FLOMAXTRA XL

Posology One tablet daily, to be taken with or without food. Paediatric Population The safety and efficacy of tamsulosin in children <18 years have not been established. 1. Method of administration For oral use. The tablet should be swallowed whole and should not be crunched or chewed as this will interfere with the prolonged release of the active ingredient.

3%) headache syncope Eye disorders Vision blurred* Visual impairment* Cardiac disorders palpitations 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, pruritis, 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 alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Flomaxtra XL, 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 Flomaxtra XL 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 severely renally impaired patients (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.

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 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.

A history of orthostatic hypotension; severe hepatic insufficiency. 1.