ZOLICO 400 micrograms tablets

Zolico is a 400 microgram folic acid tablet in a pack of 28 tablets.

Zolico is indicated for the prophylaxis of neural tube defects (spina bifida, anencephaly, encephalocele) and other congenital defects in women who are planning a pregnancy and during the first trimester of pregnancy.

2. What you need to know before taking Zolico

Do not take Zolico

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zolico.

If you need to take more than 1 mg/day of folic acid, consult your doctor to rule out a vitamin B12 deficiency anemia.

Other medications and Zolico

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Zolico may interact with folic acid antagonists (methotrexate, trimethoprim), antiepileptics, estrogens, sulfonamides, corticosteroids (prolonged use), and alcohol.

The need for folic acid may increase if you are taking any of these medications.

Taking Zolico with food and drinks

No incompatibilities have been described between taking Zolico and food or drinks.

Pregnancy and breastfeeding

Zolico is indicated for the prevention of folic acid deficiencies before and during pregnancy, as prophylaxis for congenital defects. However, if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Taking Zolico is compatible with breastfeeding, but you should consult your doctor or pharmacist before taking this medication.

Driving and using machines

No effects on the ability to drive vehicles or use machinery have been described.

Zolico contains lactose.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium per tablet; it is essentially "sodium-free".

3. How to take Zolico

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet (400 micrograms of folic acid) once a day, starting at least one month before conception and continuing treatment during the first trimester of pregnancy.

This dose may be increased to 2 tablets (800 micrograms of folic acid) daily when there are conditions that increase the need.

If you take more Zolico than you should

Do not take more than the prescribed daily dose of Zolico in one day.

If you have taken more Zolico than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

However, Zolico, at usual doses, is well tolerated by the body, and there is no risk of acute, chronic, or accidental intoxication. Very high doses of folic acid, higher than those of this medication, are well tolerated, so there is no risk of intoxication even with massive accidental ingestion.

If you forget to take Zolico

Do not take a double dose to make up for forgotten doses.

If you stop taking Zolico

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better.

Your doctor will advise you on how to gradually stop taking Zolico.

If you experience any symptoms that bother you, consult your doctor for further advice.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. Exceptionally, hypersensitivity reactions (fever, skin rash) to any of the components may occur, and with unknown frequency, severe allergic reactions (anaphylactic reaction) may occur.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Zolico

Keep this medication out of the sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice any deterioration of its contents.

Medications should not be thrown away in drains or trash. Deposit the packaging and unused medications at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Zolico

The active ingredient is folic acid. Each tablet contains 400 micrograms of folic acid (as folic acid hydrate).

The other components (excipients) are: sodium carboxymethyl starch (type A) (potato), magnesium stearate, lactose monohydrate, and microcrystalline cellulose.

Appearance of the product and package contents

Round, smooth, yellow tablets

Zolico is available in blisters of 28 tablets

Marketing authorization holder

Versalya Pharma, S.L

C/ San Rafael, 3

28108 Alcobendas, Madrid, Spain

Tel.: 91 657 23 23

Manufacturer

Italfarmaco S.P.A.

Viale Fulvio Testi, 330.

20126 Milan, Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Italfarmaco S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid, Spain

Tel.: 91 657 23 23

Date of the last revision of this leaflet: April 2018

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.