Due to the pharmacological effect of Solifenacin, it may cause anticholinergic undesirable effects of (in general) mild or moderate severity. The frequency of anticholinergic undesirable effects is dose related. The most commonly reported adverse reactionwith Solifenacin is dry mouth. It occurred in 11% of patients treated with 5 mg once daily, in 22% of patients treated with 10 mg once daily and in 4% of placebo-treated patients. The severity of dry mouth was generally mild and only occasionally led to discontinuation of treatment. In general,medicinal product compliance was very high (approximately 99%) and approximately 90% of the patients treated with Solifenacin completed the full study period of 12 weeks treatment. Gastrointestinal disorders: very common- dry mouth, common-constipation, nausea, dyspepsia, abdominal pain, uncommon- gastroesophageal reflux diseases, dry throat, rare- colonic obstruction, faecal impaction, very rare- vomiting. Infections and infestations: uncommonurinary tract infection, cystitis. nervous system disorders: uncommon- somnolence, dysgeusia, very rare-dizziness, headache. psychiatric disorders: very rare- hallucinations. eye disorders: common- blurred vision, uncommon- dry eyes. General disorders and administration site conditions: uncommon- fatigue, peripheral oedema. Respiratory, thoracic and mediastinal disorders: uncommon nasal dryness. skin and subcutaneous tissue disorders: uncommon- dry skin, very rare- pruritus, rash, urticaria. renal and urinary disorders: uncommon- difficulty in micturition, rare- urinary retention.
