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