Sodium bicarbonate	Ph Eur
Citric acid	Ph Eur
Riboflavin sodium phosphate	Ph Eur
Aspartame	Ph Eur
Lemon flavour no. 1	HSE
Lemon flavour no. 4	HSE
Saccharin Sodium	Ph Eur
Polysorbate 80	Ph Eur
Silica colloidal anhydrous	Ph Eur

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store below 30°C in a dry place.

6.5 Nature And Contents Of Container

Sachets of paper/aluminium foil/polythene laminate. One, seven, ten or thirty sachets in a cardboard outer. (Pack sizes printed in bold are currently sold).

6.6 Special Precautions For Disposal And Other Handling

Fybogel Lemon granules are to be dispersed in water forming a drink.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

HULL,

HU8 7DS,

England.

8. Marketing Authorisation Number(S)

PL 00063/0024.

9. Date Of First Authorisation/Renewal Of The Authorisation

24th April, 1995 / 20th August, 1997.

10. Date Of Revision Of The Text

19/01/2007

Fungilin Lozenge

1. Name Of The Medicinal Product

Fungilin Lozenge

2. Qualitative And Quantitative Composition

Fungilin Lozenges contain 10,000 units (10mg) amphotericin.

3. Pharmaceutical Form

Lozenge.

Round, pale yellow, engraved "929" and "Squibb".

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of candidal lesions (thrush) of the oral and perioral areas.

4.2 Posology And Method Of Administration

Adults

Dissolve one lozenge slowly in the mouth four times a day. Depending on the severity of infection, the dose may be increased to 8 lozenges daily.

To clear the condition fully may require 10-15 days treatment.

Children

Fungilin Suspension should be used in children and infants.

Elderly

No specific dosage recommendations or precautions.

4.3 Contraindications

Fungilin Lozenges are contraindicated in patients with known hypersensitivity to amphotericin or to any of the other ingredients.

4.4 Special Warnings And Precautions For Use

No specific warnings or precautions apply.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions apply; absorption of amphotericin from the gastro-intestinal tract is negligible.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Since amphotericin B is not appreciably absorbed when taken orally, even at high dose, adverse effects following oral administration of up to 3g daily have been uncommon. Rash, glossitis and gastrointestinal distress, including nausea, vomiting and diarrhoea have been reported occasionally. Transient yellowing of the teeth may occur which can easily be removed by brushing. Abnormal renal function including nephrogenic diabetes insipidus, urticaria, angioedema, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely; an association between these events and administration of Fungilin is unclear.

4.9 Overdose

Since absorption of amphotericin from the gastro-intestinal tract is negligible, overdosage causes no systemic toxicity.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Amphotericin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi including Candida albicans. Extensive clinical experience has not shown problems of toxicity or sensitisation.

5.2 Pharmacokinetic Properties

Absorption from the gastro-intestinal tract is negligible even with very large doses.

5.3 Preclinical Safety Data

No further relevant information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acacia powder, d-mannitol, flavours, magnesium stearate, polyvinyl alcohol, talc.

6.2 Incompatibilities

None known.

6.3 Shelf Life

18 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube, foil or blister pack of 20 or 60 lozenges.

6.6 Special Precautions For Disposal And Other Handling

No special handling instructions.

7. Marketing Authorisation Holder

E.R. Squibb & Sons Limited

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex UB8 1DH

8. Marketing Authorisation Number(S)

PL 0034/5034R

9. Date Of First Authorisation/Renewal Of The Authorisation

September 1971 / 25 January 2005

10. Date Of Revision Of The Text

09 May 2006

Forceval Capsules (Alliance Pharmaceuticals)

1. Name Of The Medicinal Product

Forceval Capsules

2. Qualitative And Quantitative Composition

Each capsule contains:

