TOLTERODINE TARTRATE

4). In case of troublesome undesirable effects the dose may be reduced from 2 mg to 1 mg twice daily. 1). 1). Therefore, Tolterodine tartrate is not recommended for children.

Summary of the 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.

The most commonly reported adverse reaction was dry mouth, which occurred in 35% of patients treated with tolterodine and in 10% of placebo treated patients. 4% 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. 1). The clinical relevance of these findings is unclear and will depend on individual patient risk factors and susceptibilities present. 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. 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 Tolterodin Pfizer 2 mg film-coated tablets contain less than 1 mmol sodium (23 mg) per tablet.

Patients on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’.

1) - Severe ulcerative colitis - Toxic megacolon