Boehringer Ingelheim Limited

Buscopan Ampoules 20 mg/ml Solution for Injection

Each 1 ml ampoule contains 20 mg Hyoscine Butylbromide.

For a full list of excipients, see section 6.1

Solution for injection.

A colourless or almost colourless, clear solution

Buscopan ampoules are indicated in acute spasm, as in renal or biliary colic; in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography and in other diagnostic procedures where spasm may be a problem, e.g. gastro-duodenal endoscopy.

Not recommended for children.

Adults

One ampoule (20 mg) intramuscularly or intravenously, repeated after half-an-hour if necessary. Intravenous injection should be performed "slowly", (in rare cases a marked drop in blood pressure and even shock may be produced by Buscopan). When used in endoscopy this dose may need to be repeated more frequently.

Maximum daily dose of 100 mg.

Diluent:

Buscopan injection solution may be diluted with dextrose or sodium chloride 0.9% injection solutions.

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 Ampoules should not be administered to patients with myasthenia gravis, megacolon, narrow angle glaucoma, tachycardia, prostatic enlargement with urinary retention, mechanical stenoses in the region of the gastrointestinal tract or, paralytic ileus.

Buscopan should not be used in patients who have demonstrated prior hypersensitivity to hyoscine butylbromide or any other component of the product.

Buscopan ampoules should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.

Buscopan Ampoules 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.

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 after the injection of Buscopan.

After parenteral administration of Buscopan, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving Buscopan by injection should be kept under observation.

The anticholinergic effect of drugs such as tricyclic antidepressants, antihistamines, quinidine, amantadine, phenothiazines, butyrophenones, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium) may be intensified by Buscopan.

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

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

Although Buscopan has been in wide general use for many years, there is no definitive evidence of ill-consequence during human pregnancy; animal studies have shown no hazard. Nevertheless, medicines should not be used in pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh the risk to the foetus.

Safety during lactation has not yet been established.

Because of visual accommodation disturbances patients should not drive or operate machinery after parenteral administration of Buscopan until vision has normalised.

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

Immune system disorders

Anaphylactic shock including cases with fatal outcome, anaphylactic reactions, dyspnoea, skin reactions and other hypersensitivity.

Eye disorders

Accommodation disorders

Cardiac disorders

Tachycardia

Vascular disorders

Blood pressure decreased, dizziness, flushing

Gastrointestinal disorders

Dry mouth, constipation

Skin and subcutaneous tissue disorders

Dyshidrosis

Renal and urinary disorders

Urinary retention

Injection site pain, particularly after intramuscular use, occurs.

Hyoscine butylbromide, the active ingredient of Buscopan, due to its chemical structure as a quaternary ammonium derivate, is not expected to enter the central nervous system. Hyoscine butylbromide does not readily pass the blood-brain barrier. However, it cannot totally be ruled out that under certain circumstances psychiatric disorders (e.g. confusion) may also occur after administration of Buscopan.

Symptoms

Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic symptoms such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility, and transient visual disturbances may occur, and Cheynes-Stokes respiration has been reported.

Therapy

Symptoms of Buscopan overdosage respond to parasympathomimetics. For patients with glaucoma, pilocarpine should be given locally. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis, intubation and artificial respiration. Catheterisation may be required for urinary retention.

In addition, appropriate supportive measures should be used.

Buscopan is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.

After intravenous administration hyoscine butylbromide is rapidly distributed into the tissues. The volume of distribution (Vss) is 128 l. The half-life of the terminal elimination phase (t _½γ) is approximately 5 hours. The total clearance is 1.2 l/min, approximately half of the clearance is renal.

In rat, highest concentrations of hyoscine butylbromide are found in the tissue of the gastrointestinal tract, liver and kidneys. Plasma protein binding of hyoscine butylbromide is low.

Hyoscine butylbromide does not readily pass the blood-brain barrier.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Sodium chloride

Water for injections

None known

Unopened: 5 years

Once opened, use immediately and discard any unused contents.

Store below 30°C.

Keep the ampoules in the outer carton.

1 ml clear glass (Ph. Eur. Type I) ampoules marketed in cartons containing 10 ampoules.

For single use only. Any unused solution should be discarded.

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

PA 7/16/2

Date of first authorisation: 1 April 1979

Date of last renewal: 1 April 2009

October 2009