Carsil^® Max (Capsules) Instructions for Use

Marketing Authorization Holder

Sopharma, JSC (Bulgaria)

ATC Code

A05BA03 (Silymarin)

Active Substance

Cardui mariae fructus (DAB German Pharmacopoeia)

Dosage Form

Carsil® Max

Capsules 110 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard, gelatinous, cylindrical, size No. 0; body pinkish-brown, cap brown; capsule contents – a powdery mass from light yellow to yellow-brown with agglomerates, with a faint characteristic odor.

Excipients : mannitol – from 125 to 50 mg, povidone K25 – 9.4 mg, polysorbate 80 – 3.7 mg, sodium lauryl sulfate – 3.7 mg, sodium carboxymethyl starch – 14.8 mg, magnesium stearate – 3.7 mg, colloidal anhydrous silicon dioxide – 3.7 mg, sodium bicarbonate – 6 mg.

Composition of the gelatin capsuleBody composition: iron oxide red dye (E172) – 0.5286%, iron oxide yellow dye (E172) – 0.3857%, titanium dioxide (E171) – 2%, gelatin – up to 100%.
Cap composition iron oxide black dye (E172) – 0.2857%, iron oxide red dye (E172) – 0.1619%, titanium dioxide (E172) – 0.6666%, gelatin – up to 100%.

6 pcs. – blisters (5) – 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

Herbal remedy. The main effect is hepatoprotective. Flavolignans, including silybin, dehydrosilybin, isosilybin, silymarin, dehydrosilymarin, silychristin, taxifolin (2.8-3.8%) stabilize lysosomal and cell membranes, preventing the release of enzymes from cells.

They interact with free radicals and inhibit lipid peroxidation processes. Due to their antioxidant action, they inhibit the penetration of various toxins (including chlorinated hydrocarbons, alpha-amanitin from the death cap mushroom, nitrosamines) into liver cells.

Silybin, silymarin and their derivatives stimulate specific RNA polymerase A, as a result of which the synthesis of proteins and phospholipids in hepatocytes is activated, and regeneration and detoxification processes in the liver are accelerated.

The tocopherols, macro- (potassium, magnesium) and microelements (copper, selenium) contained in the fruit contribute to the normalization of metabolic processes.

The fatty oil of the fruit (20-34%) contains a large amount of unsaturated fatty acids (including linoleic – 50-62%), which have redox properties, promote the oxidation of cholesterol and, together with beta-sitosterol, the prevention of atherosclerosis.

Mucilage polysaccharides (5%) have an enveloping and gastroprotective effect. The nitrogen-containing compound betaine improves the process of digestion and bile formation in the liver. Milk thistle fruits have a lactogenic effect.

Indications

Condition after viral and toxic hepatitis, liver injuries, abdominal surgeries; chronic hepatitis, hepatocholecystitis, biliary dyskinesia, pancreatitis, liver cirrhosis; toxic liver damage (including those caused by the use of aminoglycosides, tetracycline, immunosuppressants, NSAIDs, anti-tuberculosis drugs, barbiturates, tranquilizers; organic solvents; poisoning by mushrooms, heavy metal salts, halogenated hydrocarbons; in case of alcohol intoxication); hyperlipidemia, prevention of atherosclerosis.

ICD codes

Dosage Regimen

Take orally with a sufficient amount of water.

For adults and adolescents over 12 years, the standard therapeutic dose is one 110 mg capsule three times daily.

For severe liver conditions, the dose may be increased to a maximum of four capsules three times daily, as directed by a physician.

Administer the capsules after meals to minimize potential gastrointestinal discomfort.

The minimum course of treatment is typically three months.

For long-term therapy or prophylaxis, continue treatment as prescribed.

Adjust the dosage regimen based on the clinical response and severity of the condition.

Do not exceed the recommended daily dose without medical supervision.

Adverse Reactions

Rarely laxative effect.

Contraindications

Hypersensitivity to milk thistle.

Special Precautions

There is a report of antagonistic interaction of silymarin with yohimbine and phentolamine.

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.