Instructions for Gepadif capsules blister No. 30
Composition
active ingredients: 1 capsule contains carnitine orotate 150 mg (equivalent to 73.8 mg of orotic acid and 76.2 mg of carnitine); antitoxic fraction of liver extract 12.5 mg (containing cyanocobalamin not less than 0.000125 mg); pyridoxine hydrochloride 25.0 mg; cyanocobalamin 0.125 mg; adenine hydrochloride 2.5 mg; riboflavin 0.5 mg;
excipients: microcrystalline cellulose, anhydrous lactose, colloidal anhydrous silicon dioxide, magnesium stearate, gelatin, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172).
Dosage form
Capsules.
Main physicochemical properties: hard gelatin capsules with a light brown body and a dark brown cap, containing a light yellow powder with a brown tint.
Pharmacotherapeutic group
Combination of drugs for the treatment of liver and biliary tract diseases. ATX code A05C.
Pharmacological properties
Pharmacodynamics.
Gepadif® is a combined drug, the effects of which are due to the complex action of the components included in its composition. Stimulates the metabolism of fats - components of β-oxidative transformation of free fatty acids in the mitochondria of hepatocytes, biosynthetic processes, prevents hepatocyte necrosis, normalizes the process of hepatocyte proliferation, the system of liver enzymes and restores normal liver function. The presence of adenine, which is a component of coenzymes, nucleic acids, ensures the regulation of hematopoiesis processes. Vitamins of group B (cyanocobalamin, riboflavin, pyridoxine) regulate redox processes, participate in protein, fat and carbohydrate metabolism, in the metabolism of tryptophan, methionine, cysteine, glutamic acid and other amino acids. Pyridoxine contributes to the normalization of lipid metabolism, the functioning of the peripheral and central nervous systems. Cyanocobalamin is involved in the process of transmethylation, hydrogen transport, the formation of methionine, nucleic acids, choline, creatine, contributes to the normalization of impaired liver, nervous system, hematopoiesis functions, increases the ability of tissues to regenerate. Cyanocobalamin and pyridoxine reduce fatty infiltration of the liver, reduce hyperhomocysteinemia. Riboflavin is a component of enzymes involved in oxygen transport and ATP formation in mitochondria.
Carnitine regulates fat metabolism, promotes the breakdown of long-chain fatty acids and the replacement of the fatty acid metabolic shunt with carbohydrates, reduces the indicators of fatty liver dystrophy, and improves food absorption.
The antitoxic fraction of liver extract contains essential and non-essential amino acids that participate in protein synthesis, are donors of sulfhydryl and methyl groups, and have detoxification and antioxidant effects.
The drug stimulates bile secretion, promotes food digestion, facilitates the absorption of carbohydrates in the small intestine, is necessary for maintaining normal intestinal microflora. It helps improve glycogen-fixing, synthetic, antitoxic functions of the liver, increases the sensitivity of cells to the action of insulin, and promotes the secretion of insulin.
Pharmacokinetics.
After oral administration, the complex of active substances is released in the duodenum. Absorption of water-soluble B vitamins (cyanocobalamin, riboflavin, pyridoxine), carnitine orotate, antitoxic fraction of the liver, adenine hydrochloride occurs along the entire length of the small intestine. Cyanocobalamin is deposited in the kidneys, intestinal wall, mainly in the liver. From the liver it is excreted with bile into the intestine, where it is reabsorbed. The distribution of riboflavin in the body is uneven: the largest amount is found in the myocardium, liver, kidneys, Pyridoxine is metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxal phosphate, pyridoxaminophosphate); distributed in the muscles, liver, central nervous system. Excretion is carried out mainly by the kidneys.
Indication
As part of complex therapy:
– acute and chronic hepatitis, liver cirrhosis;
– fatty liver disease (hepatic steatosis);
– alcoholic liver damage;
– intoxication due to prolonged use of antitumor and antituberculosis drugs.
Contraindication
Individual hypersensitivity to the components of the drug. Nephrolithiasis, erythremia, erythrocytosis, thromboembolism, gastric and duodenal ulcer in the acute stage.
Interaction with other medicinal products and other types of interactions
Vitamin B6 weakens the effect of levodopa, prevents or reduces toxic manifestations observed with the use of isoniazid and other anti-tuberculosis drugs.
PASK, cimetidine, calcium preparations, ethanol reduce the absorption of vitamin B12.
Interactions due to the presence of cyanocobalamin
Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium preparations reduce the absorption of the drug and affect its kinetics.
Pharmaceutically incompatible with ascorbic acid, heavy metal salts (inactivation of cyanocobalamin); thiamine bromide, pyridoxine, riboflavin (the cobalt ion contained in the cyanocobalamin molecule destroys other vitamins).
Thiamine – the risk of developing allergic reactions caused by thiamine increases.
Chloramphenicol – reduces the hematopoietic response to the drug.
Citamen – with simultaneous use, the effect of Citamen is reduced.
