FOLICIL Tablet Ref.[28307] Active ingredients: Folic acid

Revision Year: 2018  Publisher: BIAL Portela & Cยช, S.A., ร€ Av. da Siderurgia Nacional, 4745-457 S.Mamede do Coronado Portugal

4.3. Contraindications

Hypersensitivity to folic acid or to any excipient.

4.4. Special warnings and precautions for use

Folic acid should not be administered in cases of anaemia of unknown etiology, since folic acid may mask pernicious anaemia.

FOLICIL contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5. Interaction with other medicinal products and other forms of interaction

Chloramphenicol: The concurrent administration of folic acid and chloramphenicol in folate-deficient patients may result in antagonism of the hematopoietic response to folic acid.

Phenytoin: In epileptic patients undergoing therapy with phenytoin, medicines containing folic acid may increase phenytoin metabolism, reduce its serum concentrations and increase seizure frequency.

4.6. Pregnancy and lactation

Folic acid can safely be used in pregnancy and lactation. Folic acid deficiency in such situations may occur and therefore prophylaxis with FOLICIL is indicated.

4.7. Effects on ability to drive and use machines

Folic acid has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare (>1/10,000, <1/1,000); Very rare (<1/10,000), including isolated reports; Not known (cannot be estimated from the available data).

Immune system disorders

Rare: Hypersensitivity reactions, appearing as erythema, fever, itching or bronchospasm.

Not known: Anaphylactic reaction.

6.2. Incompatibilities

Not applicable.

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