FESOTERODINE FUMARATE ARISTO

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 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 fumarate Aristo in children aged less than 6 years have not yet been established. No data are available.

The safety and efficacy of Fesoterodine fumarate Aristo 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 with liquid and swallowed whole.

Fesoterodine fumarate Aristo can be administered with or without food.

g. g. constipation, dry mouth, drowsiness, urinary retention). Fesoterodine may reduce the effect of medicinal products that stimulate the motility of the gastro-intestinal tract, such as metoclopramide. Pharmacokinetic interactions In vitro data demonstrate that the active metabolite of fesoterodine does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, or induce CYP1A2, 2B6, 2C9, 2C19, or 3A4 at clinically relevant plasma concentrations.

Thus fesoterodine is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes. 5-fold in CYP2D6 poor metabolisers, respectively. g. 4). Moderate CYP3A4 inhibitors Following blockade of CYP3A4 by coadministration of the moderate CYP3A4 inhibitor fluconazole 200 mg twice a day for 2 days, Cmax and AUC of the active metabolite of fesoterodine increased approximately 19% and 27%, respectively.

, erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice). g. cimetidine), was not examined; it is not expected to be in excess of the effect of moderate inhibitor. CYP3A4 inducers Following induction of CYP3A4 by coadministration of rifampicin 600 mg once a day, Cmax and AUC of the active metabolite of fesoterodine decreased by approximately 70% and 75%, respectively, after oral administration of fesoterodine 8 mg.

Induction of CYP3A4 may lead to subtherapeutic plasma levels. g. 4). CYP2D6 inhibitors The interaction with CYP2D6 inhibitors was not tested clinically. 7 and 2-fold higher, respectively, in CYP2D6 poor metabolisers as compared to extensive metabolisers.

Co-administration of a potent CYP2D6 inhibitor may result in increased exposure and adverse events. 4). Oral contraceptives Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception. In the presence of fesoterodine there are no changes in the plasma concentrations of combined oral contraceptives containing ethinylestradiol and levonorgestrel.

Warfarin A clinical study in healthy volunteers has shown that fesoterodine 8 mg once daily has no significant effect on the pharmacokinetics or the anticoagulant activity of a single dose of warfarin. Paediatric population Interaction studies have only been performed in adults.

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.

g. g. 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.

Some cases may be associated with upper airway swelling and may be life-threatening. If angioedema occurs, fesoterodine should be discontinued and appropriate therapy should be promptly provided. e. 5). g. g. 8). 1). Lactose and sodium Fesoterodine fumarate Aristo prolonged-release tablets contain lactose.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free’.