Oral contraceptives – reduce the concentration of cyanocobalamin in the blood.
Interactions due to the presence of pyridoxine hydrochloride
Diuretics – when used in combination with pyridoxine, the effect of diuretics is enhanced.
Hormonal contraceptives, cycloserine, penicillamine, isoniazid, hydralazine sulfate, ethionamide, immunosuppressants - when used in combination with pyridoxine, the effect of the latter is weakened.
Sleeping pills and sedatives - when used in combination with pyridoxine, the sleeping pill effect is reduced.
Antiparkinsonian drugs – when used in combination with pyridoxine, the effectiveness of drugs for the treatment of Parkinson's disease is reduced.
Phenytoin – when used in combination with pyridoxine, the effect of phenytoin is weakened.
Corticosteroids – when used in combination with pyridoxine, the amount of vitamin B6 in the body decreases.
Glutamic acid, aspartame – when used in combination with pyridoxine, resistance to hypoxia increases.
Cardiac glycosides – when used in combination with pyridoxine, the synthesis of contractile proteins in the myocardium increases.
Tricyclic antidepressants – when used in combination with pyridoxine, the latter eliminates the side effects of tricyclic antidepressants associated with their anticholinergic activity (dry mouth, urinary retention).
Levomycetin preparations of resorptive action - when used in combination with pyridoxine, the latter prevents ophthalmological complications that occur with prolonged use of levomycetin preparations of resorptive action (synthomycin, chloramphenicol).
Interactions due to the presence of riboflavin
Streptomycin – Riboflavin is incompatible with streptomycin.
Antibacterial drugs – riboflavin reduces the effectiveness of antibacterial drugs (oxytetracycline, doxycycline, erythromycin, tetracycline and lincomycin).
Tricyclic antidepressants, imipramine and amitriptyline, inhibit riboflavin metabolism, especially in heart tissues.
Application features
Use with caution in patients with a history of gastric and duodenal ulcers (due to possible increased acidity of gastric juice), severe heart and kidney diseases, and neoplasms.
Use of the drug may result in a false-positive test for urobilinogen using Ehrlich's reagent.
Since the drug contains lactose as an excipient, it should not be used in patients with lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome.
Cyanocobalamin should not be used with drugs that increase blood clotting.
For people with a tendency to thrombosis and patients with angina pectoris, caution should be exercised and blood clotting should be monitored during treatment.
You should not drink alcoholic beverages during treatment.
Use during pregnancy or breastfeeding
The negative effect of the drug during pregnancy or breastfeeding has not been registered, however, when prescribing Gepadif® to pregnant or breastfeeding women, it is necessary to carefully weigh the benefit of using the drug against the potential risk to the fetus/child.
Ability to influence reaction speed when driving vehicles or other mechanisms
No negative effects on the ability to drive or operate other mechanisms have been recorded.
Method of administration and doses
Hepadif® should be taken orally.
Adults should take 2 capsules 2-3 times a day, regardless of meals. Usually, capsules should be taken whole with water. If swallowing is difficult, the contents of the capsule can be dissolved in 50 ml of juice or water. Do not dissolve in milk!
The doctor may change the dose individually depending on the patient's condition and the course of the disease.
No dose adjustment is required for the elderly.
The duration of treatment is determined by the doctor individually and depends on the course of the underlying disease.
Children.
There is no experience in children.
Overdose
Symptoms: nausea, vomiting, diarrhea, increased manifestations of adverse reactions. With prolonged use in high doses, peripheral neuropathy is possible.
Pyridoxine hydrochloride. Long-term use of vitamin B6 (over 6-12 months) in doses exceeding 50 mg daily or in doses exceeding 1000 mg daily (over 2 months) may lead to reversible peripheral sensory neuropathy. If symptoms of peripheral sensory neuropathy (paresthesia) occur, the dose of the drug should be adjusted and, if necessary, treatment should be discontinued.
Cyanocobalamin. In rare cases, allergic reactions, eczematous skin disorders, and benign acne have been observed after oral administration of higher than recommended doses.
With prolonged use in high doses, liver enzyme activity disorders, pain in the heart area, and hypercoagulation are possible.
Treatment: gastric lavage, use of activated charcoal, hyperosmotic laxatives.
Adverse reactions
The drug is usually well tolerated.
From the nervous system: headache.
Skin and subcutaneous tissue disorders: skin rash, itching, urticaria, angioedema.
On the part of the digestive tract: dyspepsia, abdominal pain and discomfort, nausea, vomiting, diarrhea, constipation.
Sometimes, when used in individuals with individual hypersensitivity to any component of the drug, hypersensitivity reactions may occur.
Urine may turn yellow.
Expiration date
5 years.
The drug cannot be used after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister.
10 capsules in a blister; 3 or 5 or 10 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
LLC "VALARTIN PHARMA".
Location of the manufacturer and its business address
Ukraine, 08130, Kyiv region, Kyiv-Svyatoshynskyi district, Chayky village, Hrushevskoho str., 60.
