The drug "Karsil" is an effective and inexpensive remedy for the treatment of chronic liver inflammation. The composition includes only a natural component - spotted milk thistle extract. Thanks to this, the results of treatment become noticeable within a month - some patients experience cases of complete recovery. There are not many side effects of this drug, and they are rare.
Composition and description of tablets "Karsil"
"Karsil" refers to antitoxic drugs that clear the liver of toxins (hepatoprotective effect). It is produced only in the form of tablets - there are 80 pieces in one package. The active ingredient is silymarin: it is an extract of the fruit of the spotted milk thistle plant. Each tablet contains 22.5 mg of this component.
The drug is available without a prescription, but it is recommended to consult a doctor before starting therapy. The tablets are stored under normal conditions (room temperature not higher than 25 degrees, moderate humidity). The shelf life is 2 years from the date of production.
Carsil® Forte
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, isosilibinin A and B, silydianin and silicristin. Of these, the most active is silibinin. The mechanism of hepatoprotective action has not been fully studied; 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-Fe2+-ADP. Affects enzyme systems associated with glutathione and superoxide dismutase. The components of silymarin suppress the peroxidation of linoleic acid catalyzed by lipoxygenase and protect liver mitochondria and microsomes from the formation of lipid peroxides caused by various agents.
Membrane stabilizing effect.
Silymarin stabilizes cell membranes and regulates their permeability, resulting in the prevention of the entry of hepatotoxic agents into heiatocytes. It has been established that the membrane-stabilizing effect of silymarin is due to its competitive interaction with receptors for the corresponding toxins on the hepatocyte membrane. 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 activating the synthesis of structural and functional proteins (ribosomal synthesis of RNA, protein and DNA) and phospholipids. It has been experimentally established that silymarin also suppresses the transformation of liver star cells into myofibroblasts, a process responsible for the arrangement of collagen fibers. Anti-inflammatory effect. According to the results of experimental studies, it was shown that silybin in a certain concentration is able to inhibit the synthesis of leukotriene Bt (leukotriene B4/LTB4 in isolated Kupffer cells of animals. Silymarin. silybin, silydianin and silicristin inhibit the activity of lipoxygenase and prostaglandin synthase in vitro. In in vitro studies on human polymorphonuclear leukocytes It has been shown that one of the mechanisms for implementing 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 (traisaminase, gamma globulin, bilirubin).
Indications and contraindications
The drug is indicated for use in the presence of the following disorders:
- chronic liver inflammation;
- liver damage due to poisoning;
- alcohol intoxication;
- cirrhosis of the liver.
The drug is prohibited for use by children under 5 years of age inclusive, as well as in a state of acute poisoning (for various reasons). Also, use is excluded if you have an individual intolerance to silymarin or other substances included in the tablets.
Side effects
In most cases, taking the drug is not accompanied by any complications. But sometimes side effects are possible:
- allergic reactions (itching, skin rashes);
- diarrhea;
- nausea;
- alopecia;
- dyspepsia;
- problems with the vestibular apparatus.
In rare cases, other undesirable symptoms appear, but they quickly disappear after stopping the medication.
"Karsil": instructions for use
The dosage depends on the patient’s age and disease:
- adolescents from 12 years of age and adults, 1-2 tablets 3 times a day;
- children from 5 to 11 years old inclusive - 2-3 times a day in an amount calculated from the ratio of 3 mg of active substance per kilogram of body weight;
- in case of exacerbation of the disease, adults are advised to take double the norm (compared to the standard) 3 times a day.
The general course of therapy depends on the patient’s age, his general condition and the nature of the disease. Typically the duration is 3 months. After this you need to take a break. Subsequent repetition of treatment is discussed with the doctor.
Instructions for Carsil Forte
Registration number: LP-000128 Trade name: CARSIL® FORTE
International nonproprietary name or generic name: milk thistle fruit extract Dosage form: capsules
Composition 1 capsule contains: Active substance: milk thistle fruit extract dry (equivalent to 90.0 mg of silymarin): 163.6 – 225.0 mg. excipients of the capsule contents: lactose monohydrate (38.2-7.5 mg), microcrystalline cellulose (type 101) (38.2-7.5 mg), wheat starch (15.5 mg), povidone K25 (3.7 mg), polysorbate – 80 (3.7 mg), colloidal silicon dioxide anhydrous (3.4 mg), mannitol (80.0 mg), crospovidone (14.0 mg), sodium bicarbonate (6.0 mg), magnesium stearate (3.7 mg). capsule shell excipients: iron oxide black (0.02%), iron oxide red (0.03%), titanium dioxide (0.6666%), iron oxide yellow (0.35%), gelatin (up to 100%) .
