PACKAGE LEAFLET: INFORMATION FOR THE USER

FOLIDEX 400 micrograms tablets

folic acid
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. (See section 4)

Contents of this leaflet:

What Folidex is and what it is used for
What you need to know before taking Folidex
How to take Folidex
Possible side effects
How to store Folidex
Contents of the pack and other information

1. What Folidex is and what it is used for

Folic acid is a vitamin necessary for the renewal of the body's cells. You need a regular supply of folic acid to maintain your health.
In particular, women who are planning a pregnancy and pregnant women require an adequate intake of folic acid for the baby's development.
Folidex is useful in the prevention of neural tube defects such as Spina Bifida (a rare malformation of the caudal portion of the spinal column that may lead to herniation of the spinal cord, fecal and urinary incontinence, and motor and sensory deficits in the lower limbs).

2. What you should know before taking Folidex

Do not take Folidex
If you are allergic to folic acid or to any of the other ingredients of this
medicinal product (listed in section 6).
If you have a tumour that is influenced by folic acid intake (folate-
dependent tumour).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Folidex if:

you are a woman who has previously had pregnancies (completed or not) in which neural tube defects were observed;
you are a woman undergoing treatment with antiepileptic drugs: carbamazepine or valproic acid;
you are a woman with a family history of neural tube defects;
you are a woman undergoing treatment with folic acid antagonists (methotrexate, sulfasalazine);
you suffer from pernicious anaemia. Indeed, folic acid may make diagnosis of pernicious anaemia more difficult by reducing its haematological manifestations, but it cannot counteract the progression of its neurological complications.

In all these cases, you may need to take a dose of folic acid higher than that
contained in one tablet of Folidex.

Other medicines and Folidex
Inform your doctor or pharmacist if you are taking, have recently taken, or might
take any of the following medicines: antiepileptics, folic acid antagonists
(methotrexate, sulfasalazine), and chloramphenicol.

Folidex contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before
taking Folidex.

Folidex contains sodium
This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially 'sodium-free'.

3. How to take Folidex

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily, starting from when pregnancy is planned up to the 12th week of gestation.
The tablet should be taken regularly before meals.
This dose is not sufficient if you have previously had pregnancies in which neural tube defects were observed.
If you take more Folidex than you should
Even doses much higher than those contained in Folidex are not expected to cause harm to health.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects, which however occur rarely (occurring in more than 1 patient out of 10,000 but less than 1 in 1,000), are allergic reactions: erythema, pruritus, and urticaria.
Frequency not known (frequency cannot be estimated from the available data):
severe allergic reaction (anaphylactic reaction).
At doses higher than those contained in Folidex, gastrointestinal disturbances (nausea, abdominal discomfort, flatulence), irritability, and insomnia may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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.
Keep in the original container to protect the product from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation “Exp.”. The expiry date refers to the last day of the month indicated.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Folidex contains

The active substance is folic acid monohydrate. Each tablet contains folic acid monohydrate equivalent to 400 micrograms of anhydrous folic acid.
The excipients are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylamidone (type A), magnesium stearate.

Description of the appearance of Folidex and package contents
The tablets are biconvex in shape and yellow in colour. A package contains 28 tablets in blister packs, 90 tablets in 3 blisters, or 120 tablets in four blisters of 30 tablets each.

Marketing Authorization Holder and Manufacturer
ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milan, Italy

This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Italy FOLIDEX 400 micrograms tablets
Greece FOLIDEX 400 μικρογραμμάρια δισκία
France FERTIFOL 400 microgrammes, comprimé
Portugal FOLIDEX 400 microgramas comprimidos