Revision Year: 2017 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hyoscine butylbromide injection should not be administered to patients with myasthenia gravis, megacolon, narrow angle glaucoma, tachycardia, prostatic enlargement with urinary retention, mechanical stenoses in the region of the gastrointestinal tract or paralytic ileus.
Hyoscine butylbromide injection should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur. These patients can receive slow subcutaneous or intravenous injection.
In case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting, or blood in stool, appropriate diagnostic measures are needed to investigate the etiology of the symptoms.
Hyoscine butylbromide should be used with caution in conditions characterized by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate.
Because of the possibility that anticholinergics may reduce sweating, hyoscine butylbromide 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 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 after the injection of hyoscine butylbromide.
After parenteral administration of hyoscine butylbromide, cases of anaphylaxis including episodes of shock have been observed. Patients receiving hyoscine butylbromide should be kept under observation.
Bysimin contains sodium chloride.
This medicinal product contains less than 1 mmol sodium (23 mg) per 5 vials (the maximum daily dose) and therefore is essentially sodium free.
The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by hyoscine butylbromide.
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.
There are limited data from the use of hyoscine butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure hyoscine butylbromide is not recommended during pregnancy.
There is insufficient information on the excretion of hyoscine butylbromide and its metabolites in human milk. Use of hyoscine butylbromide during breastfeeding is not recommended.
No studies on the effects on human fertility have been conducted.
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as accommodation disorder or dizziness during treatment with hyoscine butylbromide. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience accommodation disorder or dizziness, they should avoid potentially hazardous tasks such as driving or operating machinery.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of hyoscine butylbromide. Anticholinergic side effects of hyoscine butylbromide are usually mild and transient.
Adverse events have been ranked under headings of frequency using the following convention: very common ≥1/10; common ≥1/100, <1/10; uncommon ≥1/1,000, <1/100; rare ≥1/10,000, <1/1,000, very rare <1/10,000; not known: cannot be estimated from the available data.
Not known*: anaphylactic shock including cases with fatal outcome, anaphylactic reactions, hypersensitivity reactions.
Common: dizziness.
Common: accommodation disorders.
Not known*: mydriasis, increased intraocular pressure.
Common: tachycardia.
Not known*: blood pressure decreased, flushing.
Not known*: dyspnoea.
Common: dry mouth, constipation.
Not known*: skin reactions (e.g. urticaria, rash, erythema, pruritus), dyshidrosis.
Not known*: urinary retention.
Injection site pain, particularly after intramuscular use, occurs.
* This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than common, but might be lower. Precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 185 patients.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued 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.
None known.
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