Losil

Buscopan 10 mg Tablets are indicated for the relief of spasm of the genito-urinary tract or gastro- intestinal tract and for the symptomatic relief of Irritable Bowel Syndrome.

Buscopan 10 mg Tablets are for oral administration only.

Buscopan 10 mg Tablets should be swallowed whole with adequate water.

Adults: 2 tablets four times daily. For the symptomatic relief of Irritable Bowel Syndrome, the recommended starting dose is 1 tablet three times daily, this can be increased up to 2 tablets four times daily if necessary.

Children 6 - 12 years: 1 tablet three times daily.

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

Buscopan 10 mg Tablets should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

Buscopan 10 mg Tablets are contraindicated in:

-patients who have demonstrated prior hypersensitivity to hyoscine butylbromide or any other component of the product

-myasthenia gravis

-mechanical stenosis in the gastrointestinal tract

-paralytical or obstructive ileus

-megacolon

-narrow angle glaucoma

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.

Buscopan 10 mg Tablets should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate. Due to the risk of anticholinergic complications, caution should be used in patients susceptible to intestinal or urinary outlet obstructions.

Because of the possibility that anticholinergics may reduce sweating, Buscopan should be administered with caution to patients with pyrexia.

Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Buscopan in patients with undiagnosed and therefore untreated narrow angle glaucoma. Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision whilst or after taking Buscopan.

As the tablet coat contains sucrose (41.2 mg), patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Buscopan Tablets.

No studies on the effects on the ability to drive and use machines have been performed. Because of possible visual accommodation disturbances patients should not drive or operate machinery if affected.

Many of the listed undesirable effects can be assigned to the anticholinergic properties of BUSCOPAN.

Adverse events have been ranked under headings of frequency using the following convention:

Very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1000, <1/100); rare (> 1/10000, <1/1000); very rare (<1/10000); not known - cannot be estimated from the available data.

Immune system disorders

Uncommon: skin reactions (e.g. urticaria, pruritus)

Not known*: anaphylactic shock , anaphylactic reactions, dyspnoea, rash, erythema, other hypersensitivity

Cardiac disorders

Uncommon: tachycardia

Gastrointestinal disorders:

Uncommon: dry mouth

Skin and subcutaneous tissue disorders

Uncommon: dyshidrosis

Renal and urinary disorders

Rare: urinary retention

* This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than uncommon (3/1,368), but might be lower. A precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 1,368 patients.

Reporting of suspected adverse reactions

Reporting suspected adverse reaction after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.