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Description
The instruction for medical use
of KARSIL® medicine
Trade name
КАРСИЛ®
the International unlicensed name
Is not present
the Dosage form
of the Tablet, coated
One tablet contains Structure:
active substance – thistles spotty fruits of extract dry (equivalent to Silymarinum in the form of Silibininum of 22.5 mg) 40.9-56.3 mg,
excipients: lactoses monohydrate, starch wheat, K 25 povidone, cellulose microcrystalline (Type 101), magnesium stearate, talc, Mannitolum, krospovidon, polysorbate 80, Natrii hydrocarbonas,
structure of a cover: cellulose acetate phthalate, diethyl phthalate, sucrose, acacias gum, gelatin, talc, the titan dioxide (E 171), a macrogoal 6000, Opalux of AS 26586 brown (in a dry form): sucrose, ferrous oxide red (E 172), ferrous oxide black (E 172), methylparahydroxy-benzoate, propilparagidroksibenzoat, glitserol.
Description
of the Tablet, coated brown color, correct round shape.
Pharmacotherapeutic group
Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a liver.
ATH code: A05BA03
the Pharmacological
Pharmacokinetics Absorption Later properties of oral administration Silymarinum short rezorbirutsya from digestive tract (up to 23-47%). The peak of plasma concentration is reached in 4-6 hours after oral administration of a single dose. A small part of amount of the absorbed drug passes through enterohepatic circulation.
Distribution
At researches with 14C marked Silibininum the highest concentrations are established in a liver, lungs, a stomach and a pancreas and in insignificant quantities in kidneys, heart and other bodies. Reversibly contacts proteins of blood plasma.
Metabolism
Is metabolized in a liver by conjugation with sulfates and glucuronic acid. As metabolites in bile glucuronides and sulfates are found.
Removal
Elimination half-life makes 1-3 hours for not changed Silymarinum and 6-8 hours for its metabolites. It is removed generally with bile (about 80%) in the form of glucuronides and sulfates and in insignificant degree (about 5%) with urine in not changed look. Does not kumulirut.
A pharmacodynamics
Silymarinum — the vegetable active component of the drug Karsil® received from extracts of fruits of a plant of a thistle of spotty (Silybum marianum). Drug possesses gepatoprotektivny and anti-toxic action. Карсил® slows down penetration of toxins into liver cells (it is shown on poisons of a death angel) and also causes physical and chemical stabilization of a cellular membrane of hepatocytes, thereby preventing an exit from a cell of enzymes (in particular, transaminases) and other substances. The antioxidant effect of Karsila® is caused by interaction of Silibininum with free radicals in a liver and their transformation to less toxic connections. Thereby process of peroxide oxidation of lipids is interrupted and there is no further destruction of cellular structures, toxins are neutralized in the physiological way. Карсил® stimulates biosynthesis of structural and functional proteins and phospholipids (due to specific stimulation of a RNA polymerase A) also accelerates regeneration of cells of a liver.
Clinical action of Karsila® is shown in improvement of the general condition of patients with liver diseases, reduction of subjective complaints (such as weakness, heavy feeling in right hypochondrium, loss of appetite, a skin itching, vomiting). Laboratory indicators improve: decrease of the activity of transaminases, gamma glutamiltransferazy, alkaline phosphatase and level of bilirubin in blood plasma. Prolonged use of Karsila® authentically increases percent of survival of the patients having cirrhosis.
Indications
– the toxic damages of a liver caused by alcohol, prolonged use of drugs, chronic intoxications
– as a part of complex therapy of chronic hepatitis and cirrhosis.
The route of administration and doses
of the Tablet accept entirely, washing down with enough liquid. The course of treatment proceeds 3 months.
Adults and children are more senior than 18 years:
For treatment of severe damages of a liver – on 4 tablets (90 mg) 3 times a day.
In less hard cases and for maintenance therapy – on 2 tablets (45 mg) 3 times a day, further – on 2 tablets (45 mg) 2 times a day.
Children are younger than 18 years
it is not recommended to children is younger than 18-year age.
