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SANOFI SpA

BUSCOPAN*30CPR RIV 10MG

BUSCOPAN*30CPR RIV 10MG

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EAN

006979025

MINSAN

006979025

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Symptomatic treatment of spastic-painful manifestations of the gastrointestinal and genitourinary tracts.


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Therapeutic indications

Symptomatic treatment of spastic-painful manifestations of the gastrointestinal and genitourinary tracts.

Dosage and method of use

Posology 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 may be increased according to the physician's judgement. In paediatrics, in children aged between 6 and 14 years, the doctor's prescription must be followed exactly. Method of administration The tablets should be taken 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 the abdominal pain.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients. - Acute angle glaucoma. - Prostatic hypertrophy or other causes of urinary retention. - Pyloric stenosis and other conditions restricting the gastrointestinal tract. - Mechanical stenosis of the gastrointestinal tract. - Paralytic or obstructive ileus. - Megacolon. - Ulcerative colitis. - Reflux oesophagitis. - Intestinal atony in the elderly and debilitated subjects. - Myasthenia gravis. - Children under the age of 6. In case of rare hereditary conditions of incompatibility with one of the excipients (see section 4.4 "Special warnings and precautions for use") the use of the medicinal product is contraindicated.

Side effects

Many of the undesirable effects listed 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, hives, itching. 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. There is a 95% probability that the frequency category is no greater than uncommon (3/1368), but could be lower. A precise frequency estimation is not possible since these adverse reactions did not occur in 1368 clinical trial patients. Cardiac disorders : Frequency uncommon: tachycardia. Gastrointestinal disorders : Frequency uncommon: dry mouth. Constipation has also been observed. Skin and subcutaneous tissue disorders : Frequency uncommon: sweating abnormal. Renal and urinary disorders : Frequency 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, state of consciousness and cardiorespiratory function. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization 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 via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

If you have severe abdominal pain for which there is no known cause, which persists or gets worse, or which occurs together with other symptoms such as fever, nausea, vomiting, changes in bowel movement, tenderness in the abdomen, decreased blood pressure, fainting, or blood in the feces, you should seek immediate medical attention. 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 an excessive anticholinergic effect, caution should be exercised in patients prone to acute 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. Because of the possibility that anticholinergics may reduce sweating, Buscopan should be administered with caution to patients with pyrexia. Treatment with high doses should not be abruptly stopped. Minor side effects can be controlled by appropriately reducing the dose; the appearance of important secondary manifestations requires the interruption of the therapy. One 10 mg coated tablet contains 41.2 mg of sucrose equal to 247.2 mg per maximum recommended daily dose. Therefore patients with rare hereditary problems of fructose intolerance should not take this medicine.

Pregnancy and breastfeeding

Limited data are available from the use of hyoscine 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 while breastfeeding. No studies on the effects on human fertility have been conducted (see section 5.3).

Expiration and conservation

Coated tablets : This medicinal product does not require any special storage conditions. Suppositories : do not store above 30°C.

Interactions with other drugs

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 lead to a reduction in the effect of both drugs on the gastrointestinal tract. Tachycardia induced by β-adrenergic drugs may be accentuated by Buscopan. Do not drink alcohol during therapy. Since antacids can reduce the intestinal absorption of anticholinergics, these drugs should not be administered concomitantly.

Overdose

Symptoms In case of overdose, anticholinergic effects may occur (such as urinary retention, dry mouth, flushing of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances). Therapy If necessary, administer parasympathomimetic drugs. In case of glaucoma, urgent referral to an ophthalmology specialist is necessary. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis: evaluate the opportunity to resort to intubation, artificial respiration. In the event of orthostatic hypotension, it is sufficient for the patient to lie down. Catheterization may be necessary for urinary retention. In addition, appropriate supportive care should be initiated as necessary.

Active principles

Coated tablets One coated tablet contains: Hyoscine butylbromide 10 mg. Excipients: sucrose. Suppositories One suppository contains: Hyoscine butylbromide 10 mg. For the full list of excipients see section 6.1.

Excipients

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.

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