Product Information

Composition3

Medicinal ingredient : hyoscine-N-butylbromide.

Non-medicinal ingredients : acacia, carnauba wax, castor oil, lactose, magnesium stearate, maize starch, sucrose, polyethylene glycol, shellac, talc, tartaric acid, titanium dioxide, and white wax.

Dosage3

Individual response to BUSCOPAN® (hyoscine butylbromide) may vary and doses should be adjusted accordingly.
Recommended Dose: One to two 10 mg tablets per day up to a maximum of 6 tablets per day. In prolonged illness which requires repeated dosing, 1 tablet 3 to 5 times a day is recommended.
In case a dose has been missed, take the next dose as scheduled. Do not double the dose.

Overdosage3

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Symptoms

Single oral doses of up to 590 mg and quantities of active drug up to 1090 mg within 5 hours have produced dry mouth, tachycardia, slight drowsiness and transient visual disorders. Other symptoms include urinary retention, reddening of the skin, and inhibition of gastrointestinal motility.
Other symptoms which occurred in animals and which may be encountered in humans include: shock, Cheyne-Stokes respiration, respiratory paralysis, clonic spasms, paresis of the striated muscle, coma, paralytic ileus and cystoparalysis.

Treatment

In the case of an oral overdose, perform gastric lavage with activated charcoal followed by magnesium sulfate (15%). BUSCOPAN® overdose symptoms respond to parasympathomimetics.
For patients with glaucoma, administer pilocarpine locally. If necessary, parasypathomimetics should be administered, e.g. neostigmine 0.5-2.5 mg i.m. or i.v.. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis: intubation, artificial respiration. Catheterisation may be required for urinary retention.
Other overdosage symptoms should be treated with standard supportive therapy.

Contradictions3

  • You are hypersensitive (allergic) to hyoscine butylbromide or atropinics or to any of the non-medicinal ingredients.

  • You have myasthenia gravis (a muscle wasting disease), megacolon (enlarged colon), untreated narrow angle glaucoma or obstructive prostatic hypertrophy (enlarged and blocked prostate).

Warnings and Precautions3

BEFORE you use BUSCOPAN® talk to your doctor or pharmacist if:

  • You are pregnant, likely to become pregnant or if you are breast feeding as it is recommended that you do not use BUSCOPAN® in these conditions
  • You are a man who suffers from prostate problems
  • You have narrow angle glaucoma, megacolon or myasthenia gravis
  • You have a very fast heart rate or other heart problems
  • You have reflux esophagitis or ulcerative colitis
  • You are hypersensitive or allergic to hyoscine-N-butylbromide or any of the other ingredients
  • You have previously been treated by a doctor for a severe sweating disorder
  • You are taking antidepressants, major tranquilizers, antihistamines, antivirals, dopamine antagonists (e.g. metoclopramide) or medicines to treat heart problems
  • You have sudden or severe abdominal pain along with symptoms such as fever, nausea, vomiting, blood in the stool, or low blood pressure (e.g., light-headedness), contact your doctor immediately
  • You have a rare hereditary condition of fructose (a sugar) intolerance you should not take this medication as it contains lactose.
  • You experience dizziness or blurred vision, avoid driving or operating machinery.

Interactions3

Drugs that may interact with BUSCOPAN include: tricyclic antidepressants, antihistamines, quinidine, disopyramide, amantadine, MAO inhibitors, anticholinergics, dopamine antagonists such as metoclopramide, beta-adrenergic agents, antacids or adsorbent antidiarrheals.

Side Effects3

After taking BUSCOPAN® tablets: All medicines sometimes cause side-effects. BUSCOPAN® may occasionally cause a dry mouth, blurred vision, mydriasis (pupil dilation), increased eye pressure, diarrhea, nausea, reduced ability to sweat, an increase in heart rate and the inability to pass urine.

Other possible rare side-effects include, dizziness, flushing, allergic reactions (particularly skin rash and itching), skin reactions (e.g., hives, rash, skin redness, itching), angioedema (swelling of the lips), decreased blood pressure, and difficulty in breathing (usually in patients who suffer with asthma or allergy).

There have been very rare reports of anaphylactic (severe, allergic) reactions and anaphylactic shock including death.

If you experience any of these effects and they persist or become troublesome, consult your doctor.

Should you suffer from a painful red eye with loss of vision, seek urgent medical advice.

If you experience any other effects not mentioned above, consult your doctor or pharmacist. This is not a complete list of side effects. For any unexpected effects while taking BUSCOPAN®, contact your doctor or pharmacist.

Storage3

BUSCOPAN® tablets should be protected from light and heat and should be stored at room temperature (15 – 30oC).

Keep out of reach of children.