PINEXEL PR

Posology One capsule daily, to be taken after the same meal each day. The capsule should be swallowed whole and should not be crunched or chewed as this will interfere with the prolonged release of the active substance. No dose adjustment is warranted in renal impairment.

No dose adjustment is warranted in patients with mild to moderate hepatic insuffiency (see also

3%) Headache Syncope Eye disorders Vision blurred*, vision impaired* Cardiac disorders Palpitations Vascular disorders Orthostatic hypotension Respiratory, thoracic and mediastinum- related disorders Rhinitis Epistaxis* Gastrointestinal disorders Constipation, diarrhoea, nausea, vomiting Dry mouth* Skin and subcutaneous tissue disorders Rash, pruritus, urticaria Angioedema Stevens- Johnson syndrome Erythema multiforme*, dermatitis exfoliative* Reproductive systems and breast disorders Ejaculation disorders, including retrograde ejaculation, ejaculation failure Priapism General disorders and administration site conditions 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 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 estimated from the available data.

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

As with other α1-adrenocepto antagonists, a reduction in blood pressure can occur in individual cases during treatment with Pinexel PR, 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 Pinexel PR 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. 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.

Discontinuing tamsulosin hydrochloride 1 – 2 weeks prior to cataract and 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.

Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype. 5). This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

). Paediatric Population There is no relevant indication for use of Pinexel PR Capsules in children, The safety and efficacy of tamsulosin in children <18 years have not been established. 1. 1; a history of orthostatic hypotension; severe hepatic insufficiency.