TAMSULOSIN HYDROCHLORIDE

Posology. One capsule daily, to be taken after breakfast or the first meal of the day. Renal and hepatic impairment No dose adjustment is warranted in renal impairment. 3). Paediatric population There is no relevant indication for use of tamsulosin in children.

The safety and efficacy of tamsulosin in children <18 years have not been established. 1. Method of administration Oral use. The capsule must be swallowed whole and must not be crushed or chewed as this interferes with the modified release of the active ingredient.

The frequencies of adverse reactions are ranked according to the following: very common (≥ 1/10), 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).

4). Post-marketing experience In addition to the adverse events listed above, the following adverse reactions have been reported in association with tamsulosin use: Cardiac disorders Not known: Atrial fibrillation, arrhythmia, tachycardia Respiratory, thoracic and mediastinal disorders Not known: Dyspnoea 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 α 1-adrenoreceptor 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 < 10 ml/min) should be approached with caution as these patients have not been studied. 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.

During pre-operative assessment, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.

1. - A history of orthostatic hypotension. - Severe hepatic insufficiency.