Obgemsa

Posology The recommended dose is 75 mg once daily. Special populations Renal impairment No dose adjustment for vibegron is recommended for patients with mild, moderate, or severe renal impairment (15 mL/min < GFR < 90 mL/min and not requiring dialysis).

2). Hepatic impairment No dose adjustment for vibegron is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A and B). 2). 3 Paediatric population The safety and efficacy of vibegron in children below 18 years of age have not yet been established.

No data are available. Method of administration Oral administration, with or without food. Swallow with a glass of water. g. applesauce) and taken immediately with a glass of water.

0%). 9%. 2% each). Tabulated list of adverse reactions The table below reflects the adverse reactions observed with vibegron obtained from the phase 3 12-week study, phase 3 long-term extension study and post-marketing data. The frequency of adverse reactions is defined as follows: 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) and not known (cannot be established from the available data).

Table 1:

Adverse reactions reported for vibegron 75 mg System organ class Adverse reaction Frequency Infections and infestations Urinary tract infection Common Nervous system disorders Headache Common Vascular disorders Hot flush Uncommon Gastrointestinal disorders Constipation, Diarrhoea, Nausea Common Skin and subcutaneous tissue disorders Rasha Uncommon Renal and urinary disorders Urinary retentionb Uncommon Investigations Residual urine volume increased Common a includes rash pruritic and rash erythematous b includes urinary straining 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Patients with bladder outlet obstruction and patients taking antimuscarinics medicinal products for OAB Urinary retention has been reported in patients taking vibegron. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medicinal product concomitantly with vibegron treatment.

Signs and symptoms of urinary retention should be monitored before and during the treatment with vibegron, particularly in patients with clinically significant bladder outlet obstruction, in patients with conditions predisposing for bladder outlet obstruction, and in patients taking muscarinic antagonist medicinal product concomitantly with vibegron.

Vibegron should be discontinued in patients who develop urinary retention. Excipients Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1.