Composition, form of production and packaging
? Dragee , coated with an outer layer of brown and an inner layer of white, biconvex form; on the break - from brownish-yellow to light-brown color.
dry extract of milk thistle (equivalent to silymarin) 35 mg
Auxiliary substances: lactose monohydrate - 55.38 mg, wheat starch - 55.38 mg, povidone (colidon 25) - 1.65 mg, microcrystalline cellulose - 67 mg, magnesium stearate - 2.5 mg, talc - 7 mg, dextrose monohydrate 20.6 mg, sorbitol 4.13 mg mg, sodium hydrogen carbonate - 1.36 mg.
The composition of the coating: cellophane - 0.84 mg, diethylphthalate 0.6 mg, sucrose 162.19 mg, acacia gum 1.562 mg, gelatin 0.86 mg, talc 26.718 mg, titanium dioxide 4.82 mg, macrogol (PEG 6000) 0.13 mg, dye Brown Opalux (sucrose, iron oxide red, iron oxide black, methyl and propyl parahydroxybenzoate, purified water) 2.25 mg, glycerol 0.03 mg.
10 pieces. - blisters (8) - packs of cardboard.
10 pieces. - blisters (18) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
Karsil В® belongs to the group of gelatoprotective medicines. Contains a dry extract of the milk thistle (equivalent to silymarin), which is a mixture of 4 isomers of flavonolignanes: silybinin, iso-silibinin, silidianin and silicristin.
The mechanism of action of the drug is still insufficiently elucidated. It has been established that hepatoprotective action of silymarin is caused by competitive interaction with toxins at the corresponding receptors in the membrane of hepatocytes, thus demonstrating membrane-stabilizing action.
Silymarin has metabolic and cellular-regulatory effects, regulating the permeability of the cell membrane, suppressing the 5-lipoxygenase pathway, especially leukotriene B 4 (LTB 4 ), and also by binding to free reactive oxygen radicals. Stimulates the synthesis of proteins (structural and functional) and phospholipids in the affected hepatocytes, accelerating the regenerative processes. The action of flavonoids, to which silymarin belongs, is also conditioned by their antioxidant and microcirculatory-enhancing effects. Clinically, these effects are expressed in the improvement of subjective and objective symptoms and in the normalization of indicators of the functional state of the liver (transaminases, gammaglobulin, bilirubin). This leads to an improvement in the general condition, a reduction in complaints related to digestion, and in patients with reduced digestion due to liver disease, leads to increased appetite and weight gain.
After oral administration, silymarin is slowly resorbed from the digestive tract. Undergoes intestinal-hepatic circulation. Do not cumulate.
In the study of silibinin labeled with C14, the highest concentrations are found in the liver and very small amounts - in the kidneys, lungs, heart and other organs.
Metabolised in the liver by conjugation. In bile, glucuronides and sulfates were detected as metabolites.
T 1/2 is 6 hours. It is excreted mainly with bile (about 80%) in the form of glucuronides and sulfates and to an insignificant extent (about 5%) in the urine.
- toxic liver damage;
- condition after hepatitis;
- chronic hepatitis of non-viral etiology;
- cirrhosis of the liver (as part of complex therapy);
- steatosis of the liver (non-alcoholic and alcoholic);
- for the prevention of long-term use of drugs, alcohol, chronic intoxication (including professional).
Adults and children over 12 years for the treatment of severe liver damage drug prescribed in a daily dose of 420 mg - 4 dragees 3 times / day.
For the treatment of more mild cases and as maintenance therapy , 1-2 tablets are prescribed 3 times a day.
For prevention appoint 2-3 tablets / day.
The course of treatment is at least 3 months.
Dragee should be taken orally, before eating, with plenty of water.
The drug is well tolerated. The following side effects are rarely observed.
From the digestive system: rarely - nausea, dyspepsia, diarrhea.
From the skin: in isolated cases, skin allergic reactions are possible - itching, rashes, alopecia.
Other: rarely - exacerbation of existing vestibular disorders.
Side effects occur rarely, have a transient nature and disappear after withdrawal of the drug.
- children's age till 12 years;
- hypersensitivity to the drug or any of the excipients.
PREGNANCY AND LACTATION
During pregnancy and lactation (breastfeeding), the use of the drug is not recommended.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is indicated for use in violations of liver function.
APPLICATION FOR CHILDREN
Contraindicated use of the drug for children under 12 years.
Be wary appoint patients with hormonal disorders (endometriosis, uterine fibroids, breast carcinoma, ovaries and uterus, carcinoma of the prostate gland) because of the possible manifestation of the estrogen-like effect of silymarin.
The drug contains wheat starch as an auxiliary substance, which can present a risk of deterioration in patients with celiac disease (gluten enteropathy), as well as glycerol, which can cause headache or irritation to the gastric mucosa by applying high doses.
To date, no cases of overdose have been reported.
Treatment: In case of accidental admission in a high dose, you should induce vomiting, perform gastric lavage with activated charcoal, symptomatic treatment.
With the joint use of silymarin with oral contraceptives and drugs that are used for hormone replacement therapy, it is possible to reduce the effects of the latter.
Silymarin may enhance the effects of such drugs as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine because of its inhibitory effect on the cytochrome P450 system.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.
Do not use after the expiry date printed on the package.