PAMSVAX XL

Posology One capsule daily, to be taken after breakfast or the first meal of the day. Paediatric population There is no relevant indication for use of Pamsvax XL in children. The safety and efficacy of tamsulosin in children <18 years have not been established.

1. Use in renal impairment No dosage adjustment is warranted in patients in renal impairment. Use in hepatic impairment No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also section

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-adrenoceptor 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 or glaucoma surgery in some patients on or previously treated with tamsulosin.

IFIS may increase the risk of eye complications during and after the operation. Discontinuing tamsulosin 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 cataract surgery. The initiation of therapy with tamsulosin in patients for whom cataract or glaucoma surgery is scheduled is not recommended.

During pre-operative assessment, cataract 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 prolonged-release capsule, hard, that is to say essentially ‘sodium-free’.

). Method of administration For oral use. The capsule should be swallowed whole and should not be crunched or chewed as this will interfere with the prolonged release of the active ingredient. 1. - History of orthostatic hypotension. - Severe hepatic insufficiency.