BENERVA 250 mg Cpr enr Plq/40

Cthiamine hydrochloride ................................................................................................................250,00 mg.

For one coated tablet

Excipient with known effect: sucrose

Treatment of vitamin B1 deficiency: Beriberi.

Gayet-Wernicke encephalopathy, as a follow-on from the injectable form

Dosage

Reserved for adults

1 to 2 tablets per day.

Method of administration

Oral use.

Swallow the tablets with a little water, without chewing them.

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

Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) must not take this medicine.

Interaction with paraclinical examinations :

Vitamin B1 may induce false positives in the urobilinogen determination test using Ehrlich's reagent.

At high doses, vitamin B1 may interfere with the determination of serum theophylline concentrations by a spectrophotometric method.

The data available to date do not suggest the existence of clinically significant interactions.

Pregnancy

There are limited data on the use of thiamine hydrochloride in pregnant women. Animal studies are insufficient to draw conclusions on reproductive toxicity.

This medicinal product may be used in pregnant women only if absolutely necessary.

Breast-feeding

Thiamine is excreted in breast milk. In the absence of data on the consequences of high doses of vitamin B1 passing into milk, this treatment should be avoided during breastfeeding.

Fertility

There are no data in animals or in humans.

The adverse effects that may occur with BENERVA 250 mg, coated tablet, are presented by system organ class and frequency in the table below.

Adverse effects are listed in decreasing order of severity and their frequency is defined according to the following 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).

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/ 

No cases of oral overdose have been reported. However, at very high doses of thiamine, the following symptoms may occur: headache, nausea, irritability and hypotension.

Pharmacotherapeutic class: ALIMENTARY TRACT AND METABOLISM, ATC code: A11DA01.

Absorption

Thiamine is absorbed in the small intestine.

Distribution

Thiamine diffuses into all tissues. It is not stored, even in cases of excess intake.

Elimination

Elimination occurs in the urine in the form of metabolites. Thiamine passes into breast milk.

2 years

Store at a temperature not exceeding 25°C.

No special requirements.