The instruction for medical use
of Gepadif® medicine
the Trade name
of Gepadif®
the International unlicensed name
Is not present
the Dosage form
of the Structure One Capsule Capsule contains
active agents: carnitine orotat 150 mg
(including acids of orotovy 73.8 mg
and carnitine of 76.2 mg)
anti-toxic fraction of extract of a liver of 12.5 mg
(including cyanocobalamine of 0.000125 mg)
pyridoxine hydrochloride of 25 mg
cyanocobalamine of 0.125 mg
of adenine hydrochloride of 2.5 mg
Riboflavinum of 0.5 mg,
excipients: microcrystalline cellulose, lactoses monohydrate, silicon dioxide colloidal anhydrous, magnesium stearate,
structure of a cover of the capsule
body: gelatin, titan dioxide (E 171), ferrous oxide black (E 172), ferrous oxide red (E 172), ferrous oxide yellow (E 172),
lid: gelatin, titan dioxide (E 171), ferrous oxide black (E 172), ferrous oxide red (E 172).
The description
Solid gelatin capsules with the body of pale chocolate color and a lid of dark chocolate color, with marking of H.S.D and hepadif, containing powder, light yellow with a brown shade.
Pharmacological group
Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a liver.
The ATX A05BA code
Pharmacological action
Pharmacokinetics
After intake a complex of active agents is released in a duodenum. Absorption of water-soluble vitamins of group B (cyanocobalamine, Riboflavinum, a pyridoxine), a carnitine of the orotat, anti-toxic fraction of a liver, adenine of a hydrochloride happens throughout a small intestine. Deposition of cyanocobalamine happens in kidneys, an intestines wall, mainly in a liver, is brought out of a liver with bile in intestines where it is repeatedly soaked up. Distribution of Riboflavinum in an organism unevenly: the greatest number is found in a myocardium, a liver, kidneys. The pyridoxine is metabolized in a liver with formation pharmacological of active metabolites (pyridoxal phosphate, piridoksaminofosfat), distributed in muscles, a liver, the central nervous system. Elimination is carried out mainly by kidneys.
A pharmacodynamics
Drug for treatment of diseases of a liver. Stimulates metabolism of fats – components of b-oxidizing process of free fatty acids in mitochondrions of hepatocytes, biosynthetic process, prevents necrosis of hepatocytes, normalizes process of proliferation of hepatocytes, a hepatic and enzymatic system and restores normal hepatic function. Presence of adenine of the hydrochloride which is a component of coenzymes, nucleic acids provides regulation of processes of a hemopoiesis. Group B vitamins (cyanocobalamine, Riboflavinum, a pyridoxine) - regulate oxidation-reduction processes, take part in protein, fat and carbohydrate metabolism, participate in exchange of tryptophane, methionine, cysteine, glutaminic acid and other amino acids. The pyridoxine contributes to normalization of lipidic exchange. Cyanocobalamine participates in transmethylation process, hydrogen transfer, formation of methionine, nucleic acids, sincaline, creatine.
The carnitine promotes splitting of fatty long-chain acids and substitution of the fatty acid metabolic shunt carbohydrate, increases secretion and activity of digestive enzymes, improves digestion of food.
The anti-toxic fraction of extract of a liver represents a complex of the amino acids participating in process of binding and removal of toxins and renders disintoxication effect.
The drug Gepadif® increases secretory function of a stomach improves a zhelchevydeleniye, facilitates absorption of carbohydrates in a small intestine, is necessary for maintenance of normal intestinal microflora. Promotes improvement of glikogenofiksiruyushchy, synthetic, anti-toxic function of a liver, increases sensitivity of hepatic cells to effect of insulin, promotes an insulin inkretion.
Indications
as a part of complex therapy in the following diseases and states:
- cirrhosis
- fat dystrophy of a liver (liver steatosis)
- alcoholic damage of a liver
- medicinal damages of a liver (long intake of antineoplastic, antitubercular medicines)
- the acute and chronic
hepatitis Route of administration and doses
the Adult inside, on 2 capsules 2-3 times a day, irrespective of meal.
Maximum single dose: 2 capsules, maximum daily dose: 6 capsules.
Duration of treatment depends on a course of a basic disease, and is defined in each case individually. It is recommended to begin treatment with parenteral administration of Gepadifa® with the subsequent transition to oral administration of drug.
Side effects
- allergic reactions (skin rash, an itching, a small tortoiseshell, a Quincke's edema)
- a headache, dizziness, hyperphrenia
- nausea, vomiting, an abdominal pain, diarrhea, a constipation
- coloring of urine in yellow color
of the Contraindication
- individual intolerance of components of drug
- pregnancy and the period of a lactation
- children's and teenage age up to 18 years (there is no experience of use for children)
- a nephrolithiasis
- an erythremia, a hyperglobulia, a thrombembolia is possible
- exacerbation of a peptic ulcer of a stomach and duodenum
Medicinal interactions
B6 Vitamin weakens action of a levodopa, prevents or reduces toxic manifestations which are observed at use of an isoniazid and other antitubercular drugs.
PASK, Cimetidinum, calcium drugs, ethanol reduce B12 vitamin absorption.
Riboflavinum is incompatible with streptomycin and reduces efficiency of antibacterial drugs (Oxytetracyclinum, doxycycline, erythromycin, tetracycline and lincomycin).
Tricyclic antidepressants, imiprimin and amitriptyline, inhibit Riboflavinum metabolism, especially in heart tissues.
Special instructions
during administration of drug of Gepadif® the purpose of the polyvitaminic complexes containing group B vitamins is not recommended.
Administration of drug can lead to the false positive urobilinigen test with use of reagent of Ehrlich.
It is recommended to exclude alcohol intake during the Gepadif® drug treatment.
It is necessary to use with care at patients with ulcer of stomach and duodenum in the anamnesis, in a serious illness of heart and kidneys, in the presence of new growths.
As drug contains lactose as auxiliary substance, it should not be applied at patients with a lactose intolerance, a galactosemia or a sprue of glucose galactose.
Features of influence on ability to run the vehicle and potentially dangerous mechanisms
Considering side effects of drug, it is necessary to be careful when driving and other potentially dangerous mechanisms.
Overdose
Symptoms: nausea, vomiting, diarrhea, strengthening of side effects. At prolonged use in high doses the development of peripheral neuropathy is possible.
Treatment: gastric lavage, intake of activated carbon, hyperosmotic laxatives.
A form of release and packing
On 10 capsules in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. On 3, 5 or 10 blister strip packagings together with the instruction for medical use in the state and Russian languages in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature not over 250C.
To store out of children's reach!
A period of storage
of 5 years
not to use drug after the expiry date specified on packing.
Prescription status
Without prescription
Celltrion Pharm Producer. Inc., Korea.
588-2, Sakok-ri, Eewol-myun, Chinchun-gun, Chungcheongbuk-do, Korea.
Packer
of Abdi Ibrahim Global Pharm LLP,
Kazakhstan Almaty, Dzhandosov St. 184 of ,
Phone number +7 727 309 74 07
Owner of the registration certificate
of Abdi Ibrahim Global Pharm LLP, Kazakhstan
Almaty, st. Dzhandosova of 184 g,
Phone number +7 727 309 74 07
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Abdi Ibrahim Global Pharm LLP, Kazakhstang. Almaty, Dzhandosov St. 184 of , Phone number +7 727 309 74 07 Fax number +7 727 309 74 14 E-mail address of globalzavod@mail.ru
of Gepadif® medicine
the Trade name
of Gepadif®
the International unlicensed name
Is not present
the Dosage form
of the Structure One Capsule Capsule contains
active agents: carnitine orotat 150 mg
(including acids of orotovy 73.8 mg
and carnitine of 76.2 mg)
anti-toxic fraction of extract of a liver of 12.5 mg
(including cyanocobalamine of 0.000125 mg)
pyridoxine hydrochloride of 25 mg
cyanocobalamine of 0.125 mg
of adenine hydrochloride of 2.5 mg
Riboflavinum of 0.5 mg,
excipients: microcrystalline cellulose, lactoses monohydrate, silicon dioxide colloidal anhydrous, magnesium stearate,
structure of a cover of the capsule
body: gelatin, titan dioxide (E 171), ferrous oxide black (E 172), ferrous oxide red (E 172), ferrous oxide yellow (E 172),
lid: gelatin, titan dioxide (E 171), ferrous oxide black (E 172), ferrous oxide red (E 172).
The description
Solid gelatin capsules with the body of pale chocolate color and a lid of dark chocolate color, with marking of H.S.D and hepadif, containing powder, light yellow with a brown shade.
Pharmacological group
Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a liver.
The ATX A05BA code
Pharmacological action
Pharmacokinetics
After intake a complex of active agents is released in a duodenum. Absorption of water-soluble vitamins of group B (cyanocobalamine, Riboflavinum, a pyridoxine), a carnitine of the orotat, anti-toxic fraction of a liver, adenine of a hydrochloride happens throughout a small intestine. Deposition of cyanocobalamine happens in kidneys, an intestines wall, mainly in a liver, is brought out of a liver with bile in intestines where it is repeatedly soaked up. Distribution of Riboflavinum in an organism unevenly: the greatest number is found in a myocardium, a liver, kidneys. The pyridoxine is metabolized in a liver with formation pharmacological of active metabolites (pyridoxal phosphate, piridoksaminofosfat), distributed in muscles, a liver, the central nervous system. Elimination is carried out mainly by kidneys.
A pharmacodynamics
Drug for treatment of diseases of a liver. Stimulates metabolism of fats – components of b-oxidizing process of free fatty acids in mitochondrions of hepatocytes, biosynthetic process, prevents necrosis of hepatocytes, normalizes process of proliferation of hepatocytes, a hepatic and enzymatic system and restores normal hepatic function. Presence of adenine of the hydrochloride which is a component of coenzymes, nucleic acids provides regulation of processes of a hemopoiesis. Group B vitamins (cyanocobalamine, Riboflavinum, a pyridoxine) - regulate oxidation-reduction processes, take part in protein, fat and carbohydrate metabolism, participate in exchange of tryptophane, methionine, cysteine, glutaminic acid and other amino acids. The pyridoxine contributes to normalization of lipidic exchange. Cyanocobalamine participates in transmethylation process, hydrogen transfer, formation of methionine, nucleic acids, sincaline, creatine.
The carnitine promotes splitting of fatty long-chain acids and substitution of the fatty acid metabolic shunt carbohydrate, increases secretion and activity of digestive enzymes, improves digestion of food.
The anti-toxic fraction of extract of a liver represents a complex of the amino acids participating in process of binding and removal of toxins and renders disintoxication effect.
The drug Gepadif® increases secretory function of a stomach improves a zhelchevydeleniye, facilitates absorption of carbohydrates in a small intestine, is necessary for maintenance of normal intestinal microflora. Promotes improvement of glikogenofiksiruyushchy, synthetic, anti-toxic function of a liver, increases sensitivity of hepatic cells to effect of insulin, promotes an insulin inkretion.
Indications
as a part of complex therapy in the following diseases and states:
- cirrhosis
- fat dystrophy of a liver (liver steatosis)
- alcoholic damage of a liver
- medicinal damages of a liver (long intake of antineoplastic, antitubercular medicines)
- the acute and chronic
hepatitis Route of administration and doses
the Adult inside, on 2 capsules 2-3 times a day, irrespective of meal.
Maximum single dose: 2 capsules, maximum daily dose: 6 capsules.
Duration of treatment depends on a course of a basic disease, and is defined in each case individually. It is recommended to begin treatment with parenteral administration of Gepadifa® with the subsequent transition to oral administration of drug.
Side effects
- allergic reactions (skin rash, an itching, a small tortoiseshell, a Quincke's edema)
- a headache, dizziness, hyperphrenia
- nausea, vomiting, an abdominal pain, diarrhea, a constipation
- coloring of urine in yellow color
of the Contraindication
- individual intolerance of components of drug
- pregnancy and the period of a lactation
- children's and teenage age up to 18 years (there is no experience of use for children)
- a nephrolithiasis
- an erythremia, a hyperglobulia, a thrombembolia is possible
- exacerbation of a peptic ulcer of a stomach and duodenum
Medicinal interactions
B6 Vitamin weakens action of a levodopa, prevents or reduces toxic manifestations which are observed at use of an isoniazid and other antitubercular drugs.
PASK, Cimetidinum, calcium drugs, ethanol reduce B12 vitamin absorption.
Riboflavinum is incompatible with streptomycin and reduces efficiency of antibacterial drugs (Oxytetracyclinum, doxycycline, erythromycin, tetracycline and lincomycin).
Tricyclic antidepressants, imiprimin and amitriptyline, inhibit Riboflavinum metabolism, especially in heart tissues.
Special instructions
during administration of drug of Gepadif® the purpose of the polyvitaminic complexes containing group B vitamins is not recommended.
Administration of drug can lead to the false positive urobilinigen test with use of reagent of Ehrlich.
It is recommended to exclude alcohol intake during the Gepadif® drug treatment.
It is necessary to use with care at patients with ulcer of stomach and duodenum in the anamnesis, in a serious illness of heart and kidneys, in the presence of new growths.
As drug contains lactose as auxiliary substance, it should not be applied at patients with a lactose intolerance, a galactosemia or a sprue of glucose galactose.
Features of influence on ability to run the vehicle and potentially dangerous mechanisms
Considering side effects of drug, it is necessary to be careful when driving and other potentially dangerous mechanisms.
Overdose
Symptoms: nausea, vomiting, diarrhea, strengthening of side effects. At prolonged use in high doses the development of peripheral neuropathy is possible.
Treatment: gastric lavage, intake of activated carbon, hyperosmotic laxatives.
A form of release and packing
On 10 capsules in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. On 3, 5 or 10 blister strip packagings together with the instruction for medical use in the state and Russian languages in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature not over 250C.
To store out of children's reach!
A period of storage
of 5 years
not to use drug after the expiry date specified on packing.
Prescription status
Without prescription
Celltrion Pharm Producer. Inc., Korea.
588-2, Sakok-ri, Eewol-myun, Chinchun-gun, Chungcheongbuk-do, Korea.
Packer
of Abdi Ibrahim Global Pharm LLP,
Kazakhstan Almaty, Dzhandosov St. 184 of ,
Phone number +7 727 309 74 07
Owner of the registration certificate
of Abdi Ibrahim Global Pharm LLP, Kazakhstan
Almaty, st. Dzhandosova of 184 g,
Phone number +7 727 309 74 07
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Abdi Ibrahim Global Pharm LLP, Kazakhstang. Almaty, Dzhandosov St. 184 of , Phone number +7 727 309 74 07 Fax number +7 727 309 74 14 E-mail address of globalzavod@mail.ru
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