In this leaflet:

1. What Zolico 400 is and what is it used for
2. Before you take Zolico 400
3. How to take Zolico 400
4. Possible side effects
5. Storing Zolico 400

Zolico 400 tablets
Folic acid (INN)

Each tablet contains 400 micrograms of folic acid (INN) as active substance. The other ingredients are type A sodium carboxymethyl starch, magnesium stearate, lactose monohydrate and microcrystalline cellulose.

Marketing Authorisation Holder:
ITALFARMACO, S.A.
C. San Rafael, 3
28108 Alcobendas (Madrid)

Manufacturer:
ITALFARMACO S.P.A.
Viale Fulvio Testi, 330
20126 Milan (ITALY)

1. WHAT Zolico 400 IS AND WHAT IT IS USED FOR
• Zolico 400 are tablets of 400 micrograms of folic acid in a container of 28 tablets
• Zolico 400 is indicated in the prophylaxis of defects in the neural tube (spina bifida, anencephaly, encephalocele) and other congenital defects in women planning a pregnancy, and during the first quarter of it.

2. BEFORE YOU TAKE Zolico 400
If you take more than 1 mg/day of folic acid, see your doctor to rule out vitamin B12 deficiency anaemia.
Do not take Zolico 400
If you know you are allergic to any of the ingredients of ZOLICO 400.
Pregnancy
Zolico 400 is indicated in the prevention of folic acid deficiencies before and during pregnancy as prophylaxis for congenital defects. Nevertheless, if you are pregnant or believe you might be, see your doctor or pharmacist before taking a medicine.
Lactation
Taking Zolico 400 is compatible with breast-feeding, but check with your doctor or pharmacist before taking a medicine.
Driving and using machines
No effects have been described on the ability to drive or use machines.
Taking other medicines:
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those not prescribed.

Zolico 400 may interact with folic acid antagonists (methotrexate, trimethoprim), antiepileptics, estrogens, sulfamides, corticosteroids (prolonged use) and alcohol.
The need for folic acid may increase if you are taking any of these medicines

3. HOW TO TAKE Zolico 400
Follow these instructions unless told to do otherwise by your doctor.
Remember to take your medicine. Your doctor will tell you the duration of your treatment with Zolico 400. Do not interrupt the treatment before that, since it will not have the expected efficacy.
If you have the impression that the effect of Zolico 400 is too strong or too weak, talk to your doctor or pharmacist.
The posology of Zolico 400 must be titrated by a doctor.
Zolico 400 is taken orally, preferably before meals:
One tablet (400 micrograms of folic acid) once a day, beginning at least one month before gestation, with treatment continuing through the first quarter of pregnancy.
This dose may be increased to 2 tablets (800 micrograms of folic acid) daily if needs increase.

If you take more Zolico 400 than you should
If you have taken more Zolico 400 than you should, consult your doctor or pharmacist immediately.
In case of overdose or accidental intake, call the Toxicological Information Service. Tel.: 91 562 04 20.
Nevertheless, Zolico 400, at the usual doses, is well tolerated by the organism, there being no possibility of acute, chronic or accidental overdose. Doses of folic acid much higher than this medicine are well tolerated, whereby there is no need for fear of overdose, even by massive accidental overdose.

If you forgot to take Zolico 400
Do not take a double dose to make up for the doses you forgot to take.

4. POSSIBLE SIDE EFFECTS
Like with all medicines, Zolico 400 can have side effects.
Exceptionally, hypersensitivity reactions to some of the ingredients may appear (fever, skin rash).
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING Zolico 400
Keep Zolico 400 out of the reach and sight of children.
Dispose of the product after use. Do not reuse.
Do not store above 30ºC.

Expiry
Do not use Zolico 400 after the expiry date indicated on the container.

This leaflet was revised in May 2003.

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