Consumer medicine information

Hyoscine Butylbromide SXP Injection

Hyoscine butylbromide

BRAND INFORMATION

Brand name

Hyoscine Butylbromide SXP

Active ingredient

Hyoscine butylbromide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Hyoscine Butylbromide SXP Injection.

What is in this leaflet

This leaflet answers some common questions about Hyoscine butylbromide SXP. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Hyoscine butylbromide SXP against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Hyoscine butylbromide SXP is used for

Hyoscine butylbromide SXP is known as an anticholinergic medicine. It is used:

  • To relieve the pain of stomach and bowel cramps by helping your digestive system to relax
  • To help relax gallbladder spasms and kidney spasms
  • As a diagnostic aid in radiology.

Hyoscine butylbromide SXP reduces the peristalsis (wave-like contractions) of smooth muscle resulting in relief from spasms in certain organs in the digestive system.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor's prescription.

Always consult your doctor or pharmacist if the pain does not improve within 48 hours or if pain worsens after treatment.

Before you are given Hyoscine butylbromide SXP

When you must not be given it

You will only receive treatment with Hyoscine butylbromide SXP injection if it has been prescribed for you by a doctor.

The medicine will be given to you by a healthcare professional.

You should not be given Hyoscine butylbromide SXP if you have an allergy to:

  • any medicine containing hyoscine butylbromide
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

You should not be given Hyoscine butylbromide SXP if you have the following medical conditions:

  • myasthenia gravis - a condition in which the muscles become weak and tire easily.
  • glaucoma - high pressure in the eye
  • porphyria – a rare blood pigment disorder
  • megacolon - a condition where the bowel is enlarged
  • a suspected or confirmed blockage of the bowel
  • paralytic or obstruction ileus - a condition where the bowel is blocked and does not work properly
  • tachyarrhythmia – a fast heart rate
  • achalasia – a condition that causes difficulty in swallowing food
  • prostatic hypertrophy – prostate problems, with urinary retention - inability to completely empty the bladder
  • intestinal atony - lack of normal muscle tone or strength in the bowel

Hyoscine butylbromide SXP must not be used when there is a blockage in the stomach or bowel or in certain conditions when there is reduced bowel activity.

These conditions are best explained by your doctor or pharmacist.

Your doctor will not give Hyoscine butylbromide SXP by the intramuscular route if you are taking medicines used to prevent blood clots. In this case, your doctor may choose to give you Hyoscine butylbromide SXP by an intravenous route.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

The use of this medicine in children is not recommended. Safety and effectiveness in children have not been established.

If you are not sure whether you should start this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. There is limited information on the use of Hyoscine butylbromide SXP during pregnancy and breastfeeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you are given Hyoscine butylbromide SXP.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Hyoscine butylbromide SXP may interfere with each other. These include:

  • medicines used to treat or prevent nausea and vomiting such as metoclopramide
  • medicines used to treat malaria such as quinine
  • medicines used to treat the symptoms of Parkinson's disease such as amantadine
  • medicines used to treat some mental conditions such as tri and tetracyclic antidepressants and antipsychotics, phenothiazines and MAOI inhibitors
  • medicines used to treat allergies such as antihistamines
  • medicines for the treatment of depression, heart disease or respiratory disease such as tiotropium, ipratropium, atropine-like compounds, betasympathomimetics and disopyramide
  • any other medicine for the treatment of stomach or bowel condition including belladonna alkaloids

These medicines may be affected by Hyoscine butylbromide SXP or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given this medicine.

How Hyoscine butylbromide SXP is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors.

The recommended dose is one or two ampoules (20 – 40 milligrams).

The maximum dose per day is 100 milligrams (equivalent to five ampoules).

Your doctor might prescribe a different dose or duration of treatment. If you need further information, ask your doctor or pharmacist.

Worsening or persistent stomach pain should be investigated by your doctor to determine the cause of the pain.

