FESOTERODINE FUMARATE STADA

Posology Adults (including elderly) The recommended starting dose is 4 mg once daily. Based upon individual response, the dose may be increased to 8 mg once daily. The maximum daily dose is 8 mg. Full treatment effect was observed between 2 and 8 weeks.

Hence, it is recommended to re- evaluate the efficacy for the individual patient after 8 weeks of treatment. 5). 2). Moderate (3) or potent (4) CYP3A4 inhibitors N o n e Moderate Potent Mild 4→8 mg (2) 4 mg Should be avoided Moderat e 4→8 mg (2) 4 mg Contraindic ated Renal impairment (1) Severe 4 mg Should be avoided Contraindic ated Mild 4→8 mg (2) 4 mg Should be avoided Hepatic impairment Moderat e 4 mg Should be avoided Contraindic ated (1) Mild GFR = 50-80 ml/min; Moderate GFR = 30-50 ml/min; Severe GFR = < 30 ml/min (2) Cautious dose increase.

2 (3) Moderate CYP3A4 inhibitors. 5 (4) Potent CYP3A4 inhibitors. 3). Paediatric population The safety and efficacy of fesoteradine in children below 18 years of age have not yet been established. No data are available. Method of administration Oral Use.

Tablets are to be taken once daily with liquid and swallowed whole. Fesoterodine fumarate can be administered with or without food.

Summary of the safety profile The safety of fesoterodine was evaluated in placebo-controlled clinical studies in a total of 2,859 patients with overactive bladder, of which 780 received placebo. Due to the pharmacological properties of fesoterodine, treatment may cause mild to moderate antimuscarinic effects like dry mouth, dry eye, dyspepsia and constipation.

Urinary retention may occur uncommonly. 5 % in the placebo group. The majority of adverse reactions occurred during the first month of treatment with the exception of cases classified as urinary retention or post void residual urine greater than 200 ml, which could occur after long-term treatment and was more common in male than female subjects.

Tabulated list of adverse reactions The table below gives the frequency of treatment emergent adverse reactions from placebo controlled clinical trials and from post-marketing experience. The adverse reactions are reported in this table with the following frequency 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. System organ Very Common Uncommon Rare class common Infections and infestations Urinary tract infection Psychiatric disorders Insomnia Confusional state Nervous system disorders Dizziness, headache Dysgeusia, somnolence Eye disorders Dry eye Blurred vision Ear and labyrinth disorders Vertigo Cardiac disorders Tachycardia, palpitations Respiratory, thoracic and mediastinal disorders Dry throat Pharyngolaryngeal pain, cough, nasal dryness Gastrointestinal disorders Dry mouth Abdominal pain, diarrhoea, dyspepsia, constipation, nausea Abdominal discomfort, flatulence, gastroesophageal reflux Hepatobiliary disorders ALT increased, GGT increased Skin and subcutaneous tissue disorders Rash, dry skin, pruritus Angioedema, urticaria Renal and urinary disorders Dysuria Urinary retention (including feeling of residual urine, micturition disorder), urinary hesitation General disorders and administration site conditions Fatigue Description of selected adverse reactions In clinical trials of fesoterodine, cases of markedly elevated liver enzymes were reported with the occurrence frequency no different from the placebo group.

2) Dose increases In patients with a combination of these factors, additional exposure increases are expected. Dose dependent antimuscarinic adverse reactions are likely to occur. In populations where the dose may be increased to 8 mg once daily, the dose increase should be preceded by an evaluation of the individual response and tolerability.

Organic causes must be excluded before any treatment with antimuscarinics is considered. Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity. Other causes of frequent urination (treatment of heart failure or renal disease) should be assessed before treatment with fesoterodine.

If urinary tract infection is present, an appropriate medical approach should be taken/antibacterial therapy should be started. Angioedema Angioedema has been reported with fesoterodine and has occurred after the first dose in some cases.

If angioedema occurs, fesoterodine should be discontinued and appropriate therapy should be promptly provided. 5). g. 8). 1). Excipients Fesoterodine fumarate prolonged-release tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1 • Urinary retention • Gastric retention • Uncontrolled narrow angle glaucoma • Myasthenia gravis • Severe hepatic impairment (Child Pugh C) • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment • Severe ulcerative colitis • Toxic megacolon