ACIDE FOLIQUE CCD 0,4 mg Cpr Plq/30

Tablet (yellow).
Box of 30 or 90, blister packs.

For one tablet:

Folic acid: 0,4 mg

• Pregnancy: primary prevention of embryonic neural tube closure defects in women with no particular history who wish to conceive.
• Folic acid deficiency.

Dosage

The daily dosage is 1 tablet per day.

To be effective, prevention must be started 4 weeks before conception and continued 8 weeks after it.

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

Data on the use of low-dose folic acid (0.4 mg) during pregnancy are numerous and show no risk to the unborn child.

FOLIC ACID CCD 0.4 mg is indicated during pregnancy (see section Indications).

Breast-feeding

Folic acid is excreted in breast milk.

No adverse effects have been observed in breastfed infants whose mothers received folic acid. Breastfeeding is possible with FOLIC ACID CCD at 0.4 mg.

Fertility

Data available in humans with FOLIC ACID CCD 0.4 mg do not indicate any adverse impact on fertility.

• Very rare cases of cutaneous allergic reactions.
• Possibility of gastrointestinal disorders.
• Anaphylactic reactions such as urticaria and angioedema have been reported with an undetermined 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: FOLIC ACID-ANTIANEMIC, ATC code: B03BB01

(B. Blood and hematopoietic organs).

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, 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.

Non-clinical data from the literature have not revealed any particular risk for humans regarding safety pharmacology, repeated-dose toxicology, genotoxicity, and carcinogenesis.

3 years

Store in the original primary packaging, protected from light.