ACIDE FOLIQUE VIATRIS 5 mg Cpr Fl/20

Tablet.

Round, biconvex tablet, yellow in colour with the marking "FO" on one side.

Folic acid.................................................................................................................................................... 5 mg

for one tablet.

This medicine contains 44,36 mg of lactose monohydrate.

Excipients:

Macrocytic anaemias due to folic acid deficiency.

Chronic disorders of intestinal absorption, whatever their origin.

Dietary deficiencies: 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.

The daily dosages range between 5 and 15 mg, i.e. 1 to 3 tablets 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.

Folic acid must not be used in cases of malignant disease, unless megaloblastic anaemia due to folic acid deficiency represents a major complication.

The administration of folic acid to patients with folate-dependent tumours must be considered and monitored with the greatest care.

High doses of folic acid may reduce the antiepileptic effect of anticonvulsants such as phenytoin, primidone, …, . Patients treated should be monitored for a possible loss of seizure control after administration of high doses of folic acid.

This medicine contains lactose. Patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) must not take this medicine.

In patients suffering from alcoholism, haemolytic anaemia or anticonvulsant treatment, it may be necessary to increase the maintenance dose.

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.

Associations to be taken into account

+ Methotrexate

Methotrexate has a high affinity for dihydrofolate reductase and can thus inhibit the reduction of folic acid to tetrahydrofolate. Folic acid may therefore interfere with the toxicity and efficacy of methotrexate.

+ Fluorouracil

Potentiation of both the cytostatic and undesirable effects of fluorouracil, such as severe diarrhoea.

Pregnancy

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

Folate deficiency, or abnormal folate metabolism, induced by non-medicinal 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, 5-methyltetrahydrofolate and 10-formyltetrahydrofolate are excreted in breast milk. There is an accumulation of folates in breast milk when the folic acid intake during pregnancy exceeds the mother's needs.

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

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

Adverse effects are listed by MedDRA system organ class. Within each system organ class, adverse events are presented in order of decreasing frequency according to the following CIOMS III convention: 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) and frequency not known (cannot be estimated from the available data).

Immune system disorders

• Frequency not known: anaphylactic reaction such as urticaria and angioedema

• Very rare: allergic skin reaction

Gastrointestinal disorders

• Frequency not known: gastrointestinal disorder

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

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

Pharmacotherapeutic class: folic acid - antianaemic preparation, ATC code: B03BB01.

Folic acid is a B group vitamin. Its active metabolites serve as coenzymes for numerous enzymatic reactions involved in purine synthesis and amino acid metabolism.

Absorption

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

Distribution

It diffuses into all tissues and body fluids, concentrates in the cerebrospinal fluid and is stored in the liver.

The mean serum level is 5 to 12 ng/mL.

Elimination

It is excreted in urine and feces.

2 years.

Bottle of 20 tablets: To be used within 30 days after 1year opening of the vial.

Store at a temperature not exceeding 25°C.

Store in the original package, protected from light.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorisation (AMM)

CIP 3400927841934 (Blister/20). CIP 3400927842016 (Vial/20). CIP 3400958655326 (Vial/500). CIP 3400930213865 (PVC/PVDC/Alu blister/20).

Price:

1,33 euros (Blister/20). 1,33 euros (Vial/20). 1,33 euros (PVC/PVDC/Alu blister/20).

Social security reimbursement at 65% (Blister/20, Vial/20).
Social security reimbursement at 65% (PVC/PVDC/Alu blister/20) in the following indications:

• Indication(s) appearing in the marketing authorisation at the publication date of this order (PVC/PVDC/Alu blister/20)

Hospital model(s) (Vial/500).
Collection.