BECILAN 250 mg/5 ml S inj 5Amp/5ml

Pyridoxine hydrochloride (Vitamin B6)...........................................................................................250,0 mg

For one ampoule of 5 ml.

Excipient(s) with known effect: sodium sulfite.

Treatment of proven vitamin B6, when the oral route is not possible.

FOR ADULTS ONLY

Dosage

1 to 2 ampoules per day.

Method of administration

IM or IV route.

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

This medicinal product is contraindicated in combination with levodopa (see section Interactions).

Contraindicated combinations

+ Levodopa:

Inhibition of the activity of levodopa when used without a peripheral dopa-decarboxylase inhibitor.

Avoid any intake of pyridoxine in the absence of a dopa-decarboxylase inhibitor.

Pregnancy

No teratogenesis study is available in animals.

In clinical practice, no malformative or foetotoxic effect has appeared to date. However, follow-up of pregnancies exposed to this medicinal product is insufficient to exclude any risk.

Consequently, as a precautionary measure, it is preferable not to use this medicine during pregnancy.

Breast-feeding

Vitamin B6 passing into milk, this medicine should be avoided during breastfeeding.

Exceptional and reversible neurological manifestations upon cessation of treatment have been reported after high doses and/or prolonged courses of vitamin B6.

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/.

Neurological manifestations such as drowsiness and/or paresthesia have been reported at high doses and/or with prolonged courses of pyridoxine hydrochloride. These manifestations are reversible upon cessation of treatment. Treatment is symptomatic.

Pharmacotherapeutic class: VITAMIN B6, ATC code: A11HA02.

(A: Alimentary tract and metabolism)

Pyridoxine is phosphorylated into active derivatives: pyridoxine phosphate, then pyridoxal phosphate. It is stored primarily in the liver, then eliminated in the urine mainly as metabolites.

Pyridoxine crosses the placenta and passes into milk.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Before opening: 5 years.

After opening, the product must be used immediately.

Before opening: Store below 25°C and protect from light.

No special requirements.