Consumer medicine information

Buscopan Tablets [8921]

Hyoscine butylbromide

BRAND INFORMATION

Brand name

Buscopan

Active ingredient

Hyoscine butylbromide

Schedule

S4 | S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Buscopan Tablets [8921].

SUMMARY CMI

Buscopan® Tablets

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I taking Buscopan?

Buscopan contains the active ingredient hyoscine butylbromide. Hyoscine butylbromide is an anticholinergic medicine. Buscopan is used to relieve the pain of stomach and bowel cramps by helping your digestive system to relax.

For more information, see Section 1. Why am I taking Buscopan? in the full CMI.

2. What should I know before I take Buscopan?

Do not use if you have ever had an allergic reaction to hyoscine butylbromide or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take Buscopan? in the full CMI.

3. What if I am taking other medicines?

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

For more information see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take Buscopan?

The recommended dose for adults and children over 6 years of age is two tablets four times a day taken about every 4 - 6 hours. If you no longer have any stomach pain it is not necessary to finish taking all the tablets in the pack.

More instructions can be found in Section 4. How do I take Buscopan? in the full CMI.

5. What should I know after taking Buscopan?

Things you should do
  • Call your doctor straight away if the pain is severe or does not improve within 48 hours of taking Buscopan.
  • Before you take any other medicine, talk to your doctor or pharmacist.
  • Remind any doctor, dentist, or pharmacist you visit that you are taking Buscopan.
Things you should not do
  • Do not drink alcohol after taking Buscopan.
Looking after your medicine
  • Store below 25°C.
  • Store in a cool, dry place away from moisture, heat, or sunlight.

For more information, see Section 5. What should I know after taking Buscopan? in the full CMI.

6. Are there any side effects?

Less serious side effects include dry mouth, redness of the skin, fast heart rate, difficulty passing urine, abnormal sweating, reduced sweating.

A serious side effect is an allergic reaction with symptoms of shortness of breath, wheezing or difficulty breathing, swelling of the face, lips tongue or other parts of the body, itch, hives, or rash and sudden life-threatening allergic reactions (anaphylaxis with episodes of shortness of breath and shock).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Buscopan® Tablets

Active ingredient: hyoscine butylbromide


Consumer Medicine Information (CMI)

This leaflet provides important information about using Buscopan. You should also speak to your doctor, or pharmacist if you would like further information or if you have any concerns or questions about using Buscopan.

Where to find information in this leaflet:

1. Why am I taking Buscopan?
2. What should I know before I take Buscopan?
3. What if I am taking other medicines?
4. How do I take Buscopan?
5. What should I know after taking Buscopan?
6. Are there any side effects?
7. Product details

1. Why am I taking Buscopan?

Buscopan contains the active ingredient hyoscine butylbromide. Hyoscine butylbromide is an anticholinergic medicine. Buscopan is used to relieve the pain of stomach and bowel cramps by helping your digestive system to relax.

2. What should I know before I take Buscopan?

Warnings

Do not take Buscopan if:

  • you are allergic to hyoscine butylbromide, or 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
  • Always check the ingredients to make sure you can use this medicine.
  • you have fructose intolerance. Buscopan contains sucrose.
  • you have myasthenia gravis - a condition in which the muscles become weak and tire easily.
  • you have glaucoma - high pressure in the eye
  • you have porphyria - a rare blood pigment disorder
  • you have a suspected or confirmed blockage of the bowel or stomach
  • 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 have a fast heart rate (tachyarrhythmia)
  • you have a condition that causes difficulty in swallowing food (achalasia)
  • you have prostate problems - prostatic hypertrophy
  • 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.

Check with your doctor if you:

  • you have any other medical conditions
  • you take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or plan to breastfeed.

Children

Do not give it to a child 6 years of age or under.

3. What if I am taking other medicines?

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

Some medicines and Buscopan may interfere with each other:

  • 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 conditions

Check with your doctor, or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Buscopan.

4. How do I take Buscopan?

How much to take and how long to take it

  • Follow the instructions provided and take Buscopan until your doctor tells you to stop.
  • The recommended dose for adults and children over 6 years of age is two tablets four times a day taken about every 4 - 6 hours.
  • If you no longer have any stomach pain it is not necessary to finish taking all the tablets in the pack.

Do not take it for extended periods.

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

How it is taken

Swallow the tablets whole with a glass of water.

If you forget to take Buscopan

If you miss your dose at the usual time and it is almost time for your next dose, skip the dose you missed and take your dose when you are next meant to.

Otherwise, take it as soon as you remember and then go back to taking your medicines as you normally would.

