Zolico 400 micrograms tablets

Package leaflet: Information for the user

Introduction

Package leaflet: patient information

Zolico 400 micrograms tablets

folic acid

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Zolico is and what it is used for
2. What you need to know before taking Zolico
3. How to take Zolico
4. Possible side effects
5. How to store Zolico
6. Contents of the pack and other information

1. What Zolico is and what it is used for

Zolico contains the active substance sodium fusidate, a type of antibiotic known as a fusidic acid derivative. It is used to treat skin infections caused by bacteria that are sensitive to fusidic acid. Zolico works by stopping the growth of bacteria, helping the body's immune system to eliminate the infection. It is available as a cream for topical application on the skin.

Zolico tablets, 400 micrograms of folic acid 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 planning a pregnancy and during the first trimester of pregnancy.

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

Do not take Zolico

• If you are allergic to the active substance or to any of the other ingredients of this medicine (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 so that vitamin B12 deficiency anaemia can be ruled out.

Other medicines and Zolico

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

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

Your requirement for folic acid may increase if you are taking any of these medicines.

Taking Zolico with food and drinks

No incompatibilities have been reported between Zolico and food or drinks.

Pregnancy and breastfeeding

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

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

Driving and using machines

No effects on the ability to drive vehicles or operate machinery have been reported.

Zolico contains lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium per tablet; this is, essentially “sodium-free”.

3. How to take Zolico

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

This dose may be increased to 2 tablets (800 micrograms of folic acid) daily when conditions exist that increase requirements.

If you take more Zolico than you should

Do not take a higher daily amount of Zolico than prescribed for you 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, contact your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

However, Zolico is well tolerated by the body at usual doses, and there is no risk of acute, chronic, or accidental intoxication. Much higher doses of folic acid than those contained in this medicine are well tolerated, so even massive accidental ingestion is not likely to cause poisoning.

If you forget to take Zolico

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

If you stop taking 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 symptoms that are bothersome, consult your doctor for further advice.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them. Hypersensitivity reactions (fever, skin rash) to one of the components may exceptionally occur, and anaphylactic reaction (severe allergic reaction) with unknown frequency may also occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolico

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging, following CAD. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any deterioration in its contents.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zolico

The active substance 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) (from potato), magnesium stearate, lactose monohydrate and microcrystalline cellulose.

Appearance of the medicinal product and contents of the pack

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 responsible for production

Italfarmaco S.P.A.

Viale Fulvio Testi, 330

20126 Milan, Italy

For further information about this medicinal product, please contact 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 most recent review of this leaflet: April 2018

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