Monday, October 17, 2016

Folicare 0.4mg / 5ml Oral Solution






Folicare 0.4mg/5ml Oral Solution



folic acid


  • Read all of this leaflet carefully before you start taking this medicine.

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

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

  • This medicine has been prescribed only 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 these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet


  • 1. What Folicare is and what it is used for

  • 2. Before you take Folicare

  • 3. How to take Folicare

  • 4. Possible side effects

  • 5. How to store Folicare

  • 6. Further information




What Folicare is and what it is used for


The name of your medicine is Folicare 0.4mg/5ml Oral Solution (called Folicare in this leaflet). It contains folic acid. This belongs to a group of vitamins called ‘B vitamins’.


Folicare is used to help prevent babies being born with Neural Tube Defects such as Spina Bifida.


  • You should use this medicine if you are trying to become pregnant and also during the first three months of your pregnancy.

  • You should also use this when you know you are pregnant or you think you are pregnant and continue to use it
    for the first three months of your pregnancy.



Before you take Folicare



Do not take Folicare and tell your doctor if:


  • You are allergic (hypersensitive) to folic acid or any other ingredients in this liquid (listed in Section 6)
    Signs of an allergic reaction include a rash, itching or shortness of breath

  • You have a tumour or cancer

If any of the above apply to you, do not take this medicine and talk to your doctor.




Take special care with Folicare


Before you take Folicare, tell your doctor if:


  • You have been told that you have something called ‘pernicious anaemia’ or a ‘vitamin B12 deficiency’.



Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Folicare can affect the way some other medicines work. Also, some medicines can affect the way Folicare works.


In particular, tell your doctor if you are taking any of the following:


  • Medicines for epilepsy and fits such as phenytoin or primidone. Your doctor may need to change the amount you
    are taking. This is because Folicare may make these medicines work less well.



Pregnancy and breast-feeding


Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.
If you are a woman and you are pregnant, this medicine is unlikely to cause any harm to you or your unborn child.




Driving and using machines


Folicare is not likely to affect you being able to drive or use any tools or machines.




Important information about what is in Folicare


This medicine contains methyl, ethyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This
allergy may happen some time after starting the medicine





How to take Folicare


Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if
you are not sure.



Taking this medicine


  • This medicine contains 0.4mg of folic acid in each 5ml

  • Take this medicine by mouth



Adults


  • Take one 5ml spoonful daily

  • Take this medicine whilst you are trying to become pregnant and up to the 12th week of pregnancy



If you take more Folicare than you should


There have been no cases of people taking an overdose with this medicine. However, if you think you have taken more than you should, talk to your doctor or go to a hospital straight away.




If you forget to take Folicare


If you forget a dose, take it as soon as you remember it.


However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose (two doses at the
same time) to make up for a forgotten dose.



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




Possible side effects


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



If you have an allergic reaction to Folicare see a doctor straight away



An allergic reaction may include:


  • Any kind of skin rash, flaking skin, boils or sore lips and mouth

  • Sudden wheezing, fluttering or tightness of the chest or collapse.



Tell your doctor if you get any of these side effects:


  • Feeling sick (nausea), being sick (vomiting) or an upset stomach.


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 Folicare


  • Keep out of the reach and sight of children

  • Do not store above 25°C

  • Take back to the pharmacy 1 month after opening.

  • Do not use after the expiry date which is stated on the label and carton (Exp: month, year)

  • The expiry date refers to the last day of that month

  • Do not use Folicare if you notice a change in the appearance or smell of the medicine. Talk to your pharmacist

  • 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 Folicare contains


  • The active ingredient is folic acid.

  • The other ingredients are mannitol (E421), glycerol (E422), methyl hydroxybenzoate (E218), ethyl hydroxybenzoate (E214), propyl hydroxybenzoate (E216), sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate (E339), strawberry flavour (containing propylene glycol (E1520)), di-sodium edetate and purified water



What Folicare looks like and contents of the pack


A pale yellow liquid with an odour of strawberry.


It comes in a brown glass bottle holding 150ml of solution.




Marketing Authorisation Holder and Manufacturer



Rosemont Pharmaceuticals Ltd

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK





This leaflet was last approved in December 2008.


P0428





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