MORVESIN

One capsule a day after breakfast or the first meal of the day. The capsule is swallowed whole with a glass of water while standing or sitting (not lying down). The capsule should not be broken or pulled apart as this may have an effect on the release of the long-acting active ingredient.

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

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 Google play or Apple App store.

As with other α1-blockers the use of tamsulosin may lower blood pressure, which in rare cases may cause fainting. If initial symptoms of orthostatic hypotension start to appear (dizziness, weakness), then the patient should sit or lie down until the symptoms have gone.

The patient should be examined before commencement of therapy with tamsulosin to exclude the presence of other conditions that can produce similar symptoms to those of BPH. The prostate should be examined via the rectum and, if necessary, the PSA count determined prior to commencement of treatment and again later at regular intervals.

The treatment of severely renally impaired patients (creatinine clearance of < 10 ml/min) should be approached with caution as these patients have not been studied. Angio-oedema has been rarely reported after the use of tamsulosin. 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. 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 and duration of requirement of stopping the therapy prior to cataract surgery 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 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 should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype. 5). Tamsulosin contains sodium. This medicinal product contains less than 1 mmol sodium (23 mg) per hard modified-release capsule, that is to say essentially ‘sodium-free’.

). Paediatric population The safety and efficacy of tamsulosine in children <18 years have not been established. 1. Orthostatic hypotension observed earlier (history of orthostatic hypotension). Severe hepatic insufficiency.