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Darsil

Препарат Дарсил. ЗАО "Фармацевтическая фирма "Дарница" Украина


Producer: CJSC Pharmaceutical Firm Darnitsa Ukraine

Code of automatic telephone exchange: A05BA03

Release form: Firm dosage forms. Tablets.

Indications to use: Cirrhosis.


General characteristics. Structure:

Active ingredient: 1 tablet contains 35 mg of Silymarinum (in recalculation on dry matter and the maintenance of the sum of flavolignan of 65%);

excipients: potato starch; lactose, monohydrate; calcium stearate; sugar crystal; magnesium carbonate easy; povidone (polyvinylpirrolidone low-molecular medical); titanium E 171 dioxide; silicon dioxide colloid anhydrous; yellow decline of FCF E 110; wax of karnaubskiya.




Pharmacological properties:

Active ingredient of the drug Darsil® – Silymarinum, substance from Silybium marianum plant seeds (A thistle spotty). Bioactive components of Silymarinum are neutralized by free radicals in a liver, interfere with destruction of cellular structures, in particular, stabilize membranes of hepatocytes. Specifically stimulate a RNA polymerase and activate synthesis of structural and functional proteins and phospholipids in the injured hepatocytes. Prevent an exit of intracellular components (transaminases) and accelerate regeneration of cells of a liver. Slow down penetration into hepatocytes of some poisons, in particular mushroom poison a death angel. Considerably reduce activity of peroxide oxidation of lipids in membranes of hepatocytes, than promote their strengthening.

Improve the general state at patients with liver diseases, reduce subjective feelings (weakness, heavy feeling in right hypochondrium). Contribute to normalization of biochemical indicators of a functional condition of a liver (activity of transaminases, γ-glyutamiltransferaza, an alkaline phosphatase, bilirubin level).

Дарсил® possesses low adsorption that is peculiar to hydrophobic Silymarinum. In a system blood-groove practically does not contact proteins of plasma. Passes biotransformation in a liver, participates in a conjugation test with formation of sulfates and glucuronides. It is excreted generally with bile, in a small intestine it is soaked up again in a system blood stream because of what makes the repeated gradually fading enterohepatic circulation. An elimination half-life (T1/2) - 6 hours. Practically does not kumulirut.


Indications to use:

Chronic toxic damages of a liver. As a part of complex treatment of patients with chronic inflammatory diseases of a liver or cirrhosis.


Route of administration and doses:

The pill Darsil® is taken inside after food, without chewing, with a small amount of liquid.

The dose for adults and children is more senior than 12 years makes 1-2 tablets (35-70 mg of Silymarinum) 3 times a day.

The daily dose for children from 5 to 12 years makes 3 mg/kg of body weight, divided into        2-3 receptions.

The course of treatment is defined by the doctor individually depending on character and the course of a disease. The average duration of treatment – 3 months.


Features of use:

As the auxiliary component enters into composition of this medicine sugar crystal, it should be considered a sick diabetes mellitus.

Medicine contains lactose therefore to patients with rare hereditary intolerance of a galactose, insufficiency of lactase or glyukozo-galaktozny malabsorption it is not necessary to accept drug.

In view of possible estrogenpodobny effect of Silymarinum, patients need to apply it with care with hormonal disturbances (endometriosis, a hysteromyoma, a carcinoma of a mammary gland, ovaries and a uterus, a prostate carcinoma). In these cases consultation of the patient with the doctor is necessary.

In case of development of jaundice it is necessary to consult with the doctor for carrying out correction of therapy.

Use during pregnancy or feeding by a breast.

Data on safety and efficiency of use of drug during pregnancy or feeding by a breast are absent.

Ability to influence the speed of reactions at control of motor transport or work with other mechanisms.

Drug usually does not influence the speed of reactions at control of motor transport or work with other mechanisms. However it must be kept in mind that at already existing disturbances of a vestibular mechanism (dizziness), use of drug can cause their aggravation.

Children.

Дарсил® it is possible to apply to treatment of children 5 years are more senior.


Side effects:

Drug is well transferred. Development of side reactions is in some cases possible:

from the central and peripheral nervous system: a headache, an aggravation of the available disturbances of a vestibular mechanism (dizziness);

from digestive tract: digestion disturbance, heartburn, abdominal distention, meteorism, anorexia, nausea, vomiting, diarrhea;

from system of a respiratory organs: asthma;

from a musculoskeletal system: arthralgia;

from an urinary system: increase in a diuresis;

allergic reactions: enanthesis, alopecia, itch.

The side reactions arising at drug use passing also disappear after drug withdrawal.


Interaction with other medicines:

Silymarinum oppresses system of P450 cytochrome, thereby strengthens effect of some medicines, namely:

- antiallergenic medicines (фексофенадин);

- gipokholesterinemichesky medicines (ловастатин);

- anticoagulants (клопидогрель, warfarin);

- antipsychotic medicines (to alprazola, diazepam, lorazepam);

- antifungal medicines (кетоконазол);

- some drugs for cancer therapy (vinblastine).

The oral contraceptives and drugs used at estrogenzamestitelny therapy – at simultaneous use with Silymarinum efficiency of these drugs decreases.


Contraindications:

Hypersensitivity to Silymarinum or to any of excipients. Chronic erosive and ulcer diseases of a stomach in an aggravation stage. Acute poisonings of a different etiology. Children's age up to 5 years.


Overdose:

Overdose cases were not observed by drug.

Treatment. At accidental reception of a high dose of drug it is necessary to cause vomiting, to wash out a stomach, to accept absorbent carbon. In case of need the symptomatic treatment is recommended.


Storage conditions:

Term godnosti2 years. To store in the place, unavailable to children, in original packaging at a temperature not above 25 °C.


Issue conditions:

Without recipe


Packaging:

On 10 tablets in a blister strip packaging, on 3, 5 or 10 blister strip packagings in a pack.



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