ARGININE VEYRON Oral solution in bottle Bottle/250ml

L(+) arginine hydrochloride...............................................................................................................16,4000 g

Corresponding quantity of L(+) arginine..........................................................................................13,5562 g

For 100 g of oral solution

One teaspoon (i.e. 5 ml of oral solution) contains 0,9184 g of L(+) arginine hydrochloride.

Excipients with known effect : one teaspoon contains 0,8000 g of sucrose, 0,0220 g of ethanol* and 0,0075 g of methyl parahydroxybenzoate (E218).

* contained in the caramel flavouring

• Adjunctive treatment of dyspeptic disorders in adults.

• Adjunctive treatment of functional asthenia in adults and children over 6 years.

• Congenital hyperammonaemias due to urea cycle deficiency in adults, children and infants.

Dosage

Adults :

• Dyspepsia:

1 to 2 teaspoons, before the 3 main meals or at the time of disorders.

• Asthenia:

1 teaspoon, 2 to 3 times a day. The duration of treatment should not exceed 4 weeks.

• Congenital hyperammonaemias:

250 to 500 mg/kg/day (up to a limit of 12 g of L(+) arginine hydrochloride per day).

Paediatric population :

• Children over 6 years of age

• Asthenia:

1 teaspoon, 2 to 3 times a day.

The duration of treatment must not exceed 4 weeks.

• Children and Infants

• Congenital hyperammonemias: 250 to 500 mg/kg/day (up to a limit of 12 g of L(+) Arginine hydrochloride per day).

Method of administration

• Oral route

• Dilute in a little water and swallow immediately.

• For infants, dilute in water or in the feeding bottle before taking.

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

USE THIS MEDICINE WITH CAUTION in cases of biliary tract obstruction and severe hepatocellular insufficiency.

In case of diarrhoea or abdominal pain, the product must be discontinued.

This medicine contains:

• 0,8 g of sucrose per teaspoon (5 ml). This must be taken into account for patients with diabetes mellitus. May be harmful to teeth. Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) must not take this medicine.

• methyl parahydroxybenzoate (E218) and may cause allergic reactions (possibly delayed).

• 22 mg of ethanol per teaspoon of solution (5 ml). The amount per teaspoon in this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medicine is not likely to produce any noticeable effect.

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

Pregnancy

There are no or limited data on the use of arginine in pregnant women.

Animal studies are insufficient to draw conclusions on reproductive toxicity (see section Preclinical safety).

ARGININE VEYRON is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding

Arginine is a natural amino acid, excreted in breast milk. There are no sufficient data on the excretion of arginine in breast milk during treatment with ARGININE VEYRON. A risk to breastfed newborns/infants cannot be excluded.

The use of ARGININE VEYRON should be avoided during breastfeeding.

Fertility

There are no data concerning the effects of arginine on fertility.

No specific study on the ability to drive vehicles and use machines has been performed. No effect is expected on the ability to drive vehicles and use machines.

List of adverse effects

The adverse effects that may occur with ARGININE VEYRON are listed below by System Organ Classes and by frequency 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), not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions

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

Risk of diarrhoea at high doses.

Pharmacotherapeutic class: CHOLAGOGUE-CHOLERETIC, ANTI-ASTHENIC, HYPOAMMONAEMIC

ATC code: A: Alimentary tract and metabolism

In the case of inherited deficiencies of ureagenesis, arginine enables detoxification and elimination of ammonia in the form of citrulline or argino-succinic acid.

Non-clinical data reveal no particular risk of acute toxicity, toxicity after repeated administration, genotoxicity or carcinogenesis.

There is no adequate toxicity data available to assess the effects of arginine on fertility and embryo-foetal development.

3 years.

This medicine does not require any particular storage precautions.

No special requirements.

• Congenital hyperammonaemia due to urea cycle deficiency