Vitamin A (as β-Carotene)	HSE	2,500.0 iu
Vitamin D2 (Ergocalciferol)	HSE	400.0 iu
Vitamin B1 (Thiamine)	USP	1.2 mg
Vitamin B2 (Riboflavin)	BP	1.6 mg
Vitamin B6 (Pyridoxine)	BP	2.0 mg
Vitamin B12 (Cyanocobalamin)	PhEur	3.0 mcg
Vitamin C (Ascorbic Acid)	BP	60.0 mg
Vitamin E (dl-α-Tocopheryl Acetate)	USP	10.0 mg
d-Biotin (Vitamin H)	FCC	100.0 mcg
Nicotinamide (Vitamin B3)	BP	18.0 mg
Pantothenic Acid (Vitamin B5)	USP	4.0 mg
Folic Acid (Vitamin B Complex)	BP	400.0 mcg
Calcium	FCC	100.0 mg
Iron	BP	12.0 mg
Copper	HSE	2.0 mg
Phosphorus	HSE	77.0 mg
Magnesium	BP	30.0 mg
Potassium	HSE	4.0 mg
Zinc	HSE	15.0 mg
Iodine	BP	140.0 mcg
Manganese	HSE	3.0 mg
Selenium	BP	50.0 mcg
Chromium	HSE	200.0 mcg
Molybdenum	HSE	250.0 mcg

3. Pharmaceutical Form

Brown and maroon, oblong, soft gelatin capsule printed with FORCEVAL in white on one side and with 6377 in white on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

1. As a therapeutic nutritional adjunct where the intake of vitamins and minerals is suboptimal, e.g. in the presence of organic disease such as malignancy and immune deficiency syndromes, such as AIDS.

2. As a therapeutic nutritional adjunct in conditions where the absorption of vitamins and minerals is suboptimal, e.g. malabsorption, inflammatory bowel disease and fistulae, short bowel syndrome and Crohn's disease, and where concurrent medication decreases vitamin and mineral absorption.

3. As a therapeutic nutritional adjunct in convalescence from illness, e.g. where anorexia or cachexia exists and following chemo- or radio-therapy.

4. As a therapeutic nutritional adjunct in convalescence from surgery, e.g. where nutritional intake continues to be inadequate.

5. As a therapeutic nutritional adjunct for patients on special or restricted diets, e.g. in renal diets and where several food groups are restricted in therapeutic weight reducing diets.

6. As a therapeutic nutritional adjunct where food intolerance exists, e.g. exclusion diets.

7. As an adjunct in synthetic diets, e.g. in phenylketonuria, galactosaemia and ketogenic diets.

4.2 Posology And Method Of Administration

Adults and the Elderly

One capsule daily, preferably taken one hour after meals. Do not exceed the stated dose. The capsule should be swallowed whole with water.

Children under 12 years of age

Forceval Capsules are not recommended for this age group.

4.3 Contraindications

Hypercalcaemia, haemochromatosis and other iron storage disorders.

4.4 Special Warnings And Precautions For Use

Whilst taking Forceval Capsules both protein and energy are also required to provide complete nutrition in the daily diet. No other vitamins, minerals or supplements with or without vitamin A should be taken with this preparation except under medical supervision.

Do not take Forceval Capsules on an empty stomach. Do not exceed the stated dose. Keep out of the reach of children. If symptoms persist, consult your doctor.

Important warning: Contains iron. Keep out of the reach and sight of children, as overdose may be fatal.

This medicine contains E123 (amaranth) and E124 (ponceau 4R red) which may cause allergic reactions.

Evidence from Randomised Control Trials suggests that high doses (20-30 mg/day) b-carotene intake may increase the risk of lung cancer in current smokers and those previously exposed to asbestos. This high-risk population should consider the potential risks and benefits of Forceval Capsules, which contain 4.5mg per recommended daily dose, before use.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Folic acid can reduce the plasma concentration of phenytoin. Oral iron and zinc sulphate reduce the absorption of tetracyclines.

4.6 Pregnancy And Lactation

Forceval Capsules may be administered during pregnancy and lactation at the recommendation of the physician.

