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Drug Buscopan have composition hyoscine butylbromide 10mg, Indications for Gastrointestinal tract spasm, spasm and dyskinesia of the biliary system, genito-urinary tract spasm.

No-Spa 40 mg Indicated for Colic biliary pain due to smooth muscle spasm  in connection

MEPRAZ treatment for Gastric ulcer, Gastroesophageal Reflux Disease

Duphalac Indications for Constipation, haemorrhoids, post colonic/anal surgery

Composition

each sugar-coated (sc.) tablet contains 10.0 mg hyoscine butylbromide.

Excipients: dibasic calcium phosphate, maize starch, starch soluble, aerosil 200, tartaric acid, stearic acid, polyvidone, saccharose, talc, acacia, titanium dioxide, polyethylene glycol 6000, carnauba wax, beeswax white.

Buscopan contains 10 mg hyoscine butylbromide

Indications

Gastrointestinal tract spasm, spasm and dyskinesia of the biliary system, genito-urinary tract spasm.

Dosage and administration

Unless otherwise prescribed by the physician, the following dosages are recommended:

Adults and children over 6 years: 3-5 times daily 1-2s.c. tablets.

Contraindications

BUSCOPAN is contraindicated in:

– patients who have demonstrated prior hypersensitivity to hyoscine butyibromide or any other component of the product

– myasthenia gravis

– megacoton

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and precautions”) the use of the product is contraindicated.

Special warnings and precautions

in case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting or blood in stool, medical advice should immediately be sought.

Because of the potential risk of anticholinergic complications, caution should be used in patients prone to narrow angle glaucoma as well as in patients susceptible to intestinal or urinary outlet obstructions and in those inclined to tachyarrhythmia.

One sugar-coated tablet of 10 mg contains 41.2 mg sucrose, resulting in 411.8 mg sucrose per maximum recommended daily dose. Patients with the rare hereditary condition of fructose intolerance should not take this medicine.

Interactions

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by BUSCOPAN.

Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.

The tachycardic effects of beta-adrenergic agents may be enhanced by BUSCOPAN.

Fertiliy, pregnancy and lactation

There is limited data from the use of hyoscine butylbromide in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

There is insufficient information on the excretion of BUSCOPAN and its metabolites in human milk.

As a precautionary measure, it is preferable to avoid the use of BUSCOPAN during pregnancy and lactation.

No studies on the effects on human fertility have been conducted.

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Side effects

Many of the listed undesirable effects can be assigned to the anticholinergic properties of BUSCOPAN. Anticholinergic side effects of BUSCOPAN are generally mild and self-limited.

Immune system disorders

Anyphylactic shock, anaphylactic reactions, dyspnoea, skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity.

Cardiac disorders Tachycardia.

Gastrointestinal disorders Dry mouth.

Skin and subcutaneous tissue disorders Dyshidrosis.

Renal and urinary disorders Urinary retention.

Please inform your doctor any undesirable effects occurs during treatment.

Overdose

Symptoms

In the case of overdose, anticholinergic effects maybe observed.

Therapy

If required, parasympathomimetic drugs should be administered. Ophthalmologicai advice should be sought in cases of glaucoma urgently. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis: intubation, artificial respiration should be considered. Catheterisation may be required for urinary retention. In addition, appropriate supportive measures should be used as required.

Pharmacological properties

BUSCOPAN exerts a spasmolytic action on the smooth muscle of the gastro-intestinal, biliary and genito-urinary tracts. As a quaternary ammonium derivative, hyoscine butylbromide does notenter the central nervous system. Therefore, anticholinergic side effects at the central nervous system do not occur. Peripheral anticholinergic action results from a ganglion-blocking action within the visceral wall as well as from an anti-muscarinic activity.

Shelf life 36 months.

Special precautions for storage

Store in the original packaging to protect the contents from moisture. Store below 30°C.

Store in a safe place out of the reach of children.

Availability

10 sugar-coated tablets per blister. 1,2, 5 or 10 blisters per box.

20 sugar-coated tablets per blister. 5 blisters per box

Manufactured by Delpharm Reims 10 rue Colonel Charbonneaux 51100 Reims. France.

Read carefully enclosed leaflet before use.

For further information please contact your Doctor or Pharmacist.

4 Comments

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