Acid folic-BP

Acidum folicum

Acid Folic-BP 5 mg tablets: each tablet contains folic acid 5 mg; Acid Folic-BP 1 mg tablets: each tablet contains folic acid 1 mg. Excipient with known effect: lactose monohydrate (87.50 mg and 91.50 mg per tablet, respectively).

Indication: Treatment and prevention of anaemias caused by folic acid deficiency (including megaloblastic anaemia and anaemias induced by drugs/ionising radiation), prevention of folate deficiency during long-term treatment with folic acid antagonists, in chronic haemolytic states or renal dialysis, prevention of foetal neural tube defects, and treatment/prevention of folic acid deficiency during pregnancy, breastfeeding and the postpartum period; treatment of polyneuritis and polyneuropathies.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. − Untreated cobalamin (vitamin B12) deficiency. − Malignant anaemias. − Malignant tumours. This medicine is not recommended for children under 6 years of age due to the unsuitable pharmaceutical form.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Long-term treatment with folic acid is contraindicated in any patient with untreated cobalamin (vitamin B12) deficiency (see section 4.3). The deficiency may be caused by undiagnosed megaloblastic anaemia, including in childhood, pernicious anaemia, or macrocytic anaemia of unknown aetiology. There are other causes of cobalamin deficiency, including lifelong vegetarianism. In elderly patients, a cobalamin absorption test should be performed before starting long-term folic acid treatment. Folates administered to such patients for 3 months or longer have caused cobalaminic neuropathy. No risk has been recorded with short-term folic acid treatment. Folic acid must never be given as monotherapy in the treatment of Addisonian pernicious anaemia and other deficiencies […]