TOLDELO XL

2). In case of troublesome side-effects the dose may be reduced from 4 mg to 2 mg once daily. The prolonged-release capsules can be taken with or without food and must be swallowed whole. 1). 1). Therefore, tolterodine is not recommended for children.

Method of administration For oral use.

Summary of safety profile Due to the pharmacological effect of tolterodine it may cause mild to moderate antimuscarinic effects, like dryness of the mouth, dyspepsia and dry eyes. Table 1 below reflects the data obtained with tolterodine in clinical trials and from post marketing experience.

7 % of placebo-treated patients. Tabulated list of adverse reactions The adverse drug reactions listed in the table below are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. confusion, disorientation, delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia.

1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

g. 2) - Autonomic neuropathy - Hiatus hernia - Risk of decreased gastrointestinal motility. 1). The clinical relevance of these findings is unclear and will depend on individual patient risk factors and susceptibilities present. Tolterodine should be used with caution in patients with risk factors for QT prolongation including: - Congenital or documented acquired QT prolongation.

- Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia. - Bradycardia. e. cardiomyopathy, myocardial ischaemia, arrhythmia, congestive heart failure). - Concomitant administration of drugs known to prolong QT-interval including Class IA (e.

g. quinidine, procainamide) and Class III (e. g. amiodarone, sotalol) anti- arrhythmics. 1). 5). Urinary retention As with all treatments for symptoms of urgency and urge incontinence, organic reasons for urge and frequency should be considered before treatment.

Excipient information Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Tolterodine is contraindicated in patients with - Urinary retention - Uncontrolled narrow angle glaucoma - Myasthenia gravis - Known hypersensitivity to tolterodine or excipients (see section 6) - Severe ulcerative colitis - Toxic megacolon