Rafacholin C film-coated tablets blister pack No. 30

Instructions for Rafaholin C film-coated tablets blister pack No. 30

Composition

active ingredients: 1 tablet contains: dry black radish extract (Raphani sativi nigri radicis) (15 – 21:1) with activated charcoal (1:1) 150 mg (extractant ethanol 85%); artichoke herb extract (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, colloidal anhydrous silicon dioxide, talc, magnesium stearate, Pigment Blend PB-277000 dye: black iron oxide (E 172), titanium dioxide (E 171).

Dosage form

Film-coated tablets.

Main physicochemical properties:

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

On the break, there is a black core surrounded by a white and black shell.

Pharmacotherapeutic group

Drugs used in diseases of the liver and biliary tract. Drugs used in cases of biliary pathology.

ATX code A05A X.

Pharmacological properties

Pharmacodynamics. The complex drug has a choleretic effect and stimulates the bile-forming function of the liver. The drug directly affects the liver, stimulates secretory functions and increases the amount of bile. It has a protective effect on the liver parenchyma, enhances intestinal peristalsis, and also has antispasmodic and diuretic effects.

Indication

Dyspeptic phenomena, hypotonic dyskinesia of the gallbladder.

Contraindication

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

Interaction with other medicinal products and other types of interactions

In high doses with antihypertensives and diuretics may cause hypokalemia.

When used simultaneously with hypocholesterolemic agents, the effect of Rafacholin C is enhanced.

Application features

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

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

If the symptoms of the disease do not disappear or constantly recur, as well as in the event of diarrhea or abdominal pain, treatment with the drug should be discontinued and a doctor should be consulted.

The drug should not be used in acute kidney disease.

The drug contains sucrose, so it should not be used in patients with hereditary fructose intolerance, glucose/galactose and sucrose/isomaltose.

Patients with diabetes should take into account that the drug contains sucrose.

Use during pregnancy or breastfeeding

The safety of use during pregnancy or breastfeeding has not been studied, therefore the use of the drug is not recommended during this period.

Ability to influence reaction speed when driving vehicles or other mechanisms

No effect.

Method of administration and doses

The drug is intended for internal use.

Children over 12 years of age and adults are prescribed 1 or 2 tablets 3 times a day after meals.

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

Children

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

Overdose

Symptoms: vomiting, diarrhea, headache, facial flushing, respiratory distress, heart rhythm disturbances, tachycardia, agitation, muscle contractions, feeling tired, nausea, or increased side effects.

Treatment. Drug withdrawal. Symptomatic therapy.

Side effects

On the part of the digestive tract: diarrhea/loose stools, biliary colic, epigastric discomfort, gastroesophageal reflux, heartburn, nausea.

On the part of the immune system: allergic reactions (including hyperemia, rash, itching, skin edema, urticaria, contact dermatitis).

If allergic reactions occur, you should stop taking the drug and consult a doctor.

Expiration date

3 years.

Storage conditions

Store at a temperature not exceeding 25 °C in a dry place, protected from light.

Keep out of reach of children.

Packaging

30 tablets in a blister. 1 blister in a carton.

Vacation category

Without a prescription.

Producer

Wroclaw Medicinal Herbs Enterprise "Herbapol" JSC.

Address

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