Side effects
Side effects are classified by frequency and by system organ class. Frequency is determined by MedDRA as follows: very frequent (& gt, 1/10), frequent (& gt, 1/100 to & lt, 1/10), infrequent (& gt, 1/1,000 to & lt, 1/100), rare (& gt, 1/10,000 to & lt, 1/1,000), very rare (& lt, 1/10,000), with an unknown frequency (on the basis of the existing data it is impossible to make assessment).
Medicine has good tolerance. Side effects were observed very seldom and were easy and passing.
Very seldom: skin allergic reactions: an itching, rash
With an unknown frequency: acute anaphylaxis
Seldom: strengthening of the existing vestibular disturbances
Is rare: diarrhea as a result of the strengthened function of a liver and a gall bladder
With an unknown frequency: nausea, vomiting, dyspepsia, reduction of appetite,
the Contraindication meteorism
– hypersensitivity to active or to any of excipients,
– mechanical jaundice,
– primary biliary cirrhosis,
– children’s age up to 18 years,
– pregnancy and the period of a lactation.
Medicinal interactions
Pharmakodinamichesky medicinal interactions
Silymarinum has no significant effect on a pharmacodynamics of other medicines.
At the combined use of Silymarinum and oral contraceptive means used at replaceable treatment by estrogen and tamoxifen the reduction of effects of the last is possible.
Pharmacokinetic medicinal interactions
Silymarinum can enhance effects of such medicines as diazepam, to alprazola, ketokonazol, lovastatin, atorvastatin, vinblastine because of its suppressing action on the system of P 450 cytochrome.
The vegetable products containing Silymarinum are widely used as gepatoprotektor in oncological practice along with cytostatics. Clinical trials show insignificant risk of possible pharmacokinetic interactions of Silymarinum as inhibitor of an isoenzyme of CYP3A4 and UGT1A1, and tsitostatik which are substrates of these enzymes.
The special
instructions Treatment cannot replace with this drug observance of a diet or abstention from alcohol intake.
Because of possible estrogenopodobny effect of Silymarinum, it should be applied with care at patients with hormonal disturbances (endometriosis, a hysteromyoma, a carcinoma of a mammary gland, ovaries and a uterus, a prostate carcinoma).
Medicine contains wheat starch in quality of excipient. Wheat starch may contain only traces of gluten and it is considered safe for persons with a Gee’s disease.
Medicine contains lactose excipient monohydrate. Patients with rare hereditary problems of intolerance of a galactose, deficit of Lapp of lactase or malabsorption of a glucose/galactose should not take this medicine.
Medicine contains excipient sucrose. Patients with rare hereditary problems of intolerance of fructose, malabsorption of a glucose/galactose or insufficiency of sukrazy-isomaltase should not use this medicine.
Are a part of drug methylparahydroxybenzoate (E 218) and propilparagidroksibenzoat (E 216) which can cause allergic reactions (perhaps – the slowed-down type).
Feature of influence of medicine on ability to run the vehicle or potentially dangerous
Karsil® mechanisms has no adverse impact on ability to run vehicles and to work with cars.
Overdose
Symptoms
Are not present messages about Silymarinum overdose cases.
Treatment
At accidental reception of a high dose it is necessary to cause vomiting, to wash out a stomach, to accept activated carbon and if necessary to carry out symptomatic treatment.
The form of release and packing
On 10 tablets, coated, place in blister strip packaging from a film of polyvinylchloride, colourless, transparent and aluminum foil.
On 8 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack from the cardboard covered with a pigment on the one hand.
Storage conditions
In original packing, in the dry place at a temperature not above 25 °C.
To store out of children’s reach!
2 years
not to accept a period of storage after an expiration date.
Prescription status
Without prescription
JSC Sofarm Producer
St. Iliyenskoye 16th 1220 Highway Sofia, Bulgaria
the Owner of the registration certificate
AO “Sofarma” St. Iliyenskoye shosse 16 1220 Sofia, Bulgaria
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
JSC Sofarm the Trade mission in Almaty, Kazakhstan, 050036, mdt. “Mamyr 4”, 190.
Phone number: 7 (727 3) 80 01 03
Fax number: 7 (727 3) 81 63 86
E-mail address:
To Develop info@sopharma.kz
Additional information
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