RAFACHOLIN C

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RAPHACHOLINC (RAFAHOLIN C)

Composition:

Active substances: 1 tablet contains: dry extract of black radish (Raphani sativi nigri radicis) (15 – 21:1) with activated charcoal (1:1) 150 mg (extractant ethanol 85%); extract of artichoke herb, thick (Cynarae herbae) 47 mg (extractant ethanol 50%); dehydrocholic acid 40 mg; peppermint oil 15 mg;

Excipients: sucrose, povidone, microcrystalline cellulose, gum arabic (E 414), calcium hydrogen phosphate dihydrate, anhydrous colloidal silicon dioxide, talc, magnesium stearate, pigment Pigment Blend PB-277000: iron oxide black (E 172), titanium dioxide (E 171).

Pharmaceutical form. Coated tablets.

Main physicochemical properties:

Round, biconvex tablets with a glossy surface, coated with a black film.

In cross-section – a black core surrounded by white and black coating.

Pharmacotherapeutic group.

Agents used in liver and biliary tract disorders. Medicinal products used in biliary pathology.

ATC code A05AX.

Pharmacological properties.

Pharmacodynamics. The combination drug exerts a choleretic effect and stimulates the bile-forming function of the liver. The drug directly affects the liver, stimulates secretory functions, and increases bile production. It has a protective effect on the liver parenchyma, enhances intestinal peristalsis, and also exerts spasmolytic and diuretic actions.

Clinical characteristics.

Indications.

Dyspeptic disorders, hypotonic biliary dyskinesia.

Contraindications.

Increased individual sensitivity to the components of the drug or to other plants of the Asteraceae family. Severe liver diseases, severe hepatic insufficiency, biliary tract obstruction (including obstruction, stenosis), acute and chronic inflammation of the stomach and intestines, cholelithiasis, empyema of the gallbladder.

Interaction with other medicinal products and other forms of interaction.

In high doses, may cause hypokalemia when used concomitantly with antihypertensive and diuretic agents.

When used simultaneously with hypolipidemic agents, the effect of Rafaholin C is enhanced.

Special precautions for use.

Use with caution in diseases that may lead to biliary tract obstruction.

Patients with gastroesophageal reflux (heartburn) should avoid using peppermint leaves, as heartburn may increase.

If disease symptoms do not resolve or recur persistently, as well as in case of diarrhea or abdominal pain, treatment with the medicinal product should be discontinued and medical advice should be sought.

The medicinal product must not be used in acute kidney diseases.

The medicinal product contains sucrose; therefore, it should not be used in patients with hereditary fructose intolerance, glucose/galactose malabsorption, or sucrose/isomaltase deficiency.

Diabetic patients should take into account that the medicinal product contains sucrose.

Use during pregnancy or breastfeeding.

Safety during pregnancy or breastfeeding has not been studied; therefore, use of the medicinal product is not recommended during these periods.

Ability to influence reaction rate when driving or operating machinery.

Does not influence.

Dosage and Administration.

The medicine is intended for oral use.

For children aged 12 years and older and adults: 1 or 2 tablets three times daily after meals.

For abdominal bloating: adults should take 2 tablets in the morning and evening, half an hour before meals.

Children.

Clinical studies on the use of the medicine in children under 12 years of age have not been conducted.

Overdose.

Symptoms: vomiting, diarrhea, headache, facial flushing, respiratory disturbances, cardiac arrhythmia, tachycardia, excitement, muscle contractions, fatigue, nausea, or intensification of adverse effects.

Treatment: Discontinue the medicine. Symptomatic therapy.

Side effects.

Gastrointestinal disorders: diarrhea / loose stools, biliary colic, epigastric discomfort, gastroesophageal reflux, heartburn, nausea.

Immune system disorders: allergic reactions (including hyperemia, rash, itching, skin swelling, urticaria, contact dermatitis).

If allergic reactions occur, discontinue use of the drug and consult a physician.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in a dry, dark-protected place.

Keep out of reach of children.

Packaging.

30 tablets in a blister pack. 1 blister pack in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Wroclaw Herb Pharmaceutical Company "Herbapol" S.A.

Manufacturer's address.

65/68, St. Nicholas Street, 50-951 Wroclaw, Poland.