4.7 Effects On Ability To Drive And Use Machines

None anticipated.

4.8 Undesirable Effects

No undesirable effects due to Forceval therapy have been reported and none can be expected if the dosage schedule is adhered to.

4.9 Overdose

No cases of overdosage due to Forceval therapy have been reported. Any symptoms which may be observed due to the ingestion of large quantities of Forceval capsules will be due to the fat soluble vitamin content. If iron overdosage is suspected, symptoms may include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may also occur. Treatment should be implemented immediately. In severe cases, after a latent phase, relapse may occur after 24 - 48 hours, manifest by hypotension coma and hepatocellular necrosis and renal failure.

Treatment

The following steps are recommended to minimise or prevent further absorption of the medication:

1. Administer an emetic.

2. Gastric lavage may be necessary to remove drug already released into the stomach. This should be undertaken using desferrioxamine solution (2 g/l). Desferrioxamine 5 g in 50 - 100 ml water should be introduced into the stomach following gastric emptying. Keep the patient under constant surveillance to detect possible aspiration of vomitus; maintain suction apparatus and standby emergency oxygen in case of need.

3. A drink of mannitol or sorbitol should be given to induce small bowel emptying.

4. Severe poisoning: in the presence of shock and/or coma with high serum iron levels (>142 μmol/l) immediate supportive measures plus i.v. infusion of desferrioxamine should be instituted. The recommended dose of desferrioxamine is 5 mg/kg/h by slow i.v. infusion up to a maximum of 80 mg/kg/24 hours. Warning: hypotension may occur if the infusion rate is too rapid.

5. Less severe poisoning: i.m. desferrioxamine 50 mg/kg up to a maximum dose of 4 g should be given.

6. Serum iron levels should be monitored throughout.

7. Any fluid or electrolyte imbalance should be corrected.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The following account summarises the pharmacological effects of the vitamins and minerals in Forceval Capsules and describes the conditions caused by deficiency of these.

Vitamin A

Vitamin A plays an important role in the visual process. It is isomerised to the 11-cis isomer and subsequently bound to the opsin to form the photoreceptor for vision under subdued light. One of the earliest symptoms of deficiency is night blindness which may develop into the more serious condition xerophthalmia. Vitamin A also participates in the formation and maintenance of the integrity of epithelial tissues and mucous membranes. Deficiency may cause skin changes resulting in a dry rough skin with lowered resistance to minor skin infections. Deficiency of Vitamin A, usually accompanied by protein-energy malnutrition, is linked with a frequency of infection and with defective immunological defence mechanisms.

Vitamin D

Vitamin D is required for the absorption of calcium and phosphate from the gastro-intestinal tract and for their transport. Its involvement in the control of calcium metabolism and hence the normal calcification of bones is well documented. Deficiency of Vitamin D in children may result in the development of rickets.

Vitamin B₁ (Thiamine)

Thiamine (as the coenzyme, thiamine pyrophosphate) is associated with carbohydrate metabolism. Thiamine pyrophosphate also acts as a co

Vitamin B₂ (Riboflavine)

Riboflavine is phosphorylated to flavine mononucleotide and flavine adenine dinucleotide which act as co-enzymes in the respiratory chain and in oxidative phosphorylation. Riboflavine deficiency presents with ocular symptoms, as well as lesions on the lips and at angles of the mouth.

Vitamin B₆ (Pyridoxine)

Pyridoxine, once absorbed, is rapidly converted to the co-enzymes pyridoxal phosphate and pyridoxamine phosphate which play an essential role in protein metabolism. Convulsions and hypochromic anaemia have occurred in infants deficient in pyridoxine.

Vitamin B₁₂ (Cyanocobalamin)

Vitamin B₁₂ is present in the body mainly as methylcobalamin and as adenosylcobalamin and hydroxocobalamin. These act as co-enzymes in the trans methylation of homocysteine to methionine; in the isomerisation of methylmalonyl co₁₂ interferes with haemopoiesis and produces megaloblastic anaemia.

