TAMUREX

One capsule daily to be taken with or without food. The capsule should be swallowed whole with a glass of water in sitting or in standing position (not in lying position). The capsule should not be broken or chewed as this will interfere with the modified release of the active ingredient.

In cases when patients have difficulties swallowing (e. g. dysphagia), the capsule may be opened and the contents swallowed without chewing. No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patient with mild to moderate hepatic insufficiency (see also

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 3%) headache syncope Eye disorders Floppy Iris Syndrome (IFIS, variant of small pupil syndromes during cataract surgery) Vision blurred* Visual impairment* Cardiac disorders Palpitations, Tachycardia Vascular disorders orthostatic hypotension Respiratory, thoracic and mediastinal disorders rhinitis Epistaxis* Gastrointestinal disorders constipation, diarrhoea, nausea, vomiting Dry mouth* Skin and subcutaneous tissue disorders rash, itching, urticaria angioedema Stevens- Johnson syndrome Erythema multiforme* Dermatitis exfoliative* Reproductive system and breast disorders ejaculation disorders including retrograde ejaculation and ejaculation failure priapism General disorders and administration site conditions asthenia *observed post-marketing As with other alpha-blockers, drowsiness, blurred vision or oedema can occur.

4).

Post-marketing experience:

In addition to the adverse events listed above, atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported in association with tamsulosin use. Because these spontaneously reported events are from the worldwide post marketing experience, the frequency of events and the role of tamsulosin in their causation cannot be reliably determined.

Reporting of suspected adverse reactions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

As with other α1-adrenoceptors antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared.

Before therapy with tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as benign prostatic hyperplasia. Digital rectal examination and when necessary determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.

The treatment of patients with severe renal impairment (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied. Angio-oedema has been rarely reported after the use of tamsulosin.

Treatment should be discontinued immediately, patient should be monitored until disappearance of the oedema, and tamsulosin should not be re-administered. The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients on or previously treated with tamsulosin.

Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

Discontinuing tamsulosin hydrochloride 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not been established. IFIS has also been reported in patients who had discontinued tamsulosin for a longer period prior to the surgery.

). Paediatric population The safety and efficacy of tamsulosin in children < 18 years have not been established. 1. 3 Contraindications Hypersensitivity to tamsulosin including drug-induced angio-oedema, or to any of the excipients. A history of orthostatic hypotension.

Severe hepatic insufficiency.