Buscopan 30 Tablets Rev 10mg

NAME
BUSCOPAN COATED TABLETS / SUPPOSITORIES

PHARMACOTHERAPEUTIC CATEGORY
Semisynthetic nightshade alkaloids, quaternary ammonium compounds.

ACTIVE PRINCIPLES
Hyoscine N-Butylbromide 10 mg.

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

INDICATIONS
Symptomatic treatment of painful spastic manifestations of the gastrointestinal and genitourinary tract.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to one of the excipients; acute angle glaucoma; prostatic hypertrophy or other causes of urinary retention; pyloric stenosis and other conditions stenosing the gastrointestinal canal; paralytic ileus, ulcerative colitis, megacolon; 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, the use of the drug is contraindicated.

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 medical judgment. In pediatrics 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. The medicine should not be taken daily on a regular basis or for prolonged periods without looking for the cause of the abdominal pain.

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

WARNINGS
In the presence of intense abdominal pain of which the cause is not known, which persists or worsens, or which 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 seek immediate medical attention. Glianticolinergics 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 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 the time of gastric emptying and lead to stasis of the antrum. Due to the possibility that anticholinergics may reduce sweating, the drug 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.

INTERACTIONS
The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, phenothiazines, butyrophenones, antihistamines, antipsychotics, quinidine, amantadine, diisopyramide and other anticholinergics (eg tiotropium, ipratropium and atropine-like compounds) can be accentuated by the drug. Concomitant treatment with dopamine antagonists, such as metoclopramide, may result in a reduction in the effect of both drugs on the gastrointestinal tract. Tachycardia induced by beta-adrenergic drugs can 'be accentuated by the drug. Do not drink alcohol during therapy. Since antacids can reduce intestinal absorption of anticholinergics, these drugs should not be administered simultaneously.

SIDE EFFECTS
Many of the listed side effects can be attributed to the anticholinergic properties of the drug. The side effects of the drug are generally mild and self-limiting. Disorders of the immune system. 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. At 95% probability, the frequency category is not greater than uncommon (3/1368), but it 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 pathologies. Uncommon frequency: tachycardia. Gastrointestinal disorders. Frequency uncommon: dry mouth. Constipation has also been observed. Skin and subcutaneous tissue disorders. Uncommon frequency: 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: drowsiness. High doses can cause signs of central stimulation and more serious signs of interference with the nervous system, the state of consciousness and cardiorespiratory function. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

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. There is insufficient information on the excretion of the drug and its metabolites in human milk. As a precautionary measure, it is preferable to avoid the use of the drug during pregnancy and breastfeeding. No studies on the effects on human fertility have been conducted.