Buscopan tablets p / o 10mg, No. 20

• Renal colic,

• biliary colic

• spastic dyskinesia of the biliary tract and gallbladder,

• cholecystitis,

• intestinal colic,

• pylorospasm,

• peptic ulcer of the stomach and duodenum in the acute phase (as part of complex therapy), algodismenorrhea.

Inside.

Unless otherwise prescribed by a doctor, the following dosing regimen is recommended:

Adults and children over 6 years old: 1-2 tablets 3-5 times a day with water.

The drug should not be used daily for more than 3 days without consulting a doctor.

1 tablet contains 10 mg of hyoscine butyl bromide

Excipients: calcium hydrogen phosphate anhydrous (calcium hydrogen phosphate) 33 mg; dried corn starch 30 mg; soluble starch (hydrolyzed potato starch) 2 mg; colloidal silicon dioxide 4 mg; tartaric acid 0.5 mg; stearic acid 0.5 mg.
Sheath: povidone (polyvinylpyrrolidone) 0.505 mg; sucrose 41.182 mg; talc 23.671 mg; gum arabic (acacia gum) 2,761 mg; titanium dioxide 1.802 mg; macrogol 6000 (polyethylene glycol) 0.055 mg; carnauba wax 0.012 mg; white wax (white beeswax) 0.012 mg.

• Hypersensitivity to hyoscine butyl bromide or any other component of the drug.

• Myasthenia gravis, megacolon.

• Children under 6 years old.

• Pregnancy, lactation.

• Buscopan tablet contains 41.2 mg sucrose. The maximum recommended daily dose (10 tablets) contains 411.8 mg of sucrose. Patients with rare hereditary disorders (fructose intolerance), such as glucose-galactose malabsorption or sucrase-isomaltase deficiency, should not take the drug.

With care The
drug should be prescribed with caution in the following clinical situations: suspicion of intestinal obstruction (including pyloric stenosis); obstruction of the urinary tract (including benign prostatic hyperplasia), tachyarrhythmias (including atrial fibrillation), angle-closure glaucoma.

In cases where abdominal pain of unknown origin continues or intensifies, or when symptoms such as fever, nausea, vomiting, changes in stool consistency and frequency of bowel movements, abdominal tenderness, decreased blood pressure, fainting or blood in the stool are simultaneously noted, it is necessary immediately seek medical advice.

Trademarked name: Buscopan

MNI or Group Name: hyoscine butyl bromide

Dosage form:

film-coated tablets

Composition:

1 tablet contains 10 mg of hyoscine butyl bromide

Excipients: calcium hydrogen phosphate anhydrous (calcium hydrogen phosphate) 33 mg; dried corn starch 30 mg; soluble starch (hydrolyzed potato starch) 2 mg; colloidal silicon dioxide 4 mg; tartaric acid 0.5 mg; stearic acid 0.5 mg.
Sheath: povidone (polyvinylpyrrolidone) 0.505 mg; sucrose 41.182 mg; talc 23.671 mg; gum arabic (acacia gum) 2,761 mg; titanium dioxide 1.802 mg; macrogol 6000 (polyethylene glycol) 0.055 mg; carnauba wax 0.012 mg; white wax (white beeswax) 0.012 mg.

Description:

White, round, biconvex sugar-coated tablets. The smell is almost imperceptible

Pharmacological group: m-anticholinergic

Pharmacological properties
Has a local spasmolytic effect on the smooth muscles of internal organs (gastrointestinal tract, biliary tract, urinary tract), reduces the secretion of the digestive glands. The local antispasmodic effect is explained by the ganglion-blocking and antimuscarinic activity of the drug. As a quaternary ammonium derivative, hyoscine butyl bromide does not penetrate the blood-brain barrier, therefore there is no anticholinergic effect on the central nervous system.

Pharmacokinetics
As a quaternary ammonium derivative with high polarity, hyoscine butyl bromide is slightly absorbed from the gastrointestinal tract. After oral administration, the absorption of the drug is 8%. The average absolute bioavailability is less than 1%. After a single oral administration of hyoscine butylbromide in doses of 20-400 mg, the average peak plasma concentrations were reached after about 2 hours and ranged from 0.11 to 2.04 ng / ml. Hyoscine butyl bromide, due to its high affinity for muscarinic and nicotinic receptors, is distributed mainly in the muscle cells of the abdominal and pelvic organs, as well as in the intramural ganglia of the abdominal organs. The connection with plasma proteins (albumin) is low and amounts to about 4.4%. Establishedthat the drug (at a concentration of 1 mmol) in vitro interacts with the transport of choline (1.4 nmol) in the epithelial cells of the human placenta.

