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 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:
e Hyoscine Butylbromide Tablets Do not take Hyoscine Butylbromide Tablets if:
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
, 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:
By reporting side effects you can help provide more information on the safety of this medicine.
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.
What Hyoscine Butylbromide Tablets contain
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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.
The active substance in Hyoscine Butylbromide 20 mg Film-coated Tablets is hyoscine butylbromide.
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.
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 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: 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.
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.
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.
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.
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.
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 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.
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.
Medicines sold in Poland with the same active substance: W Polsce znany jako
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 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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