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Author: Admin | 2025-04-28
Used in patients susceptible to intestinal or urinary outlet obstructions. Because of the possibility that anticholinergics may reduce sweating, Hyoscine Butylbromide Tablets should be administered with caution to patients with pyrexia. Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Hyoscine Butylbromide Tablets in patients with undiagnosed and therefore untreated narrow angle glaucoma. Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision whilst or after taking Hyoscine Butylbromide Tablets. Lactose This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose galactose malabsorption should not take this medicine. 4.5 Interaction with other medicinal products and other forms of interaction The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. butyrophenones, phenothiazines), disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by Hyoscine Butylbromide Tablets. Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract. The tachycardic effects of beta-adrenergic agents may be enhanced by Hyoscine Butylbromide Tablets. 4.6 Fertility, pregnancy and lactation Pregnancy There are limited data from the use of hyoscine butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). As a precautionary measure Hyoscine Butylbromide Tablets are not recommended during pregnancy. Breast-feeding There is insufficient information on the excretion of hyoscine butylbromide and its metabolites in human milk. A risk to the breastfeeding child cannot be excluded. Use of Hyoscine Butylbromide Tablets during breastfeeding is not recommended. Fertility No studies on the effects on human fertility have been conducted. 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed. Because of possible visual accommodation disturbances patients should not drive or operate machinery if affected. 4.8 Undesirable effects Many of the listed undesirable effects can be assigned to the anticholinergic properties of Hyoscine Butylbromide Tablets. Adverse events have been ranked under headings of frequency using the following convention: Very common (≥ 1/10); common (≥ 1/100 to System Organ class Frequency Undesirable Effect Immune system disorders Not Known* Anaphylactic shock, anaphylactic reactions, dyspnoea, other hypersensitivity Cardiac disorders Uncommon Tachycardia Gastrointestinal disorders Uncommon Dry mouth Skin and subcutaneous tissue disorders Uncommon Skin reactions
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