Sofcare 5 Special Precautions

Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Solifenacin succinate. If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Solifenacin succinate 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), and doses should not exceed 5 mg for these patients; moderate hepatic impairment (Child-Pugh score of 7 to 9), and doses should not exceed 5 mg for these patients; concomitant use of a potent CYP3A4 inhibitor, e.g. Ketoconazole; hiatus hernia/gastroesophageal reflux and/or who are concurrently taking medicinal products (such as Bisphosphonates) that can cause or exacerbate esophagitis; autonomic neuropathy.
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, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Angioedema with airway obstruction has been reported in some patients on Solifenacin succinate. If angioedema occurs, Solifenacin 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 should be discontinued and appropriate therapy and/or measures should be taken.
The maximum effect of Solifenacin succinate can be determined after 4 weeks at the earliest.