Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hyoscine butylbromide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR
Take special care with BUSCOPAN CRAMPS Check with your pharmacist or doctor before taking your medicine if any of the following apply to you:
Pregnancy and breast-feeding Do not take BUSCOPAN CRAMPS if you are pregnant, likely to get pregnant or are breast-feeding. Driving and using machines Some people may have temporary blurring of vision while taking this medicine. If this happens to you, wait until your vision returns to normal before driving or using any tools or machines. Important information about some of the ingredients of Buscopan Cramps Buscopan Cramps contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
BUSCOPAN CRAMPS Always take this medicine exactly as your pharmacist or doctor has told you. You should check with them if you are not sure. BUSCOPAN CRAMPS should not be taken continuously for more than two weeks. Talk to your pharmacist or doctor if you develop new symptoms or if your symptoms get worse or have not improved over two weeks. Taking this medicine
Isolated events – some side effects are so rare that it is not known how many people may be affected
Like all medicines, BUSCOPAN CRAMPS can cause side effects in some people. The following side effects may happen with this medicine:
Do not take BUSCOPAN CRAMPS after the expiry date which you will find printed on the packaging. 6. FURTHER INFORMATION What BUSCOPAN CRAMPS contains Each tablet contains 10 mg of the active ingredient hyoscine butylbromide. The other ingredients are: calcium hydrogen phosphate, maize starch, soluble starch, colloidal silica, tartaric acid, stearic acid, sucrose, talc, acacia, titanium dioxide, macrogol 6000, carnauba wax, white beeswax and povidone. What BUSCOPAN CRAMPS looks like and contents of the pack The tablets are white. BUSCOPAN CRAMPS is available in blister packs of 20 tablets. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation is held by: Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT United Kingdom Tel: 0800 035 2525 Email: [email protected] and the tablets are manufactured by:
Mild side effects that do not normally require medical treatment: Uncommon – affects fewer than 1 in 100 people
Istituto De Angeli S.r.l. Loc. Prulli, 103/C 50066 Reggello (FI) Italy This leaflet was revised in February 2024.
If you get any of the side effects described below stop taking this medicine and tell your doctor straight away. You may need urgent medical treatment: Uncommon – affects fewer than 1 in 100 people
MORE INFO
For electronic version of the leaflet scan the QR code. This paper leaflet might not be the latest version and thus different to the electronic leaflet which is the last updated version available.
439246/GB/2
BUSCOPAN CRAMPS Do not store above 25°C. Keep in the original packaging. Keep out of the sight and reach of children.
How much to take For relief of painful spasm of the stomach, bowel or bladder and urinary tubes (urinary tract). Adults, and children 12 years or over:
The active substance in Buscopan Cramps is hyoscine butylbromide.
This leaflet reproduces the patient information leaflet approved for Buscopan Cramps, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Buscopan Cramps 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 Cramps are for oral administration only.
Buscopan Cramps 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 Cramps should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
Buscopan Cramps 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 Cramps 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 Cramps.
Additional warnings for the Patient Information Leaflet (in relation to the Irritable Bowel Syndrome Indication)
Special warnings if you are taking Buscopan Cramps for Irritable Bowel Syndrome
If this is the first time you have had symptoms of Irritable Bowel Syndrome, consult your doctor before using any treatment.
If any of the following apply to you do not take Buscopan Cramps. It may not be the right treatment for you. See your doctor as soon as possible.
• you are aged 40 years or over
• you have passed blood from the bowel
• you are feeling sick or vomiting
• you have lost your appetite or lost weight
• you are looking pale and feeling tired
• you are suffering from severe constipation
• you have a fever
• you have recently travelled abroad
• you have abnormal vaginal bleeding or discharge
• you have difficulty or pain passing urine
Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks of treatment.
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.
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.
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.
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 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.
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 Cheynes-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 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.
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Buscopan Cramps. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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