Foli-Doce 400/2 micrograms tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Foli-doce 400/2 microgram tablets
folic acid/cyanocobalamin (vitamin B12)
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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, 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
- What Foli-doce is and what it is used for
- What you need to know before taking Foli-doce
- How to take Foli-doce
- Possible side effects
- How to store Foli-doce
- Contents of the pack and other information
1. What Foli-doce is and what it is used for
Foli-doce provides the recommended daily intake of folic acid and vitamin B12 in certain physiological situations such as pregnancy, for the prevention of neural tube defects (NTDs).
It is used to prevent folic acid and vitamin B12 deficiency states in women of childbearing age who have planned a pregnancy, starting one month before conception and continuing for three months afterwards, as prophylaxis against neural tube defects.
2. What you need to know before starting to take Foli-doce
Do not take Foli-doce
- If you are allergic to folic acid, vitamin B12, or any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Foli-doce.
Other medicines and Foli-doce
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interfere with Foli-doce; in such cases it may be necessary to adjust the dose, interrupt treatment with one of the medicines, or wait at least 3 hours between administrations.
It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:
- Antiulcer agents such as cimetidine, omeprazole, and ranitidine, and antacids containing magnesium and/or aluminium salts (medicines for gastric acidity). It is recommended to take Foli-doce 2 or 3 hours before taking these medications.
- Chloramphenicol (an antibiotic).
- -Phenytoin, phenobarbital, primidone (medicines for seizures).
- Folic acid antagonists (methotrexate, a medicine used in rheumatoid arthritis and in the treatment of certain cancers).
- Fluorouracil (a medicine for cancer).
- Cholestyramine or colestipol (medicines 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 agents, 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Foli-doce is indicated for the prevention of folic acid and vitamin B12 deficiencies before and during pregnancy. Nevertheless, consult your doctor or pharmacist before using this medicine.
Both vitamin B12 and folic acid cross the placenta, but without adverse effects on the fetus. Both are excreted into breast milk, although no related problems have been reported.
Driving and use of machines
No effects on the ability to drive or operate machinery have been observed.
Foli-doce contains lactose and sodium
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 (1 mmol) per tablet; hence, it is essentially “sodium-free”.
3. How to take Foli-doce
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
The usual dose is 1 tablet taken orally once daily before meals.
If you take more Foli-doce than you should
Very high doses of folic acid and vitamin B12, exceeding those in Foli-doce, are well tolerated, so poisoning is not expected even after accidental massive ingestion. However, in case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91562 0420, indicating the medicine and the amount ingested.
If you forget to take Foli-doce
Do not take a double dose to make up for missed doses.
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.
Exceptionally, hypersensitivity reactions to one of the components, and with unknown frequency, severe allergic reaction (anaphylactic reaction).
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 may 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. Foli-doce Storage
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.
Store in a cool, dry place.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This helps protect the environment.
6. Contents of the package 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 components (excipients) are: sodium carboxymethyl starch (type A) (from potato), microcrystalline cellulose, magnesium stearate and monohydrate lactose.
Appearance of the product and contents of the package
The tablets are round and yellow in colour.
Pack containing 28 tablets.
Marketing Authorization 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
Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:
Italfarmaco, S.A.
C/ San Rafael, 3
28108 Alcobendas, Madrid
Spain
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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.