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Composition:


active ingredients: extract of the dry herb dymyanka officinalis (Fumaria officinalis L.), dry milk thistle fruit extract (Silybum marianum L. Gaetner);


1 capsule contains an extract of the dry herb dymyanka officinalis (Fumaria officinalis L., the ratio of medicinal plant raw materials and extract 4-6: 1, extractant: water) – 275.1 mg; extract of dried milk thistle fruit (Silybum marianum L. Gaetner, the ratio of medicinal plant raw materials and extract is 30-44:1, extractant: ethyl acetate) – 80-98 MG, which is equivalent to silymarin 50 mg;


excipients: microcrystalline cellulose, corn starch, copovidone, talc, macrogol, colloidal anhydrous Silicon Dioxide, Magnesium Stearate;


capsule shell composition: gelatin, titanium dioxide (e 171), black iron oxide (e 172), red iron oxide (e 172), yellow iron oxide (E 172).


Dosage form. Capsules.


Basic physical and chemical properties: solid gelatin capsules No. 0 of cylindrical shape of light brown color, filled with a mixture of powder from yellow-brown to dark brown color.


Pharmacotherapeutic group. Drugs used for diseases of the liver and biliary tract. Drugs used for biliary pathology. ATX code A05A X.


Pharmacological properties.


Pharmacodynamics.


Fumarta® is a combined herbal medicine containing dry dymyanka officinalis extract and dry milk thistle extract.


The composition of dymyanka officinalis extract includes the alkaloid fumarin, which has a choleretic effect, normalizes bile secretion, reduces the tone of the Oddi sphincter. Milk thistle extract contains silymarin, a bioflavonoid that includes the isomers silibinin, silidianin, and silicristin. Silymarin has a hepatoprotective effect in acute and chronic intoxications, has membrane-stabilizing properties and promotes the restoration of liver cells.


Pharmacokinetics.


After oral administration, silymarin is mainly eliminated from the bile and is subject to enterohepatic circulation.


Clinical characteristics.


Indications.


Additional treatment of patients with biliary dyskinesia (including after cholecystectomy) and concomitant chronic liver diseases.


Contraindications.


Acute inflammatory diseases of the liver, biliary tract and gallbladder; acute hepatitis and cholangitis; acute poisoning of various etiologies; cholelithiasis; biliary tract obstruction; children and adolescents under 18 years of age; pregnancy and lactation.


Interactions with other drugs and other types of interactions.


With the simultaneous use of drugs containing Silymarin, and oral contraceptives and drugs used in estrogen replacement therapy, it is possible to reduce the effectiveness of the latter.


The drug can enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine, fexofenadine, clopidogrel, warfarin, by inhibiting the cytochrome P450 system.


Herbal products containing silymarin are widely used as hepatoprotectors in oncological practice simultaneously with cytostatics. Clinical studies show a small risk of possible pharmacokinetic interactions of Silymarin as an inhibitor of the CYP3A4 and UGT1A1 isoenzymes and cytostatics, which are substrates of these enzymes.


It is forbidden to drink alcohol when using the drug.


Application features.


General principles of treatment of liver parenchymal diseases – diet, rest and Prohibition of alcohol consumption, which should not be ignored.


For the elderly, dosage adjustment of the drug is not necessary.


Due to the possible estrogen-like effect of Silymarin in the highest possible doses, it should be used with caution in patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma). In these cases, you should consult your doctor.


If jaundice develops (the appearance of light yellow to dark yellow skin tone, yellowing of the whites of the eyes), it is necessary to consult a doctor for correction of therapy.


Use during pregnancy or lactation.


Do not use during pregnancy and/or lactation due to insufficient clinical data.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


It doesn't affect you. Patients with existing vestibular disorders should use the drug with caution when driving vehicles or working with other mechanisms.


Dosage and administration.


Take Fumarta®capsules with a meal. The capsule should be swallowed whole, without chewing, and washed down with a sufficient amount of liquid.


Adults are recommended to take Fumarta® 1 capsule 3 times a day.


In the presence of nighttime pain, an additional 1 capsule is recommended before bedtime. If necessary, increase the daily dose of the drug to a maximum of 6 capsules (2 capsules 3 times a day).


The course of treatment is determined by the doctor individually, depending on the nature and course of the disease.


If there is no improvement after prolonged use (2 weeks), you should seek medical attention.


Children.


Do not use in children (under 18 years of age) due to insufficient data on the safety and efficacy of the drug.


Overdose.


No cases of overdose were observed. In case of overdose, diarrhea and abdominal pain are possible. In this case, you should stop using the drug.


Treatment is symptomatic.


Adverse reactions.


Frequency of adverse reactions according to MedDRA classification: rare (≥1/10, 000 –


From the digestive tract: dry mouth, nausea, vomiting, dyspepsia, heartburn, mild diarrhea (rare).


From the urinary system: increased diuresis.


Immune system disorders: allergic reactions, including hives, skin rashes, pruritus, anaphylactic reactions, difficulty breathing (very rare).


Vascular disorders: hot flashes.


From the skin and subcutaneous tissue: increased alopecia; skin rashes (very rare).


Nervous system disorders: headache.


Others: increased existing vestibular disorders.

Tags: Fumarta