TAMSULOSIN HYDROCHLORIDE ZENTIVA

Posology One capsule daily after breakfast or after the first daily meal. Hepatic/renal impairment No dose adjustment is warranted in renal impairment. 3). Paediatric population The safety and efficacy of tamsulosin hydrochloride in children < 18 years have not been established.

1. Method of administration Oral use. The capsule is swallowed whole, without crushing or chewing, because otherwise the controlled release of the active ingredient would be affected.

Tabulated list of adverse reactions The frequency of adverse reactions of tamsulosin listed below is defined using the following convention: Common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

3%) Uncommon Headache Nervous system disorders Rare Syncope Eye disorders Not known Vision blurred*, visual impairment* Cardiac disorders Uncommon Palpitations Vascular disorders Uncommon Orthostatic hypotension Uncommon RhinitisRespiratory, thoracic and mediastinal disorders Not known Epistaxis* Uncommon Constipation, diarrhoea, nausea, vomiting Gastrointestinal disorders Not known Dry mouth* Uncommon Rash, pruritus, urticaria Rare Angioedema Very rare Stevens-Johnson syndrome Skin and subcutaneous tissue disorders Not known Erythema multiforme*, dermatitis exfoliative* Common Ejaculation disorder, retrograde ejaculation, ejaculation failure Reproductive system and breast disorders Very rare Priapism General disorders and administration site conditions Uncommon Asthenia * Observed post-marketing.

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 hydrochloride 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 hydrochloride 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 hydrochloride 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 < 10 ml/min) should be approached with caution, as these patients have not been studied. Angioedema has been rarely reported after the use of tamsulosin.

In case of angioedema, treatment should be discontinued immediately, the 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 hydrochloride.

IFIS may increase the risk of eye complications during and after the operation. Discontinuing tamsulosin hydrochloride 1 – 2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not yet been established.

IFIS has also been reported in patients who had discontinued tamsulosin for a longer period prior to the surgery. . The initiation of therapy with tamsulosin hydrochloride in patients for whom cataract or glaucoma surgery is scheduled is not recommended.

1. • History of orthostatic hypotension. • Severe hepatic insufficiency.