Tamulsin Special Precautions

As with other alpha1-blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, leading in rare cases of syncope. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared. Prior to commencement of therapy with Tamsulosin, the patient should be examined in order to exclude the presence of other conditions which may produce similar symptoms to those of benign prostatic hyperplasia. Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed prior to commencement of treatment and at regular intervals afterwards. The treatment of patients with severe renal impairment (creatinine clearance 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. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with Tamsulosin in patients scheduled for cataract or glaucoma surgery is not recommended.
Discontinuing Tamsulosin 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 surgery.
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 prolonged-release tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Tamsulosin should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype.
Tamsulosin should be used with caution in combination with strong and moderate inhibitors of CYP3A4.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. However patients should be aware of the fact that drowsiness, blurred vision, dizziness and syncope can occur.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation for further information.