Carsil Forte capsules 90mg, No. 30
Russian Pharmacy name:
Карсил Форте капсулы 90мг, №30
As part of complex therapy:
toxic liver damage;
conditions after acute hepatitis;
chronic hepatitis of non-viral ethnology;
liver steatosis (not alcoholic and alcoholic);
cirrhosis of the liver;
prevention of liver damage with prolonged use of drugs, alcohol, and chronic intoxication (including occupational).
The capsules are taken orally with plenty of water.
Adults and children over 12 years of age
Treatment of severe liver damage begins with a dose of 1 capsule 3 times a day.
In lighter and moderate cases, the dosage is 1 capsule 1-2 times a day.
For the prevention of chemical intoxication - 1-2 capsules per day. The course of treatment lasts at least 3 months.
Children under 12 years of age
There is insufficient clinical data on the use in children.
1 capsule contains:
active substance: milk thistle fruit dry extract (equivalent to 90.0 mg of silymarin): 163.6 - 225.0 mg.
excipients of the capsule contents: lactose monohydrate, microcrystalline cellulose (type 101), wheat starch, povidone K25, polysorbate - 80; anhydrous colloidal silicon dioxide, mannitol, crospovidone, sodium bicarbonate, magnesium stearate.
excipients of the capsule shell: iron oxide black, iron oxide red, titanium dioxide, iron oxide yellow, gelatin.
Hypersensitivity to the active or any of the excipients;
Children under 12 years of age;
Lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome (due to the presence of lactose in the composition).
Celiac disease (gluten enteropathy) (due to the presence of wheat starch in the composition).
With caution: prescribed to patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma) due to the possible manifestation of the estrogen-like effect of silymarin.
Trade name: CARSILЃ FORTE
International non-proprietary name or grouping name: Milk thistle fruit extract
Dosage form: capsules
Composition:
1 capsule contains:
active substance: milk thistle fruit dry extract (equivalent to 90.0 mg of silymarin): 163.6 - 225.0 mg.
excipients of the capsule contents: lactose monohydrate, microcrystalline cellulose (type 101), wheat starch, povidone K25, polysorbate - 80; anhydrous colloidal silicon dioxide, mannitol, crospovidone, sodium bicarbonate, magnesium stearate.
excipients of the capsule shell: iron oxide black, iron oxide red, titanium dioxide, iron oxide yellow, gelatin.
Description
Hard gelatin capsules No. 0 light brown.
The content of the capsule is a powdery mass from light yellow to yellow-brown color with agglomerates.
Pharmacotherapeutic group
Hepatoprotective agent.
ATX code: [A05BA03]
Pharmacological properties
Pharmacodynamics
Carsil Forte contains milk thistle fruit extract, the main active ingredients of which are a mixture of 6 isomers of flavonolignans (silymarin):
silibinin A and B, iso-silibinin A and B, silidianin and silicristin. Of these, silibinin is the most active. The mechanism of hepatoprotective action is not fully understood; existing data prove the presence of several main mechanisms of action.
Antioxidant action. Silymarin interacts with free radicals in the liver and converts them into less toxic compounds, interrupting the process of lipid peroxidation, prevents the destruction of cellular structures by binding to free radicals and regulating the intracellular content of glutathione. Depending on the concentration, it suppresses microsomal peroxidation caused by NADPH-Fe 2-LDF. Influences enzyme systems associated with glutathione and superoxide dismutase. The components of silymarin inhibit the peroxidation of linoleic acid catalyzed by lipoxygenase and protect the hepatic mitochondria and microsomes from the formation of lipid peroxides caused by various agents.
Membrane stabilizing action. Silymarin stabilizes cell membranes and regulates their permeability, thereby preventing the intake of
hepatotoxic agents in hepatocytes. It was found that the membrane-stabilizing effect of silymarin is due to its competitive interaction with receptors for the corresponding toxins on the membrane of hepatocytes. The effect of silymarin on membrane permeability is associated with qualitative and quantitative changes in membrane lipids - cholesterol and phospholipids. Silymarin stimulates regeneration processes in the liver (restoration of damaged hepatocytes) as a result of activation of the synthesis of structural and functional proteins (ribosomal synthesis of RNA, protein and DNA) and phospholipids. It has been experimentally established that silymarin also inhibits the transformation of stellate liver cells into myofibroblasts, a process responsible for the arrangement of collagen fibers.
