ABRIDGED PRESCRIBING INFORMATION
Composition: HepaMerzTM Tablet: Each enteric coated tablet contains: L-Ornithine-L-Aspartate INN : 150 mg, Pancreatin USP: 100 mg, Colour: Red Oxide of Iron, Black Oxide of Iron and Titanium Dioxide. 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. Pancreatin is a combination of digestive enzymes. It is composed of amylase, lipase and protease. Pancreatin is used to support the pancreas.
Indication: Tablet: Supportive and maintenance therapy in chronic liver disorders such as hepatitis etc.
Dosage and Administration: Tablet: 1-2 tablets, 3 times daily after meals, for 3-6 months or as directed by the physician.
Contraindications: 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: L-Ornithine-L-Aspartate may be harmful to the teeth (caries) in long-term use. Side effects: Uncommon: Nausea, vomiting, stomach ache, flatulence, diarrhoea and Very rare: Pain in the limbs.
Use in pregnancy & lactation: HepaMerzTM tablets should be taken during pregnancy and lactation only upon consultation with the physician.
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 30°C. Keep out of the reach of children.
Presentation: HepaMerzTM Tablet: Each box contains 2×30’s tablets in blister strips.