Do not take a double dose to make up for the dose you missed.

If you take too much Buscopan

If you think you have taken too much Buscopan, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26 if you are in Australia), or
  • phone the National Poisons Information Centre
    (by calling 0800 POISON or 0800 764 766 if you are in New Zealand), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

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.

Do not drive a car or operate machinery if you have taken more than the recommended or prescribed dose of Buscopan.

5. What should I know after taking Buscopan?

Things you should do

Before you take any other medicine, talk to your doctor or pharmacist.

Call your doctor straight away if:

  • the pain is severe or does not improve within 48 hours of taking Buscopan.
    Cramps in the stomach or bowel may be temporary or may signal the presence of a more serious problem.
  • your abdominal pain continues or worsens or occurs with symptoms like:
    - fever
    - nausea
    - vomiting
    - changes in bowel movements
    - fainting
    - blood in faeces

Remind any doctor, dentist, or pharmacist you visit that you are taking Buscopan.

Drinking Alcohol

Do not drink alcohol after taking Buscopan.

Alcohol may increase the chance of side effects such as drowsiness.

Looking after your medicine

  • Store below 25°C.
  • Keep your tablets in the pack until it is time to take them.

Store it in a cool dry place away from moisture, heat or sunlight; for example:

  • do not store it in the bathroom or near a sink, or
  • do not store it in the car or on windowsills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor, or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Skin-related
  • Redness of the skin
  • Itching
  • A skin condition called dyshidrosis (small blisters on the hands and feet)
  • Rash
  • Abnormal sweating
  • Reduced sweating
Heart-related
  • Fast heart rate
Others
  • Dry mouth
  • Difficulty with passing urine
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Allergy-related
  • rash, itching or hives
  • swelling of the face, lips, tongue, or other parts of the body
  • sudden life-threatening allergic reactions (anaphylaxis with episodes of shortness of breath and shock)
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

Buscopan is available in blister packs of 10*#, 20# and 100 tablets.

*Not currently distributed in Australia

#Not available in New Zealand

Buscopan blister packs of 100 tablets are only available with a doctor's prescription.

Buscopan blister packs of 20 tablets are available only at a pharmacy in Australia.

What Buscopan contains

Active ingredient
(main ingredient)
10 mg of hyoscine butylbromide per tablet
Other ingredients
(inactive ingredients)
Tablet Core
  • calcium hydrogen phosphate dihydrate
  • maize starch
  • soluble starch
  • colloidal anhydrous silica
  • tartaric acid
  • stearic acid
Tablet Coating
  • sucrose
  • povidone
  • purified talc
  • acacia
  • titanium dioxide
  • macrogol 6000
  • carnauba wax
  • white beeswax
Potential allergensNone

Do not take this medicine if you are allergic to any of these ingredients.

Do not take this medicine if you have fructose intolerance. Buscopan contains sucrose.

What Buscopan looks like

Buscopan tablets are round, white, biconvex and sugar-coated (Aust R 48256).

Who distributes Buscopan

In Australia:

Sanofi Consumer Healthcare
87 Yarraman Place
Virginia QLD 4014
Australia
Toll-Free: 1800 818 806

In New Zealand:

Sanofi-Aventis New Zealand Limited
Auckland
New Zealand
Toll-free: 0800 283 684

This leaflet was prepared in September 2020.

buscopan-ccdsv01-cmiv12-22sep20

Published by MIMS February 2021

BRAND INFORMATION

Brand name

Buscopan

Active ingredient

Hyoscine butylbromide

Schedule

S4 | S2

 

1 Name of Medicine

Hyoscine butylbromide.

2 Qualitative and Quantitative Composition

Buscopan tablets contain 10 mg hyoscine butylbromide per tablet.

Excipients of known effect.

Sucrose.
Buscopan Forte tablets contain 20 mg hyoscine butylbromide per tablet.

Excipients of known effect.

Lactose monohydrate.
Buscopan ampoules contain 20 mg/1 mL hyoscine butylbromide per ampoule.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Buscopan tablets.

Round, white, biconvex sugar coated tablet.

Buscopan Forte tablets.

White round biconvex film-coated tablets. One side is marked "20", other side is marked "B".

Buscopan ampoules.

Colourless clear solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Buscopan and Buscopan Forte tablets.

Spasm of the gastrointestinal tract.

Buscopan ampoules.

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

4.2 Dose and Method of Administration

Tablets.

Adults and children over 6 years.

2 Buscopan tablets (2 x 10 mg) four times daily or 1 Buscopan Forte tablet (1 x 20 mg) four times daily.
Buscopan tablets are not recommended for children under 6 years of age.

