Coated tablets One coated tablet contains: N-butyl hyoscine bromide 10 mg. Excipients: sucrose. Suppositories One suppository contains: N-butyl hyoscine bromide 10 mg. For a full list of excipients, see section 6.1.
Coated tablets : Core: calcium hydrogen phosphate, maize starch, soluble starch, colloidal anhydrous silica, tartaric acid, stearic acid. Coating: povidone, sucrose , talc, gum arabic, titanium dioxide (E171), macrogol 6000, carnauba wax, white wax. Suppositories : solid semi-synthetic glycerides.
Symptomatic treatment of spastic-painful manifestations of the gastrointestinal tract.
Dosage The following dosages are recommended for adults and children over 14 years of age. Coated tablets 1-2 coated tablets 3 times a day. Suppositories 1 suppository 3 times a day. Single doses can be increased according to the doctor's judgment. In pediatrics, in children between the ages of 6 and 14, the doctor's prescription must be followed exactly. Method of administration The tablets should be swallowed whole with an adequate amount of water. Buscopan should not be taken daily on a regular basis or for prolonged periods without investigating the cause of abdominal pain.
Coated tablets : This medicinal product does not require any special storage conditions. Suppositories : do not store above 30°C.
If severe abdominal pain of unknown cause persists or worsens, or occurs with other symptoms such as fever, nausea, vomiting, changes in bowel movement, abdominal tenderness, decreased blood pressure, fainting, or blood in the stool, seek medical attention immediately. Anticholinergics should be used with caution in the elderly, in patients with autonomic nervous system disorders, cardiac tachyarrhythmias, arterial hypertension, congestive heart failure, hyperthyroidism, and in patients with liver and kidney disease. Because of the potential risk of complications related to excessive anticholinergic effect, caution should be exercised in patients subject to narrow-angle glaucoma as well as in patients susceptible to intestinal and urinary stasis and in those prone to tachyarrhythmias. Anticholinergics may prolong gastric emptying time and cause antral stasis. Due to the possibility that anticholinergics may reduce sweating, Buscopan should be administered with caution in patients with pyrexia. Treatment with high doses should not be stopped abruptly. Minor side effects can be controlled by appropriately reducing the dose; the appearance of important secondary manifestations requires the interruption of therapy. One 10 mg coated tablet contains 41.2 mg of sucrose equivalent to 247.2 mg per maximum recommended daily dose. Therefore, patients with rare hereditary problems of fructose intolerance should not take this medicine.
The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, phenothiazines, butyrophenones, antihistamines, antipsychotics, quinidine, amantadine, diisopyramide and other anticholinergics (e.g. tiotropium, ipratropium and atropine-like compounds) may be enhanced by Buscopan. Concomitant treatment with dopamine antagonists, such as metoclopramide, may reduce the effect of both drugs on the gastrointestinal tract. Tachycardia induced by β-adrenergic drugs may be enhanced by Buscopan. Do not consume alcohol during therapy. Since antacids may reduce the intestinal absorption of anticholinergics, these drugs should not be administered concomitantly.
Symptoms In case of overdose, anticholinergic effects (such as urinary retention, dry mouth, skin redness, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances) may occur. Therapy If necessary, administer parasympathomimetic drugs. In case of glaucoma, it is necessary to consult an ophthalmology specialist urgently. Cardiovascular complications must be treated according to the usual therapeutic principles. In case of respiratory paralysis: consider the opportunity to resort to intubation, artificial respiration. In case of orthostatic hypotension, it is sufficient for the patient to lie down. For urinary retention, catheterization may be necessary. In addition, if necessary, appropriate supportive therapies must be undertaken.
PREGNANCY AND BREASTFEEDING
There are limited data from the use of hyoscine N-butylbromide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 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 breastfeeding. No studies on the effects on human fertility have been performed (see section 5.3).
Many of the listed adverse reactions can be attributed to the anticholinergic properties of Buscopan. The anticholinergic side effects of Buscopan are generally mild and self-limiting. Immune system disorders : Frequency uncommon: skin reactions, urticaria, pruritus. Frequency not known*: anaphylactic shock, anaphylactic reactions, dyspnoea, skin rash, erythema and other manifestations of hypersensitivity. * These adverse reactions have been observed in post-marketing experience. With a 95% probability, the frequency category is not greater than uncommon (3/1368), but could be lower. A precise estimate of the frequency is not possible since these adverse reactions did not occur in 1368 patients in clinical trials . Cardiac disorders : Frequency uncommon: tachycardia. Gastrointestinal disorders : Frequency uncommon: dry mouth. Constipation has also been observed. Skin and subcutaneous tissue disorders : Uncommon: sweating disorders. Renal and urinary disorders : Rare: urinary retention. The following undesirable effects have also been observed: Eye disorders : mydriasis, accommodation disorders, increased ocular tone. Nervous system disorders : drowsiness. High doses may cause signs of central stimulation and more serious signs of interference with the nervous system, the state of consciousness and cardiorespiratory function. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
