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PACKAGE LEAFLET: INFORMATION FOR THE USER
FOLIDEX 400 microgram tablets
folic acid
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4..
In this leaflet:
1. What Folidex is and what it is used for.
2. What you need to know before you use Folidex.
3. How to use Folidex.
4. Possible side effects.
5 How to store Folidex.
6 Contents of the pack and other information.
1. What Folidex is and what it is used for
Folic acid is a vitamin and is needed to make new cells in the body. You need a regular fresh supply
of folic acid to keep healthy. In particular women who are planning a pregnancy and pregnant
women need a good supply of folic acid which is used by the developing baby.
Folidex is useful in helping to prevent babies being born with neural tubes defects e.g. Spina Bifida
(rare malformation involving the caudal part of spine, which can lead to herniation of the spinal
cord, bowel and urinary incontinence and deficit of motility and sensitivity of inferior limbs).
2. What you need to know before you use Folidex
Do not take Folidex
If you are allergic to folic acid or to any of the other ingredients of Folidex
If you have cancer
Warnings and precautions
 If you are a woman who have previously given birth to a baby (or aborted a foetus) with a
neural tube defects;
 If you are a woman under treatment with antiepileptics: carbamazepine or valproic acid;
 If you have familial occurrence of neural tube defects;
 If you are a woman treated with folic acid antagonists (methotrexate, sulphasalazine);
 If you have pernicious anaemia, since folic acid may obscure the diagnosis by alleviating
hematologic manifestations of the disease, while allowing neurologic complications to
progress.
In all the above situations you should take a dose of folic acid higher than the one contained in a
tablet of Folidex .
Other medicines and Folidex
Please tell your doctor if you are taking or have recently taken any of the following medicines:
antiepileptics, antagonists of folic acid (methotrexate, sulphasalazine) and chloramphenicol.
Folidex contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product
Folidex does not contain gluten, therefore it is not contraindicated for patients affected by celiac
disease.
3. How to take Folidex
Always take Folidex exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The usual dose is one tablet daily from the time you start trying to become pregnant and continue
until twelfth week of pregnancy. You should take it at regular time before meals.
The dose is not adequate if you are a woman who have previously given birth to a baby with a
neural tube defects
If you take more Folidex than you should
Even far higher doses than those contained in Folidex are unlikely to cause you any harm.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, Folidex can cause side effects, although not everybody gets them.
The most common side effects, even if they occur rarely (likely to affect up to 1 in every 1000
people), are allergic reactions: erythema, itching, urticaria.
With higher doses than those contained in Folidex you could have gastrointestinal disorders
(nausea, abdominal disorders, flatulence), irritability and insomnia.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in Appendix V. By
reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Folidex
Do not store above 30° C.
Store in the original container to protect from moisture.
Keep out of the sight and reach of children.
Do not take Folidex after the expire date which is stated on the carton box after "exp".The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Folidex contains
The active substance is Folic acid, 400 micrograms per tablet
The other ingredients are: Lactose monohydrate, cellulose microcrystalline, sodium starch glycolate
(Type A), magnesium stearate.
What Folidex looks like and contents of pack
Tablets have a round shape and are yellow.
Carton box containing 28 tablets in one blister or 120 tablets in 4 blister of 30 tablets each.
Marketing Authorisation Holder and Manufacturer
ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milano.
Tel. + 39 02 64431
Fax. + 39 02644346
e-mail: [email protected]
This leaflet was last revised in :