Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: PIERRE FABRE MEDICAMENT, Les Cauquillous, 81500 Lavaur, France
Obgemsa is indicated in symptomatic treatment of adult patients with overactive bladder (OAB) syndrome.
The recommended dose is 75 mg once daily.
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). Vibegron has not been studied in patients with end-stage renal disease (GFR < 15 mL/min with or without haemodialysis) and is therefore not recommended in these patients (see section 5.2).
No dose adjustment for vibegron is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A and B). Vibegron has not been studied in patients with severe hepatic impairment (Child-Pugh C) and is therefore not recommended in this patient population (see section 5.2).
The safety and efficacy of vibegron in children below 18 years of age have not yet been established. No data are available.
Oral administration, with or without food. Swallow with a glass of water.
Obgemsa 75 mg film-coated tablets may also be crushed, mixed with a tablespoon (approximately 15 mL) of soft food (e.g. applesauce) and taken immediately with a glass of water
The cases of overdose have been reported in a dose range between 100 and 375 mg per day. All observed adverse events following the reported overdose were non-serious. The reported adverse events were gastrointestinal disorders, headache and dyspnoea.
In case of suspected overdose, treatment should be symptomatic and supportive.
4 years.
This medicinal product does not require any special storage conditions.
HDPE white, square or round bottle respectively closed with a child resistant polypropylene (PP) cap and an inner seal containing a polyethylene (PE) layer in contact with the tablets. Each bottle contains 7, 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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