Instructions for Fumarate capsules blister No. 20
Composition
active ingredients: dry extract of medicinal rutabaga herb (Fumaria officinalis L.), dry extract of milk thistle fruits (Silybum marianum L. Gaetner); 1 capsule contains dry extract of medicinal rutabaga herb (Fumaria officinalis L., ratio of medicinal plant raw materials and extract 4–6:1, extractant: water) – 275.1 mg; dry extract of milk thistle fruits (Silybum marianum L. Gaetner, ratio of medicinal plant raw materials and extract 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. Main physicochemical properties: hard gelatin capsules No. 0, cylindrical in shape, light brown in color, filled with a mixture of powder from yellow-brown to dark brown in color.
Pharmacotherapeutic group
Drugs used in diseases of the liver and biliary tract. Drugs used in biliary pathology. ATX code A05A X.
Pharmacological properties
Pharmacodynamics. Fumarta® is a combined herbal medicine containing dry extract of rue and dry extract of milk thistle. The extract of rue contains the alkaloid fumarin, which has a choleretic effect, normalizes bile secretion, and reduces the tone of the sphincter of Oddi. Milk thistle extract contains silymarin, a bioflavonoid that includes isomers silibinin, silidianin, and silychristin. Silymarin has a hepatoprotective effect in acute and chronic intoxications, has membrane-stabilizing properties, and promotes the regeneration of liver cells. Pharmacokinetics. After oral administration, silymarin is mainly eliminated with bile and is subject to enterohepatic circulation.
Indication
Additional treatment of patients with biliary dyskinesia (including after cholecystectomy) and with concomitant chronic liver diseases.
Contraindication
Hypersensitivity to the active substances or to other plants from the Asteraceae family or to any of the components of the drug; acute inflammatory diseases of the liver, biliary tract and gallbladder; acute hepatitis and cholangitis; acute poisoning of various etiologies; cholelithiasis; obstruction of the biliary tract; children and adolescents under 18 years of age; pregnancy and breastfeeding.
Interaction with other medicinal products and other types of interactions
With the simultaneous use of drugs containing silymarin and oral contraceptives and drugs used in estrogen replacement therapy, the effectiveness of the latter may decrease. The drug may enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine, fexofenadine, clopidogrel, warfarin, due to inhibition of the cytochrome P450 system. Herbal products containing silymarin are widely used as hepatoprotectors in oncological practice simultaneously with cytostatics. Clinical studies show a slight 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 while using the drug.
Application features
General principles of treatment of liver parenchymal diseases are diet, rest and prohibition of alcohol consumption, which should not be ignored. Dosage adjustment of the drug is not required for the elderly. 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, carcinoma of the breast, ovaries and uterus, carcinoma of the prostate gland). In these cases, consultation with a doctor is necessary. In the event of jaundice (appearance of a light yellow to dark yellow skin tone, yellowing of the whites of the eyes), it is necessary to consult a doctor to correct the therapy. Use during pregnancy or breastfeeding. Do not use during pregnancy and/or breastfeeding due to insufficient clinical data. Ability to affect the speed of reaction when driving or using other mechanisms. No effect. Patients with existing vestibular disorders should use the drug with caution when driving or operating other mechanisms.
Method of administration and doses
Fumarta® capsules should be taken with meals. The capsule should be swallowed whole, without chewing, and washed down with sufficient liquid. Adults are recommended to take Fumarta® 1 capsule 3 times a day. In the presence of night pain, it is recommended to additionally take 1 capsule before bedtime. If necessary, the daily dose of the drug should be increased to the maximum - 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 after prolonged use (2 weeks) there is no improvement, you should seek medical help. 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 have been observed. In case of overdose, diarrhea and abdominal pain are possible. In this case, the drug should be discontinued. Treatment is symptomatic.
Side effects
Frequency of adverse reactions according to MedDRA classification: rare (≥1/10,000 - <1/1000), very rare (<1/10,000), including isolated cases. From the digestive tract: dry mouth, nausea, vomiting, dyspepsia, heartburn, mild diarrhea (rare). From the urinary system: increased diuresis. From the immune system: allergic reactions, including urticaria, skin rash, itching, anaphylactic reactions, difficulty breathing (very rare). Vascular disorders: hot flashes. From the skin and subcutaneous tissue: increased alopecia; skin rash (very rare). From the nervous system: headache. Others: increased pre-existing vestibular disorders.
Expiration date
2 years. Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children.
Packaging
10 capsules in a blister. 2 or 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
