Carsil tablets p / o 35mg, No. 180

As a symptomatic agent in complex therapy:

• toxic liver damage caused by alcohol, prolonged use of drugs,

• chronic intoxication (including occupational),

• chronic inflammatory liver diseases (chronic hepatitis of non-viral etiology),

• cirrhosis of the liver.

The tablets are taken orally before meals with plenty of water. The course of treatment lasts at least 3 months.

Adults and children over 12 years of age: treatment of severe liver damage begins with a daily dose of 420 mg (4 tablets 3 times a day).

In milder cases and as maintenance therapy - 1-2 tablets 3 times a day.

Prophylactically take 2-3 tablets per day.

1 coated tablet contains:

Active ingredient: milk thistle fruit extract dry - from 44.19 to 56.68 mg (equivalent to 35 mg of silymarin).

Core excipients: lactose monohydrate (from 33.70 to 46.19 mg), wheat starch (55.380 mg), povidone-K 25 (1.650 mg), microcrystalline cellulose (type 101) (67,000 mg), magnesium stearate (2,500 mg ), talc (7,000 mg), dextrose monohydrate (20,600 mg), sorbitol (4,130 mg), sodium bicarbonate (1,360 mg).

Shell excipients : cellacephate (0.840 mg), diethyl phthalate (0.600 mg), sucrose (162.190 mg), acacia gum (1.562 mg), gelatin (0.860 mg), talc (26.718 mg), titanium dioxide (4.820 mg), macrogol 6000 (0.130 mg), Brown Opalux dye (sucrose, iron dye red oxide, iron dye black oxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water) (2.250 mg), glycerol (0.030 mg).

• Hypersensitivity to the active ingredient or any of the excipients,

• children under 12 years old,

• lactose intolerance,

• lactase deficiency

• glucose-galactose malabsorption,

• intolerance to fructose,

• deficiency of sucrase / isomaltase.

Carefully

Prescribed to patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma) due to the possible estrogen-like effect of silymarin; children from the age of 12.

Trade name:

Carsil

International non-proprietary or group name:

Milk thistle extract

Dosage form:

Pills

Composition

1 coated tablet contains:

Active ingredient: milk thistle fruit extract dry - from 44.19 to 56.68 mg (equivalent to 35 mg of silymarin).

Core excipients: lactose monohydrate (from 33.70 to 46.19 mg), wheat starch (55.380 mg), povidone-K 25 (1.650 mg), microcrystalline cellulose (type 101) (67,000 mg), magnesium stearate (2,500 mg ), talc (7,000 mg), dextrose monohydrate (20,600 mg), sorbitol (4,130 mg), sodium bicarbonate (1,360 mg).

Shell excipients : cellacephate (0.840 mg), diethyl phthalate (0.600 mg), sucrose (162.190 mg), acacia gum (1.562 mg), gelatin (0.860 mg), talc (26.718 mg), titanium dioxide (4.820 mg), macrogol 6000 (0.130 mg), Brown Opalux dye (sucrose, iron dye red oxide, iron dye black oxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water) (2.250 mg), glycerol (0.030 mg).

Description

Film-coated tablets are biconvex with a brown outer layer and a white inner layer. In cross section, the kernel is from brownish yellow to light brown.

Pharmacotherapeutic group

Hepatoprotective agent of plant origin.

ATX code:

A05BA03.

Pharmacological properties

Pharmacodynamics:

CarsilЃ belongs to the group of hepatoprotective drugs. Contains dry extract of milk thistle fruit (silymarin equivalent), which is a mixture of 4 flavolignan isomers: silibinin, isosilybinin, silidianin and silicristin. The mechanism of action of the drug is still not well understood. It has been established that the hepatoprotective effect of silymarin is due to a competitive interaction with toxins on the corresponding receptors in the membrane of hepatocytes, thus exhibiting a membrane stabilizing effect. Silymarin has metabolic and cell-regulatory effects, regulating the permeability of the cell membrane, inhibiting the 5-lipoxygenase pathway, in particular leukotriene B4 (LTB4), and also binds 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 due to their antioxidant and microcirculation-improving 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, gamma globulin, bilirubin). This leads to an improvement in the general condition, a decrease in complaints related to digestion, and in patients with reduced absorption of food due to liver disease, it leads to an increase in appetite and an increase in body weight.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, gamma globulin, bilirubin). This leads to an improvement in the general condition, a decrease in complaints related to digestion, and in patients with reduced absorption of food due to liver disease, it leads to an increase in appetite and an increase in body weight.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, gamma globulin, bilirubin). This leads to an improvement in the general condition, a decrease in complaints related to digestion, and in patients with reduced absorption of food due to liver disease, it leads to an increase in appetite and an increase in body weight.

