4.1. Therapeutic indications

Buscopan IBS Relief 10 mg Coated Tablets are indicated for the relief of gastro-intestinal tract spasm associated with medically confirmed Irritable Bowel Syndrome.

4.2. Posology and method of administration

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

Adults and Children 12 years or over:

The recommended starting dose is 1 tablet three times daily; this can be increased up to 2 tablets four times daily if necessary.

Children under 12 years:

Not recommended.

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

4.3. Contraindications

Buscopan IBS Relief 10 mg Coated 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

4.4. Special warnings and precautions for use

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 IBS Relief 10 mg Coated 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 also be used in patients susceptible to intestinal or urinary outlet obstructions.

Because of the possibility that anticholinergics may reduce sweating, Buscopan IBS Relief 10 mg Coated Tablets should be administered with caution to patients with pyrexia.

Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as hyoscine butylbromide in patients with undiagnosed and therefore untreated narrow angle glaucoma. Therefore, patients should seek urgent ophthalmological advice if they develop a painful, red eye with loss of vision whilst, or after taking, Buscopan IBS Relief 10 mg Coated Tablets.

As the tablet coating contains a small quantity of sucrose (41.2 mg), patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Buscopan IBS Relief 10 mg Coated Tablets.

Special warnings to be included in the Patient Information Leaflet:

Only take Buscopan IBS Relief 10 mg Coated Tablets if your doctor has diagnosed Irritable Bowel Syndrome.

If any of the following now apply to you, you must not use Buscopan IBS Relief 10 mg Coated Tablets without first discussing it with your doctor, even if you know you have IBS:

• if you are 40 years or over and it is some time since your last attack of IBS or the symptoms are different this time

• if you have recently passed blood from the bowel

• if you suffer from severe constipation

• if you are feeling sick or vomiting

• if you have lost your appetite or lost weight

• if you have difficulty or pain passing urine

• if you have a fever

• if you have recently travelled abroad

Consult your doctor if you develop new symptoms, or if your symptoms worsen or have not improved over two weeks.

4.5. Interaction with other medicinal products and other forms of interaction

The anticholinergic effect of drugs 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 IBS Relief 10 mg Coated Tablets.

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 IBS Relief 10 mg Coated Tablets.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are limited data from the use of hyoscine butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). As a precautionary measure Buscopan is not recommended during pregnancy.

Lactation

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.

4.7. Effects on ability to drive and use machines

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.

4.8. Undesirable effects

Many of the listed undesirable effects can be assigned to the anticholinergic properties of Buscopan IBS Relief 10 mg Coated Tablets.

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

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to <1/100); rare (≥ 1/10000 to <1/1000); very rare (<1/10000); 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

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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms:

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

Therapy:

In the case of oral poisoning, gastric lavage with medicinal charcoal should be followed by magnesium sulfate (15%). Symptoms of Buscopan IBS Relief 10 mg Coated Tablets 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 should be considered. Catheterisation may be required for urinary retention.

In addition, appropriate supportive measures should be administered as required.