Anti-inflammatory action. According to the results of experimental studies, it has been shown that silybin at a certain concentration is able to inhibit the synthesis of leukotriene B 4 (leukotriene B4 / LTB4) in isolated Kupffer cells of animals. Silymarin, silybin, silidianin and silicristin inhibit the activity of lipoxygenase and prostaglandin synthase in vitro. In vitro studies on human polymorphonuclear leukocytes have shown that one of the mechanisms of the anti-inflammatory effect of silybin is the suppression of the formation of hydrogen peroxide. Clinically, the pharmacodynamic properties of silymarin are expressed in the improvement of subjective and objective symptoms and the normalization of indicators of the functional state of the liver (transaminase, gamma globulin, bilirubin).
Pharmacokinetics:
Absorption
After oral administration, silymarin is not completely absorbed from the gastrointestinal tract (GIT) (up to 23-47%).
The maximum plasma concentration is reached 4-6 hours after oral administration of a single dose.
Distribution
In studies with C14-labeled silibinin, the highest concentrations are found in the liver, lungs, stomach and pancreas and in small amounts in the kidneys, heart and other organs.
Metabolism
Undergoes enterohepatic recirculation. It is metabolized in the liver by conjugation with sulfates and glucuronic acid. Glucuronides and sulfates were found as metabolites in bile.
Withdrawal
The half-life is 1-3 hours for unchanged silymarin and 6-8 hours for its metabolites. It is excreted mainly in the bile (about 80%) in the form of glucuronides and sulfates, to a small extent (about 5%) by the kidneys unchanged. Does not cumulate.
Indications for use
As part of complex therapy:
toxic liver damage;
conditions after acute hepatitis;
chronic hepatitis of non-viral ethnology;
liver steatosis (not alcoholic and alcoholic);
cirrhosis of the liver;
prevention of liver damage with prolonged use of drugs, alcohol, and chronic intoxication (including occupational).
Contraindications
Hypersensitivity to the active or any of the excipients;
Children under 12 years of age;
Lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome (due to the presence of lactose in the composition).
Celiac disease (gluten enteropathy) (due to the presence of wheat starch in the composition).
With caution: prescribed to patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma) due to the possible manifestation of the estrogen-like effect of silymarin.
Application during pregnancy and during breastfeeding
It is not recommended to use the drug during pregnancy and during breastfeeding.
Method of administration and dosage
The capsules are taken orally with plenty of water.
Adults and children over 12 years of age
Treatment of severe liver damage begins with a dose of 1 capsule 3 times a day.
In lighter and moderate cases, the dosage is 1 capsule 1-2 times a day.
For the prevention of chemical intoxication - 1-2 capsules per day. The course of treatment lasts at least 3 months.
Children under 12 years of age
There is insufficient clinical data on the use in children.
Side effect:
The drug is well tolerated.
Adverse reactions are very rare and are usually mild and transient.
Adverse reactions are classified by frequency and by systemic organ class. MedDRA frequency is defined as follows: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1000 to <1/100), rarely (> 1/10000 to < 1/1000), very rare (<1/10000), with unknown frequency (no estimate can be made from existing data).
Immune system disorders.
Very rare: allergic skin reactions - itching. rash;
With an unknown frequency: anaphylactic shock.
Hearing disorders and labyrinthine disorders:
Rare: exacerbation of existing vestibular disorders.
Gastrointestinal disorders:
Rare: diarrhea as a result of increased liver and gallbladder function.
With an unknown frequency: nausea, vomiting, dyspepsia, decreased appetite, flatulence.
Overdose
There is no evidence of drug overdose.
Treatment in case of accidental intake of a high dose: induction of vomiting, gastric lavage, the use of activated charcoal, and, if necessary, symptomatic therapy.
Interaction with other medicinal products
Pharmacodynamic drug interactions
Silymarin does not significantly affect the pharmacodynamics of other drugs. With the combined use of silymarin with oral contraceptives and drugs that are used in hormone replacement therapy, it is possible to reduce the effects of the latter.
Pharmacokinetic drug interactions
Since silymarin has an inhibitory effect on the cytochrome P450 system, it is possible to increase the plasma concentration of drugs such as diazepam, alprazolam, ketoconazole, lovastin, vinblastine.
special instructions
Influence on the ability to drive vehicles and work with mechanisms: the use of the drug in monotherapy does not affect the ability to drive vehicles and work with mechanisms.
Release form
Capsules 90 mg.
6 capsules in a blister made of PVC film and aluminum foil.
5 blisters with instructions for use in a cardboard box.
Shelf life
3 years. Do not use after the expiration date printed on the package.
Storage conditions
In a dry, dark place, at a temperature not exceeding 25 ? C.
Keep out of the reach of children!
Conditions of dispensing from pharmacies
Without recipe.