Vitamin C (Ascorbic Acid)

Vitamin C cannot be synthesised by man therefore a dietary source is necessary. It acts as a cofactor in numerous biological processes including the hydroxylation of proline to hydroxyproline. In deficiency, the formation of collagen is, therefore, impaired. Ascorbic acid is important in the hydroxylation of dopamine to noradrenaline and in hydroxylations occurring in steroid synthesis in the adrenals. It is a reducing agent in tyrosine metabolism and by acting as an electron donor in the conversion of folic acid to tetrahydrofolic acid is indirectly involved in the synthesis of purine and thymine. Vitamin C is also necessary for the incorporation of iron into ferritin. Vitamin C increases the phagocytic function of leucocytes; it possesses anti-inflammatory activity and it promotes wound healing. Deficiency can produce scurvy. Features include swollen inflamed gums, petechial haemorrhages and subcutaneous bruising. The deficiency of collagen leads to development of thin watery ground substances in which blood vessels are insecurely fixed and readily ruptured. The supportive components of bone and cartilage are also deficient causing bones to fracture easily and teeth to become loose. Anaemia commonly occurs probably due to Vitamin C's role in iron metabolism.

Vitamin E

Vitamin E deficiency has been linked to disorders such as cystic fibrosis where fat absorption is impaired. It is essential for the normal function of the muscular system and the blood.

Nicotinamide

The biochemical functions of nicotinamide as NAD and NADP (nicotinamide adenine dinucleotide phosphate) include the degradation and synthesis of fatty acids, carbohydrates and amino acids as well as hydrogen transfer. Deficiency produces pellagra and mental neurological changes.

Calcium (Dicalcium Phosphate)

Calcium is an essential body electrolyte. It is involved in the maintenance of normal muscle and nerve function and essential for normal cardiac function and the clotting of blood. Calcium is mainly found in the bones and teeth. Deficiency of calcium leads to rickets, osteomalacia in children and osteoporosis in the elderly.

Phosphorus (Dicalcium Phosphate)

Phosphate plays important roles in the osteoblastic and osteoclastic reactions. It interacts with calcium to modify the balance between these two processes. Organic phosphate esters play a key role in the metabolism of carbohydrates, fats and proteins and in the formation of 'high energy phosphate' compounds. Phosphate also acts as a buffer and plays a role in the renal excretion of sodium and hydrogen ions.

Pantothenic Acid

Pantothenic acid is incorporated into co-enzyme A and is involved in metabolic pathways involving acetylation which includes detoxification of drug molecules and biosynthesis of cholesterol, steroid hormones, mucopolysaccharides and acetylcholine. CoA has an essential function in lipid metabolism.

Folic Acid

Folic acid is reduced in the body to tetrahydrofolate which is a co-enzyme for various metabolic processes, including the synthesis of purine and pyrimidine nucleotides and hence in the synthesis of DNA. It is also involved in some amino acid conversion and in the formation and utilisation of formate. Deficiency of folic acid leads to megaloblastic anaemia.

Vitamin H (d-Biotin)

Biotin is a co-enzyme for carboxylation during the metabolism of proteins and carbohydrates.

Selenium

Selenium is an essential trace element, deficiency of which has been reported in man. It is thought to be involved in the functioning of membranes and the synthesis of amino acids. Deficiency of selenium in the diet of experimental animals produces fatty liver followed by necrosis.

Iron

Iron, as a constituent of haemoglobin, plays an essential role in oxygen transport. It is also present in the muscle protein myoglobin and in the liver. Deficiency of iron leads to anaemia.

Copper (Copper Sulphate)

Traces of copper are essential to the body as constituents of enzyme systems involved in oxidation reactions.

Magnesium (Magnesium Oxide)

Magnesium is essential to the body as a constituent of skeletal structures and in maintaining cell integrity and fluid balance. It is utilised in many of the functions in which calcium is concerned but often exerts the opposite effect. Some enzymes require the magnesium ion as a co-factor.