Safety and effectiveness of Hyoscine butylbromide SXP in children have not been established and is therefore not recommended.

How it is given

This medicine should only be given by a doctor or nurse and in a setting where appropriate equipment is readily available for diagnosis and patient monitoring.

The injections can be given deeply into a muscle (e.g. the buttock, upper leg or upper arm) or can be given as a slow injection into the vein.

Overdose

These injections are given under medical supervision and it is very unlikely that you will be given too much.

Symptoms of an overdose may include: drowsiness, dry mouth, difficulty passing urine, reddening of the skin, decreased gastrointestinal tract movement, fast heart rate and sight disturbances.

Tell your doctor or medical staff immediately if you experience any signs of overdose.

While you are being given Hyoscine butylbromide SXP

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given Hyoscine butylbromide SXP.

Tell any other doctors, dentists and pharmacists who treat you that you are being given this medicine.

Tell your doctor immediately if your abdominal pain continues or worsens or occurs with symptoms like:

  • fever
  • nausea
  • vomiting
  • changes in bowel movements
  • fainting
  • blood in faeces
  • abdominal tenderness
  • drowsiness

Tell your doctor or pharmacist if the pain is severe or does not improve within 48 hours of taking Hyoscine butylbromide SXP. Cramps in the stomach or bowel may be temporary or may signal the presence of a more serious problem.

If you have a heart condition, your doctor will closely monitor you for additional side effects.

Things to be careful of

Be careful driving or operating machinery until you know how Hyoscine butylbromide SXP affects you. This medicine may cause dizziness, tiredness, drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Do not drink alcohol while you are being given this medicine. Alcohol may increase the chance of side effects such as drowsiness.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Hyoscine butylbromide SXP.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • dry mouth
  • fast heart rate
  • reduced sweating
  • rash
  • itching
  • redness of the skin
  • a skin condition called dyshidrosis (blisters on the feet and hands)
  • difficulty with passing urine or inability to completely empty the bladder
  • eye conditions including temporary blurred vision (due to reduced eye focusing), dilated pupils, visual disturbances
  • dizziness
  • a drop in blood pressure
  • flushing
  • shortness of breath

Vary rarely there have also been isolated reports of coma, hallucinations (seeing, feeling or hearing things that are not there), dystonia (unusual muscle tone causing distortion of the body), confusion, agitation and dizziness. These side effects were relieved when the patients stopped Hyoscine butylbromide SXP therapy and received appropriate medical treatment.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • allergic reactions (such as skin rashes, or swelling of the face and difficulty in breathing).
  • sudden life-threatening allergic reactions (anaphylaxis with episodes of shortness of breath and shock).

Allergic reactions can be very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After being given Hyoscine butylbromide SXP

Storage

Hyoscine butylbromide SXP Injection should be kept in a cool dry place where the temperature stays below 25°C.

Protect from light.

Each ampoule is for single use only and unused contents of opened ampoules must be discarded.

Product description

What it looks like

Hyoscine butylbromide SXP injection 1 mL glass ampoules contain a clear, colourless or almost colourless solution.

Hyoscine butylbromide SXP injection is available in packs of 5 and 10 ampoules. Not all pack sizes may be marketed.

Ingredients

Each Hyoscine butylbromide SXP injections contains 20 mg of hyoscine butylbromide as the active ingredient.

The ampoules also contain the following inactive ingredients:

  • sodium chloride
  • water for injections
  • sodium hydroxide (for pH adjustment)
  • hydrochloric acid (for pH adjustment)

Distributor

Hyoscine butylbromide SXP is distributed in Australia by:

Southern Cross Pharma Pty Ltd
Suite 5/118 Church St
Hawthorn VIC 3122

This leaflet was prepared in July 2020.

