Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Vesicare. If urinary tract infection is present, an appropriate antibacterial therapy should be started.



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Vesicare should be used with caution in patients with:
   clinically significant bladder outflow obstruction at risk of urinary retention.
   gastrointestinal obstructive disorders.
   risk of decreased gastrointestinal motility.
   severe renal impairment (creatinine clearance ≤ 30 ml/min; see Section 4.2 and 5.2), and doses should not exceed 5 mg for these patients.
   moderate hepatic impairment (Child-Pugh score of 7 to 9; see Section 4.2 and 5.2), and doses should not exceed 5 mg for these patients.
   concomitant use of a potent CYP3A4 inhibitor, e.g. ketoconazole (see 4.2 and 4.5).
   hiatus hernia/gastro-oesophagal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.
   autonomic neuropathy.

QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as pre-existing long QT syndrome and hypokalaemia.
Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Angioedema with airway obstruction has been reported in some patients on solifenacin succinate. If angioedema occurs, solifencin succinate should be discontinued and 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, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.

The maximum effect of Vesicare can be determined after 4 weeks at the earliest.

Effects on Driving

4.7   Effects on ability to drive and use machines

Since solifenacin, like other anticholinergics may cause blurred vision, and, uncommonly, somnolence and fatigue (see section 4.8. undesirable effects), the ability to drive and use machines may be negatively affected.