Ampoules.

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.
Buscopan tablets and ampoules should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

4.3 Contraindications

Buscopan are contraindicated in patients with:
known hypersensitivity to hyoscine butylbromide or to any of the excipients of the product (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.
Buscopan 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, Buscopan ampoules are contraindicated in patients being treated with anticoagulant drugs as intramuscular haematoma may occur. In these patients, intravenous routes may be used.
Buscopan and Buscopan Forte tablets should not be used in patients with rare hereditary conditions that may be incompatible with the tablet excipients (see Section 4.4 Special Warnings and Precautions for Use).

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, Buscopan 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 Buscopan, 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 Buscopan 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 Buscopan.
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 Buscopan by injection should be kept under observation.
One Buscopan tablet contains 41.2 mg sucrose, resulting in 329.6 mg sucrose per maximum recommended daily dose. Patients with the rare hereditary condition of fructose intolerance should not take this medicine.
One Buscopan Forte tablet contains 138.5 mg lactose, resulting in 554 mg lactose per maximum recommended daily dose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Patients with cardiac conditions who are undergoing parenteral treatment with Buscopan ampoules should be monitored.
Buscopan 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.

See Section 4.2 for information on paediatric dosing.

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 Buscopan.
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 Buscopan during pregnancy.
There is insufficient information on the excretion of Buscopan and its metabolites in human milk. As a precautionary measure, it is preferable to avoid the use of Buscopan 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 Buscopan 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 Buscopan can be attributed to its anticholinergic properties. Anticholinergic side effects of Buscopan are generally mild and self limited.

Immune system disorders.

Tablets: anaphylactic reactions with episodes of dyspnoea and anaphylactic shock, skin reactions (e.g. urticaria, rash, erythema, pruritus), facial and periorbital swelling and other hypersensitivity reactions.
Ampoules: anaphylactic shock including fatal outcome, anaphylactic reactions, dyspnoea, skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity reactions.

Eye disorders.

Ampoules: accommodation disorders, mydriasis, increased intraocular pressure.

Cardiac disorders.

Tablets and ampoules: tachycardia.

Vascular disorders.

Ampoules: decreased blood pressure, dizziness and flushing.

Gastrointestinal disorders.

Tablets and ampoules: dry mouth.

Skin and subcutaneous tissue disorders.

Tablets and ampoules: dyshidrosis, abnormal sweating.

Renal and urinary disorders.

Tablets and ampoules: 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 (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

4.9 Overdose

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.

After oral overdose, induce emesis, gastric lavage, activated charcoal followed by magnesium sulfate (15%). 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.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) or the National Poisons Centre on 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Buscopan is a quaternary ammonium compound which, as an anticholinergic agent, has a ganglion blocking component. Due to its anticholinergic action, Buscopan 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.
Buscopan 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.
Buscopan is a powerful smooth muscle relaxant, effective when given by mouth or by injection. In the recommended dosages, Buscopan 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.

Buscopan is poorly absorbed from the gastrointestinal tract and is rapidly distributed. The bioavailability of oral Buscopan, as calculated from plasma levels, is reported to be 0.13%.

Distribution.

Upon oral administration hyoscine butylbromide concentrates especially in the tissue of the gastrointestinal tract, liver and kidneys. 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, while 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

Buscopan tablets also contain calcium hydrogen phosphate, maize starch, soluble starch, colloidal anhydrous silica, tartaric acid, stearic acid and, in the tablet coating, sucrose, povidone, purified talc, acacia, titanium dioxide, macrogol 6000, carnauba wax and white beeswax.
Buscopan Forte tablets also contain povidone, lactose, cellulose - microcrystalline, magnesium stearate and Opadry II white 85G18490.
Buscopan ampoules also contain sodium chloride and distilled water.

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

Buscopan tablets.

Store below 25°C.

Buscopan Forte tablets and Buscopan ampoules.

Store below 30°C.

6.5 Nature and Contents of Container

Buscopan tablets.

Blister packs of 10*, 20 and 100.

Buscopan Forte tablets.

Blister packs of 10.

Buscopan ampoules (1 mL).

Boxes of 5.
* Not sold in Australia.

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.

No data available.

CAS number.

No data available.

7 Medicine Schedule (Poisons Standard)

Buscopan tablets, blister packs of 10, 20.

(S2) Pharmacy Medicine.

Buscopan tablets, blister packs of 100.

(S4) Prescription Only Medicine.

Buscopan Forte tablets.

(S2) Pharmacy Medicine.

Buscopan ampoules.

(S4) Prescription Only Medicine.

Summary Table of Changes