Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Hyoscine Butylbromide 20 mg Film-coated Tablets

⚠ This medicine appears to have been discontinued

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.

Active substance: Hyoscine butylbromide
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for The name of your medicine is Hyoscine Butylbromide 10 mg and 20 mg Film-coated Tablets (called Hyoscine Butylbromide Tablets in the rest of this leaflet). Hyoscine Butylbromide Tablets contain a medicine called "hyoscine butylbromide". This belongs to a group of medicines called "antispasmodics". Hyoscine Butylbromide Tablets are used to relieve cramps in the muscles of your:

  • Stomach
  • Gut (intestine)
  • Bladder and the tubes that lead to the outside of your body (urinary system). It can also be used to relieve the symptoms of Irritable Bowel Syndrome (IBS).

What you need to know before you take it

e Hyoscine Butylbromide Tablets Do not take Hyoscine Butylbromide Tablets if:

  • you are allergic to hyoscine butylbromide or any of the other ingredients of this medicine (listed in section 6)
  • you have glaucoma (an eye problem)
  • you have something called 'myasthenia gravis' (a very rare muscle weakness problem)
  • you have a suspected or confirmed blockage of the bowel
  • you have a condition where the bowel is blocked and does not work properly (paralytic or obstructive ileus). Symptoms include severe abdominal pain with lack of stools and/or nausea/vomiting
  • you have a very enlarged bowel (megacolon)
  • you are pregnant, likely to get pregnant, or are breast-feeding. Do not take Hyoscine Butylbromide Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Warnings and precautions Talk to your doctor or pharmacist before taking Hyoscine Butylbromide Tablets if:
  • you have a very fast heart rate or other heart problems
  • you have a problem with your thyroid gland such as an overactive thyroid gland
  • you have difficulty or pain passing water (urine) such as men with prostate problems
  • you have constipation
  • you have a fever. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Hyoscine Butylbromide Tablets. Check with your doctor or pharmacist straight away if you have unexplained abdominal pain which persists or worsens or occurs with:
  • fever
  • feeling sick
  • being sick
  • changes in your bowel movements
  • abdominal tenderness
  • low blood pressure
  • feeling faint or,
  • blood in your bowel movements. Other medicines and Hyoscine Butylbromide Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines. This is because Hyoscine Butylbromide Tablets can affect the way some other medicines work, and some other medicines can affect the way Hyoscine Butylbromide Tablets work. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
  • Medicines for depression called "tetracyclic antidepressants" or "tricyclic antidepressants" such as doxepin
  • Medicines for allergies and travel sickness called "antihistamines"
  • Medicines to control your heart beat such as quinidine or disopyramide
  • Medicines for severe mental illness called 'antipsychotics' such as haloperidol or fluphenazine
  • Medicines usually used for breathing problems such as tiotropium, ipratropium or atropine-like medicines
  • Amantadine – for Parkinson's disease and flu
  • Metoclopramide – for feeling sick (nausea). If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hyoscine Butylbromide Tablets. Pregnancy, breast-feeding and fertility Do not take this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Driving and using machines Some people may have sight problems while taking this medicine. If this happens to you, wait until your sight returns to normal before driving or using any tools or machines. Hyoscine Butylbromide Tablets contain lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take it

Hyoscine Butylbromide Tablets Always take your 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 Tablets should not be taken continuously for long periods of time. Taking this medicine

  • Take your tablets with water.
  • Do not break, crush or chew the tablets. How much to take Adults and children over 12 years
  • The recommended dose is two tablets of 10 mg or one tablet of 20 mg 4 times a day.
  • For Irritable Bowel Syndrome, your doctor may give you a lower starting dose of one tablet of 10 mg 3 times a day. This dose may be increased, if further relief is necessary. Children 6 – 12 years:
  • The recommended dose is one tablet of 10 mg 3 times a day. Hyoscine Butylbromide Tablets are not recommended for children under 6 years. If you take more Hyoscine Butylbromide Tablets than you should If you take more Hyoscine Butylbromide Tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you even if there are no Hyoscine Butylbromide Tablets left. If you forget to take Hyoscine Butylbromide Tablets If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Hyoscine Butylbromide Tablets Do not stop taking Hyoscine Butylbromide Tablets without talking to your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause

Possible side effects

, although not everybody gets them. The following side effects may happen with this medicine: Stop taking your medicine and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

  • Allergic reactions such as skin reactions e.g. nettle rash, itching (Uncommon – may affect up to 1 in 100 people), rash, redness of the skin.
  • Severe allergic reactions (anaphylactic shock) such as difficulty breathing, feeling faint or dizzy (shock).
  • Painful red eye with loss of vision. Other side effects
  • Dry mouth (Uncommon – may affect up to 1 in 100 people).
  • Abnormal sweating or reduced sweating (Uncommon – may affect up to 1 in 100 people).
  • Increased heart rate (Uncommon – may affect up to 1 in 100 people).
  • Being unable to pass water (urine) (Rare may affect up to 1 in 1,000 people). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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.

By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Hyoscine Butylbromide Tablets Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after 'EXP'. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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.

Contents of the pack and other information

What Hyoscine Butylbromide Tablets contain

  • The active substance is hyoscine butylbromide. Each film-coated tablet contains either 10 mg or 20 mg of hyoscine butylbromide.
  • The other ingredients are: Tablet core: lactose monohydrate; cellulose, microcrystalline; povidone and magnesium stearate. Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), polyethylene glycol (E1521) and lecithin (E422). What Hyoscine Butylbromide Tablets look like and contents of the pack Hyoscine Butylbromide 10 mg Film-coated Tablets are white to off-white round, biconvex, film-coated tablets with '10' debossed on one side and plain on other side. Hyoscine Butylbromide 20 mg Film-coated Tablets are white to off-white round, biconvex, film-coated tablets with '20' debossed on one side and plain on other side. For both 10 mg and 20 mg tablets pack sizes of 28, 56, 100 and 500 tablets are available. Not all pack sizes may be marketed. Marketing Authorisation Holder Morningside Healthcare Ltd. Unit C, Harcourt Way Leicester, LE19 1WP, UK Manufacturer Morningside Pharmaceuticals Ltd. 5 Pavilion Way Loughborough, LE11 5GW, UK This leaflet was last revised in October 2021.

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Frequently asked questions about Hyoscine Butylbromide 20 mg Film-coated Tablets

How do I take Hyoscine Butylbromide 20 mg Film-coated Tablets?

Hyoscine Butylbromide 20 mg Film-coated Tablets comes as tablet containing 20mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Hyoscine Butylbromide 20 mg Film-coated Tablets?

The active substance in Hyoscine Butylbromide 20 mg Film-coated Tablets is hyoscine butylbromide.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Hyoscine Butylbromide 20 mg Film-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.

Can I get Hyoscine Butylbromide 20 mg Film-coated Tablets without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Hyoscine butylbromide (10 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Hyoscine Butylbromide 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.

4.2. Posology and method of administration

Posology

Adults: Two 10 mg tablets or one 20 mg tablet 4 times daily. For the symptomatic relief of Irritable Bowel Syndrome, the recommended starting dose is one 10 mg tablet 3 times daily, this can be increased up to two 10 mg tablets or one 20 mg tablet 4 times daily if necessary.

Children 6 - 12 years: One 10 mg tablet 3 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 Tablets should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

Method of administration

For oral administration only.

Hyoscine Butylbromide Tablets should be swallowed whole with adequate water.

4.3. Contraindications

Hyoscine Butylbromide Tablets are contraindicated in:

• hypersensitivity to the active substance or to any of the excipients listed in section 6.1

• 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.

Hyoscine Butylbromide 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 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 Tablets 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 Tablets.

Lactose

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose galactose malabsorption should not take this medicine.

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 Hyoscine Butylbromide 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 Hyoscine Butylbromide 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 Hyoscine Butylbromide Tablets are not recommended during pregnancy.

Breast-feeding

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 Tablets 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 Hyoscine Butylbromide 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 (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

System Organ class

Frequency

Undesirable Effect

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 reactions 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 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 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.

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • BuscopanHyoscini butylbromidum · taken by mouth
  • Buscopan forteHyoscini butylbromidum · taken by mouth
  • AuroGastroHyoscini butylbromidum · taken by mouth

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 about this leaflet

Ask anything about Hyoscine Butylbromide 20 mg Film-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.

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