The terminal half-life of the drug after a single oral administration in doses of 100-400 mg ranged from 6.2 to 10.6 hours. Metabolism is carried out mainly by hydrolysis of the ether bond. After oral administration, the drug is excreted in feces and urine. After oral administration: renal elimination is from 2 to 5%, elimination through the intestine is 90%. Renal excretion of metabolites of hyoscine butyl bromide is less than 0.1% of the dose. After oral administration of the drug in doses of 100-400 mg, the average clearance values ??are from 881 to 1420 l / min, while the corresponding volumes of distribution for the same dose range vary from 6.13 to 11.3 x 105 l, which may be explained by the low systemic bioavailability.

Urinary metabolites bind weakly to muscarinic receptors, so they are inactive and have no pharmacological properties.

Indications for use

• Renal colic,

• biliary colic

• spastic dyskinesia of the biliary tract and gallbladder,

• cholecystitis,

• intestinal colic,

• pylorospasm, i

• peptic ulcer of the stomach and duodenum in the exacerbation phase (as part of complex therapy),

• algodismenorrhea.

Contraindications

• Hypersensitivity to hyoscine butyl bromide or any other component of the drug.

• Myasthenia gravis, megacolon.

• Children under 6 years old.

• Pregnancy, lactation.

• Buscopan tablet contains 41.2 mg sucrose. The maximum recommended daily dose (10 tablets) contains 411.8 mg of sucrose. Patients with rare hereditary disorders (fructose intolerance), such as glucose-galactose malabsorption or sucrase-isomaltase deficiency, should not take the drug.

With care The
drug should be prescribed with caution in the following clinical situations: suspicion of intestinal obstruction (including pyloric stenosis); obstruction of the urinary tract (including benign prostatic hyperplasia), tachyarrhythmias (including atrial fibrillation), angle-closure glaucoma.

In cases where abdominal pain of unknown origin continues or intensifies, or when symptoms such as fever, nausea, vomiting, changes in stool consistency and frequency of bowel movements, abdominal tenderness, decreased blood pressure, fainting or blood in the stool are simultaneously noted, it is necessary immediately seek medical advice.

Fertility, pregnancy and lactation

Data on the use of the drug during pregnancy and on the penetration of the drug and its metabolites into breast milk are limited.
Studies on the effect of the drug on fertility have not been conducted.
As a precautionary measure, the use of the drug during pregnancy and lactation is not recommended.

Method of administration and dosage

Inside.

Unless otherwise prescribed by a doctor, the following dosing regimen is recommended:

Adults and children over 6 years old: 1-2 tablets 3-5 times a day with water.

The drug should not be used daily for more than 3 days without consulting a doctor.

Side effects

Many of the listed undesirable effects can be associated with the anticholinergic properties of the drug. Anticholinergic side effects are usually mild and go away on their own.

Immune system disorders:
Anaphylactic shock, anaphylactic reactions, shortness of breath, skin reactions (eg, urticaria, rash, erythema, pruritus) and other manifestations of hypersensitivity

On the part of the cardiovascular system:
Tachycardia

From the digestive system:
dry mouth

On the part of the skin and subcutaneous tissues:
Dyshidrotic eczema

From the urinary system:
urinary retention.

Drug interactions

Buscopan can enhance the anticholinergic effect of tricyclic and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine and disopyramide and anticholinergics (for example, tiotropium bromide, ipratropium bromide, atropine-like use of anaphylamines) the action of both drugs on the gastrointestinal tract. Buscopan can increase tachycardia caused by beta-adrenergic drugs.

Overdose

Until now, cases of overdose with buscopan have not been described, so the following symptoms and recommendations are theoretical.

Symptoms
Anticholinergic symptoms are possible: urinary retention, dry mouth, skin redness, tachycardia, suppression of gastrointestinal motility, and transient visual impairment.

Treatment
Symptoms of an overdose with buscopan are controlled by cholinomimetics. Glaucoma patients are prescribed pilocarpine in the form of eye drops. If necessary, cholinomimetics are administered systemically, for example, neostigmine 0.5-2.5 mg intramuscularly or intravenously. Cardiovascular complications are treated according to the usual therapeutic guidelines. With paralysis of the respiratory muscles, intubation, artificial ventilation of the lungs is indicated. In case of urinary retention, the bladder is catheterized. Supportive therapy is underway.

Effects on the ability to drive vehicles and use machinery

Studies on the effect of the drug on the ability to drive vehicles and use mechanisms have not been conducted.

Release form

Coated tablets 10 mg
10 or 20 tablets in a blister made of PVC / AI) -foil.
1 or 2 blisters with instructions for use in a cardboard box.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 25 ? C.

Shelf life is 3 years.

Do not use after the expiration date.

Conditions of dispensing from pharmacies

The drug is dispensed without a prescription.