Buscopan

Buscopan

hyoscine

Manufacturer:

Sanofi

Distributor:

Zuellig
/
Four Star
Full Prescribing Info
Contents
Hyoscine butylbromide.
Description
Sugar-coated tab: Each tablet contains 10 mg of the active ingredient hyoscine butylbromide.
Inj: Each 1 ml ampoule contains 20 mg hyoscine butylbromide.
Excipients/Inactive Ingredients: Sugar-coated tab: Calcium hydrogen phosphate, maize starch, soluble starch, colloidal silica, tartaric acid, stearic acid, sucrose, talc, acacia, titanium dioxide, macrogol 6000, carnauba wax, white beeswax and povidone.
Inj: Sodium Chloride, Water for injections.
Action
Sugar-coated tab: BUSCOPAN Tablets contain a medicine called "hyoscine butylbromide". This belongs to a group of medicines called "antispasmodics".
Inj: Pharmacology: Pharmacodynamics: Buscopan is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.
Pharmacokinetics: Plasma protein-binding of hyoscine-N-butylbromide is low.
Absorption and Distribution: After intravenous administration, hyoscine butylbromide is rapidly distributed (t½α=4 min, t½β=29 min) into the tissues. The volume of distribution (Vss) is 128 L (corresponding to approx. 1.7 L/kg). Because of its high affinity for muscarinic receptors and nicotinic receptors, hyoscine butylbromide is mainly distributed on muscle cells of the abdominal and pelvic area as well as in the intramural ganglia of the abdominal organs. Plasma protein binding (albumin) of hyoscine butylbromide is approximately 4.4%. Animal studies demonstrate that hyoscine butylbromide does not pass the blood-brain barrier, but no clinical data to this effect is available. Hyoscine butylbromide (1 mM) has been observed to interact with the choline transport (1.4 nM) in epithelial cells of human placenta in vitro.
Metabolism and elimination: The main metabolic pathway is the hydrolytic cleavage of the ester bond. The half-life of the terminal elimination phase (t½γ) is approximately 5 hours. The total clearance is 1.2 L/min. Clinical studies with radiolabeled hyoscine butylbromide show that after intravenous injection, 42 to 61% of the radioactive dose is excreted renally and 28.3 to 37% faecally.
The portion of unchanged active ingredient excreted in the urine is approximately 50%. The metabolites excreted via the renal route bind poorly to the muscarinic receptors and are therefore not considered to contribute to the effect of the hyoscine butylbromide.
Paediatric population: No particular pharmacokinetic studies concerning hyoscine butylbromide have been performed in children.
Toxicology: Preclinical safety data: In limited reproductive toxicity studies hyoscine butylbromide showed no evidence of teratogenicity in rats at 200 mg/kg in the diet or in rabbits at 200 mg/kg by oral gavage or 50 mg/kg by subcutaneous injection. Fertility in the rat was not impaired at doses of up to 200 mg/kg in the diet.
Indications/Uses
Sugar-coated tab: BUSCOPAN Tablets are used to relieve cramps in the muscles of: Stomach; Gut (intestine); Bladder and the tubes that lead to the outside of the body (urinary system).
It can also be used to relieve the symptoms of Irritable Bowel Syndrome (IBS).
Inj: Buscopan Ampoules are indicated in acute spasm, as in renal or biliary colic, in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography, and in other diagnostic procedures where spasm may be a problem, e.g. gastro-duodenal endoscopy.
Dosage/Direction for Use
Sugar-coated tab: Always take the medicine exactly as prescribed by the doctor or pharmacist. Check with the doctor or pharmacist if not sure. BUSCOPAN Tablets should not be taken continuously for long periods of time.
Taking this medicine: Take the tablets with water; Do not break, crush or chew the tablets.
How much to take: Adults and children over 12 years: The usual dose is two tablets 4 times a day.
For Irritable Bowel Syndrome, the doctor may give a lower starting dose of one tablet 3 times a day. This dose may be increased, if further relief is necessary.
Children 6 ‐ 12 years: The usual dose is one tablet 3 times a day.
BUSCOPAN Tablets are not recommended for children under 6 years.
If the patient has forgotten to take BUSCOPAN Tablets: If a dose has been forgotten, take it as soon as remembered. However, if it is time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
Inj: Adults: One ampoule (20 mg) intramuscularly or intravenously, repeated after half an hour if necessary. Intravenous injection should be performed 'slowly' (in rare cases a marked drop in blood pressure and even shock may be produced by Buscopan). When used in endoscopy this dose may need to be repeated more frequently.
Maximum daily dose of 100 mg.
Special populations: Elderly: No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.
Paediatric population: Not recommended for children.
Buscopan Ampoules should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
