Expiration date: 10/2025

Release form and composition:

Tablets, coated (sugar) white, round, lenticular, with an almost imperceptible odor.

1 tablet contains:

hyoscine butylbromide 10 mg

Excipients: calcium hydrogen phosphate (calcium gidrogenfosfat anhydrous), corn starch dried, potato starch hydrolyzed (soluble starch), silica colloidal anhydrous, tartaric acid, stearic acid.

Shell composition: povidone (polyvinylpyrrolidone), sucrose, talc, acacia gum (Arabian gum), titanium dioxide, macrogol 6000 (polyethylene glycol 6000), Carnauba wax, white beeswax (white wax).

10 PCs. - blisters (1) - packs of cardboard.

10 PCs. - blisters (2) - packs of cardboard.

20 PCs. - blisters (1) - packs of cardboard.

20 PCs. - blisters (2) - packs of cardboard.

Pharmacological action:

Blocker m-holinoretseptorov. Has antispasmodic effect on smooth muscles of internal organs, decreases the secretion of digestive glands. Do not cross the BBB (since hyoscine butylbromide is a Quaternary ammonium derivative), so there is no anticholinergic effects on the CNS.

Pharmacokinetics:

Suction

After intake of poorly absorbed from the gastrointestinal tract.

Distribution

Linking blood plasma low.

The highest quantity of active substance present in the gastrointestinal tract, gall bladder, bile ducts, kidneys, uterus.

Indications:

— spastic dyskinesia biliary tract and gall bladder (including renal colic, biliary colic, intestinal colic, cholecystitis, pilorospazme)

— stomach ulcer and duodenal ulcer in acute phase (in the complex therapy)

— algomenorrhea.

Dosing regimen:

Adults and children over 6 years assign inside of 1-2 tablets. 3-5 times/day.

The tablets should be taken orally with water.

Side effects:

Side effects associated with holinoblokirutm action of the drug: dry mouth, dry skin, tachycardia, possible urinary retention (usually mild and resolves on its own).

Allergic reactions: in rare cases, - skin manifestations, anaphylaxis with episodes of shortness of breath.

Contraindications:

— myasthenia gravis

— megacolon

— children up to age 6 years

— hypersensitivity to the drug.

Pregnancy and lactation:

The use of the drug during pregnancy and lactation (breastfeeding) is possible only in the case when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Special instructions:

Be wary appoint drug in cases of suspected intestinal obstruction (including pyloric stenosis), when obstruction of the urinary tract (including prostate cancer), the propensity to tachyarrhythmia (including atrial fibrillation), angle-closure glaucoma.

Buscopan tablet contains 41.2 mg of sucrose. Maximum recommended daily dose contains 411.8 mg sucrose.

Overdose:

Currently, the cases of drug overdose Buscopan® is not described, so the following symptoms and recommendations are theoretical.

Symptoms: possible anticholinergic effects - urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility, and transient visual disturbances.

Treatment: gastric lavage with activated charcoal and then a 15% solution of magnesium sulfate. Further shows the use of cholinomimetics. In glaucoma topically administered pilocarpine (eye drops). If necessary, designate holinomimetiki for systemic use (for example, injected into the/m or/in the dose of neostigmine 0.5-2.5 mg), cardiovascular complications are treated according to the usual therapeutic rules supportive and symptomatic therapy if paralysis of respiratory muscles - intubation and mechanical ventilation if urinary retention - catheterization of the bladder.

Drug interactions:

Buscopan® can enhance the anticholinergic effect of tricyclic antidepressants, antihistamines, quinidine, amantadine, disopyramide, anticholinergic drugs (e.g., tiotropiya bromide, ipratropium bromide).

The simultaneous use of Buscopan and dopamine antagonists (e.g. metoclopramide) leads to a weakening action on the gastrointestinal tract of both drugs.

Buscopan® can potentiate tachycardia caused by beta-agonists.

Terms and conditions of storage:

The drug should be stored out of reach of children at temperature not exceeding 25°C. shelf Life - 5 years.