Riabal tablets

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Riabal tablets
riaa

Selective anti-spasmodic drug.

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Composition
active substance: prifinium bromide;
Each tablet contains prifinium bromide 30 mg;
excipients: lactose, potato starch, povidone 30, silicon dioxide colloidal anhydrous, magnesium stearate, croscarmellose sodium, erythrosin (E 127);
coating: Instacoat Aqua II (IA-II-30107).
Pharmacotherapeutic group
Drugs for functional gastrointestinal disorders. Synthetic anticholinergics, quaternary ammonium compounds. АТС А03А В18.
Riabal selectively blocks peripheral muscarinic receptors of gastrointestinal, biliary and urinary tract mucosa, and endometrium. Riabal does not cross the blood-brain barrier. Selectively blocking muscarinic receptors it makes them resistant to acetylcholine formed in postganglionic parasympathetic nerve endings. It causes decreased smooth muscle tone of esophagus, intestine, gallbladder, bile ducts, urinary tract and uterus, and reduced pepsinia and hydrochloric acid secretion, decreased pancreatic exocrine function.
The long-term administration of Riabal has no negative impact on hepatic, renal and hematopoietic tissue functions.
The drug is poorly absorbed from the digestive tract. Its half-life period is 2.13 hours. Serum and renal clearance is 12.5 and 5.8 ml/ min/ kg, respectively. It is excreted in feces and urine.
Indications
Pain due to the gastrointestinal spasms and hypermotility: gastritis, gastro-duodenal ulcer, enteritis, colitis, post-gastrectomy syndrome.
Pain due to the bile duct spasm and dyskinesia: cholecystitis, and cholelithiasis. Pain due to pancreatitis.
Pain due to urinary tract spasm: lithureteria, vesical tenesmus, cystitis and pyelitis.
Premedication for gastric endoscopy and gastrointestinal radiography.
Dysmenorrhea.
Сontraindications
Hypersensitivity to prifinium bromide and any component of the preparation. Glaucoma, degree III prostatic hypertrophy, acute urinary retention.
Dosage and administration
Riabal tablets are administered orally.
Children at the age of 6-12 years old: 15-30 mg 2-3 times a day.
Children at the age of 12 years old and older and adults: 30-60 mg three times a day. In acute pain, 90mg as a single dose may be prescribed to adults. In case of necessity to administer prifinium bromide in a 15 mg dose it is prescribed as a syrup.
Side effects
Allergic reactions may develop in patients with hypersensitivity.
Skin disorders: angioedema, urticaria, hyperemia, rash, itching, flushed skin.
In rare cases the following reactions are possible:
Eye disorders: accommodation disorder, blurred vision;
Gastrointestinal disorders: dry mouth, constipation, nausea;
Cardiovascular disorders: flashes, tachycardia, hypertension;
Nervous system disorders: tremor, headache, asthenia;
Urinary tract disorders: urinary retention.
These symptoms, however, disappear after decreasing a dosage or discontinuing the medication.
Marketing authorization
UA/2908/03/01