INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BONJIGAR (BONJIGAR)

Composition:

Active substances: 1 capsule contains:
Dry leaf extract of Eclipta alba (3.55:1) (extracting solvent – water) 70.4 mg;
Dry root and rhizome extract of Picrorrhiza kurroa (3.57:1) (extracting solvent – water) 28.0 mg;
Dry fruit extract of Solanum nigrum (3.47:1) (extracting solvent – water) 14.4 mg;
Dry seed extract of Cichorium intybus (3.64:1) (extracting solvent – water) 48.0 mg;
Dry root and rhizome extract of Glycyrrhiza glabra (3.57:1) (extracting solvent – water) 56.0 mg;
Dry fruit extract of Tamarix gallica (3.57:1) (extracting solvent – water) 28.0 mg;
Dry seed extract of Raphanus sativus (3.47:1) (extracting solvent – water) 14.4 mg;
Dry fruit extract of Berberis aristata (3.54:1) (extracting solvent – water) 42.4 mg;
Dry seed and leaf extract of Silybum marianum (3.57:1) (extracting solvent – water) 56.0 mg;
Dry fruit extract of Sphaeranthus indicus (3.47:1) (extracting solvent – water) 14.4 mg;
Dry leaf extract of Boerhavia diffusa (3.57:1) (extracting solvent – water) 28.0 mg;

Excipient: talc.

Pharmaceutical form. Capsules.

Main physicochemical properties: Size "0" capsules, dark brown in color, with imprint "BONJIGAR" on both body and cap, containing brown-colored powder.

Pharmacotherapeutic group. Agents used in biliary tract pathology.
ATC code: A05AX.

Pharmacological properties.

A complex herbal medicinal product whose effect is manifested due to the combined action of its components. The drug activates the detoxification function of the liver, accelerates the tricarboxylic acid cycle, promoting the elimination of protein metabolism products (including ammonia) from the body, and possesses hepatoprotective properties. It exerts an anti-inflammatory effect. Improves bile outflow. Prevents the formation of fatty deposits in the liver. Protects liver cells against the action of toxic substances (alcohol, D-galactosamine, carbon tetrachloride). Normalizes the metabolic function of the liver.

Clinical characteristics.

Indications. As part of complex therapy in chronic toxic hepatitis, and dysfunction of the gallbladder and biliary tract.

Contraindications. Hypersensitivity to the components of the medicinal product. Hypersensitivity to plants of the Asteraceae family (Cichorium intybus L.). Pregnancy, impaired kidney function, arterial hypertension, hypokalemia, severe obesity; organic heart lesions (myocarditis, pericarditis, myocardial infarction).

Acute poisonings of various etiologies.

If symptoms persist for more than 2 weeks, medical advice must be sought.

Interaction with other medicinal products and other types of interactions. Concurrent use with cardiac glycosides, antiarrhythmic agents (quinidine), thiazide and loop diuretics, adrenocorticosteroids, and laxatives may enhance hypokalemia.

Concomitant use of silymarin with oral contraceptives and drugs used in estrogen replacement therapy may result in reduced efficacy of the latter.

Due to inhibition of the cytochrome P450 system, silymarin may thereby enhance the effect of certain medicinal products, namely: antiallergic agents (fexofenadine); hypocholesterolemic agents (lovastatin); anticoagulants (clopidogrel, warfarin); antipsychotic agents (alprazolam, diazepam, lorazepam); antifungal agents (ketoconazole); and some anticancer drugs (vinblastine).

Special precautions for use.

In the presence of concrements in the biliary tract, the appropriateness of using the medicinal product should be considered depending on the size of the concrements (based on ultrasound findings).

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, uterus, or prostate cancer).

Use with caution in patients with severe renal function impairment, hypokalemia, or severe obesity. Prolonged use of the drug is not recommended. If jaundice develops, consult a physician for therapy adjustment.

Use during pregnancy or breastfeeding. The medicinal product is contraindicated during pregnancy because licorice root, one of its components, increases estrogen levels, thereby disrupting hormonal balance. If it is necessary to use the drug, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery. No effect.

Dosage and Administration.

For adults, administer 1 - 2 capsules twice daily after meals. The treatment course should last at least 2 weeks. Therapy should continue until symptoms of the disease disappear and enzyme levels return to normal. The duration of treatment is determined individually by a physician.

Children. Do not use in children.

Overdose. Symptoms: nausea, vomiting, weakness. Treatment is symptomatic.

Prolonged use (more than 2 months) may cause disturbances in water-electrolyte balance (including hypokalemia).

Side effects.

In isolated cases, allergic reactions may occur, including itching, skin rashes, skin hyperemia, angioneurotic edema, dyspnea; increased diuresis; dyspeptic symptoms, nausea, vomiting, diarrhea, disturbances in water-electrolyte balance (appearance of edema), increased blood pressure.

If any adverse reactions occur, discontinue use of the medicinal product and consult a physician immediately.

Reporting of suspected adverse reactions. Reporting suspected adverse reactions after medicinal product registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all cases of suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 20 or 60 capsules in a bottle No. 1, in a cardboard box.

Availability (dispensing category). Over-the-counter.

Manufacturer. Herbion Pakistan Private Limited

Herbion Pakistan Private Limited

Manufacturer's address and place of business.

Plot No. 30, Sector 28, Korangi Industrial Area, Karachi, Pakistan