Buscopan 40 Coated Tablets 10 mg

Buscopan is a drug used to treat abdominal cramps and pain, especially 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 .

ACTIVE INGREDIENTS

Active ingredients contained in Buscopan 40 Coated Tablets 10 mg - What is the active ingredient of Buscopan 40 Coated Tablets 10 mg?

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.

EXCIPIENTS

Composition of Buscopan 40 Coated Tablets 10 mg - What does Buscopan 40 Coated Tablets 10 mg contain?

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.

DIRECTIONS

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

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Buscopan 40 Coated Tablets 10 mg - When should Buscopan 40 Coated Tablets 10 mg not be used?

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 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 medicinal product is contraindicated.

DOSAGE

Quantity and method of taking Buscopan 40 Coated Tablets 10 mg - How to take Buscopan 40 Coated Tablets 10 mg?

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 aged between 6 and 14 years, the doctor's prescription must be followed exactly. Method of administration: The tablets must be swallowed whole with an adequate amount of water. Buscopan must not be taken daily on a regular basis or for prolonged periods without looking for the cause of the abdominal pain.

CONSERVATION

Storage Buscopan 40 Coated Tablets 10 mg - How to store Buscopan 40 Coated Tablets 10 mg?

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

WARNINGS

Warnings Buscopan 40 Coated Tablets 10 mg - About Buscopan 40 Coated Tablets 10 mg it is important to know that:

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.

INTERACTIONS

Interactions Buscopan 40 Coated Tablets 10 mg - 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, may cause a reduction in the effect of both drugs on the gastrointestinal tract. Tachycardia induced by beta-adrenergic drugs may be accentuated by Buscopan. Do not consume alcohol during therapy. Since antacids may reduce the intestinal absorption of anticholinergics, these drugs should not be administered concomitantly.

SIDE EFFECTS

Like all medicines, Buscopan 40 Coated Tablets 10 mg can cause side effects - What are the side effects of Buscopan 40 Coated Tablets 10 mg?

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. Uncommon frequency: skin reactions, urticaria, pruritus; unknown frequency*: 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. Uncommon frequency: tachycardia. Gastrointestinal disorders. Uncommon frequency: 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

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Buscopan 40 Coated Tablets 10 mg.

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).