Buskospazm Neo (Tablets) Instructions for Use

Marketing Authorization Holder

Salvus, LLC (Russia)

Manufactured By

Advanced Pharma, LLC (Russia)

ATC Code

A03BB01 (Hyoscine butylbromide)

Active Substance

Hyoscine butylbromide (BAN)

Dosage Form

Buskospazm Neo

Film-coated tablets, 10 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex; the core is white on the cross-section.

Excipients (core) lactose monohydrate – 121.6 mg, microcrystalline cellulose (type 102) – 90 mg, povidone (K30) – 3 mg, colloidal silicon dioxide – 3 mg, sodium starch glycolate – 10 mg, magnesium stearate – 2.4 mg.

Excipients (coating) ready-made mixture for white coating – 5 mg (polyvinyl alcohol – 45%, soy lecithin – 3%, macrogol 4000 – 11%, talc – 11%, titanium dioxide (E171) – 30%).

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – plastic jars (1) – cardboard packs.
20 pcs. – plastic jars (1) – cardboard packs.

Clinical-Pharmacological Group

M-Cholinoreceptor blocker

Pharmacotherapeutic Group

M-cholinoblocker

Pharmacological Action

M-cholinoreceptor blocker. Reduces the tone of smooth muscles of internal organs, reduces their contractile activity.

Causes a decrease in the secretion of exocrine glands. Increases heart rate. Causes mydriasis, paralysis of accommodation, increases intraocular pressure.

Pharmacokinetics

Poorly absorbed from the gastrointestinal tract. Plasma protein binding is low.

It is found in the greatest amount in the gastrointestinal tract, gallbladder and ducts, liver and kidneys.

Indications

Renal colic, ureteral spasms, biliary colic, hypermotor dyskinesia of the biliary tract and gallbladder, cholecystitis, intestinal colic, pylorospasm, gastric and duodenal ulcer in the acute phase (as part of complex therapy), dysmenorrhea.

ICD codes

Dosage Regimen

Orally or rectally for adults and children over 6 years old – 10-20 mg 3-5 times/day; for children aged 1 to 6 years – orally 5-10 mg or rectally – 7.5 mg 3-5 times/day; for children under 1 year – orally 5 mg 2-3 times/day or rectally 7.5 mg up to 5 times/day.

In acute conditions, administered intramuscularly or intravenously: adults – 20-40 mg; children – 5-10 mg; frequency of administration 3 times/day.

Adverse Reactions

From the digestive system dryness of mucous membranes (including in the oral cavity), bloating, nausea and vomiting, constipation.

From the urinary system urination disorder or urinary retention.

From the organ of vision mydriasis, accommodation paresis, blurred vision, increased intraocular pressure.

From the cardiovascular system palpitations, tachycardia, increased blood pressure.

From the nervous system dizziness, headache, nervousness, weakness, ataxia, speech impairment, agitation or confusion (most often in the elderly), memory impairment or amnesia (with long-term use in elderly patients, especially those with pre-existing memory impairment), sleep disorder (insomnia or drowsiness).

Allergic reactions urticaria or other skin manifestations.

Other decreased potency, reduced sweating, redness of the skin at the injection site.

Contraindications

Glaucoma, benign prostatic hyperplasia, pyloric stenosis, tachyarrhythmias, megacolon, mechanical intestinal obstruction, acute pulmonary edema, severe cerebral atherosclerosis.

Use in Pregnancy and Lactation

Use with caution during pregnancy, only in cases where the expected benefit of therapy for the mother outweighs the potential risk of side effects in the fetus.

Use Hyoscine butylbromide with caution during lactation (breastfeeding).

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal insufficiency (risk of side effects due to reduced excretion).

Pediatric Use

Use the drug with caution in chronic lung diseases in young children (reduction of bronchial secretion can lead to thickening of secretions and formation of plugs in the bronchi), in brain damage in children (CNS effects may be enhanced), Down’s disease (unusual pupil dilation and increased heart rate may occur), central paralysis in children (the reaction to anticholinergic agents may be most pronounced).

Geriatric Use

Prescribe with caution to elderly patients (possible development of intestinal obstruction), patients over 40 years of age (danger of manifestation of undiagnosed glaucoma).

Special Precautions

Prescribe with caution in diseases of the cardiovascular system in which an increase in heart rate may be undesirable (including atrial fibrillation, tachycardia, coronary artery disease, mitral stenosis, arterial hypertension, acute bleeding), hyperthyroidism (tachycardia may increase), elevated temperature (may further increase due to suppression of sweat gland activity), reflux esophagitis, hiatal hernia combined with reflux esophagitis (decreased motility of the esophagus and stomach and relaxation of the lower esophageal sphincter may contribute to delayed gastric emptying and increased gastroesophageal reflux through the sphincter with impaired function), intestinal atony in elderly or debilitated patients (possible development of obstruction), paralytic ileus, patients over 40 years of age (danger of manifestation of undiagnosed glaucoma), in nonspecific ulcerative colitis (high doses can inhibit intestinal peristalsis, increasing the likelihood of paralytic ileus; moreover, manifestation or exacerbation of such a severe complication as toxic megacolon is possible), xerostomia (long-term use may cause further reduction in salivation), hepatic insufficiency (reduced metabolism) and renal insufficiency (risk of side effects due to reduced excretion), chronic lung diseases, especially in young children and debilitated patients (reduction of bronchial secretion can lead to thickening of secretions and formation of plugs in the bronchi), myasthenia gravis (the condition may worsen due to inhibition of acetylcholine action), autonomic neuropathy (urinary retention and accommodation paralysis may increase), urinary retention or predisposition to it or diseases accompanied by obstruction of the urinary tract (including bladder neck due to prostatic hypertrophy), pregnancy toxemia (arterial hypertension may increase), brain damage in children (CNS effects may be enhanced), Down’s disease (unusual pupil dilation and increased heart rate may occur), central paralysis in children (the reaction to anticholinergic agents may be most pronounced), tachycardia (may increase).

Treatment withdrawal should be carried out gradually (with rapid withdrawal, nausea, sweating, dizziness may occur).

The patient should avoid alcohol consumption during treatment.

During treatment, avoid overheating during intense physical exertion and in hot weather, as well as hot baths and saunas.

Effect on the ability to drive vehicles and mechanisms

During treatment, it is not recommended to engage in activities requiring concentration and speed of psychomotor reactions.

Drug Interactions

Tricyclic antidepressants, quinidine, amantadine enhance the effects of hyoscine butylbromide.

Antihistamines, disopyramide, antacids, laxatives containing kaolin or attapulgite, ketoconazole, metoclopramide weaken the effects of hyoscine butylbromide.

With simultaneous use, Hyoscine butylbromide enhances the effect of agents that have a depressant effect on the central nervous system.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.