Buscopan

Hyoscine butylbromide.

Sugar-coated tablet: Each tablet (round and white) contains 10 mg of the active ingredient hyoscine butylbromide.
Injection: Solution (colourless or almost colourless, clear solution): Containing 20 mg of hyoscine butylbromide in 1 mL aqueous solution.
Excipients/Inactive Ingredients: Sugar-coated tablet: The other ingredients are: 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.
Injection: Non-medicinal ingredients include sodium chloride and water for injection.

Sugar-coated tablet: BUSCOPAN Tablets contain a medicine called "hyoscine butylbromide". This belongs to a group of medicines called "antispasmodics".
Injection: Pharmacology: Mechanism of Action: BUSCOPAN (hyoscine butylbromide) is an antispasmodic agent which relaxes the smooth muscle of the gastrointestinal, biliary and urinary (parenteral formulation) tracts. It is believed to act predominantly at the parasympathetic ganglia in the walls of the viscera of these organs. Structurally, BUSCOPAN exists as a quaternary ammonium compound and as a single positively charged cation throughout the entire pH range.
Pharmacokinetics: Absorption and distribution: After intravenous administration, hyoscine butylbromide is rapidly distributed (t_1/2α = 4 min, t_1/2β = 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 (t_1/2γ) 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.

Sugar-coated tablet: 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).
Injection: BUSCOPAN solution is indicated for: The relief of acute genitourinary or gastrointestinal spasm (e.g., renal or biliary colic), or to produce smooth muscle relaxation prior to radiological procedures such as pyelography or other diagnostic procedures where spasm may be a problem (e.g., gastroduodenal endoscopy).
Geriatrics: No data is available.
Pediatrics: No data is available.

Sugar-coated tablet: Always take the medicine exactly as told by the doctor or pharmacist. Check with the doctor or pharmacist if unsure. 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.
Forgotten intake of BUSCOPAN Tablets: If a dose has been forgotten, take it as soon as it is 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.
Injection: Dosing Considerations: Individual response to BUSCOPAN (hyoscine butylbromide) may vary and doses should be adjusted accordingly.
Recommended Dose and Dosage Adjustment: One half (10 mg/0.5 mL) to one ampoule (20 mg/1 mL) administered parenterally by intramuscular, subcutaneous, or intravenous routes, at a slow injection rate of 1 mL/min. No dilution of the solution is necessary prior to administration. The maximum dose should not exceed 100 mg/day (5 ampoules).
Missed Dose: In case a dose has been missed, take the next dose as scheduled. Do not double the dose.
Administration: The rapid action of injected BUSCOPAN is advantageous in acutely ill patients and in those situations where prompt spasmolytic activity facilitates diagnostic procedures such as radiological examinations. BUSCOPAN solution may also be used intramuscularly 10-15 minutes before radiological examinations of the stomach to slow peristaltic movements.

Sugar-coated tablet: If more BUSCOPAN Tablets are taken 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.
Injection: For management of a suspected drug overdose, contact the regional Poison Control Centre immediately.
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: BUSCOPAN overdose symptoms respond to parasympathomimetics.
For patients with glaucoma, administer pilocarpine locally. If necessary, parasympathomimetics 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.

Sugar-coated tablet: Do not take BUSCOPAN Tablets if: allergic (hypersensitive) to hyoscine butylbromide or any of the other ingredients (listed in Description); with glaucoma (an eye problem); with something called "myasthenia gravis" (a very rare muscle weakness problem); with a suspected or confirmed blockage of the bowel; with 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]; with a very enlarged bowel (megacolon); pregnant, likely to get pregnant, or breast-feeding.
Do not take this medicine if any of the previously mentioned apply. If unsure, talk to the doctor or pharmacist before taking this medicine.
Injection: Hypersensitivity to hyoscine butylbromide, atropinics (see Precautions) or to any of the product excipients (see Description).
Parenteral administration is contraindicated in patients with myasthenia gravis, untreated narrow angle glaucoma, prostatic hypertrophy with urinary retention, stenotic lesions or mechanical stenosis of the gastrointestinal tract, tachycardia, angina, cardiac failure, paralytic or obstructive ileus, and megacolon.
BUSCOPAN solution should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur. In these patients, the subcutaneous or intravenous routes may be used.

