Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Medsurge Hyoscine Butylbromide solution for injection.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine. Those updates may contain important information about the medicine and its use which you should be aware.

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

If you have any concerns about being given this medicine, talk to doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Hyoscine Butylbromide injection is used for

Hyoscine Butylbromide injection is an anticholinergic medicine. It relieves the pain of stomach and bowel cramps by helping your digestive system to relax.

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

Your doctor, however, may have prescribed Hyoscine Butylbromide injection for another purpose.

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

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

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

Before you use Hyoscine Butylbromide injection

When you must not have this medicine

You should not have Hyoscine Butylbromide injection if you are allergic to hyoscine butylbromide or any of the ingredients listed at the end of this leaflet. If you are uncertain as to whether you have such an allergy you should raise this concern with your doctor or pharmacist.

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 take Hyoscine Butylbromide injection if you have:

• 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
• a suspected or confirmed blockage of the bowel
• 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
• a very enlarged bowel (megacolon)
• tachyarrhythmia – a fast heart rate
• achalasia – a condition that causes difficulty in swallowing food
• prostatic hypertropy – prostate problems.

These conditions are best explained by your doctor or pharmacist.

Your doctor will not give Hyoscine Butylbromide injection 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 injection by an intravenous route.

Do not use this medicine after the expiry date (EXP) printed on the pack. If you are given it after the expiry date has passed, it may not work very well.

Do not use this medicine if the packaging is torn or shows signs of tampering or if the injection shows any visible signs of deterioration. If it has expired or is damaged, return it to your pharmacist for disposal.

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

Before you start to have this medicine

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

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.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

If you have not told your doctor about any of the above, tell them before you start taking Hyoscine Butylbromide injection.

Taking other medicines

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

Some medicines and Hyoscine Butylbromide injection 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
• medicines used to treat allergies such as antihistamines
• medicines for the treatment of depression, heart disease or respiratory disease such as tiotropium, ipratropium or atropine-like compounds
• any other medicine for the treatment of stomach or bowel condition.

These medicines may be affected by Hyoscine Butylbromide injection or may affect how well it works. You may need to use different amounts of the medicines or take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while using this medicine.

Pregnancy
Ask for your doctor's advice if you are pregnant, or likely to become pregnant during your course of medication. Special care is recommended during pregnancy, particularly in the first three months.

Breastfeeding
Ask for your doctor's advice if you are breastfeeding or likely to breastfeed during the course of your medication. Special care is recommended if you are breastfeeding as no studies have been conducted in nursing women.

Ability to drive or operate machinery
In rare cases, Hyoscine Butylbromide injection may cause drowsiness. If affected, do not drive or operate machinery.

Alcohol
Do not drink alcohol while on medication with Hyoscine Butylbromide injection. Alcohol may increase the chance of side effects such as drowsiness.

How to use Hyoscine Butylbromide injection

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much medicine is given

Adults and adolescents over 12 years:
The recommended dose is one or two ampoules (20 – 40 milligrams). It can be given as a slow intravenous or intramuscular injection. The maximum dose per day is 100 milligrams (equivalent to five ampoules).

Your doctor might prescribe a different dose or duration of treatment to that described here.

If you want more information, ask your doctor.

Hyoscine Butylbromide injection should only be used under the supervision of a doctor and in a setting where appropriate equipment is readily available for diagnosis and patient monitoring.

If you use too much (overdose)

Overdose of Hyoscine Butylbromide injection is unlikely as it is used under medical supervision. If you do receive too much Hyoscine Butylbromide injection, signs 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 healthcare immediately if you experience any signs of overdose.

While you are given Hyoscine Butylbromide injection

Things you must do

Before you start on a new medicine, remind your doctor and pharmacist that you are being given Hyoscine Butylbromide injection.

Tell any other doctors and pharmacists who treat you that you are having 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.

Cramps in the stomach or bowel may be temporary or may signal the presence of a more serious problem.

Always consult your doctor or pharmacist if the pain is severe or does not improve within 48 hours of taking Hyoscine Butylbromide injection.

Things you must not do

Do not drink alcohol while you are being given this medicine.

Side effects

All medicines may have some unwanted side effects. Sometimes they are serious but most of the time they are not. Your doctor has weighed the risks of this medicine against the benefits they expect it will have for you.

