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.
Hyoscine butylbromide 20 mg/ml solution for injection
⚠ 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.
What it is and what it is used for
for Allergic reactions have been observed after 2. What you need to know before you are given injection of hyoscine butylbromide (see section 4). Hyoscine butylbromide Therefore, you will be monitored after injection of 3. How Hyoscine butylbromide will be given hyoscine butylbromide and treated appropriately in 4. Possible side effects case such reactions occur. 5. How to store Hyoscine butylbromide 6. Contents of the pack and other information Other medicines and Hyoscine butylbromide Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 1. What Hyoscine butylbromide is and what it medicines. This includes medicines obtained is used for without a prescription and herbal medicines. The name of the medicine is Hyoscine butylbromide 20 mg/ml solution for injection (called hyoscine butylbromide throughout this leaflet). Hyoscine butylbromide belongs to a group of medicines called 'antispasmodics'. These medicines relieve spasms (cramp-like contractions) of internal organs and alleviate related spastic pain. This medicine is used to relieve spasms of smooth muscles of gastrointestinal tract and urogenital tract (stomach, intestines, biliary tract, pancreas and urinary tract). Hyoscine butylbromide can also be used in diagnostic and therapeutic medical procedures where spasm may be a problem (e.g. barium enema).
What you need to know before you take it
Hyoscine butylbromide
In particular tell your doctor or pharmacist if you are taking any of the following:
- medicines for depression called 'tricyclic antidepressants' or 'tetracyclic antidepressants' (such as doxepin or mirtazapine)
- medicines to treat allergies (antihistamines)
- medicines to treat mental illness (such as fluphenazine or haloperidol)
- medicines to treat heart rhythm disorders (quinidine or disopyramide)
- amantadine (used to treat Parkinson's disease)
- medicines for treating breathing disorders (such as tiotropium, ipratropium, atropine-like medicines)
- metoclopramide (used to treat nausea, vomiting or gastrointestinal disorders). If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you are being given this medicine.
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you You should not be given Hyoscine butylbromide may be pregnant or are planning to have a baby, ‒ if you are allergic to hyoscine butylbromide or ask your doctor for advice before this medicine any of the other ingredients of this medicine is being given to you. (listed in section 6) There are limited data on the use of hyoscine ‒ if you have glaucoma (eye disease) butylbromide in pregnant or breast-feeding ‒ if you have enlarged prostate gland and have women. As a precautionary measure, this medicine difficulty or pain passing urine is not recommended during pregnancy and ‒ if you have gut blockage problems breast-feeding. ‒ if you have obstruction of the intestine due to There are no data on the effects on human fertility. paralysis of the intestinal muscles (paralytic ileus) ‒ if you have abnormally enlarged bowel Driving and using machines (megacolon) Some people may experience sight problems or ‒ if you have increased heart rate dizziness after being treated with this medicine. ‒ if you have a condition called 'myasthenia If you are affected, wait until your sight returns gravis' (characterised by extreme muscle to normal or you stop feeling dizzy before weakness). driving or using machines. You should not be given hyoscine butylbromide injection into the muscle if you are taking medicines to prevent blood clots forming (blood thinners) as haematoma (bruising) may occur. Warnings and precautions Talk to your doctor, pharmacist or nurse before being given this medicine: ‒ 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 stool
Hyoscine butylbromide contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
How to take it
Hyoscine butylbromide will be given to you by a doctor or nurse as a slow injection into your vein or muscle. The medicine may be diluted with other solutions if needed. The dosage will be determined by a doctor.
The following information is intended for healthcare professionals only:
periods without investigating the cause of abdominal pain.
Hyoscine butylbromide 20 mg/ml solution for injection
Overdose Symptoms: Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdose, anticholinergic symptoms 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.
Method of administration For intravenous and intramuscular injection. Hyoscine butylbromide 20 mg/ml solution for injection may be used diluted, see instructions below. Posology Adults: One ampoule (20 mg) intravenously or intramuscularly, repeated after half an hour if necessary. Intravenous injection should be performed 'slowly' (in rare cases a marked drop in blood pressure and even shock may be produced by hyoscine injection). When used in endoscopy this dose may need to be repeated more frequently. Maximum daily dose is 100 mg (5 ampoules). Elderly: No specific information on the use of this medicine 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.