Sugar-coated tablet: Check with the doctor or pharmacist before taking the medicine if: with a very fast heart rate or other heart problems; with a problem with the thyroid gland such as an overactive thyroid gland; with difficulty or pain passing water (urine) such as men with prostate problems; with constipation; with a fever.
If unsure if any of the previously mentioned apply, 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 bowel movements; abdominal tenderness; low blood pressure; feeling faint; or blood in bowel movements.
Important information about some of the ingredients of BUSCOPAN Tablets: BUSCOPAN Tablets contain sucrose. The patient should talk to the doctor before taking this medicine if told by the doctor that some sugars cannot be tolerated or digested.
Driving and using machines: Some people may have sight problems while taking this medicine. If this happens, wait until sight returns to normal before driving or using any tools or machines.
Injection: General: BUSCOPAN should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
Patients intolerant of one belladonna alkaloid or derivative may also be intolerant of other belladonna alkaloids or derivatives such as hyoscine butylbromide.
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.
Parenteral BUSCOPAN can cause serious and severe cardiac adverse reactions consisting of tachycardia and hypotension (see Cardiovascular as follows and Contraindications).
Cardiovascular: Parenteral BUSCOPAN can cause adverse reactions of tachycardia and hypotension, which may be more serious or more severe in patients with cardiac conditions such as coronary heart disease, cardiac arrhythmias, hypertension, and mitral stenosis, and in cardiac surgery. Monitoring of these patients is advised until conditions return to normal. Emergency equipment and personnel trained in its use must be readily available.
Parenteral BUSCOPAN should be used with caution in patients with cardiac conditions.
Parenteral BUSCOPAN is contraindicated in patients with tachycardia, angina, and cardiac failure (see Contraindications).
The increase in heart rate may also be undesirable in patients with unstable cardiovascular status in an acute hemorrhage situation.
In addition, exercise caution in patients inclined to tachyarrhythmia.
Gastrointestinal: Exercise caution in patients with reflux esophagitis or gastrointestinal tract obstructive disease (i.e., achalasia and pyloroduodenal stenosis) due to the ability of anticholinergics/systemic antispasmodics to decrease smooth muscle motility and tone resulting in gastric retention.
Anticholinergics may aggravate hiatal hernia associated with reflux esophagitis, myasthenia gravis or pyloric obstruction.
In patients with ulcerative colitis, large anticholinergic doses may suppress intestinal motility, possibly causing paralytic ileus or resulting in obstruction; also, use may precipitate or aggravate toxic megacolon.
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.
Genitourinary: Parenteral BUSCOPAN (hyoscine butylbromide) should be used with caution in patients with prostatic enlargement. BUSCOPAN may precipitate or aggravate urinary retention in patients with the following conditions: non-obstructive prostatic hypertrophy, urinary retention (or the predisposition to) or obstructive uropathy such as a bladder neck obstruction due to prostatic hypertrophy (see Contraindications).
Ophthalmologic: The parenteral administration of hyoscine butylbromide, particularly of higher doses, has been reported to cause transient disturbances of accommodation which recede spontaneously. Therefore, patients should be cautioned about potential visual problems and the need to exercise care while driving or operating machinery after receiving BUSCOPAN solution.
Therapy should be discontinued if the patient reports any unusual visual disturbances or pressure pain within the eyes.
The mydriatic effect of anticholinergics/systemic antispasmodics may result in increased intraocular pressure. BUSCOPAN should be used with caution in patients with angle-closure glaucoma or with this predisposition, as anticholinergics/systemic antispasmodics may precipitate an acute angle-closure glaucoma attack (see Contraindications).
Patients should seek urgent ophthalmological advice in case they should develop a painful eye with loss of vision after injection of BUSCOPAN.
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 solution. 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 Children: BUSCOPAN is not currently recommended for use in children.
Use in the Elderly: Geriatric patients are especially susceptible to the anticholinergic side effects of constipation, dryness of mouth and urinary retention (especially in males). If these side effects continue or are severe, discontinuation of medication should be considered.
Due care is necessary when anticholinergics are administered to geriatric patients due to the danger of precipitating undiagnosed glaucoma.
Administration of anticholinergics/systemic antispasmodics to elderly patients with intestinal atony or in debilitated patients may result in intestinal obstruction.

Sugar-coated tablet: Do not take BUSCOPAN Tablets if pregnant, likely to get pregnant or breast-feeding.
Injection: There is limited data from the use of hyoscine butylbromide in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
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 pregnancy and lactation.
No studies on the effects on human fertility have been conducted.

Injection: Adverse Drug Reaction Overview: 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.
Accumulated clinical and postmarketing experience indicates that the following adverse reactions can be expected with the use of BUSCOPAN: Cardiac disorders: Tachycardia.
Eye disorders: Visual accommodation disorders, mydriasis, increased intraocular pressure.
Gastrointestinal disorders: Xerostomia (dry mouth).
Immune system disorders: There have been very rare reports of anaphylactic reactions and anaphylactic shock including fatal outcome.
Skin reactions (e.g. urticaria, rash, erythema, pruritus), and other hypersensitivity, angioedema and fixed drug eruptions have been reported rarely.
Dyspnea.
Renal and urinary disorders: Urinary retention.
Skin and subcutaneous tissue disorders: Hypohidrosis, heat sensation/transpiration.
Vascular disorders: There have been rare reports of dizziness, blood pressure decreased and flushing.

Sugar-coated tablet: Like all medicines, BUSCOPAN Tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Serious side effects: Stop taking the medicine and see a doctor straight away if any of the following serious side effects are noticed [urgent medical treatment may be needed]: 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); Abnormal sweating or reduced sweating (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 any of the side effects occur, talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed. Side effects can also be reported directly. By reporting side effects, help can be provided for more information on the safety of this medicine.

Sugar-coated tablet: Tell the doctor or pharmacist if taking or have 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 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 unsure if any of the previously mentioned apply, talk to the doctor or pharmacist before taking BUSCOPAN Tablets.
Injection: Overview: As hyoscine butylbromide can reduce the motility and secretory activity of the gastrointestinal system, the systemic absorption and pharmacologic effects of other oral medications may be delayed.
Drug-Drug Interactions: See table.

Click on icon to see table/diagram/image

Drug-Food Interactions: Interactions with food have not been established.
Drug-Herb Interactions: Interactions with herbs have not been established.
Drug-Laboratory Interactions: Interactions with laboratory tests have not been established.

Sugar-coated tablet: BUSCOPAN Tablets should be protected from light and stored in a dry place below 25°C.

Antispasmodics

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