ACIDE FOLIQUE CCD 5 mg Cpr Plq/20

Tablet.
Box of 20 or of 90, in thermoformed blister packs.

For one tablet:

Folic acid: 5 mg

Macrocytic anaemias due to folic acid deficiency.

Chronic disorders of intestinal absorption, whatever their origin.

Dietary deficiency: malnutrition, alcoholism.

Pregnancy: in case of proven deficiency. In women who have already had children with neural tube closure abnormalities (spina bifida), some authors have observed that periconceptional folic acid supplementation of 5 mg per day in the month preceding and the 3 months following conception reduced the recurrence of the malformation risk for subsequent pregnancies.

Nevertheless, antenatal diagnosis to screen for this type of malformation remains essential.

Dosage

Daily dosages range between 5 and 15 mg, i.e. 1 to 3 tablet(s) per day.

Pregnancy, in case of proven deficiency: see section Indications.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

Associations requiring precautions for use

+ Phenobarbital, phenytoin, primidone:

Decrease in plasma concentrations of enzyme-inducing anticonvulsants, due to increased hepatic metabolism of them, for which folates are one of the cofactors.

Clinical monitoring, possibly of plasma levels, and adjustment, if necessary, of the antiepileptic dosage during folic acid supplementation and after its discontinuation.

Pregnancy

There are no known dangers in using folic acid during pregnancy. Folic acid supplementation is often beneficial.

A deficiency of folates, or an abnormal folate metabolism, induced by drug products is linked to the occurrence of defects in newborns and certain neural tube closure abnormalities.

Concomitant administration, early in pregnancy, of certain medicines inducing a disturbance of folic acid metabolism or folate deficiency (such as anticonvulsants or certain antineoplastics) may cause congenital abnormalities.

A lack of folic acid (vitamin B9) or of its metabolites may also be responsible for certain cases of spontaneous abortion or intrauterine growth retardation.

Breast-feeding

Folic acid is excreted in breast milk. Folate accumulates in breast milk when folic acid intake during pregnancy exceeds the mother's needs.

The concentration of folic acid is relatively low in colostrum. The concentration of folic acid is higher in breast milk.

No adverse effects have been observed in infants who were breastfed by a mother who received folic acid supplementation during pregnancy.

Very rare cases of cutaneous allergic reactions.

Possibility of gastrointestinal disorders.

Anaphylactic reactions such as urticaria and angioedema have been reported with an indeterminate frequency.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

Excessive intake of folic acid is followed by an increase in urinary elimination.

Pharmacotherapeutic class: Anti-anaemic preparation, ATC code: B03BB01

Folic acid is a vitamin of the B group. Its active metabolites serve as coenzymes for many enzymatic reactions involved in the synthesis of purines and the metabolism of amino acids.

Absorption

Folic acid is rapidly absorbed (5 to 20 minutes), the serum peak is observed 1 to 2 hours after absorption.

Distribution

It diffuses into all tissues and body fluids, it concentrates in the CSF and is stored in the liver. The mean serum level is 5 to 12 ng/mL.

Elimination

It is excreted in urine and feces.

3 years

Store at a temperature not exceeding +25 °C and protected from light.