ABRIDGED PRESCRIBING INFORMATION

Composition: HepaMerzTM Granules: Each 5 g sachet contains : L-Ornithine-L-Aspartate : 3 g, Flavoured base, Colour : Sunset Yellow FCF. Pharmacology: L-Ornithine-L-Aspartate exerts its effects through the amino acids; ornithine and aspartate, via two key methods of ammonia detoxification: urea synthesis and glutamine synthesis.

Indication:Treatment of concomitant disease and sequelae due to impaired hepatic detoxification activity (e.g. in cirrhosis of the liver) with the symptoms of latent and manifest hepatic encephalopathy.

Dose & administration: The dissolved contents of 1-2 sachets of HepaMerzTM granules are taken up to 3 times daily. HepaMerzTM granules are dissolved in plenty of fluid (e.g. a glass of water, tea or juice) and taken with or after meals.

Contraindication: Hypersensitivity to L-Ornithine-L-Aspartate or any of the excipients and severely impaired renal function (renal insufficiency). A serum creatinine value over 3 mg/100 ml can be used as a guideline value.

Warning and precaution: HepaMerzTM granules contain fructose. Patients with rare hereditary problems of fructose intolerance, should not take this medicine.

Side effects: Uncommon nausea, vomiting, stomach ache, flatulence, diarrhoea and very rare pain in the limbs.

Use in pregnancy & lactation: Safety of use of HepaMerzTM granules has not been established during pregnancy. Therefore, only take HepaMerzTM granules, if directed by a physician. It is not known whether the active substance contained in HepaMerzTM granules crosses into the breast milk. Therefore, only take HepaMerzTM granules, if directed by a physician during lactation.

Use in children & adolescents: No data are so far available on the use of the drug in children. Drug interaction: No interaction studies have been performed. Up to now interactions are not known.

Overdose: Signs of intoxication have not been observed following an overdose of L-Ornithine-L-Aspartate. Symptomatic treatment is recommended, if overdose occurs.

Storage: Store protected from light and moisture at a temperature not exceeding 300C. Keep out of reach of children.

Presentation: HepaMerzTM Granules: Each box contains one sachet.