Description Hard gelatin capsules No. 0 are light brown in color. The contents of the capsule are a powdery mass from light yellow to yellow-brown 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, isosilibinin A and B, silydianin and silicristin. Of these, the most active is silibinin. 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-Fe2+ -ADP. Affects enzyme systems associated with glutathione and superoxide dismutase. The components of silymarin suppress the peroxidation of linoleic acid catalyzed by lipoxygenase and protect liver mitochondria and microsomes from the formation of lipid peroxides caused by various agents.
Membrane stabilizing effect. Silymarin stabilizes cell membranes and regulates their permeability, resulting in the prevention of the entry of hepatotoxic agents into hepatocytes. It has been established that the membrane-stabilizing effect of silymarin is due to its competitive interaction with receptors for the corresponding toxins on the hepatocyte membrane. 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 activating the synthesis of structural and functional proteins (ribosomal synthesis of RNA, protein and DNA) and phospholipids. It has been experimentally established that silymarin also suppresses the transformation of liver star cells into myofibroblasts, a process responsible for the arrangement of collagen fibers. Anti-inflammatory effect. According to the results of experimental studies, it was shown that silybin at a certain concentration is able to inhibit the synthesis of leukotriene B4 (leukotriene B4/LTB4) in isolated Kupffer cells of animals. Silymarin, silybin, silydianin 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 for implementing 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 normalization of indicators of the functional state of the liver (transaminases, gamma globulin, bilirubin).
Pharmacokinetics: Absorption After oral administration, silymarin is not completely absorbed from the gastrointestinal tract (GIT) (up to 23-47%). Maximum plasma concentration is achieved 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 minor quantities in the kidneys, heart and other organs. Metabolism Subject to enterohepatic recirculation. Metabolized in the liver by conjugation with sulfates and glucuronic acid. Glucuronides and sulfates were found as metabolites in bile. Elimination The half-life is 1-3 hours for unchanged silymarin and 6-8 hours for its metabolites. It is excreted mainly with bile (about 80%) in the form of glucuronides and sulfates, and to a small extent (about 5%) by the kidneys unchanged. Does not accumulate.
Indications for use As part of complex therapy: - toxic liver damage; — conditions after acute hepatitis; — chronic hepatitis of non-viral etiology; - liver steatosis (non-alcoholic and alcoholic); - liver cirrhosis; - prevention of liver damage with prolonged use of medications, - alcohol, chronic intoxication (including occupational).
Contraindications - Hypersensitivity to the active substance 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). — 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. Use during pregnancy and breastfeeding It is not recommended to use the drug during pregnancy and breastfeeding. Directions for use and doses: Capsules are taken orally with a sufficient amount 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. For milder and moderate cases, the dosage is 1 capsule 1-2 times a day. To prevent 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 use in children.
Side effects The drug is well tolerated. Adverse reactions are very rare and are usually mild and transient. Undesirable adverse reactions are classified by frequency and system-organ class. MedDRA frequency is defined as follows: very common (> 1/10), common (> 1/100 to <1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 up to < 1/1,000), very rare (< 1/10,000), with unknown frequency (cannot be estimated from existing data). Immune system disorders: Very rare: allergic skin reactions - itching, rash; With unknown frequency: anaphylactic shock. Hearing and labyrinthine disorders: Rare: exacerbation of existing vestibular disorders. Gastrointestinal disorders: Rarely: diarrhea as a result of increased liver and gallbladder function. With unknown frequency: nausea, vomiting, dyspepsia, decreased appetite, flatulence.
Overdose There is no evidence of drug overdose. Treatment for accidental ingestion of a high dose: induction of vomiting, gastric lavage, use of activated charcoal, and symptomatic therapy if necessary. Interaction with other drugs Pharmacodynamic drug interactions Silymarin does not have a significant effect on the pharmacodynamics of other drugs. When silymarin is used together with oral contraceptives and drugs used in hormone replacement therapy, the effects of the latter may be reduced. Pharmacokinetic drug interactions Since silymarin has an inhibitory effect on the cytochrome P450 system, it is possible to increase the concentration in the blood plasma of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine.
