Buscopan 0.1 % Syrup

BUSCOPAN is used in the treatment of conditions associated with gastrointestinal spasm.

Posology

Babies older than 1 month up to 3 months: 2,5 mL three times daily

Infants older than 3 months up to 1 year: 2,5 mL u2013 5 mL three times daily

Children older than 1 year up to 3 years: 5 mL u2013 10 mL three times daily

Children older than 3 years up to 6 years: 10 mL three times daily

Children older than 6 years up to 12 years: 10 mL u2013 20 mL three times daily

Children older than 12 years and adults: 20 mL four times daily

The initial dose must be the lowest recommended for age. Do not exceed the maximum recommended dose for age. BUSCOPAN should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

BUSCOPAN is contraindicated in:

• patients who have demonstrated prior hypersensitivity to hyoscine butylbromide or any other component of the product (see section 6.1)
• myasthenia gravis
• mechanical stenosis in the gastrointestinal tract
• paralytic or obstructive ileus
• megacolon
• narrow angle glaucoma
• porphyria
• enlarged prostate
• fever
• tachycardia.

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.

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 medicines 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.

Caution is advised in patients with impaired metabolic, liver or kidney function, as adverse central nervous system effects may be more likely in these patients.

Cases of anaphylaxis including episodes of shock have been observed.

The anticholinergic effect of medicines such as tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. butyrophenones, phenothiazines), 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 medicines on the gastrointestinal tract.

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

BUSCOPAN should be used with caution in patients receiving other central depressants concomitantly as central nervous system depression may be enhanced.

Pregnancy

There are limited data from the use of hyoscine butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure BUSCOPAN is not recommended during pregnancy.

Breastfeeding

There is insufficient information on the excretion of hyoscine butylbromide and its metabolites in human milk. A risk to the breastfeeding child cannot be excluded. Use of BUSCOPAN during breastfeeding is not recommended.

Fertility

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

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 (u2265 1/10); common (u2265 1/100 to < 1/10); uncommon (u2265 1/1 000 to < 1/100); rare (u2265 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Immune system disorders

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

Cardiac disorders

Uncommon: tachycardia

Not known: bradycardia followed by tachycardia with palpitations and arrhythmias

Gastrointestinal disorders

Uncommon: dry mouth

Skin and subcutaneous tissue disorders

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

Not known*: rash, erythema

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.

Symptoms

In case of overdose, anticholinergic effects may be observed. Toxic doses cause tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement, and hallucinations passing into delirium. A rash may appear on the face and upper trunk. In severe intoxication depression of the central nervous system may occur with hypertension or circulatory failure and respiratory depression. Quaternary ammonium anticholinergic medicines such as BUSCOPAN usually have some ganglion-blocking activity so that high doses may cause postural hypotension; in toxic doses non-depolarising neuro-muscular block may be produced.

Therapy

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