Instructions for Hepa-Merz granules 3 g/5 g, package 5 g No. 30
Composition
active ingredient: L-ornithine-L-aspartate;
1 packet contains L-ornithine-L-aspartate 3 g;
excipients: anhydrous citric acid, sodium saccharin, sodium cyclamate, povidone 25, fructose, lemon flavor, orange flavor, orange yellow S (E 110).
Dosage form
Granulate.
Main physicochemical properties: white-orange to orange free-flowing granules with an orange odor.
Pharmacotherapeutic group
Drugs used in liver diseases, lipotropic substances. Hepatotropic drugs. ATX code A05B A.
Pharmacological properties
Pharmacodynamics
In vivo, the action of L-ornithine-L-aspartate, driven by the amino acids ornithine and aspartate, is mediated by two key ammonia detoxification pathways: urea synthesis and glutamine synthesis.
Urea synthesis occurs in periportal hepatocytes, where ornithine acts as an activator of two enzymes: ornithine carbamoyltransferase and carbamoylphosphate synthetase, as well as a substrate for urea synthesis.
Glutamine synthesis occurs in perivenous hepatocytes. In particular, under pathological conditions, aspartate and dicarboxylate, including products of ornithine metabolism, are absorbed into the cells and used there to bind ammonia in the form of glutamine.
Glutamate is an amino acid that binds ammonia under both physiological and pathological conditions. The resulting amino acid glutamine is not only a non-toxic form for ammonia excretion, but also activates intracellular glutamine metabolism.
Under physiological conditions, ornithine and aspartate do not limit urea synthesis.
Experimental animal studies have shown that the ammonia-lowering properties of L-ornithine-L-aspartate are due to increased glutamine synthesis. In some clinical studies, this improvement has been shown to be relative to branched-chain amino acids/aromatic amino acids.
Pharmacokinetics
L-ornithine-L-aspartate is rapidly absorbed and broken down into ornithine and aspartate. The half-life of both amino acids is short – 0.3–0.4 hours. Part of the aspartate is excreted in the urine unchanged.
Indication
Treatment of concomitant diseases and complications caused by impaired liver detoxification function (e.g., cirrhosis) with symptoms of latent or overt hepatic encephalopathy.
Contraindication
Hypersensitivity to L-ornithine-L-aspartate, orange yellow S dye or to any of the excipients.
Severe kidney dysfunction (renal failure) if creatinine level is above 3 mg/100 ml.
Interaction with other drugs and other types of interactions.
Interaction studies have not been conducted. Data are not available.
Application features.
Hepa-Merz granules contain 1.13 g of fructose in each packet (equivalent to 0.11 XO), which should be taken into account by patients with diabetes.
Do not use in patients with congenital fructose intolerance.
Long-term use of the drug Hepa-Merz may be harmful to teeth (development of caries).
Orange Yellow S (E 110) may cause allergic reactions.
The use of high doses of the drug Hepa-Merz may cause an increase in the level of uric acid in the blood plasma, therefore it is necessary to monitor the level of urea in the blood plasma and urine.
Do not use in patients with phenylketonuria.
Use during pregnancy or breastfeeding.
There are no data on the use of Hepa-Merz granules during pregnancy. Animal studies with L-ornithine-L-aspartate to study its toxic effects on reproductive function have not been conducted. Therefore, the use of Hepa-Merz granules during pregnancy should be avoided.
However, if treatment with Hepa-Merz during pregnancy is considered necessary for vital indications, the doctor should carefully weigh the potential risk to the fetus/child against the expected benefit to the mother.
It is not known whether L-ornithine-L-aspartate passes into breast milk. Therefore, the use of Hepa-Merz should be avoided during breastfeeding.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Due to liver disease, the ability to drive or operate other machinery may be impaired during treatment with L-ornithine-L-aspartate, so such activities should be avoided during treatment.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted. Data are not available.
Application features
Hepa-Merz granules contain 1.13 g of fructose in each packet (equivalent to 0.11 XO), which should be taken into account by patients with diabetes.
Do not use in patients with congenital fructose intolerance.
Long-term use of the drug Hepa-Merz may be harmful to teeth (development of caries).
