Spazmonet tablets 40mg, No. 20

With spasms and pain (spastic nature) arising from the following conditions:

- spasm of smooth muscles of internal organs (renal colic, biliary colic, intestinal colic),

- with dyskinesia of the biliary tract and gallbladder of the hyperkinetic type, with cholecystitis, postcholecystectomy syndrome;

- pyelite;

- with spastic constipation, spastic colitis, proctitis, tenesmus;

- pylorospasm, gastroduodenitis, gastric ulcer and duodenal ulcer (in the acute phase, as part of complex therapy - to relieve spastic pain syndrome);

- with endarteritis,

- Spasm of peripheral, coronary arteries, as well as spasm of cerebral arteries, accompanied by headaches;

- algodismenorrhea;

- to reduce the excitability of the uterus during pregnancy (threatening miscarriage, threatening premature birth); spasm of the pharynx of the uterus during childbirth, prolonged opening of the pharynx, postpartum contractions.

To prevent the onset of spasm

- when carrying out some instrumental studies, cholecystography.

Inside, with a little liquid.

Children under 6 years of age in a single dose of 10-20 mg, the frequency of administration is 1-2 times a day, the maximum daily dose is 120 mg.

Children aged 6 to 12 years - 1/2 tablet 2 times a day (20 - 40 mg of drotaverine); the maximum daily dose is 200 mg.

Adults and children over 12 years old - 1-2 tablets 3 times a day (120-240 mg of drotaverine).

Active ingredient : drotaverine hydrochloride 40.0 mg

Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, croscarmellose sodium, colloidal anhydrous silicon dioxide, talc, magnesium stearate.

• Hypersensitivity

• severe renal and hepatic impairment,

• chronic heart failure

• atrioventricular block II and III degree,

• cardiogenic shock,

• arterial hypotension.

Spazmonet tablets contain lactose, therefore, patients with congenital galactose intolerance, lactose deficiency or glucose-galactose malabsorption should not take the drug.

Carefully

Children under 6 years of age, severe atherosclerosis of the coronary arteries, angle-closure glaucoma, prostatic hyperplasia.

Active substance

drotaverine

Dosage form

pills

Composition

Composition for one tablet.

Active ingredient : drotaverine hydrochloride 40.0 mg

Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, croscarmellose sodium, colloidal anhydrous silicon dioxide, talc, magnesium stearate.

Description

Tablets from light yellow with a greenish tinge to yellow with a greenish tinge, flat-cylindrical, with a score on one side and a chamfer. Marbling is allowed.

Pharmacotherapeutic group

Antispasmodic

ATX

A.03.AD02 Drotaverin

Pharmacodynamics

Drotaverine is a myotropic antispasmodic, in terms of chemical structure and pharmacological properties, it is close to papaverine, but has a stronger and longer-lasting effect. Reduces the flow of calcium ions into smooth muscle cells. Reduces the tone of smooth muscles of internal organs and intestinal motility, dilates blood vessels. Does not affect the autonomic nervous system, does not penetrate the central nervous system. The direct effect on smooth muscles allows it to be used as an antispasmodic when drugs from the group of M-anticholinergics are contraindicated (angle-closure glaucoma, prostatic hypertrophy).

Pharmacokinetics

When taken orally, absorption is high. Bioavailability is 100%. It is evenly distributed over the tissues, penetrates into smooth muscle cells. The maximum concentration in the blood reaches after 2 hours. Communication with blood plasma proteins - 80 - 90%. The half-life is 7-12 hours.
actively metabolized in the liver, excreted mainly by the kidneys, to a lesser extent with bile. Does not penetrate the blood-brain barrier.

Indications

With spasms and pain (spastic nature) arising from the following conditions:

- spasm of smooth muscles of internal organs (renal colic, biliary colic, intestinal colic),

- with dyskinesia of the biliary tract and gallbladder of the hyperkinetic type, with cholecystitis, postcholecystectomy syndrome;

- pyelite;

- with spastic constipation, spastic colitis, proctitis, tenesmus;

- pylorospasm, gastroduodenitis, gastric ulcer and duodenal ulcer (in the acute phase, as part of complex therapy - to relieve spastic pain syndrome);

- with endarteritis,

- Spasm of peripheral, coronary arteries, as well as spasm of cerebral arteries, accompanied by headaches;

- algodismenorrhea;

- to reduce the excitability of the uterus during pregnancy (threatening miscarriage, threatening premature birth); spasm of the pharynx of the uterus during childbirth, prolonged opening of the pharynx, postpartum contractions.

To prevent the onset of spasm

- when carrying out some instrumental studies, cholecystography.

Contraindications

• Hypersensitivity

• severe renal and hepatic impairment,

• chronic heart failure

• atrioventricular block II and III degree,

• cardiogenic shock,

• arterial hypotension.

Spazmonet tablets contain lactose, therefore, patients with congenital galactose intolerance, lactose deficiency or glucose-galactose malabsorption should not take the drug.

Carefully

Children under 6 years of age, severe atherosclerosis of the coronary arteries, angle-closure glaucoma, prostatic hyperplasia.

Pregnancy and lactation

Prescribing the drug during pregnancy and lactation is not contraindicated. It is prescribed with caution during pregnancy (I trimester) and during lactation.

Method of administration and dosage

Inside, with a little liquid.

Children under 6 years of age in a single dose of 10-20 mg, the frequency of administration is 1-2 times a day, the maximum daily dose is 120 mg.

Children aged 6 to 12 years - 1/2 tablet 2 times a day (20 - 40 mg of drotaverine); the maximum daily dose is 200 mg.

Adults and children over 12 years old - 1-2 tablets 3 times a day (120-240 mg of drotaverine).

Side effects

Nausea, dizziness, palpitations, fever, increased sweating, decreased blood pressure, allergic skin reactions.

Overdose

Symptoms in high doses disrupts atrioventricular conduction, reduces the excitability of the heart muscle, can cause cardiac arrest and paralysis of the respiratory center.

Interaction

With simultaneous use, it
can weaken the antiparkinsonian effect of levodopa.

Enhances the action of papaverine, bendazole and other antispasmodics (including M-anticholinergics), reduces blood pressure caused by tricyclic antidepressants, quinidine and procainamide.
increases the severity of the antispasmodic action of drotaverine.
reduces the spasmodic activity of morphine.

special instructions

In the treatment of gastric ulcer and duodenal ulcer, the drug is used in combination with other antiulcer drugs.

Impact on the ability to drive vehicles. Wed and fur.

During the period of use of the drug, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require concentration of attention and speed of psychomotor reactions.

Release form / dosage

Tablets, 40 mg.

Packaging

On 10 tablets in a blister strip packaging from a combined material (polyamide / aluminum foil / polyvinyl chloride) and printed aluminum foil varnished. 2 or 10 blisters, together with instructions for use, are placed in a cardboard box.

Storage conditions

At a temperature not exceeding 25 ? C, in its original packaging.
Keep out of the reach of children.

Shelf life

3 years.

Do not use the drug after the expiration date.

Conditions of dispensing from pharmacies

Without recipe