Diluent: Buscopan injection solution may be diluted with dextrose or with sodium chloride 0.9% injection solutions.
Overdosage
Sugar-coated tab: If the patient has taken more BUSCOPAN Tablets than necessary: If the patient has taken more BUSCOPAN Tablets than necessary, talk to a doctor or go to a hospital straight away. Take the medicine pack even if there are no BUSCOPAN Tablets left.
Inj: Symptoms: Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic symptoms such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur, and Cheynes-Stokes respiration has been reported.
Therapy: Symptoms of Buscopan overdosage respond to parasympathomimetics. For patients with glaucoma, pilocarpine should be given locally. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis, intubation and artificial respiration. Catheterisation may be required for urinary retention.
In addition, appropriate supportive measures should be used as required.
Contraindications
Sugar-coated tab: BUSCOPAN Tablets should not be taken if: The patient is allergic (hypersensitive) to hyoscine butylbromide or any of the other ingredients (listed in Description).
The patient has glaucoma (an eye problem).
The patient has something called "myasthenia gravis" (a very rare muscle weakness problem).
The patient has a suspected or confirmed blockage of the bowel.
The patient has 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.
The patient has a very enlarged bowel (megacolon).
The patient is pregnant, likely to get pregnant, or is breast‐feeding.
The medicine should not be taken if any of the above apply to the patient. If not sure, talk to the doctor or pharmacist before taking this medicine.
Inj: Buscopan should not be used in patients who have demonstrated prior sensitivity to hyoscine-N-butylbromide or any other component of Buscopan.
Patients with untreated narrow-angle glaucoma, prostate hypertrophy with urinary retention, mechanical stenosis in the gastrointestinal tract, tachycardia.
Buscopan Ampoules should not be administered to patients with myasthenia gravis, megacolon, narrow angle glaucoma, tachycardia, prostatic enlargement with urinary retention, mechanical stenoses in the region of the gastrointestinal tract or paralytic ileus.
BUSCOPAN ampoules should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.
Special Precautions
Sugar-coated tab: Check with the doctor or pharmacist before taking the medicine if: The patient has a very fast heart rate or other heart problems.
The patient has a problem with the thyroid gland such as an overactive thyroid gland.
The patient has difficulty or pain passing water (urine) such as men with prostate problems.
The patient has constipation.
The patient has a fever.
If not sure if any of the above apply to the patient, talk to the doctor or pharmacist before taking BUSCOPAN Tablets.
Check with the doctor or pharmacist straight away if with unexplained abdominal pain which persists or worsens or occurs with: fever; feeling sick; being sick; changes in the bowel movements; abdominal tenderness; low blood pressure; feeling faint or; blood in the bowel movements.
Important information about some of the ingredients of BUSCOPAN Tablets: BUSCOPAN Tablets contain sucrose. Talk to the doctor before taking this medicine if they have told that the patient cannot tolerate or digest some sugars.
Driving and using machines: Some people may have sight problems while taking this medicine. If this happens, wait until the sight returns to normal before driving or using any tools or machines.
Inj: In case of 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, appropriate diagnostic measures are needed to investigate the etiology of the symptoms.
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.
Because of the possibility that anticholinergics may reduce sweating, Buscopan should be administered with caution to patients with pyrexia.
Elevation of intraocular pressure may be produced by the administration of anticholinergic agents in patients with undiagnosed and therefore untreated narrow-angle glaucoma. Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision after the injection of Buscopan.
After parenteral administration of Buscopan, 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.
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. 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.
Use In Pregnancy & Lactation
Sugar-coated tab: Do not take BUSCOPAN Tablets if the patient is pregnant, likely to get pregnant or is breast‐feeding.
Inj: Pregnancy: There are limited data from the use of hyoscine butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure Buscopan is not recommended during pregnancy.
Lactation: There is insufficient information on the excretion of hyoscine butylbromide and its metabolites in human milk. A risk to the breastfeeding child cannot be excluded. Use of Buscopan during breastfeeding is not recommended.