Special instructions Effect on the ability to drive vehicles and operate machinery: the use of the drug in monotherapy does not affect the ability to drive vehicles and operate machinery.
Release form Capsules 90 mg. 6 capsules per blister made of PVC film and aluminum foil. 5 blisters along with instructions for use in a cardboard box.
Shelf life: 3 years. Do not use after the expiration date stated on the package.
Storage conditions In a dry place, protected from light, at a temperature not exceeding 25º C. Keep out of the reach of children!
Conditions for dispensing from pharmacies Without a prescription.
Manufacturer : SOPHARMA JSC, Bulgaria, 1220 Sofia, st. Ilienskoye Highway No. 16 tel.: (+3592) 813 42 00, fax: (+3592) 936 02 86 Consumer complaints and information about adverse events should be sent to the following address: Representative office of SOPHARMA JSC 109004, Moscow, st. Taganskaya 17-23, fl. 10 phone/fax
Official instructions for the drug Karsil Forte.
special instructions
"Karsil" is used mainly to restore liver function. But the treatment will not give a lasting effect if the patient does not adjust his lifestyle. It is necessary to completely avoid alcoholic beverages, fried, and too fatty foods. It is advisable to prepare a diet in consultation with your doctor.
If patients have hormonal imbalance (concomitant diseases: in women: uterine fibroids, endometriosis, uterine or breast carcinoma, in men - prostate carcinoma), tablets can only be taken in consultation with a doctor. This is due to the fact that silymarin has an estrogen-like effect.
It is also important to keep in mind that the tablets contain wheat starch as an additional component, so patients with celiac disease should not take it. Another excipient is lactose. If the patient has sugar intolerance, use is also excluded.
In rare cases, while taking Karsil, jaundice develops. In this case, therapy is immediately suspended and a doctor is consulted.
Attention!
"Karsil" is also used to treat kidney problems in dogs, cats and other pets. For calculation, take 3 mg per kilogram of live weight.
Karsil tablets p/o 22.5 mg No. 10x8
Product description
Karsil.
Dosage form
Film-coated tablets. Basic physicochemical properties: film-coated tablets, regular round shape, brown, odorless.
Dosage
22.5 mg, package: 80 pcs.
Compound
active ingredient: dry extract of milk thistle fruits; 1 film-coated tablet contains dry extract of milk thistle fruit (Silybi mariani fructus extractum siccum) (35-50:1) (extractant: methanol ≥ 99.0%) - 40.9-56.3 mg, which is equivalent to 22. 5 mg silymarin; excipients: lactose monohydrate, wheat starch, povidone K 25, microcrystalline cellulose, magnesium stearate, talc, mannitol (E 421), crospovidone, polysorbate 80, sodium bicarbonate; shell: cellulose acetyl phthalate, diethyl phthalate, sucrose, acacia, gelatin, talc, titanium dioxide (E 171), macrogol 6000, Opalux AS 26586 brown
sucrose, iron oxide red (E 172), iron oxide black (E 172), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216)
, glycerin.
Pharmacotherapeutic group
Drugs used for liver diseases, lipotropic substances. Hepatoprotective drugs. ATX code A05B A03.
Pharmacological properties
Pharmacodynamics. Silymarin is a herbal active component of the drug Karsil®, obtained from extracts of the fruits of the milk thistle plant (Silybum marianum). The drug has hepatoprotective and antioxidant effects. Karsil® inhibits the penetration of toxins into liver cells (shown in the case of toadstool venoms), and also causes physicochemical stabilization of the cell membrane of hepatocytes, limits or prevents the loss of soluble components (including transaminases) of liver cells. The antioxidant effect of Karsil® is due to the interaction of silibinin with free radicals in the liver and their conversion into less toxic compounds. Thus, the process of lipid peroxidation is interrupted and further destruction of cellular structures does not occur; toxins are neutralized physiologically. Silymarin stimulates the synthesis of proteins (structural and functional) and phospholipids in damaged liver cells (normalizing lipid metabolism), stabilizes their cell membranes, binds free radicals (antioxidant effect), thus protecting liver cells from harmful effects and promoting their regeneration. The clinical effect of the drug Karsil® is manifested in improving the general condition of patients with liver diseases, reducing subjective complaints (such as weakness, a feeling of heaviness in the right hypochondrium, loss of appetite, itching, vomiting). Laboratory parameters improve: the activity of transaminases, gamma-glutamyltransferase, alkaline phosphatase and the level of bilirubin in the blood plasma decreases. Long-term use of the drug Karsil® significantly increases the survival rate of patients suffering from liver cirrhosis. Pharmacokinetics. After oral administration, silymarin is slowly and incompletely absorbed from the gastrointestinal tract. Subjected to enterohepatic circulation. Does not accumulate in the body. The half-life of silymarin is 6.3 hours. It is excreted mainly with bile in the form of glucuronides and sulfates. Clinical characteristics.
