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.
e Hyoscine butylbromide coated tablets Do not take Hyoscine butylbromide coated tablets if:
Take special care with Hyoscine butylbromide coated tablets Check with your doctor or pharmacist before taking your medicine if:
P1540700
Package leaflet: Information for the user
Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Hyoscine butylbromide should not be taken continuously for long periods of time. Taking this medicine
You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting
you can help provide more information on the safety of this medicine.
Hyoscine butylbromide coated tablets •
• •
•
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Hyoscine butylbromide coated tablets should be stored below 30°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Keep this medicine out of the sight and reach of children.
What Hyoscine butylbromide coated tablets contains The active substance is hyoscine butylbromide. Each tablet contains 10 mg hyoscine butylbromide. The other ingredients are calcium hydrogen phosphate dihydrate, maize starch, tartaric acid, silica colloidal anhydrous, and stearic acid. The tablet coating contains sucrose, talc, hypromellose 2910, glycerol monostearate, triglycerides medium chain, poly vinyl alcohol, macrogol 4000 and polysorbate 80. What Hyoscine butylbromide coated tablets look like and contents of the pack Hyoscine butylbromide coated tablets are white to off-white, sugar coated circular, biconvex tablets plain on both sides. Hyoscine butylbromide coated tablets are marketed in white opaque PVC/PVdCAluminium foil blister packs. Pack sizes: 56 tablets Marketing Authorisation Holder Milpharm Limited 1 Roundwood Avenue Stockley Park, Uxbridge UB11 1AF United Kingdom Manufacturer APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta or Milpharm Limited 1 Roundwood Avenue Stockley Park, Uxbridge UB11 1AF United Kingdom or Generis Farmaceutica, S.A., Rua Joao de Deus, n° 19, Venda Nova, 2700-487 Amadora, Portugal This leaflet was last revised in 10/2025. P1540700
Hyoscine butylbromide 10 mg coated tablets comes as tablet containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Hyoscine butylbromide 10 mg coated tablets is hyoscine butylbromide.
Medicines with the same active substance, strength and form include: Boots IBS Cramps Relief 10mg Tablets, Buscopan 10 mg Tablets, Buscopan IBS Relief 10 mg Coated Tablets. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Hyoscine butylbromide 10 mg coated tablets, 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.
Hyoscine butylbromide 10 mg coated 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.
Posology
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.
Hyoscine butylbromide 10 mg coated tablets should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
Method of administration
Hyoscine butylbromide 10 mg coated tablets are for oral administration only.
Hyoscine butylbromide 10 mg coated tablets should be swallowed whole with adequate water.
Hyoscine butylbromide 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
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.
Hyoscine butylbromide 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 be used in patients susceptible to intestinal or urinary outlet obstructions.
Because of the possibility that anticholinergics may reduce sweating, Hyoscine butylbromide 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 in case they should develop a painful, red eye with loss of vision whilst or after taking hyoscine butylbromide.
As the tablet coat contains sucrose (12.125 mg), patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Hyoscine butylbromide coated tablets.
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 hyoscine butylbromide.
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 Hyoscine butylbromide.
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 Hyoscine butylbromide 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 hyoscine butylbromide 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 Hyoscine butylbromide.
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
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. 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 hyoscine butylbromide 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.
Ask anything about Hyoscine butylbromide 10 mg coated tablets. 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.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.