Carsil^® (Tablets) Instructions for Use

Marketing Authorization Holder

Sopharma, JSC (Bulgaria)

ATC Code

A05BA03 (Silymarin)

Active Substance

Silibinin (Rec.INN registered by WHO)

Dosage Form

Carsil®

Coated tablets, 35 mg: 80 or 180 pcs.

Dosage Form, Packaging, and Composition

Coated tablets with a brown outer layer and a white inner layer, biconvex in shape; on a cross-section, the core is from brownish-yellow to light brown in color.

Excipients : lactose monohydrate – 33.7-46.19 mg, wheat starch – 55.38 mg, povidone K25 – 1.65 mg, microcrystalline cellulose (type 101) – 67 mg, magnesium stearate – 2.5 mg, talc – 7 mg, dextrose monohydrate – 20.6 mg, sorbitol – 4.13 mg, sodium bicarbonate – 1.36 mg.

Shell composition cellacephate – 0.84 mg, diethyl phthalate – 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 6000 – 0.13 mg, Brown Opalux dye (sucrose, red iron oxide dye, black iron oxide dye, methylparahydroxybenzoate – 0.064%, propylparahydroxybenzoate – 0.043%, purified water) – 2.25 mg, glycerol – 0.03 mg.

10 pcs. – blisters (8) – cardboard packs.
10 pcs. – blisters (18) – cardboard packs.

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of liver diseases, lipotropic agents

Pharmacological Action

Hepatoprotective agent of plant origin. It contains a dry extract of milk thistle fruit (Silybum marianum (L.) Gaertn.) – equivalent to silymarin, which is a sum of flavonolignans: silibinin (silibin), isosilibinin, silidianin, and silicristin.

It has hepatoprotective and antitoxic action. The therapeutic effect is due to the impact on the metabolism of hepatocytes.

It activates the synthesis of proteins and enzymes in hepatocytes, has a stabilizing effect on the hepatocyte membrane, inhibits the penetration of toxins into liver cells, inhibits dystrophic and potentiates regenerative processes in the liver.

Pharmacokinetics

When taken orally, absorption from the gastrointestinal tract is low and slow (half-absorption period – 2.2 h), it is metabolized in the liver by conjugation, T_1/2 – 6 h.

It is excreted mainly with bile in the form of glucuronides and sulfates. It does not accumulate in the body.

After repeated oral administration of 140 mg 3 times/day, a stable level of excretion with bile is achieved. Enterohepatic circulation takes place.

Silymarin is excreted from the body mainly with bile and, to a lesser extent, by the kidneys.

Indications

Toxic liver damage, chronic hepatitis, liver cirrhosis (as part of complex therapy), after hepatitis.

As a prophylactic agent for chronic intoxications (including occupational), long-term use of medications and alcohol.

ICD codes

Dosage Regimen

Administer orally. Swallow the tablet whole with a sufficient amount of water.

For adults and adolescents over 12 years of age, the standard therapeutic dose is 1 to 2 tablets (35 mg to 70 mg), taken three times daily.

For severe liver conditions, the dose may be increased to 4 tablets (140 mg) taken three times daily.

For long-term prophylactic use against chronic intoxications, the recommended dose is 1 tablet (35 mg), taken three times daily.

Take the tablets after meals to improve absorption and minimize potential gastrointestinal discomfort.

The duration of treatment is determined by the clinical situation. For chronic diseases, continue treatment for at least three months.

Conduct repeated courses of treatment after a 1 to 3 month interval for chronic conditions, as directed by a physician.

Do not use in children under 12 years of age. Do not exceed the recommended daily dose.

Adverse Reactions

Rarely laxative effect, allergic reactions.

Contraindications

Hypersensitivity to silibinin; children under 12 years of age; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children under 12 years of age.

Drug Interactions

With the combined use of silymarin with oral contraceptives and drugs used for hormone replacement therapy (HRT), a decrease in the effects of the latter is possible.

With the combined use, silymarin may enhance the effects of such medicines as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine due to its suppressive effect on the cytochrome P450 isoenzyme system.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.