Consumer medicine information

Buscopan Tablets [8921]

Hyoscine butylbromide

BRAND INFORMATION

Brand name

Buscopan Tablets

Active ingredient

Hyoscine butylbromide

Schedule

S2: 20's; S4: 100's

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some common questions about Buscopan tablets.

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

This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Buscopan against the benefits they expect it will have for you.

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

Keep this information with the medicine.

You may need to read it again.

What Buscopan is used for

Buscopan is known as an anticholinergic medicine. It relieves the pain of stomach and bowel cramps by helping your digestive system to relax.

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

Buscopan blister packs of 100 tablets are 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 take Buscopan

When you must not take it

Do not take Buscopan if you are allergic to hyoscine butylbromide or to any of the other 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.

Do not take this medicine if you have fructose intolerance.

Buscopan contains sucrose as an ingredient.

Do not take Buscopan 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
  • megacolon - a condition of the colon
  • tachyarrhythmia - a fast heart rate
  • achalasia - a condition that causes difficulty in swallowing food
  • prostatic hypertrophy - prostate problems.

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

Safety and effectiveness in children younger than 6 years have not been established.

Do not take it 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.

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

Before you start to take it

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 breastfeeding.

There is limited information on the use of Buscopan 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 him/her before you start taking Buscopan.

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 Buscopan 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 Buscopan 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 taking this medicine.

How to take Buscopan

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 to take

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.

How to take it

Swallow the tablets whole with a glass of water.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition, but does not cure it.

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.

If you forget to take it

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

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

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

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you no longer have any stomach pain it is not necessary to finish taking all the tablets in the pack

If you take too much (overdose)

Seek medical advice if you have used more than the recommended or prescribed dose of Buscopan.

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.

Advice can be provided by a doctor, pharmacist or Poisons Information Centre (in Australia telephone 13 11 26; in New Zealand telephone 0800 764 766).

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

While you are taking Buscopan

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Buscopan.

Tell your doctor or pharmacist if you begin taking any other medicine while you are taking this medicine.

Tell your doctor or pharmacist 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.

Things to be careful of

Be careful driving or operating machinery until you know how Buscopan 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 taking Buscopan.

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 taking Buscopan.

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of taking this medicine.

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

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 (small blisters on the hands and feet)
  • difficulty passing urine.

There have also been very rare 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 Buscopan therapy and received appropriate medical treatment.

If any of the following happen, tell your doctor immediately or go to 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 taking Buscopan

Storage

Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store Buscopan or any other medicine in the bathroom or near a sink.

Do not leave it on a window sill or in the car.

Heat and dampness can damage 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.

Disposal

If the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product Description

Buscopan is available in blister packs of 10*, 20 and 100 tablets. Australian Registration number on outer carton is AUST R 48256.

* Not currently distributed in Australia.

What it looks like

Buscopan tablets are small, shiny and white in colour.

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

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

Ingredients

Buscopan contains 10 mg of hyoscine butylbromide as the active ingredient.

It also contains in the tablet core:

  • calcium hydrogen phosphate
  • maize starch
  • soluble starch
  • colloidal anhydrous silica
  • tartaric acid
  • stearic acid.

The sugar coating contains:

  • sucrose
  • povidone, purified talc
  • acacia
  • titanium dioxide
  • macrogol 6000
  • carnauba wax
  • white beeswax.

Supplier

Buscopan is supplied in Australia by:
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
78 Waterloo Road
NORTH RYDE NSW 2113

Buscopan is supplied in New Zealand by:
Boehringer Ingelheim (N.Z.) Limited
Auckland
New Zealand

This leaflet was prepared in May 2013.

BUSCOPAN is a registered trademark of Boehringer Ingelheim

© Boehringer Ingelheim Pty Limited 2013

BRAND INFORMATION

Brand name

Buscopan Tablets

Active ingredient

Hyoscine butylbromide

Schedule

S2: 20's; S4: 100's

 

1 Name of Medicine

Hyoscine butylbromide.

6.7 Physicochemical Properties

Chemical structure.

No data available.

CAS number.

No data available.

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.

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.

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.

4.3 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.

4.8 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.

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).

4.2 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.

4.7 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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

Buscopan tablets.

10's, 20's: S2; 100's: S4.

Buscopan Forte tablets.

S2.

Buscopan ampoules.

S4.

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.

Summary Table of Changes