AUST R 278817

[Hyoscine butylbromide SXP]_cmi\0720/17

Published by MIMS September 2020

BRAND INFORMATION

Brand name

Hyoscine Butylbromide SXP

Active ingredient

Hyoscine butylbromide

Schedule

S4

 

Notes

Distributed by Southern XP Pty Ltd

1 Name of Medicine

Hyoscine butylbromide.

2 Qualitative and Quantitative Composition

Ampoule containing hyoscine butylbromide 20 mg in 1 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Clear, colourless or almost colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Spasm of the gastrointestinal tract, biliary spasm, renal spasm, diagnostic aid in radiology.

4.2 Dose and Method of Administration

1 or 2 ampoules (20 or 40 mg) by intramuscular or slow intravenous injection. A maximum daily dose of 100 mg should not be exceeded.
Hyoscine butylbromide ampoules should not be administered on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
Product is for single use in one patient only. Discard any residue.

4.3 Contraindications

Hyoscine butylbromide is contraindicated in patients with:
known hypersensitivity to hyoscine butylbromide or to any excipients of the product (excipients are listed under List of Excipients);
mechanical stenoses of the gastrointestinal tract;
achalasia;
paralytic or obstructive ileus;
intestinal atony;
prostatic hypertrophy with urinary retention;
myasthenia gravis;
glaucoma;
pathological tachyarrhythmias;
megacolon.
Hyoscine butylbromide should not be given to patients with porphyria as, according to a single report, it has been said to exacerbate the disease.
By intramuscular injection, hyoscine butylbromide ampoules are contraindicated in patients being treated with anticoagulant drugs as intramuscular haematoma may occur. In these patients, intravenous routes may be used.

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 may cause drowsiness: patients so affected should not drive or operate machinery. Patients should abstain from alcohol. However, as a quaternary ammonium compound with low lipid solubility, hyoscine butylbromide cannot cross the blood/brain barrier easily and only rarely causes the central nervous system side effects associated with atropine and hyoscine.
After parenteral administration of hyoscine butylbromide, patients with visual accommodation disturbances should not drive or operate machinery until vision has normalised.
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. Patients should be advised to seek urgent ophthalmological advice if they develop a painful, red eye with loss of vision after an injection of hyoscine butylbromide. Because of the potential risk of anticholinergic complications, caution should be used in patients prone to narrow angle glaucoma as well as in patients susceptible to intestinal or urinary outlet obstructions and in those inclined to tachyarrhythmia.
After parenteral administration, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving hyoscine butylbromide by injection should be kept under observation.
Patients with cardiac conditions who are undergoing parenteral treatment with hyoscine butylbromide ampoules should be monitored.
Hyoscine butylbromide ampoules 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.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The anticholinergic effects of drugs such as amantadine, tri- and tetracyclic antidepressants, quinidine, antihistamines, antipsychotics, disopyramide, phenothiazines, belladonna alkaloids, other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) and MAO inhibitors etc, together with the tachycardia induced by beta-sympathomimetics, can be potentiated by hyoscine butylbromide.
The concomitant administration of dopamine antagonists, such as metoclopramide, can reciprocally antagonise the effect on gastrointestinal tract motility.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
There is limited data from the use of hyoscine butylbromide in pregnant women. As a precautionary measure, it is preferable to avoid the use of hyoscine butylbromide during pregnancy.
 There is insufficient information on the excretion of hyoscine butylbromide and its metabolites in human milk. As a precautionary measure, it is preferable to avoid the use of hyoscine butylbromide during lactation.

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 disorder or dizziness during treatment with hyoscine butylbromide ampoules.
Therefore, caution should be recommended when driving a car or operating machinery. If patients experience accommodation disorder or dizziness, they should avoid potentially hazardous tasks such as driving or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

Many of the listed adverse effects of hyoscine butylbromide can be attributed to its anticholinergic properties. Anticholinergic side effects of hyoscine butylbromide are generally mild and self limited.

Immune system disorders.

