FOLI-DOCE 400/2 micrograms tablets

Introduction

Package Leaflet: Information for the User

Foli-doce400/2 micrograms tablets

folic acid/cyanocobalamin (vitamin B12)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Foli-doce and what is it used for

Foli-doce provides the daily recommended supplement of folic acid and vitamin B12 in certain physiological situations such as pregnancy, for the prevention of neural tube defects (NTDs).

It is used for the prevention of deficiency states of folic acid and vitamin B12, in women of childbearing age who have planned a pregnancy, one month before conception and three months after, as prophylaxis of neural tube defects.

2. What you need to know before you take Foli-doce

Do not take Foli-doce

• If you are allergic to folic acid, vitamin B12 or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before you start taking Foli-doce.

Other medicines and Foli-doce

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

Certain medicines may interfere with Foli-doce; in these cases, it may be necessary to change the dose, interrupt treatment with one of them, or wait at least 3 hours between administration of both.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Anti-ulcer medicines such as cimetidine, omeprazole, and ranitidine, and antacids with magnesium and/or aluminum salts (medicines for gastric acidity). It is recommended to take Foli-doce 2 or 3 hours before this type of medication.
• Chloramphenicol (antibiotic).
• Phenytoin, phenobarbital, primidone (medicines for seizures)
• Folic acid antagonists (methotrexate, a medicine used in rheumatoid arthritis and in the treatment of some cancers).
• Fluorouracil (a medicine for cancer).
• Cholestyramine or colestipol (a medicine to reduce cholesterol levels in the blood).
• Other possible interactions: antiepileptics (valproic acid, carbamazepine), estrogens (oral contraceptives), prolonged use of corticosteroids, trimethoprim/sulfamethoxazole combination (treatment for certain infections), antimalarials, antituberculars, and alcohol abuse.
• Sulfasalazine (used for the treatment of inflammatory bowel diseases, such as ulcerative colitis).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Foli-doce is indicated in the prevention of folic acid and vitamin B12 deficiencies before and during pregnancy. However, consult your doctor or pharmacist before taking this medicine.

Both vitamin B12 and folic acid cross the placenta, although without adverse effects on the fetus. When eliminated, they reach breast milk, although no related problems have been described.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Foli-doce contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Foli-doce

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The normal dose is 1 tablet orally, administered once a day before meals.

If you take more Foli-doce than you should

Very high doses of folic acid and vitamin B12, higher than those of Foli-doce, are well tolerated, so there is no fear of intoxication even with massive accidental ingestion. However, in case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone 915620420, indicating the medicine and the amount ingested.

If you forget to take Foli-doce

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Exceptionally, hypersensitivity reactions to any of the components, and with unknown frequency, severe allergic reaction (anaphylactic reaction).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Foli-doce

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

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

Store in a cool and dry place.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Foli-doce

• The active substances are: folic acid and cyanocobalamin (vitamin B12). Each tablet contains 400 micrograms of folic acid (as folic acid hydrate) and 2 micrograms of vitamin B12.
• The other ingredients (excipients) are: sodium carboxymethyl starch (type A) (potato), microcrystalline cellulose, magnesium stearate, and lactose monohydrate.

Appearance and packaging

The tablets are round and yellow in color.

Container with 28 tablets.

Marketing authorisation holder

ITF Abacus Farma, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Tel. 916572323

Manufacturer

ITALFARMACO SpA

Viale Fulvio Testi 330

20126 Milan

Italy

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Italfarmaco, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Date of last revision of this leaflet:April 2018

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