FESOTERODINE DR. REDDYS

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 reevaluate the efficacy for the individual patient after 8 weeks of treatment. 5). 2). Moderate(3) or potent(4) CYP3A4 inhibitors None Moderate Potent Mild 4→8 mg(2) 4 mg Should be avoided Moderate 4→8 mg(2) 4 mg Contraindicated Renal impairment(1) Severe 4 mg Should be avoided Contraindicated Mild 4→8 mg(2) 4 mg Should be avoidedHepatic impairment Moderate 4 mg Should be avoided Contraindicated (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 fesoterodine in children aged less than 6 years have not yet been established. No data are available. The safety and efficacy of fesoterodine in children aged 6 years to 17 years have not been established.

2 but no recommendation on a posology can be made. Method of administration Tablets are to be taken once daily w ith liquid and sw allow ed w hole. Fesoterodine can be administered w ith or w ithout food.

Summary of the safety profile The safety of fesoterodine w as evaluated in placebo-controlled clinical studies in a total of 2859 patients w ith overactive bladder, of w hich 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 w ith the exception of cases classified as urinary retention or post void residual urine greater than 200 ml, w hich could occur after long term treatment and w as more common in male than female subjects.

Tabulated list of adverse reac tions 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 w ith the follow ing 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 class Very common Common Uncommon Rar e 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 Pharyngolaryng eal pain; Cough; Nasal dryness System organ class Very common Common Uncommon R ar e Gastrointestin al disorders Dry mouth Abdominal pain; Diarrhoea; Dyspepsia; Constipation; Nausea Abdominal discomfort; Flatulence, Gastroesophage al reflux Hepatobiliary disorders ALT increased; GGT increased Skin and subcutaneous tissue disorders Rash; Dry skin; Pruritus Angioedem a; Urticaria Renal and urinary disorders Dysuria Urinary retention (including feeling of residual urine; micturition disorder); Urinary hesitation General disorders and administration site conditions Fatigue Desc ription of selec ted adverse reac tions In clinical trials of fesoterodine, cases of markedly elevated liver enzymes w ere reported w ith the occurrence frequency no different from the placebo group.

g. g. pyloric stenosis) • gastro-oesophageal reflux and/or w ho are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis • decreased gastrointestinal motility • autonomic neuropathy • controlled narrow -angle glaucoma.

2). Dose inc reases In patients w ith a combination of these factors, additional exposure increases are expected. Dose dependent antimuscarinic adverse reactions are likely to occur. In populations w here 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 w ith antimuscarinics is considered. Safety and efficacy have not yet been established in patients w ith a neurogenic cause for detrusor overactivity. Other causes of frequent urination (treatment of heart failure or renal disease) should be assessed before treatment w ith fesoterodine.

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

If angioedema occurs, fesoterodine should be discontinued and appropriate therapy sh ould be promptly provided. e. 5). g. g. 8). 1). Lac tose fesoterodine prolonged-release tablets contain lactose. Patients w ith rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sodium This product contains less then 1mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Glycerol May cause headach, stomach upset and diarrhea.

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 w ith moderate to severe hepatic or renal impairment • severe ulcerative colitis • toxic megacolon.