Anaphylactic reactions including fatal outcomes, anaphylactic reactions, dyspnoea, skin reactions (e.g. urticarial rash, erythema, pruritus), facial and periorbital swelling and other hypersensitivity reactions.

Eye disorders.

Accommodation disorders, mydriasis, increased intraocular pressure.

Cardiac disorders.

Tachycardia.

Vascular disorders.

Decreased blood pressure, dizziness and flushing.

Gastrointestinal disorders.

Dry mouth.

Skin and subcutaneous tissue disorders.

Dyshidrosis, abnormal sweating.

Renal and urinary disorders.

Impaired micturition, urinary retention.

Nervous system disorders.

Very rarely in the national post marketing surveillance data base, there have been isolated reports following parenteral administration of coma, hallucinations, dystonia, confusion, agitation and dizziness from which the patient recovered after drug withdrawal and appropriate treatment. In very rare cases, dyspnoea has been reported.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Symptoms.

Serious signs of poisoning have not been observed in man. In case of overdose, anticholinergic symptoms such as urinary retention, dry mouth, reddening of the skin, inhibition of gastrointestinal motility, tachycardia, drowsiness and transient visual disorders may occur.
Toxicity data from studies in animals after parenteral administration suggest that the following may be possible: shock, Cheyne-Stokes respiration, respiratory paralysis, clonic spasms, paralysis of striated muscle, coma, paralytic ileus, bladder atony.

Management.

Supportive measures if necessary should be instituted. Symptoms of overdosage may respond to parasympathomimetics. Ophthalmological advice should be sought urgently in cases of glaucoma. Pilocarpine may be administered locally in patients with glaucoma. Sympathomimetics may be used for circulatory support. For mental excitation, diazepam.
Cardiovascular complications as a result of using this medicine should be treated according to usual therapeutic principles. In case of respiratory paralysis, intubation and assisted respiration.
Catheterisation may be required for urinary retention. In addition, appropriate supportive measures should be used as required.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Hyoscine butylbromide is a quaternary ammonium compound which, as an anticholinergic agent, has a ganglion blocking component. Due to its anticholinergic action, hyoscine butylbromide reduces the tone and peristalsis of smooth muscle in hollow organs with parasympathetic innervation. As a quaternary ammonium compound with low lipid solubility, it cannot pass the blood/brain barrier easily and only rarely causes the central nervous system side effects associated with atropine and hyoscine.
Hyoscine butylbromide is a spasmolytic. The anticholinergic spasmolytic effect is based both on competitive inhibition of the parasympathetic activation of smooth muscle mediated through muscarinic receptors and, more markedly, through ganglionic blockade of neural transmission.
Hyoscine butylbromide is a powerful smooth muscle relaxant, effective when given by mouth or by injection. In the recommended dosages, hyoscine butylbromide relieves smooth muscle spasm rapidly. Undesirable 'atropine-like' side effects such as blurred vision, palpitation or dry mouth are rare.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Hyoscine butylbromide is poorly absorbed from the gastrointestinal tract.

Distribution.

Hyoscine butylbromide is rapidly distributed. The bioavailability of oral hyoscine butylbromide, as calculated from plasma levels, is reported to be 0.13%. Upon oral administration hyoscine butylbromide concentrates especially in the tissue of the gastrointestinal tract, liver and kidneys.

Metabolism.

The high affinity of this agent to the tissue is reflected by the very short half-life, t-alpha of 3 minutes (distribution phase) of the blood levels.

Excretion.

Despite the very short half life, the excretion rates are slow. Thus, in spite of the extremely low blood levels measurable over a short period of time, hyoscine butylbromide remains available at the site of action in the tissue in high concentrations.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hyoscine butylbromide ampoules also contain sodium chloride and water for injections, sodium hydroxide and hydrochloric acid (for pH adjustment).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Packs of 5 and 10 clear Type I glass ampoules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Molecular formula: C21H30NO4+.
Molecular weight: 440.4.

CAS number.

149-64-4.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes