Instructions for use: Carsil film-coated tablets 22.5 mg No. 80
Composition
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 of silymarin;
excipients: lactose monohydrate, wheat starch, povidone K 25, microcrystalline cellulose, magnesium stearate, talc, mannitol (E 421), crospovidone, polysorbate 80, sodium bicarbonate;
shell: cellulose acetylphthalate, diethylphthalate, sucrose, acacia, gelatin, talc, titanium dioxide (E 171), macrogol 6000, Opalux AS 26586 brown [sucrose, red iron oxide (E 172), black iron oxide (E 172), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216)], glycerin.
Dosage form
Film-coated tablets.
Main physicochemical properties: coated tablets, regular round shape, brown color, odorless.
Pharmacotherapeutic group
Drugs used in liver diseases, lipotropic substances. Hepatoprotective drugs. ATX code A05B A03.
Pharmacological properties
Pharmacodynamics
Silymarin is a plant-based active ingredient of the drug Carsil®, obtained from the extract of the fruits of the milk thistle plant (Silybum marianum). The drug has hepatoprotective and antioxidant effects. Carsil® inhibits the penetration of toxins into liver cells (shown in the poison of the milk thistle), 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 Carsil® is due to the interaction of silibinin with free radicals in the liver and their transformation into less toxic compounds. This interrupts the process of lipid peroxidation and prevents further destruction of cellular structures; toxins are neutralized physiologically.
Silymarin stimulates the synthesis of proteins (structural and functional) and phospholipids in affected 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 Carsil® is manifested in improving the general condition of patients with liver diseases, reducing subjective complaints (such as weakness, feeling of heaviness in the right hypochondrium, loss of appetite, skin itching, vomiting). Laboratory indicators improve: the activity of transaminases, gamma-glutamyltransferase, alkaline phosphatase and the level of bilirubin in blood plasma decreases. Long-term use of the drug Carsil® significantly increases the survival rate of patients suffering from liver cirrhosis.
Pharmacokinetics
After oral administration, silymarin is slowly and partially absorbed from the gastrointestinal tract. It undergoes enterohepatic circulation. It does not accumulate in the body.
The half-life of silymarin is 6.3 hours. It is excreted mainly in the bile in the form of glucuronides and sulfates.
Indication
Toxic liver damage: for supportive treatment in patients with chronic inflammatory liver disease or cirrhosis.
Contraindication
Hypersensitivity to the active substance or to any of the excipients. Acute poisoning of various etiologies.
Interaction with other medicinal products and other types of interactions
With the simultaneous use of silymarin and oral contraceptives and drugs used in estrogen replacement therapy, tamoxifen treatment may reduce the effectiveness of the latter.
By inhibiting the cytochrome P450 system, silymarin enhances the effects of antiallergic drugs (fexofenadine) and anticoagulants (clopidogrel, warfarin).
Silymarin may enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, atorvastatin, vinblastine, due to its inhibitory effect on the cytochrome P450 system.
Herbal products containing silymarin are widely used as hepatoprotectors in oncology practice simultaneously with cytostatics. Clinical studies show a low risk of possible pharmacokinetic interactions between silymarin as an inhibitor of 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 from, for example, alcohol.
In case of jaundice, it is necessary to consult a doctor to correct the therapy.
Due to the possible estrogen-like effect of silymarin, it should be used with caution in patients with hormonal disorders (endometriosis, uterine fibroids, carcinoma of the breast, ovaries and uterus, carcinoma of the prostate gland). In such cases, the patient should consult a doctor.
The excipients of the drug include lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take the drug.
The medicinal product contains sucrose in the coating. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine.
The tablet coating contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216). They may cause allergic reactions (possibly delayed).
Ability to influence reaction speed when driving vehicles or other mechanisms
Carsil® does not affect the ability to drive or operate other mechanisms.
Patients with vestibular disorders should use the drug with caution when driving vehicles and working with other mechanisms.
Use during pregnancy or breastfeeding
There is no data on the safety and efficacy of the drug during pregnancy or breastfeeding, so it should not be prescribed during this period.
Method of administration and doses
Tablets should be taken orally whole, without chewing, with sufficient liquid.
Adults and children aged 12 years and over:
Carsil® should be taken 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
The drug is not recommended for use in children under 12 years of age.
Overdose
There are no reports of overdose. In case of accidental ingestion of a high dose, induce vomiting, rinse the stomach, take activated charcoal, and if necessary, apply symptomatic treatment prescribed by a doctor.
Adverse reactions
The drug is well tolerated. Rarely, in isolated cases and with individual hypersensitivity, the following side effects may be observed.
On the part of the digestive system: diarrhea as a result of increased liver and gallbladder function, nausea, dyspepsia, vomiting, decreased appetite, flatulence, heartburn.
On the part of the immune system: allergic reactions (possibly delayed type); hypersensitivity reactions, including skin rashes, itching, anaphylactic shock.
On the part of the organs of hearing and labyrinth: exacerbation of already existing vestibular disorders.
Respiratory system: shortness of breath.
From the urinary system: increased diuresis.
Skin and subcutaneous tissue disorders: increased alopecia.
Side effects are transient and disappear after stopping the drug without taking any special measures.
Expiration date
3 years.
Storage conditions
Keep out of reach of children. Store in original packaging at a temperature not exceeding 25 °C.
Packaging
10 tablets in a PVC film/aluminum foil blister; 8 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
JSC "Sopharma".
Location of the manufacturer and its business address
16 Ilienskoe Shose St., Sofia, 1220, Bulgaria.