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

Tell your doctor as soon as possible if you do not feel well while you are having Hyoscine Butylbromide injection.

Do not be alarmed by this list of possible side effects. Not everybody experiences them.

Many of the side effects listed for Hyoscine Butylbromide injection are due to its anticholinergic properties. If side effects occur, they are usually mild when Hyoscine Butylbromide injection is used at the recommended dose, and may disappear when you have stopped taking Hyoscine Butylbromide injection.

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
• difficulty passing urine
• 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).
• dizziness
• a drop in blood pressure
• flushing
• temporary blurred vision (due to reduced eye focusing).

Very 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 injection 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).

The above list includes very serious side effects. You may need urgent medical attention or hospitalization.

When seeking medical attention take this leaflet and any remaining medicine with you to show the doctor.

Unexpected effects, not listed above, can occur with any medicine. You should tell your doctor or pharmacist if you notice anything unusual, during or after taking Hysocine Butylbromide injection.

After having it

Storage

Keep the unopened ampoules in a cool, dry place where the temperature stays below 25°C. Protect from light.

Do not store it or any other medicine in the bathroom, near a sink or on a windowsill.

Do not leave it in the car. Heat and damp can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and- a-half metres above the ground is a good place to store medicines.

Each ampoule can be used only once and unused contents of opened ampoules must be discarded.

Disposal

If your doctor tells you to stop having this medicine or the medicine has passed the expiry date, ask your pharmacist how to dispose of medicines no longer required.

Product description

What it looks like

Medsurge Hyoscine Butylbromide solution for injection is available in clear glass ampoules containing a clear, colourless or almost colourless solution in the following presentation and pack sizes.

Presentation

20 mg in 1 mL

Pack Sizes (Ampoules)

5 x 20 mg/1 mL; 10 x 20 mg/1 mL

Not all pack sizes are marketed.

Ingredients

Active ingredient:

1 mL of Medsurge Hyoscine Butylbromide solution for injection 20 mg in 1 mL contain 20 mg of hyoscine butylbromide.

Inactive ingredients:

• sodium chloride
• hydrochloric acid
• sodium hydroxide
• water for injections.

This medicine does not contain lactose, sucrose, gluten, tartrazine or other azo dyes.

Sponsor

Australian Sponsor

Medicianz Healthcare Pty Ltd
Unit 2, 6-7 Gilda Court
MULGRAVE
VICTORIA 3170

Marketed and distributed by

Tel: 1300 788 261
www.medsurge.com.au

Australian Registration Number(s):

Medsurge Hyoscine Butylbromide 20 mg/1 mL: AUST R 326541

This leaflet was updated in October 2020.

Published by MIMS December 2020

1 Name of Medicine

Hyoscine butylbromide.

2 Qualitative and Quantitative Composition

Hyoscine butylbromide 20 mg/1 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Hyoscine butylbromide injection is a clear, colourless or almost colourless solution. The solution does not contain any antioxidant or preservative.

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 injection should not be taken 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 injection are contraindicated in patients with: known hypersensitivity to hyoscine butylbromide or to any of the excipients of the product (excipients are listed, see Section 6.1 List of Excipients); mechanical stenosis in the gastrointestinal tract; achalasia; paralytic or obstructive ileus; intestinal atony; prostatic hypertrophy with urinary retention; myasthenia gravis; glaucoma; pathological tachyarrhythmias; megacolon.
Hyoscine butylbromide injection 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 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 injection should be monitored.
Hyoscine butylbromide injection 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.

Paediatric use.

Effects on laboratory tests.

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.

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 injection.
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 injection can be attributed to its anticholinergic properties. Anticholinergic side effects of hyoscine butylbromide injection are generally mild and self-limited.

Immune system disorders.

Eye disorders.

Cardiac disorders.

Vascular disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

Renal and urinary disorders.

Nervous system disorders.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Management.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.

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

Hyoscine butylbromide injection should be stored below 25°C. Protect from light.

6.5 Nature and Contents of Container

Hyoscine butylbromide injection is a clear colourless or almost colourless solution, available in Type 1 clear colourless glass ampoules in the following presentation and pack sizes:

Strength.

Pack sizes (ampoules).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes