The instruction for medical use
of Gepabene Torgovoye medicine
Gepabene
Mezhdunarodnoye's name the unlicensed name
Is not present
the Dosage form
of the Structure One Capsule Capsule contains
active agents: fumitories of an officinal grass of extract of dry 275.10 mg, thistles spotty fruits of extract dry (it is equivalent to Silymarinum) 83.10 mg
excipients: microcrystalline cellulose, starch corn, talc, polyethyleneglycol (Makrogol 6000), kopolividon (Kopovidon), magnesium stearate, silicon dioxide colloidal
structure of a cover of the capsule: gelatin, the titan dioxide (E 171), gland (III) oxide yellow (E 172), gland (III) oxide red (E 172), gland (III) oxide black (E 172), the water purified.
Description
Solid gelatin capsules of 0 in size of light brown color. Contents of capsules - powder from light till dark brown uneven color with fine particles of white or yellowish or gray color (existence of conglomerates or the integral condensed weight is allowed).
Pharmacotherapeutic group
Drugs for treatment of diseases of a liver and biliary tract.
The ATX And 05BA code
the Pharmacological
Pharmacokinetics Later properties of intake Silymarinum representing Silibininum, silidianin and silikristin is selected with the most part (80%) through bile and is exposed to enterogepatichesky circulation (10%). The half-life period is 2.2 hours. Bioavailability of Silibininum of 20-40%.
The pharmacokinetics of a fumarin was not studied.
Gepabene's pharmacodynamics is the combined drug of plant origin, contains extract of a fumitory medicinal and dry extract of a thistle spotty.
Researches of reproductive toxicity, genotoxicity and carcinogenicity were not conducted. Pharmacological researches of toxicity of repeated doses and safety of use did not reveal danger to the person.
Extract of a fumitory medicinal, contains alkaloid fumarin, normalizes amount of the cosecreted bile, removes a spasm of a sphincter of Oddi and bile ducts, facilitating intake of bile in intestines, eliminating, thus, a cholestasia and dyskinesia of biliary tract. Besides, through a feedback mechanism fumarin reduces absorption of cholesterol in intestines, secretion of cholesterol in bile that reduces a bile litogennost.
Extract of fruits of a thistle contains Silymarinum. Which mechanism of action consists in inhibition of peroxide oxidation of lipids by binding of free radicals in liver tissue. Silymarinum stabilizes a cellular membrane of hepatocytes, stimulates synthesis of protein and phospholipids, promotes liver cell regeneration, prevents intracellular intake of toxins, showing, thus, the gepatoprotektivny, antioxidant and improving microcirculation effects. Clinically these effects are expressed in normalization of indicators of a functional condition of a liver. Drug normalizes function of a liver at various chronic morbid conditions.
Indications
Vegetable medicine for stimulation of bilious secretion and for simplification of complaints in a digestive disturbance of light severity and also spastic character (pains, swelling, a meteorism).
The route of administration and
Gepabene's doses appoint on 1 capsule 3 times a day before food, without chewing, with enough liquid. If complaints are aggravated or if the patient does not experience improvement of health in 2 weeks, it is necessary to consult with the doctor.
Side effects
Sometimes
- small laxative effect
- small diuretic effect
Seldom
- nausea, dyspepsia, diarrhea
- allergic reactions (rash, an itching)
It is very rare
- dizziness at patients with already existing vestibular disturbances,
the Contraindication alopecia
- the increased individual sensitivity to drug components
- cholelithiasis
- acute inflammatory diseases of a liver and biliary tract
- children's age up to 18 years
Medicinal interactions
At simultaneous use of Gepabene and:
- oral contraceptives and drugs which are used for the hormonal substituting therapy reduction of effects of the last is possible,
- Silymarinum can enhance effect of such drugs as diazepam, to alprozola, ketokonazol, lovastatin, vinblastine because of its suppressing action on the system of P 450 cytochrome.
The special
instructions Pregnancy and the period of a lactation
use of drug at pregnancy and during breastfeeding because of insufficiency of data is not recommended.
These influences on fertility are absent.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Overdose does not influence
So far the phenomena of overdose are not described. In case of overdose it is necessary to see the attending physician.
A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinyldichloride and aluminum foil. On 3 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not over 25C in original packing in the place protected from moisture.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date!