Treatment: Symptoms of hyoscine butylbromide overdose 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 used as required. Shelf life Unopened ampoule: 5 years
Paediatric population: Not recommended.
Shelf life after first opening: The medicinal product should be used immediately after opening the ampoule.
Hyoscine butylbromide injection should not be used on a continuous daily basis or for extended
Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for
This medicine should not be used every day for long periods of time.
on the safety of this medicine.
Adults You will usually be given one ampoule (20 mg), but you may be given a further ampoule after half an hour if required. If you are being given hyoscine butylbromide as part of an endoscopy your dose may need to be given more often. Maximum daily dose is 5 ampoules (100 mg).
Possible side effects
not listed in this leaflet. 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 side effects you can help provide more information
05.07.2024. HUK/I/20/6
24 hours at 25°C and 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions. Instructions for use and other handling For single use only. Once opened, any unused portion should be discarded. The medicinal product is to be visually inspected prior to use. Only clear solutions free from particles should be used. May be diluted with glucose or with sodium chloride 0.9% solution for injection. Instruction of ampoule opening 1) Turn the ampoule with coloured point up. If there is any solution in the upper part of the ampoule, gently tap with your finger to get all the solution to the lower part of the ampoule. 2) Use both hands to open; while holding the lower part of the ampoule in one hand, use the other hand to break off the upper part of the ampoule in the direction away from the coloured point (see the pictures below).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
How to store it
Hyoscine butylbromide
Elderly No specific information on the use of this medicine in the elderly is available. No adverse reactions specific to this age group have been reported.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
This medicine is not recommended for use in children. If you have been given too much Hyoscine butylbromide If you think that you have been given too much medicine talk to your doctor or nurse immediately. The following symptoms may occur: dry mouth, reddening of the skin, difficulty passing urine, increased heart rate and visual disturbances. 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 side effects, although not everybody gets them. Tell your doctor or nurse immediately if you notice any of the following side effects. These may be serious and you may need urgent medical treatment:
- Sudden difficulty breathing, feeling faint or dizzy, or skin reactions (e.g. hives, rash, skin redness, itching). These may be symptoms of severe allergic reaction (anaphylactic reaction and anaphylactic shock) that sometimes may have with fatal consequences
- Painful, red eye with loss of vision Other side effects Common (may affect up to 1 in 10 people)
- Blurred vision
- Increased heart rate
- Dizziness
- Dry mouth
- Constipation Not known (frequency cannot be estimated from the available data)
- Hypersensitivity reactions
- Difficulty breathing
- Skin reactions (hives, rash, skin redness, itching)
- Dilated pupils
- Increased pressure inside the eye
- Low blood pressure
- Flushing
- Small blisters on hands and feet
- Difficulty passing urine
Keep this medicine out of the sight and reach of children. 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 contains − The active substance is hyoscine butylbromide. Each ampoule (1 ml) contains 20 mg of hyoscine butylbromide. − The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections. What Hyoscine butylbromide looks like and contents of the pack Clear, colourless or almost colourless solution free from visible particles. Type I clear glass ampoules of 1 ml. Ampoules are packed in PVC liners. Liners are packed into cardboard carton. Pack sizes: 5 or 10 ampoules Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer AS KALCEKS Krustpils iela 71E, Rīga, LV-1057, Latvia Tel.: +371 67083320 E-mail: [email protected] This leaflet was last revised in 11/2023
Pain at the site of injection may occur if you have been given this medicine into a muscle. Although unlikely, in certain circumstances it may be possible that hyoscine butylbromide may pass into the brain and cause side effects (such as confusion). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
Frequently asked questions about Hyoscine butylbromide 20 mg/ml solution for injection
How do I take Hyoscine butylbromide 20 mg/ml solution for injection?
Hyoscine butylbromide 20 mg/ml solution for injection comes as injection containing 20mg/ml. 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/ml solution for injection?
The active substance in Hyoscine butylbromide 20 mg/ml solution for injection is hyoscine butylbromide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Hyoscine butylbromide 20 mg/ml solution for injection, 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/ml solution for injection 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: hyoscine butylbromide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Hyoscine butylbromide is indicated in acute spasm, as in renal or biliary colic, in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography, and in other diagnostic procedures where spasm may be a problem (e.g. gastroduodenal endoscopy).
