Foli-doce 400/2 microgramos comprimidos

Leaflet: information for the user

Foli-doce400/2 microgram tablets

acid folic/cyanocobalamin (vitamin B12)

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Foli-doce

4. Possible side effects

5. Storage of Foli-doce

6. Contents of the pack and additional information

Foli-doce provides the daily recommended supplement of folic acid and vitamin B12in certain physiological situations such as pregnancy, for the prevention of neural tube defects (NTDs).

It is used for the prevention of folic acid and vitamin B12deficiency states, in fertile women who have planned a pregnancy, during one month before conception and three months after the same, as prophylaxis of neural tube defects.

Do not take Foli-doce

• If you are allergic to folic acid, vitamin B12, 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 Foli-doce.

Other medications and Foli-doce

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

Certain medications 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 essential to inform your doctor if you are taking or have taken recently any of the following medications:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

No effects have been observed on the ability to drive and operate machinery.

Foli-doce contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

The usual dose is 1 tablettaken orally, administered once a day beforemeals.

If you take more Foli-doce than you should

Very high doses of folic acid and vitamin B12beyond those of Foli-doce are well tolerated, so there is no need to fear poisoning even in the event of accidental ingestion. However, in the event of an overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, telephone 91562 0420, indicating the medication and the amount ingested.

If you forgot to take Foli-doce

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

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 to one of the components, and frequently unknown, severe allergic reaction (anaphylactic reaction).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.esBy 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 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.

Keep in a cool and dry place.

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

Composition of Foli-doce

• The active principles 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 components (excipients) are: sodium carboxymethylcellulose (type A) (from potato), microcrystalline cellulose, magnesium stearate, and lactose monohydrate.

Appearance of the product and contents of the packaging

The tablets are round and yellow in color.

Packaging containing 28 tablets.

Holder of the marketing authorization

ITF Abacus Farma, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Tel. 916572323

Responsible for manufacturing

ITALFARMACO SpA

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

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/.