Tamsoli Special Precautions

Tamsoli should be used with caution in patients with: Severe renal impairment, risk of urinary retention, gastrointestinal obstructive disorders, risk of decreased gastrointestinal motility, hiatus hernia/gastroesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis, autonomic neuropathy.
The patient should be examined in order to exclude the presence of other conditions, which can cause similar symptoms to benign prostatic hyperplasia.
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Tamsoli is initiated. If a urinary tract infection is present, appropriate antibacterial therapy should be started.
QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as pre-existing long QT syndrome and hypokalaemia, who are treated with solifenacin succinate.
Angioedema with airway obstruction has been reported in some patients on solifenacin succinate and tamsulosin. If angioedema occurs, Tamsoli should be discontinued and not restarted. Appropriate therapy and/or measures should be taken.
Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, Tamsoli should be discontinued and appropriate therapy and/or measures should be taken.
As with other alpha₁-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. Patients starting treatment with Tamsoli should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have disappeared.
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. Therefore, the initiation of therapy with Tamsoli in patients for whom cataract or glaucoma surgery is scheduled is not recommended. Discontinuing treatment with Tamsoli 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not been established. 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 Tamsoli in order to ensure that appropriate measures will be in place to manage IFIS during surgery.
Tamsoli should be used with caution in combination with moderate and strong inhibitors of CYP3A4 and it should not be used in combination with strong inhibitors of CYP3A4, e.g., ketoconazole, in patients who are of the CYP2D6 poor metaboliser phenotype or who are using strong inhibitors of CYP2D6, e.g., paroxetine.
Effects on ability to drive and use machines: No studies on the effects of combination of tamsulosin and solifenacin on the ability to drive or use machines have been performed. However, patients should be informed about the possible occurrence of dizziness, blurred vision, fatigue and uncommonly, somnolence, which may negatively affect the ability to drive or use machines.