Storage:
active substance: drotaverine;
1 tablet contains drotaverine hydrochloride 80 mg;
excipients: lactose, monohydrate; potato starch; povidone; magnesium stearate; croscarmellose sodium.
Pharmaceutical form. Tablets.
Main physicochemical properties: tablets from light yellow to yellowish-green color.
Pharmacotherapeutic group. Means used in functional gastrointestinal disorders
Clinical characteristics.
Indication.
For the treatment of:
– spasms of smooth muscles associated with diseases of the biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis;
– spasms of smooth muscles in diseases of the urinary tract: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder tenesmus.
As an auxiliary treatment for:
– spasms of the smooth muscles of the gastrointestinal tract: peptic ulcer disease of the stomach and duodenum, gastritis, cardio- and/or pylorospasm, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome accompanied by flatulence;
– tension headache;
– gynecological diseases (dysmenorrhea).
Contraindication.
Hypersensitivity to drotaverine or any component of the drug. Severe liver, kidney or heart failure (low cardiac output syndrome). Lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome.
Interaction with other medicinal products and other types of interactions.
Phosphodiesterase inhibitors, such as papaverine, reduce the antiparkinsonian effect of levodopa. The drug should be used with caution at the same time as levodopa, since the antiparkinsonian effect of the latter decreases, and rigidity and tremor increase.
Method of application and dosage.
Adults: The usual average dose is 120-240 mg per day in 2-3 doses.
Children over 12 years of age: if necessary, as prescribed by a doctor, the maximum daily dose is 160 mg (divided into 2-4 doses).
To achieve the prescribed doses of the drug, dosage forms of drotaverine with the appropriate content of the active substance should be used.
The duration of treatment is determined by the doctor individually.
Children. The use of the drug for the treatment of children under the age of 12 is contraindicated.
Overdose.
Symptoms: With a significant overdose of drotaverine, disturbances of cardiac rhythm and conduction, including complete blockade of the His bundle and cardiac arrest, have been observed, which can be fatal.
In case of overdose, the patient should be under the close supervision of a doctor and receive symptomatic and supportive treatment. It is recommended to induce vomiting and/or wash the stomach.
Expiry date. 5 years.
Storage conditions. Store in the original packaging at a temperature not higher than 25 °C.
Keep out of the reach of children.
Packaging. Tablets No. 10, No. 10×2, No. 20 in a blister in a box.
Leave category. Without a prescription.
Producer.
Limited Liability Company “Experimental Plant “GNTSLS”.
Limited Liability Company “Pharmaceutical Company “Zdorovya”.
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