Pharmacokinetics:

Absorption is low and slow. Undergoes enterohepatic recirculation. Does not cumulate. In the study of C14-labeled silibinin, the highest concentrations are found in the liver and very small amounts in the kidneys, lungs, heart and other organs. It is metabolized in the liver by conjugation. Glucuronides and sulfates are found in bile as metabolites. The half-life is 6 hours. It is excreted mainly in the bile (about 80%) in the form of glucuronides and sulfates and to a small extent (about 5%) in the urine.

Indications for use

• As a symptomatic agent in the complex therapy of toxic liver damage caused by alcohol, prolonged use of drugs, chronic intoxication (including occupational), chronic inflammatory liver diseases (chronic hepatitis of non-viral etiology), liver cirrhosis.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients,

• children under 12 years old,

• lactose intolerance,

• lactase deficiency

• glucose-galactose malabsorption,

• intolerance to fructose,

• deficiency of sucrase / isomaltase.

Carefully

Prescribed to patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma) due to the possible estrogen-like effect of silymarin; children from the age of 12.

Application during pregnancy and during breastfeeding

It is not recommended to prescribe the drug during pregnancy and during breastfeeding due to the lack of data on the safety of the drug in this category of patients.

Method of administration and dosage

The tablets are taken orally before meals with plenty of water. The course of treatment lasts at least 3 months.

Adults and children over 12 years of age: treatment of severe liver damage begins with a daily dose of 420 mg (4 tablets 3 times a day).

In milder cases and as maintenance therapy - 1-2 tablets 3 times a day.

Prophylactically take 2-3 tablets per day.

Side effect

Adverse reactions are classified by frequency and by systemic organ class. MedDRA frequency is defined as follows: very frequent (> 1/10), frequent (> 1/100 to <1/10), infrequent (> 1/1000 to <1/100), rare (> 1/10000 up to <1/1000), very rare (<1/10000), with unknown frequency (cannot be estimated from existing data).

Immune system disorders:
Very rare: allergic skin reactions - itching, rash, alopecia.
With an unknown frequency: anaphylactic shock.

Hearing disorders and labyrinthine disorders:
Rare: exacerbation of existing vestibular disorders.

Gastrointestinal disorders:
Rare: diarrhea due to increased liver and gallbladder function.
With an unknown frequency: nausea, vomiting, dyspepsia, decreased appetite, flatulence.
If you have any side effects indicated in the instructions or they are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose

To date, there have been no cases of overdose when using the drug.
If a high dose is accidentally taken, dose-dependent side effects may increase.
Treatment: induce vomiting, wash out the stomach, take activated charcoal and, if necessary, carry out symptomatic treatment.

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
Silymarin can enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine, due to its suppressive effect on the cytochrome P 450 system.
Clinical studies show a slight risk of possible pharmacokinetic interactions of silymarin, as an inhibitor of the UCYP3A4 isoenzyme and , and cytostatics, which are substrates of these enzymes.

special instructions

Check with your doctor before taking this medication. You must inform your doctor if you are taking or have recently taken other drugs, including over-the-counter drugs. Treatment with this drug cannot replace diet or alcohol abstinence. The duration of the course of treatment is determined by your doctor. It is not recommended to take the drug for more than 1 month without consulting a doctor. If you miss one dose, take it as soon as possible. If it's time for your next dose, take it as usual. Do not take a double dose to make up for a missed dose. Continue taking this medicine as directed by your doctor. If your complaints persist, consult your doctor.

Influence on the ability to drive vehicles, mechanisms

The use of the drug in monotherapy does not affect the ability to perform potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions (driving, working with moving mechanisms).

Release form

Film-coated tablets, 35 mg.
10 coated tablets in a blister made of PVC film and aluminum foil.
8 or 18 blisters with instructions for use in a cardboard box.

Storage conditions

In its original packaging at a temperature not exceeding 25 ? C.
Keep out of the reach of children!

Shelf life

2 years.
Do not use after the expiration date printed on the package.

Vacation conditions

Available without a prescription.