Fumarata capsules 20 pcs.

One capsule contains (active ingredients):

• dry extract of medicinal ruta herb (Fumaria officinalis L., ratio of medicinal plant raw materials and extract 4-6: 1, extractant: water) – 275.1 mg;
• extract of dry milk thistle fruit (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).

• 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 poisonings of various etiologies;
• gallstone disease;
• biliary tract obstruction;
• children and adolescents under 18 years of age;
• pregnancy and breastfeeding.

Take Fumarata capsules with meals. The capsule should be swallowed whole, without chewing, and washed down with sufficient liquid.

Adults are recommended to take one capsule of Fumarata 3 times a day.

In case of night pain, it is recommended to take one additional capsule before going to bed. If necessary, the daily dose of the drug can be increased to the maximum – 6 capsules (two 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 (two weeks), you should seek medical attention.

Pregnant women

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

Children

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

Drivers

The drug does not affect the reaction speed when driving or using other mechanisms. Patients with existing vestibular disorders should use the drug with caution when driving or using other mechanisms.

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.

Frequency of adverse reactions according to MedDRA classification: rare (≥ 1/10,000 – <1/1000), very rare (<1/10,000), including isolated cases.

Gastrointestinal tract: dry mouth, nausea, vomiting, dyspepsia, heartburn, mild diarrhea (rare).

From the urinary system: increased diuresis.

On the part of the immune system: allergic reactions, including urticaria, skin rash, itching, anaphylactic reactions, difficulty breathing (very rare).

Vascular disorders: hot flashes.

Skin and subcutaneous tissue disorders: increased alopecia; skin rash (very rare).

From the nervous system: headache.

Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life – 2 years.