Prescription status
Without prescription
of Proizvoditel Merkle GmbH, Blauboyren, Germany
the Owner of the registration certificate of Ratiopharm GmbH, Ulm, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of limited liability partnership ratiopharm Kazakhstan, 050059 (A15E2P), Almaty, Al-Farabi Ave. 17/1, BC Nurly-Tau, 5B, 6 the floor. Phone number: (727) 3251615, (727) 3251690
The address of the organization, in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine
of limited liability partnership ratiopharm Kazakhstan, 050059 (A15E2P), Almaty, Al-Farabi Ave. 17/1, Nurla Tau's BC, 5B, 6 the floor. Phone number: (727) 3251642, e-mail: Safety.Kazakhstan@tevapharm.com
of Gepabene Torgovoye medicine
Gepabene
Mezhdunarodnoye's name the unlicensed name
Is not present
the Dosage form
of the Structure One Capsule Capsule contains
active agents: fumitories of an officinal grass of extract of dry 275.10 mg, thistles spotty fruits of extract dry (it is equivalent to Silymarinum) 83.10 mg
excipients: microcrystalline cellulose, starch corn, talc, polyethyleneglycol (Makrogol 6000), kopolividon (Kopovidon), magnesium stearate, silicon dioxide colloidal
structure of a cover of the capsule: gelatin, the titan dioxide (E 171), gland (III) oxide yellow (E 172), gland (III) oxide red (E 172), gland (III) oxide black (E 172), the water purified.
Description
Solid gelatin capsules of 0 in size of light brown color. Contents of capsules - powder from light till dark brown uneven color with fine particles of white or yellowish or gray color (existence of conglomerates or the integral condensed weight is allowed).
Pharmacotherapeutic group
Drugs for treatment of diseases of a liver and biliary tract.
The ATX And 05BA code
the Pharmacological
Pharmacokinetics Later properties of intake Silymarinum representing Silibininum, silidianin and silikristin is selected with the most part (80%) through bile and is exposed to enterogepatichesky circulation (10%). The half-life period is 2.2 hours. Bioavailability of Silibininum of 20-40%.
The pharmacokinetics of a fumarin was not studied.
Gepabene's pharmacodynamics is the combined drug of plant origin, contains extract of a fumitory medicinal and dry extract of a thistle spotty.
Researches of reproductive toxicity, genotoxicity and carcinogenicity were not conducted. Pharmacological researches of toxicity of repeated doses and safety of use did not reveal danger to the person.
Extract of a fumitory medicinal, contains alkaloid fumarin, normalizes amount of the cosecreted bile, removes a spasm of a sphincter of Oddi and bile ducts, facilitating intake of bile in intestines, eliminating, thus, a cholestasia and dyskinesia of biliary tract. Besides, through a feedback mechanism fumarin reduces absorption of cholesterol in intestines, secretion of cholesterol in bile that reduces a bile litogennost.
Extract of fruits of a thistle contains Silymarinum. Which mechanism of action consists in inhibition of peroxide oxidation of lipids by binding of free radicals in liver tissue. Silymarinum stabilizes a cellular membrane of hepatocytes, stimulates synthesis of protein and phospholipids, promotes liver cell regeneration, prevents intracellular intake of toxins, showing, thus, the gepatoprotektivny, antioxidant and improving microcirculation effects. Clinically these effects are expressed in normalization of indicators of a functional condition of a liver. Drug normalizes function of a liver at various chronic morbid conditions.
Indications
Vegetable medicine for stimulation of bilious secretion and for simplification of complaints in a digestive disturbance of light severity and also spastic character (pains, swelling, a meteorism).
The route of administration and
Gepabene's doses appoint on 1 capsule 3 times a day before food, without chewing, with enough liquid. If complaints are aggravated or if the patient does not experience improvement of health in 2 weeks, it is necessary to consult with the doctor.
Side effects
Sometimes
- small laxative effect
- small diuretic effect
Seldom
- nausea, dyspepsia, diarrhea
- allergic reactions (rash, an itching)
It is very rare
- dizziness at patients with already existing vestibular disturbances,
the Contraindication alopecia
- the increased individual sensitivity to drug components
- cholelithiasis
- acute inflammatory diseases of a liver and biliary tract
- children's age up to 18 years
Medicinal interactions
At simultaneous use of Gepabene and:
- oral contraceptives and drugs which are used for the hormonal substituting therapy reduction of effects of the last is possible,
- Silymarinum can enhance effect of such drugs as diazepam, to alprozola, ketokonazol, lovastatin, vinblastine because of its suppressing action on the system of P 450 cytochrome.
The special
instructions Pregnancy and the period of a lactation
use of drug at pregnancy and during breastfeeding because of insufficiency of data is not recommended.
These influences on fertility are absent.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Overdose does not influence
So far the phenomena of overdose are not described. In case of overdose it is necessary to see the attending physician.
A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinyldichloride and aluminum foil. On 3 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not over 25C in original packing in the place protected from moisture.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date!
Prescription status
Without prescription
of Proizvoditel Merkle GmbH, Blauboyren, Germany
the Owner of the registration certificate of Ratiopharm GmbH, Ulm, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of limited liability partnership ratiopharm Kazakhstan, 050059 (A15E2P), Almaty, Al-Farabi Ave. 17/1, BC Nurly-Tau, 5B, 6 the floor. Phone number: (727) 3251615, (727) 3251690
The address of the organization, in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine
of limited liability partnership ratiopharm Kazakhstan, 050059 (A15E2P), Almaty, Al-Farabi Ave. 17/1, Nurla Tau's BC, 5B, 6 the floor. Phone number: (727) 3251642, e-mail: Safety.Kazakhstan@tevapharm.com
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