Karsil
Producer: Sopharma (JSC Sofarm) Bulgaria
Code of automatic telephone exchange: A05BA03
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: Silymarinum of 22,5 mg
Other ingredients: lactoses monohydrate, starch wheat, K 25 povidone, cellulose microcrystallic, magnesium stearate, talc, mannitol (Е 421), кросповидон, polysorbate 80, Natrii hydrocarbonas, cellulose ацетилфталат, diethyl phthalate, sucrose, acacia, gelatin, titanium dioxide (Е 171), macrogoal 6000, dye brown AS 26586 (sucrose, iron oxides, E 216, E 218), glycerin.
1 tablet, coated, contains 40,9–56,3 mg of dry extract of fruits of a thistle of spotty (Silybi mariani fructus extractum siccum) (35–50:1) that is equivalent to 22,5 mg of Silymarinum determined by Silibininum.
Pharmacological properties:
Drug concerns to group of hepatoprotective medicines. Silymarinum — the vegetable active component of drug Karsil and Karsil Forte allocated from fruits of a thistle spotty. Silymarinum represents mix from 4 isomers of flavonolignan: Silibininum, isosilibininum, силидианин and силикристин. Drug has hepatoprotective and anti-toxic effect.
Silymarinum stimulates protein synthesis (structural and functional) and phospholipids in the struck liver cells (normalizing lipidic exchange), stabilizes their cellular membranes, connects free radicals (antioxidant action), protecting thus liver cells from adverse effects and promoting their recovery. Thanks to it development of a steatosis and fibrosis of a liver is slowed down. Silymarinum reveals the metabolic and cellular regulating effects, controlling permeability of a cellular membrane, suppressing a 5-lipooksigenazny way, especially B4 (LTB4) leukotriene, and also contacting free reactive radicals of oxygen.
It is established that hepatoprotective action of Silymarinum is caused by its competing interaction with receptors to the corresponding toxins on a membrane of hepatocytes, showing thus membrane stabilizing action. Anti-toxic action at poisoning with a death angel is revealed.
Action of flavonoids to which Silymarinum belongs is also caused their antioxidant and improving microcirculation by effects. Clinically these effects are expressed in improvement of subjective and objective symptomatology, normalization of indicators of a functional condition of a liver (level of transaminases, gamma-globulin, bilirubin). It leads to improvement of the general state, reduction of the complaints connected with digestion, and at patients with bad digestion of food owing to a liver disease — to appetite improvement. As a result of use of Silymarinum the state after the postponed acute hepatitis improves and at chronic hepatitis (at use as a part of complex therapy).
After oral administration Silymarinum vsysyvatsya slowly in a GIT. Is exposed to enterohepatic circulation, does not kumulirut in an organism.
Intesivno is distributed in an organism. According to a research using 14C-mechenny Silibininum it is noted that the highest concentration reveal in a liver, insignificant quantity — in kidneys, lungs, heart and other bodies.
Silymarinum is metabolized in a liver by means of conjugation. As metabolites in bile glucuronides and sulfates are revealed.
Т½ Silymarinum makes 6 h. It is removed preferential (about 80%) with bile in the form of glucuronides and sulfates and in insignificant degree (about 5%) — with urine.
Indications to use:
Toxic damages of a liver: for a maintenance therapy at patients with chronic inflammatory diseases of a liver and cirrhosis.
Route of administration and doses:
Karsil a pill is taken inside entirely without chewing, washing down with enough liquid.
Adults and children are aged more senior than 12 years: apply orally at diseases of easy and average degree — 1–2 tablets 3 times a day. At severe forms of a disease it is possible to double a dose to 2–4 tablets 3 times a day.
Children at the age of 5–12 years: the daily dose at children is aged more senior than 5 years makes 3 mg/kg of body weight, divided into 2–3 receptions. The course of treatment is defined by the doctor individually depending on character and the course of a disease. The average duration of treatment — 3 months.
Karsil Forte capsules accept inside whole, washing down with enough liquid.
Adults and children aged from 12 years: on 1 capsule 1–3 times a day within 1 month. At serious condition of the patient duration of a course of treatment is determined by the doctor individually.
In case of the admission of a dose it is necessary to accept it as soon as possible. If time was suitable for the following dose, it is necessary to accept it as usual. It is impossible to accept a double dose for the purpose of compensation missed.
Features of use:
Due to the probable estrogenopodobny effect of Silymarinum it should be applied with care at patients with hormonal disturbances (endometriosis, a hysteromyoma, a carcinoma of a mammary gland, ovary, uterus and prostate). In these cases consultation of the specialist is necessary.
Drug is not used for treatment of acute intoxication.
Drug contains wheat starch in quality of excipient.
Wheat starch may contain gluten, but in insignificant quantity and therefore it is considered safe for patients with a Gee's disease. Patients with an allergy to wheat (but not a Gee's disease) should not accept this drug.
Drug in the form of tablets as excipient contains sucrose. Patients with rare hereditary intolerance of fructose, a galactose, glyukozo-galaktozny malabsorption or deficit of invertase-isomaltase should not accept drug.
Lactose is a part of excipients of drug. Patients with rare hereditary intolerance of a galactose, a lactose intolerance of Lapp or a sprue of glucose galactose should not accept drug. Patients with intolerance of some other sugars need to consult with the doctor.
As a part of a cover of a tablet contain methylparahydroxybenzoate (E218) and пропилпарагидроксибензоат (E216). They can cause allergic reactions (perhaps slowed down type).
In case of jaundice consultation of the doctor is necessary for carrying out differential diagnosis and correction of therapy.
Period of pregnancy and feeding by a breast. As there are no sufficient data about safety and efficiency of use of drug during pregnancy and feeding by a breast, it should be applied only under control of the doctor provided that the expected advantage of treatment for mother exceeds probable risk for the fruit/child.
Children. Karsil at children under 5 years, drug Karsil Forte — at children aged up to 12 years is not recommended to use drug.
Ability to influence control of vehicles and to work with mechanisms. Drug does not influence these functions. Patients with vestibular disturbances need to use with care drug at control of vehicles and work with other mechanisms.
Side effects:
Drug has good tolerance. Seldom, in some cases, at individual hypersensitivity the following side effects are possible:
from a GIT: nausea, dyspepsia, diarrhea;
from skin: in isolated cases skin allergic reactions — an itch, rash, strengthening of an alopecia are possible;
others: very seldom — strengthening of the existing vestibular disturbances, an asthma.
Side effects passing, disappear after the termination of administration of drug and do not demand acceptance of special measures.
Interaction with other medicines:
At the combined use of Silymarinum and peroral contraceptive drugs used at replacement therapy by estrogen decrease in efficiency of the last is possible.
Silymarinum can strengthen effects of such medicines as diazepam, to alprozola, кетоконазол, ловастатин, vinblastine because of its inhibiting effect on system of P450 cytochrome.
Contraindications:
Hypersensitivity to active ingredient or any component of drug. Acute poisonings of various etiology.
Dosage form Karsil of a tablet — to children under 5 years.
Karsil Forte in the form of capsules — to children aged up to 12 years.
Overdose:
There are no messages on overdose cases. At accidental reception of the dose several times exceeding therapeutic it is necessary to cause vomiting, to wash out a stomach, to accept absorbent carbon and if necessary to carry out a symptomatic treatment.
Storage conditions:
In original packaging (in the dry, protected from light place) at a temperature not above 25 °C.
Issue conditions:
According to the recipe
Packaging:
The tab. п / about 22,5 mg, No. 80.