Orange Yellow S (E 110) may cause allergic reactions.
The use of high doses of the drug Hepa-Merz may cause an increase in the level of uric acid in the blood plasma, therefore it is necessary to monitor the level of urea in the blood plasma and urine.
Use during pregnancy or breastfeeding
There are no data on the use of Hepa-Merz granules during pregnancy. Animal studies with L-ornithine-L-aspartate to study its toxic effects on reproductive function have not been conducted. Therefore, the use of Hepa-Merz granules during pregnancy should be avoided.
However, if treatment with Hepa-Merz during pregnancy is considered necessary for vital indications, the doctor should carefully weigh the potential risk to the fetus/child against the expected benefit to the mother.
It is not known whether L-ornithine-L-aspartate passes into breast milk. Therefore, the use of Hepa-Merz should be avoided during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Due to liver disease, the ability to drive or operate other machinery may be impaired during treatment with L-ornithine-L-aspartate, so such activities should be avoided during treatment.
Method of administration and doses
Dissolve the contents of 1–2 packets of Hepa-Merz in a glass of water and take up to 3 times a day during or after meals.
The duration of treatment is determined by the doctor depending on the patient's clinical condition.
Children.
Experience in children is limited, so the drug should not be used in pediatric practice.
Overdose
In case of overdose, an increase in urea levels in the blood and urine and increased manifestations of adverse reactions may occur.
To date, no signs of intoxication caused by an overdose of L-ornithine-L-aspartate have been observed.
Treatment: No specific antidote is known. Gastric lavage and symptomatic treatment are recommended.
Adverse reactions.
The frequency of adverse reactions was determined as follows:
very common (≥ 1/10);
common (≥ 1/100, < 1/10);
uncommon (≥ 1/1000, < 1/100);
rare (≥ 1/10,000, < 1/1,000);
very rare (< 1/10,000);
unknown: cannot be estimated from the available data.
From the gastrointestinal tract:
Infrequent: nausea, vomiting, stomach pain, flatulence, diarrhea, constipation.
From the musculoskeletal system:
very rare: pain in the joints and muscles.
Skin and subcutaneous tissue disorders: skin rash, redness of the skin, itching, urticaria.
Neurological disorders: dizziness.
Immune system disorders: hypersensitivity reactions, including angioedema, anaphylactic shock, sneezing, lacrimation.
Metabolic disorders: when used in large doses, an increase in uric acid levels in blood plasma is possible.
These adverse reactions are usually short-lived and do not require discontinuation of the drug.
Orange Yellow S (E 110) may cause allergic reactions.
Side effects
The frequency of adverse reactions was determined as follows:
very common (≥ 1/10);
common (≥ 1/100, < 1/10);
uncommon (≥ 1/1000, < 1/100);
rare (≥ 1/10,000, < 1/1,000);
very rare (< 1/10,000);
unknown: cannot be estimated from the available data.
From the gastrointestinal tract:
Infrequent: nausea, vomiting, stomach pain, flatulence, diarrhea, constipation.
From the musculoskeletal system:
very rare: pain in the joints and muscles.
Skin and subcutaneous tissue disorders: skin rash, redness of the skin, itching, urticaria.
Neurological disorders: dizziness.
Immune system disorders: hypersensitivity reactions, including angioedema, anaphylactic shock, sneezing, lacrimation.
Metabolic disorders: when used in large doses, an increase in uric acid levels in blood plasma is possible.
These adverse reactions are usually short-lived and do not require discontinuation of the drug.
Orange Yellow S (E 110) may cause allergic reactions.
Expiration date
5 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store the drug at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
5 g of granules in a bag; 30 or 50 or 100 bags in a cardboard box.
Vacation category
Without a prescription.
Producer
Merz Pharma GmbH and Co. KGaA / Merz Pharma GmbH & Co. KGaA.
Location of the manufacturer and address of its place of business.
Ludwigstrasse 22, 64354 Rheinheim, Germany/
Ludwigstrasse 22, 64354 Reinheim, Germany.
Address
Ludwigstrasse 22, 64354 Rheinheim, Germany/
Ludwigstrasse 22, 64354 Reinheim, Germany.