4.2. Posology and method of administration
Adults
One ampoule (20 mg) intravenously or intramuscularly, repeated after half an hour if necessary. Intravenous injection should be performed 'slowly' (in rare cases a marked drop in blood pressure and even shock may be produced by hyoscine injection).
When used in endoscopy this dose may need to be repeated more frequently.
Maximum daily dose is 100 mg (5 ampoules).
Special populations
Elderly: No specific information on the use of this medicine 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.
Paediatric population
Not recommended.
Hyoscine butylbromide injection should not be used on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
Method of administration
For intravenous and intramuscular injection.
Hyoscine butylbromide 20 mg/ml solution for injection may be used diluted with glucose or with sodium chloride 0.9% solution for injection (see section 6.6).
4.3. Contraindications
Hyoscine butylbromide is contraindicated in patients with:
‒ hypersensitivity to the active substance or to any of the excipients listed in section 6.1
‒ narrow angle glaucoma
‒ prostate hypertrophy with urinary retention
‒ mechanical stenosis in the gastrointestinal tract
‒ paralytic or obstructive ileus
‒ megacolon
‒ tachycardia
‒ myasthenia gravis
Hyoscine butylbromide should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.
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, appropriate diagnostic measures are needed to investigate the aetiology of the symptoms.
Hyoscine butylbromide can cause tachycardia, hypotension and anaphylaxis, therefore use with caution in patients with cardiac conditions such as cardiac failure, coronary heart disease, cardiac arrhythmia or hypertension, and in cardiac surgery. Monitoring of these patients is advised. Emergency equipment and personnel trained in its use must be readily available.
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 after the injection of hyoscine butylbromide.
After parenteral administration of hyoscine butylbromide, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving hyoscine butylbromide should be kept under observation.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially “sodium‑free”.
4.5. Interaction with other medicinal products and other forms of interaction
The anticholinergic effect of drugs such as tri‑ and tetracyclic antidepressants, antihistamines, antipsychotics (e.g. phenothiazines,butyrophenones), quinidine, disopyramide, amantadine, and other anticholinergics (e.g. tiotropium, ipratropium, atropine‑like compounds) may be intensified by hyoscine butylbromide.
The tachycardic effects of beta‑adrenergic agents may be enhanced 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.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited data on 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.
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 during breast‑feeding 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. However, patients should be advised that they may experience undesirable effects such as accommodation disorders or dizziness during treatment with hyoscine butylbromide. Therefore, caution should be observed when driving a car or operating machinery. If patients experience accommodation disorders or dizziness, they should avoid potentially hazardous tasks such as driving or operating machinery.
4.8. Undesirable effects
Many of the listed undesirable effects can be assigned to the anticholinergic properties of hyoscine butylbromide.
Undesirable effects are listed by system organ classes by using the following frequency convention:
Very common
Common
Uncommon
Rare
Very rare
Not known
≥1/10
≥1/100, <1/10
≥1/1,000, <1/100
≥1/10,000, <1/1,000
<1/10,000
cannot be estimated from the available data
Immune system disorders
Not known*: anaphylactic shock including cases with fatal outcome, anaphylactic reactions, dyspnoea, skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity reactions.
Eye disorders
Common: accommodation disorders.
Not known*: mydriasis, increased intraocular pressure.
Cardiac disorders
Common: tachycardia.
Vascular disorders
Common: dizziness.
Not known*: blood pressure decreased, flushing.
Gastrointestinal disorders
Common: dry mouth, constipation.
Skin and subcutaneous tissue disorders
Not known*: dyshidrosis.
Renal and urinary disorders
Not known*: urinary retention.
Injection site pain, particularly after intramuscular use, occurs.
Hyoscine butylbromide due to its chemical structure as a quaternary ammonium derivate, is not expected to enter the central nervous system. Hyoscine butylbromide does not readily pass the blood-brain barrier. However, it cannot totally be ruled out that under certain circumstances psychiatric disorders (e.g. confusion) may also occur after administration of this medicine.
*This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than 'common', but might be lower. Precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 185 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, Website: 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 overdose, anticholinergic symptoms 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.
Treatment
Symptoms of hyoscine butylbromide overdose 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 used as required.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- BuscolysinHyoscini butylbromidum · injection / infusion
- Scopolamine butylbromide KalceksHyoscini butylbromidum · injection / infusion
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/ml solution for injection. 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.