Potassium (Potassium Sulphate)

Potassium is the principle cation of intracellular fluid and is intimately involved in the cell function and metabolism. It is essential for carbohydrate metabolism and glycogen storage and protein synthesis and is involved in transmembrane potential where it is necessary to maintain the resting potential in excitable cells. Potassium ions maintain intracellular pH and osmotic pressure. Prolonged or severe diarrhoea may lead to potassium deficiency.

Zinc (Zinc Sulphate)

Zinc is a constituent of many enzymes and is, therefore, essential to the body. It is present with insulin in the pancreas. It plays a role in DNA synthesis and cell division. Reported effects of deficiency include delayed puberty and hypogonadal dwarfism.

Manganese (Manganese Sulphate)

Manganese is a constituent of enzyme systems including those involved in lipid synthesis, the tricarboxylic acid cycle and purine and pyrimidine metabolism. It is bound to arginase of the liver and activates many enzymes.

Iodine (Potassium Iodide)

Iodine is an essential constituent of the thyroid hormones.

Chromium (Chromium Amino Acid Chelate 10%)

Chromium is an essential trace element involved in carbohydrate metabolism.

Molybdenum (Sodium Molybdate)

Molybdenum is an essential trace element although there have been no reports of deficiency states in man. Molybdenum salts have been used to treat copper poisoning in sheep.

5.2 Pharmacokinetic Properties

The following account describes the absorption and fate of each of the active constituents of Forceval Capsules.

Vitamin A

Except when liver function is impaired, Vitamin A is readily absorbed. β

Vitamin D

The metabolism of ergocalciferol is similar to that of cholecalciferol. Cholecalciferol is absorbed from the gastro-intestinal tract into the circulation. In the liver, it is hydroxylated to 25-hydroxycholecalciferol, is subject to entero-hepatic circulation and is further hydroxylated to 1,25

Vitamin B₁ (Thiamine)

Thiamine is absorbed from the gastro-intestinal tract and is widely distributed to most body tissues. Amounts in excess of the body's requirements are not stored but excreted in the urine as unchanged thiamine or its metabolites.

Vitamin B₂ (Riboflavine)

Riboflavine is absorbed from the gastro-intestinal tract and in the circulation is bound to plasma proteins. It is widely distributed. Little is stored and excess amounts are excreted in the urine. In the body riboflavine is converted to flavine mononucleotide (FMN) and then to flavine adenine dinucleotide (FAD).

Vitamin B₆ (Pyridoxine)

Pyridoxine is absorbed from the gastro-intestinal tract and converted to the active pyridoxal phosphate which is bound to plasma proteins. It is excreted in the urine as 4

Vitamin B₁₂ (Cyanocobalamin)

Cyanocobalamin is absorbed from the gastro-intestinal tract and is extensively bound to specific plasma proteins. A study with labelled Vitamin B₁₂ showed it was quickly taken up by the intestinal mucosa and held there for 2

Vitamin C (Ascorbic Acid)

Ascorbic acid is readily absorbed from the gastro-intestinal tract and is widely distributed in the body tissues. Ascorbic acid in excess of the body's needs is rapidly eliminated in the urine and this elimination is usually accompanied by a mild diuresis.

Vitamin E

Vitamin E is absorbed from the gastro-intestinal tract. Most appears in the lymph and is then widely distributed to all tissues. Most of a dose is slowly excreted in the bile and the remainder is eliminated in the urine as glucuronides of tocopheronic acid or other metabolites.

Nicotinamide (Nicotinic Acid Amide)

Nicotinic acid is absorbed from the gastro-intestinal tract, is widely distributed in the body tissues and has a short half-life.

Calcium (Dicalcium Phosphate)

A third of ingested calcium is absorbed from the small intestine. Absorption of calcium decreases with age.

Phosphorus (Dicalcium Phosphate)

The body contains from 600 - 800 g of phosphorus, over 80% of which is present in the bone as phosphate salts, mainly hydroxyapatite crystals. The phosphate in these crystals is available for exchange with phosphate ions in the extra-cellular fluids.

