Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

As with other α 1 -adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with Omnic Ocas 0,4, 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 Omnic Ocas 0,4 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 and glaucoma surgery in some patients on or previously treated with tamsulosin hydrochloride. IFIS may lead to 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 and duration of stopping of therapy prior to cataract or glaucoma surgery has not yet been established. IFIS has also been reported in patients who had discontinued tamsulosin for a longer period to that 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 hydrochloride should not be given in combination with strong inhibitors of CYP3A4 (e.g. ketoconazole) in patients with poor metaboliser CYP2D6 phenotype.
Tamsulosin hydrochloride should be used with caution in combination with strong (e.g.
ketoconazole) and moderate (e.g. erythromycin) inhibitors of CYP3A4 (see section 4.5).
It is possible that a remnant of the tablet is observed in the faeces.

Effects on Driving

     4.7 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 dizziness can occur.