Prospecto: information for the patient

Zolico 400 micrograms tablets

folic acid

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Zolico and what it is used for

2.What you need to know before starting to take Zolico

3.How to take Zolico

4.Possible adverse effects

5.Storage of Zolico

6.Contents of the package and additional information

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

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

Do not take Zolico

• If you are allergic to the active ingredient or to 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

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

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

Your folic acid needs may increase if you are taking any of those medications.

Taking Zolico with food and drinks

No incompatibilities of taking Zolico with food and drinks have been described.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

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

Zolico contains lactose.

This medication contains lactose. If your doctor has indicated 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".

Follow exactly the administration instructions for this medication 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 pregnancy and continuing treatment during the first trimester of pregnancy.

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

If you take more Zolico than you should

Do not take more than the daily dose of Zolico that your doctor has prescribed.

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 Toxicological 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 possibility of acute, chronic, or accidental poisoning. Very high doses of folic acid above those of this medication are well tolerated, so poisoning is not to be feared, even in case of massive accidental ingestion.

If you forgot to take Zolico

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Zolico

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

Your doctor will advise you on how to gradually discontinue treatment with Zolico.

If you experience any symptom that bothers you, consult your doctor for further advice.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them. Exceptionally, hypersensitivity reactions (fever, skin rash) to one of the components and an unknown severe allergic reaction (anaphylactic reaction) may appear.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directlythrough the Spanish System of Pharmacovigilance of human use medicines:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 86°F (30°C).

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGREcollection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

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 carboxymethylcellulose (type A) (from potato), magnesium stearate, lactose monohydrate, and microcrystalline cellulose.

Appearance of the product and contents of the packaging

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

Phone: 91 657 23 23

Responsible for Manufacturing

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

Phone: 91 657 23 23

Last review date of this leaflet: April 2018

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.