Calcium Pantothenate

Pantothenic acid is readily absorbed from the gastro-intestinal tract and is widely distributed in the body tissues. About 70% of pantothenic acid is excreted unchanged in the urine and about 30% in the faeces.

Folic Acid

Folic acid is absorbed mainly from the proximal part of the small intestine. Folate polyglutamates are considered to be deconjugated to monoglutamates during absorption. Folic acid rapidly appears in the blood where it is extensively bound to plasma proteins. Some folic acid is distributed in body tissues, some is excreted as folate in the urine and some is stored in the liver as folate.

Vitamin H (d-Biotin)

Following absorption, biotin is stored in the liver, kidney and pancreas.

Selenium

Although it has been established that selenium is essential to human life, very little information is available on its function and metabolism.

Ferrous Fumarate (Iron)

Iron is absorbed chiefly in the duodenum and jejunum. Absorption is aided by the acid secretion of the stomach and if the iron is in the ferrous state as in ferrous fumarate. In conditions of iron deficiency, absorption is increased and, conversely, it is decreased in iron overload. Iron is stored as ferritin.

Copper Sulphate (Copper)

Copper is absorbed from the gastro-intestinal tract and its major route of excretion is in the bile.

Magnesium Oxide (Magnesium)

Magnesium salts are poorly absorbed from the gastro-intestinal tract; however, sufficient magnesium will normally be absorbed to replace deficiency states. Magnesium is excreted in both the urine and the faeces but excretion is reduced in deficiency states.

Potassium Sulphate (Potassium)

Potassium salts are absorbed from the gastro-intestinal tract. Potassium is excreted in the urine, the faeces and in perspiration. Urinary excretion of potassium continues even when intake is low.

Zinc Sulphate (Zinc)

Zinc is poorly absorbed from the gastro-intestinal tract. It is widely distributed throughout the body. It is excreted in the faeces with traces appearing in the urine.

Manganese Sulphate (Manganese)

Manganese salts are poorly absorbed.

Potassium Iodide (Iodine)

Iodides are absorbed and stored in the thyroid gland as thyroglobulin. Iodides are excreted in the urine with smaller amounts appearing in the faeces, saliva and sweat.

Chromium Amino Acid Chelate 10% (Chromium)

Although it has been established that chromium is essential to human life, little information is available on its function and metabolism.

Sodium Molybdate (Molybdenum)

Although it has been established that molybdenum is essential to human life, little information is available on its function and metabolism.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Soya Bean Oil	BP
Soya Lecithin	HSE
Hard Vegetable Fat (Biscuitine 621)	HSE
Yellow Beeswax	BP
Purified Water	PhEur
Gelatin	BP
Glycerine	BP
Ponceau 4R (E124)	HSE
Amaranth (E123)	HSE
Titanium Dioxide (E171)	BP
Red Iron Oxide Paste (E172)	HSE
Vegetable Black Paste (E153)	HSE

6.2 Incompatibilities

No major incompatibilities are known.

6.3 Shelf Life

24 months, as packaged for sale.

6.4 Special Precautions For Storage

Store in a cool dry place at a temperature not exceeding 25°C.

Protect from light.

6.5 Nature And Contents Of Container

The product is presented in press-thru blister packs, each blister strip containing 15 Forceval capsules. The blister strip is composed of PVC/PVdC with a printed aluminium foil lidding. The foil is printed (red on gold) with the name and PL number of the product, the number of vitamins and minerals per capsule and the daily dose.

The product is available in packs of 15, 30, 45 or 90 capsules.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

2 Bath Road

Chippenham

Wiltshire

SN15 2BB

United Kingdom

8. Marketing Authorisation Number(S)

PL 16853/0079

9. Date Of First Authorisation/Renewal Of The Authorisation

30/11/2005

10. Date Of Revision Of The Text

14/02/2007