Instructions for Carsil forte hard capsules 90 mg No. 30
Composition
active ingredient: dry extract of milk thistle fruits;
1 capsule contains 163.6-225.0 mg of dry extract of milk thistle fruits (Silybi mariani fructus extractum siccum) (35-50:1), which is equivalent to 90 mg of silymarin, determined by silibinin (HPLC);
excipients: lactose monohydrate, microcrystalline cellulose, wheat starch, povidone, polysorbate 80, colloidal anhydrous silica, mannitol (E 421), crospovidone, sodium bicarbonate, magnesium stearate, hard gelatin capsule (gelatin, titanium dioxide (E 171), iron oxide (E 172)).
Dosage form
The capsules are hard.
Main physicochemical properties: hard cylindrical gelatin capsules of light brown color. Capsule contents: powdery mass with agglomerates, from pale yellow to yellow-brown color, with a faint specific odor.
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 in the medicinal product Carsil® Forte, obtained from the extract of the fruits of the milk thistle plant (Silybum marianum).
The drug has a hepatoprotective and antitoxic effect. Carsil® Forte inhibits the penetration of toxins into liver cells (shown in the poisons of the pale toadstool), and also causes physicochemical stabilization of the cell membrane of hepatocytes.
The antioxidant effect of Carsil® Forte 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.
Carsil® Forte stimulates the biosynthesis of structural and functional proteins and phospholipids (due to specific stimulation of RNA polymerase A) and accelerates the regeneration of liver cells.
The clinical effect of Carsil® Forte is manifested in the improvement of the general condition of patients with liver diseases, the reduction of subjective complaints (such as weakness, a 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 the blood plasma decreases. Long-term use of Carsil® Forte significantly increases the survival rate of patients with liver cirrhosis.
Pharmacokinetics.
Absorption. After oral administration, silymarin is slowly and incompletely absorbed from the digestive tract. It undergoes enterohepatic circulation. It does not accumulate in the body.
Excretion: 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 lesions: for the supportive treatment of patients with chronic inflammatory liver diseases and 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, the effectiveness of the latter may decrease.
Silymarin may enhance the effects of drugs such as diazepam, alprazolam, lorazepam, ketoconazole, lovastatin, atorvastatin, vinblastine, due to its inhibitory effect on the cytochrome P450 system.
By inhibiting the cytochrome P450 system, silymarin enhances the effects of antiallergic drugs (fexofenadine) and anticoagulants (clopidogrel, warfarin).
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 the CYP3A4 and UGT1A1 isoenzymes and cytostatics that are substrates of these enzymes.
Application features
Treatment with Carsil® Forte for liver diseases will be more effective if you follow a diet and avoid alcohol.
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 these cases, a doctor's consultation is necessary.
The medicinal product contains wheat starch as an excipient. Wheat starch may contain gluten, but only in small amounts and is therefore considered safe for patients with celiac disease. Patients with a wheat allergy (different from celiac disease) should not use this medicinal product.
If signs of jaundice develop (change in skin color from light yellow to dark yellow, yellowing of the whites of the eyes), you should consult a doctor to adjust your therapy.
Use during pregnancy or breastfeeding
There are no data on the safety and efficacy of the drug during pregnancy or breastfeeding, so it should not be prescribed during this period.
Ability to influence reaction speed when driving vehicles or other mechanisms
Carsil® Forte does not affect the ability to drive or operate other mechanisms.
Patients with vestibular disorders should use the drug with caution when driving or operating other mechanisms.
Method of administration and doses
Capsules should be taken orally, with sufficient liquid.
Adults and children aged 12 and over
Treatment of severe liver damage begins with a dose of 1 capsule 3 times a day.
In cases of mild to moderate liver damage, 1 capsule should be taken 1-2 times a day.
The course of treatment lasts at least 3 months.
Children.
Do not use the drug 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.
Side effects
Rarely, with individual hypersensitivity, the following adverse reactions may be observed.
Gastrointestinal: diarrhea due to increased liver and gallbladder function, nausea, dyspepsia, vomiting, decreased appetite, flatulence, heartburn.
Immune system disorders: hypersensitivity reactions, including skin rashes, itching, anaphylactic shock.
On the part of the hearing organs: exacerbation of pre-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 the original packaging at a temperature not exceeding 25 °C.
Packaging
6 capsules in a blister, 5 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
JSC "Sopharma".
Address
16 Ilienskoe Shose St., Sofia, 1220, Bulgaria.
