Active ingredient: papaverine hydrochloride.

1 suppository contains papaverine hydrochloride 20 mg;

Excipient: solid fat.

Main physical and chemical properties: white or cream-coloured suppositories. The cut may contain an air-porous core and a dimpled pit.

Pharmacodynamics.

Papaverine hydrochloride is a myotropic spasmolytic agent. It inhibits the synthesis of phosphodiesterase, which leads to the accumulation of cyclic 3,5-AMP in the cell and a decrease in Ca content. Relaxes smooth muscles of internal organs (digestive tract, respiratory tract, urogenital system) and blood vessels.

In large doses, it reduces the excitability of the heart muscle, slows down intracardiac conduction.

Pharmacokinetics.

The bioavailability of the medicine after rectal administration is about 25%. Papaverine binds to plasma proteins (about 90%). Papaverine is metabolised by the liver and excreted in the urine as glucuronide.

Drugs used in functional disorders of the digestive tract.

ATC code A03A D01.

Hypersensitivity to certain components of the medicine. Atrioventricular block, glaucoma, severe hepatic impairment, respiratory depression, bronchial obstructive syndrome, arterial hypotension, coma, concomitant use of monoamine oxidase inhibitors (MAOIs), elderly age (risk of hyperthermia), children’s age.

Spasm of smooth muscles: abdominal organs (in case of cholecystitis, pylorospasm, spastic colitis, renal colic); peripheral vessels (in case of endarteritis); brain vessels.

The medicine reduces the antiparkinsonian effect of levodopa and the hypotensive effect of methyldopa. The antispasmodic effect of papaverine is enhanced by diphenhydramine (Dimedrol), metamizole (analgin), diclofenac. The antihypertensive effect is enhanced by concomitant use with antihypertensive drugs of other groups. When used concomitantly with cardiac glycosides, there is a marked increase in myocardial contractility due to a decrease in total peripheral vascular resistance. Concomitant use with novocainamide, tricyclic antidepressants, procainamide, reserpine, quinidine sulfate may increase the hypotensive effect.

The tonic effect of anticholinesterase drugs on smooth muscle may be reduced under the influence of papaverine hydrochloride.

The spasmolytic activity of papaverine hydrochloride may be reduced under the influence of morphine. However, papaverine hydrochloride should be used in combination with morphine hydrochloride to reduce the spasmogenic effect of the latter and with promethol in pain associated with smooth muscle spasms.

There is evidence of hepatitis development in combination with furadonin.

Papaverine hydrochloride potentiates the effect of alcohol.

In patients who smoke, papaverine metabolism is accelerated, and its plasma concentration and pharmacokinetic effects are reduced. It is pharmaceutically compatible with dibazole.

The antispasmodic effect of the drug is enhanced by concomitant use with barbiturates.

The drug should be administered with caution and in low doses to weakened patients, in conditions after traumatic brain injury, chronic renal failure, adrenal insufficiency, hypothyroidism, prostatic hyperplasia, supraventricular tachycardia, shock.

Alcohol consumption should be avoided during the period of use. The vasodilator effect is reduced by smoking.

Use during pregnancy and lactation.

Safety of use has not been established. The use of the drug during pregnancy is possible only as prescribed by a physician if the expected benefit to the mother outweighs the potential risk to the fetus and child. It is recommended to discontinue breastfeeding during treatment.

The ability to influence the reaction rate when driving vehicles or using other mechanisms.

It should be used with caution in case of side effects from the nervous system.

The suppository should be inserted deeply into the anus after a cleansing enema or natural bowel movement.

Adults take 1 suppository 2-3 times a day.

The duration of use depends on the severity and course of the disease and is determined by the physician individually.

Do not use the medicine in children.

Symptoms: diplopia, weakness, drowsiness, arterial hypotension, dry mouth, digestive tract disorders, visual disturbances, redness of the skin of the upper body, tachycardia, asystole, ventricular flutter, collapse, hyperventilation, nystagmus, ataxia; arrhythmia or complete atrioventricular block; papaverine hydrochloride in very high doses has a moderate sedative effect.

Treatment: discontinuation of the drug, symptomatic treatment. There is no specific antidote. It is completely removed from the blood by haemodialysis.

• From the skin and subcutaneous tissue: allergic reactions, skin hyperemia, urticaria, itching, skin rash, anaphylactic shock.
• From the hematopoietic system: eosinophilia.
• From the heart: atrioventricular block, arrhythmia, ventricular fibrillation, ventricular extrasystole, tachycardia, asystole, ventricular flutter, collapse.
• From the vascular system: arterial hypotension.
• From the nervous system: drowsiness, weakness, headache, dizziness; apnea.
• From the organs of vision: visual impairment (diplopia).
• From the digestive tract: increased activity of hepatic transaminases, jaundice, nausea, diarrhea, constipation, anorexia, dry mouth.
• Other: increased sweating.

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

Keep out of the reach of children.

2 years.

5 suppositories in a blister. 2 blisters in a cardboard box.

Without a prescription.