Indications
Toxic liver damage: for maintenance treatment in patients with chronic inflammatory liver diseases or cirrhosis.
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Acute poisoning of various etiologies.
Interaction with other drugs and other types of interactions
With the simultaneous use of silymarin and oral contraceptives and drugs used in estrogen replacement treatment, treatment with tamoxifen, the effectiveness of the latter may decrease. By inhibiting the cytochrome P450 system, silymarin enhances the effect of antiallergic drugs (fexofenadine) and anticoagulants (clopidogrel, warfarin). Silymarin can enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, atorvastatin, vinblastine, due to its inhibitory effect on the cytochrome P450 system. Plant products containing silymarin are widely used as hepatoprotectors in oncological practice along with cytostatics. Clinical studies show a slight risk of possible pharmacokinetic interactions between silymarin as an inhibitor of the CYP3A4 and UGT1A1 isoenzymes and cytostatics that are substrates of these enzymes.
Application Features
Treatment with Carsil® for liver damage will be effective if you follow a diet or abstain, for example, from alcohol. If jaundice develops, you should consult a doctor to adjust your therapy. Due to the possible estrogen-like effect of silymarin, it should be used with caution in patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma). In such cases, the patient must consult a doctor. The drug contains wheat starch as an excipient. Wheat starch may contain gluten, but only in trace amounts, and is therefore considered safe for patients with celiac disease (celiac disease). The excipients of the drug include lactose monohydrate. Patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take the drug. The drug in the shell contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency should not take the drug. The tablet shell contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216). They can cause allergic reactions (possibly delayed).
Use during pregnancy or breastfeeding
There are no data on the safety and effectiveness of the drug during pregnancy or breastfeeding, so it should not be prescribed during this period.
The ability to influence the reaction rate when driving vehicles or other mechanisms
Karsil® does not affect the ability to drive vehicles or operate other machinery. Patients with vestibular disorders should use the drug with caution when driving vehicles and operating other mechanisms.
Directions for use and doses
Take the tablets whole, without chewing, with a sufficient amount of liquid. Adults and children over 12 years of age: Use Karsil® orally, in mild and moderate cases - 1-2 tablets 3 times a day. In severe forms of the disease, the dose can be doubled to 2-4 tablets 3 times a day. The course of treatment is determined individually depending on the nature and course of the disease. The average duration of treatment is 3 months. Children. It is not recommended to use the drug for children under 12 years of age.
Overdose
There are no reports of cases of overdose. If you accidentally take a high dose, you should induce vomiting, rinse the stomach, take activated charcoal, and, if necessary, apply symptomatic treatment prescribed by your doctor.
Side effects
The drug is well tolerated. Rarely, in some cases and with individual hypersensitivity, the following side effects can be observed. From the digestive system: diarrhea as a result of increased liver and gallbladder function, nausea, dyspepsia, vomiting, decreased appetite, flatulence, heartburn. From the immune system: allergic reactions (possibly delayed); hypersensitivity reactions, including skin rashes, itching, anaphylactic shock. From the organs of hearing and labyrinth: strengthening of existing vestibular disorders From the respiratory system: shortness of breath. From the urinary system: increased diuresis. From the skin and its derivatives: increased alopecia. Side effects are transient and disappear after stopping the drug without taking special measures.
Best before date
3 years.
Storage conditions
Keep out of the reach of children. Store in original packaging at a temperature not exceeding 25 °C.
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Instructions for use for Karsil tablets p/o 22.5 mg No. 10x8
