Buscopan 40 Coated Tablets 10 mg

Buscopan is a drug used to treat cramps and abdominal pain, particularly those related to gastrointestinal and urinary tract disorders. The active ingredient, butylscopolamine bromide, acts as an antispasmodic, relaxing the smooth muscles of the gastrointestinal and urinary tract, thus reducing pain and discomfort. Thanks to its localized action, Buscopan is effective in the treatment of intestinal spasms, colic and similar disorders

Buscopan is indicated for:

• Symptomatic treatment of abdominal cramps and pain caused by gastrointestinal spasms.

• Relief of pain from renal and biliary colic.

• Treatment of spasms and pain related to urinary tract disorders.

INDICATIONS

Why is Buscopan 40 Coated Tablets 10 mg used? What is it for?

Symptomatic treatment of spastic-painful manifestations of the gastrointestinal tract.

ACTIVE INGREDIENTS AND EXCIPIENTS

What is the composition of Buscopan 40 Coated Tablets 10 mg?

Coated tablets, one coated tablet contains: Hyoscine N-butylbromide 10 mg. Excipients: sucrose. Suppositories, one suppository contains: Hyoscine N-butylbromide 10 mg. For the complete list of excipients see section 6.1.

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 semi-synthetic glycerides.

DOSAGE

How is Buscopan 40 Coated Tablets 10 mg taken?

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, children between the ages of 6 and 14 must follow the doctor's prescription exactly. Method of administration: the tablets must be taken whole with an adequate quantity of water. Buscopan should not be taken daily on a regular basis or for prolonged periods without investigating the cause of abdominal pain.

CONTRAINDICATIONS AND SIDE EFFECTS

When should Buscopan 40 Coated Tablets 10 mg not be used and what side effects can it cause?

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 that stenose the gastrointestinal tract. Mechanical stenosis of the gastrointestinal tract. Paralytic or obstructive ileus. Megacolon. Ulcerative colitis. Reflux esophagitis. Intestinal atony in the elderly and debilitated subjects. Myasthenia gravis. Children under 6 years of age. 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 medicine is contraindicated.

Many of the side 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. Uncommon frequency: skin reactions, urticaria, 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. At 95% probability, the frequency category is no higher 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 diseases. Uncommon frequency: tachycardia. Gastrointestinal disorders. Uncommon frequency: dry mouth. Constipation was also observed. Pathologies of the skin and subcutaneous tissue. Uncommon frequency: alterations in sweating. Renal and urinary disorders. Rare frequency: urinary retention. The following side 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 authorization 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

INTERACTIONS

Which medicines or foods can modify the effect of Buscopan 40 Coated Tablets 10 mg?

anticholinergic 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 accentuated by Buscopan. Concomitant treatment with dopamine antagonists, such as metoclopramide, can lead to a reduction in the impact of both drugs on the gastrointestinal tract. Tachycardia induced by beta-adrenergic drugs may be accentuated by Buscopan. Do not drink alcohol during therapy. Because antacids may reduce the intestinal absorption of anticholinergics, these drugs should not be administered simultaneously.

PREGNANCY AND BREASTFEEDING

Can Buscopan 40 Coated Tablets 10 mg be used during pregnancy and breastfeeding?

Limited data are available regarding the use of hyoscine N-butylbromide in pregnant women. Animal studies do not indicate direct or indirect harmful effects of 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 conducted (see section 5.3).

WARNINGS

What are the warnings of Buscopan 40 Coated Tablets 10 mg?

If you experience severe abdominal pain of unknown cause, that persists or worsens, or that occurs together with other symptoms such as fever, nausea, vomiting, changes in bowel movement, abdominal tenderness, decreased blood pressure, fainting or blood in the stool, you should contact your doctor immediately. 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 patients with liver and kidney disease. Due to the potential risk of complications related to an excessive anticholinergic effect, caution should be exercised in patients subject 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 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. A 10 mg coated tablet contains 41.2 mg of sucrose equal to 247.2 mg per maximum recommended daily dose. Therefore patients suffering from rare hereditary problems of fructose intolerance should not take this medicine.

CONSERVATION

How is Buscopan 40 Coated Tablets 10 mg stored?

Coated tablets: this medicine does not require any special storage conditions. Suppositories: Do not store above 30 degrees C.

FORMAT

What is the format of Buscopan 40 Coated Tablets 10 mg?

40 Coated Tablets 10 mg

DRUG LEGAL TEXT

Content responsibility

This sheet contains information that is not intended to replace a doctor's diagnosis or advice, as only the doctor can draw up any prescription and give therapeutic indications. All contents must be understood and are of an exclusively informative nature and aimed exclusively at bringing to the attention of customers or potential customers in the pre-purchase phase of the products sold through this site. In case of pathologies, disorders or allergies it is always best to consult your doctor first.

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