Fertility: No studies on the effects on human fertility have been conducted.
Side Effects
Sugar-coated tab: Like all medicines, BUSCOPAN Tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Stop taking the medicine and see a doctor straight away for any of the following serious side effects ‐ the patient may need urgent medical treatment: Allergic reactions such as skin reactions e.g. nettle rash, itching (affects fewer than 1 in 100 people), rash, redness of the skin; Severe allergic reactions (anaphylactic shock) such as difficulty breathing, feeling faint or dizzy (shock); Painful red eye with loss of vision.
Other side effects: Dry mouth (affects fewer than 1 in 100 people); Small blisters on hands and feet (affects fewer than 1 in 100 people); Increased heart rate (affects fewer than 1 in 100 people); Being unable to pass water (urine) (affects fewer than 1 in 1,000 people).
Reporting of side effects: If the patient gets any of the side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed. The patient can also report side effects directly. By reporting side effects, the patient can help provide more information on the safety of this medicine.
Inj: Many of the listed undesirable effects can be assigned to the anticholinergic properties of BUSCOPAN. Anticholinergic side effects of Buscopan are generally mild and self-limited.
Adverse events have been ranked under headings of frequency using the following convention: Very common ≥ 1/10; Common ≥ 1/100, < 1/10; Uncommon ≥ 1/1,000, <1/100; Rare ≥ 1/10,000, <1/1,000; Very rare <1/10,000; Not known cannot be estimated from the available data.
Immune system disorders: Not known*: anaphylactic shock including cases with fatal outcome, anaphylactic reactions, dyspnoea, skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity.
Eye disorders: Common: accomodation disorders; Not known*: mydriasis, increased intraocular pressure.
Cardiac disorders: Common: tachycardia.
Vascular disorders: Common: dizziness; Not known*: blood pressure decreased, flushing.
Gatrointestinal disorders: Common: dry mouth, constipation.
Skin and subcutaneous tissue disorders: Not known*: dyshidrosis.
Renal and urinary disorders: Not known*: urinary retention; injection site pain, particularly after intramuscular use, occurs.
Hyoscine butylbromide, the active ingredient of Buscopan, due to its chemical structure as a quaternary ammonium derivate, is not expected to enter the central nervous system. Hyoscine butylbromide does not readily pass the blood-brain barrier. However, it cannot totally be ruled out that under certain circumstances psychiatric disorders (e.g. confusion) may also occur after administration of Buscopan.
*This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than common, but might be lower. A precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 185 patients.
Drug Interactions
Sugar-coated tab: Please tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because BUSCOPAN Tablets can affect the way some other medicines work. Also some other medicines can affect the way BUSCOPAN Tablets work.
In particular, tell the doctor or pharmacist if the patient is taking any of the following: Medicines for depression called "tetracyclic antidepressants" or "tricyclic antidepressants" such as doxepin; Medicines for allergies and travel sickness called "antihistamines"; Medicines to control the heart beat such as quinidine or disopyramide; Medicines for severe mental illness called 'antipsychotics' such as haloperidol or fluphenazine; Medicines usually used for breathing problems such as tiotropium, ipratropium or atropine-like medicines; Amantadine‐for Parkinson's disease and flu; Metoclopramide‐for feeling sick (nausea).
If not sure if any of the above apply to the patient, talk to the doctor or pharmacist before taking BUSCOPAN Tablets.
Inj: The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. phenothiazines, butyrophenones), disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intesified by Buscopan.
The tachycardic effects of beta-adrenergic agents may be enhanced by Buscopan.
Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.
Caution For Usage
Incompatibilities: None known.
Storage
Store in a dry place below 25°C. Protect from light.
Inj: Shelf life: Once opened, use immediately and discard any unused contents.
MIMS Class
ATC Classification
A03BB01 - butylscopolamine ; Belongs to the class of belladonna alkaloids, semisynthetic, quaternary ammonium compounds. Used in the treatment of functional gastrointestinal disorders.
Tab: P1, Inj: P1S1S3
Presentation/Packing
Sugar-coated tab (round and white) 10 mg x 56's. Inj (amp) (colourless or almost colourless, clear solution) 20 mg/mL x 10's, 100's.
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