BUSCOPAN * 30CPR RIV 10MG

BUSCOPAN * 30CPR RIV 10MG

Therapeutic indications

Symptomatic treatment of painful spastic manifestations of the gastrointestinal tract.

Dosage and method of use

Dosage The following dosages are recommended for adults and children over the age of 14.Coated tablets1-2 coated tablets 3 times a day.Suppositories1 suppository 3 times a day. Single doses can be increased according to the physician'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 taken whole with an adequate amount of water. Buscopan should not be taken daily on a regular basis or for prolonged periods without researching the cause of 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 stenosing the gastrointestinal canal. - Mechanical stenosis of the gastrointestinal tract. - Paralytic or obstructive ileus. - Megacolon. - Ulcerative colitis. - Reflux esophagitis. - Intestinal atony of 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 listed side effects can be attributed to the anticholinergic properties of Buscopan. The anticholinergic side effects of Buscopan are generally mild and self-limiting.Disorders of the immune system: 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. 95% likely, the frequency category is not greater than uncommon (3/1368), but it could be lower. A precise frequency estimate is not possible as these adverse reactions did not occur in 1368 patients in clinical trials..Cardiac pathologies: Frequency uncommon: tachycardia.Gastrointestinal disorders: Frequency uncommon: dry mouth. Constipation has also been observed.Skin and subcutaneous tissue disorders: Frequency uncommon: changes in sweating.Renal and urinary disorders: Frequency rare: urinary retention. The following side effects have also been observed:Eye disorders: mydriasis, accommodation disturbances, increased ocular tone.Nervous system disorders: sleepiness. High doses can lead to signs of central stimulation and more serious signs of interference with the nervous system, state of consciousness and cardiorespiratory function.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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

Special warnings

If you have severe abdominal pain of which the cause is not known, which persists or worsens, or which occurs in conjunction with other symptoms such as fever, nausea, vomiting, changes in bowel movement, abdominal tenderness, decreased blood pressure, fainting or blood in the feces, you need to seek immediate medical attention. Anticholinergics should be used with caution in the elderly, in patients with disorders of the autonomic nervous system, in cardiac tachyarrhythmias, in arterial hypertension, in congestive heart failure, in hyperthyroidism and in those with liver and kidney disease. Due to 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 can prolong gastric emptying time and lead to stasis of the antrum. 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 abruptly stopped. 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 corresponding 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

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. Studies on the effects on human fertility have not been conducted (see section 5.3).

Expiry and retention

Coated tablets: This medicine 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) can be enhanced by Buscopan. Concomitant treatment with dopamine antagonists, such as metoclopramide, may result in a reduction in the effect of both drugs on the gastrointestinal tract. Β-adrenergic drug-induced tachycardia 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 concurrently.

Overdose

SymptomsAnticholinergic effects (such as urinary retention, dry mouth, skin redness, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances) may occur in the event of overdose.TherapyIf necessary, administer parasympathomimetic drugs. In case of glaucoma it is necessary to urgently refer to an ophthalmology specialist. Cardiovascular complications must be treated according to the usual therapeutic principles. In case of respiratory paralysis: evaluate the opportunity to resort to intubation, artificial respiration. In case of orthostatic hypotension, it is sufficient for the patient to lie down. Catheterization may be required for urinary retention. In addition, if necessary, appropriate supportive care should be undertaken.

Active principles

Coated tabletsOne coated tablet contains: 10 mg hyoscine butylbromide. Excipients: sucrose.SuppositoriesOne suppository contains: hyoscine N-butylbromide 10 mg. For the full list of excipients see section 6.1.

Excipients

Coated tablets: Core: calcium hydrogen phosphate, corn starch, soluble starch, anhydrous colloidal silica, tartaric acid, stearic acid. Coating: povidone,sucrose, talc, gum arabic, titanium dioxide (E171), macrogol 6000, carnauba wax, white wax.Suppositories: solid semisynthetic glycerides.