Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**POSOLOGY AND METHOD OF ADMINISTRATION:** _Adults, including the elderly:_ The recommended dose is 5 mg Solifenacin succinate film-coated tablet once daily. If needed, the dose may be increased to 10 mg Solifenacin succinate film-coated tablet once daily. _Children and adolescents:_ Solifenacin succinate is not indicated for treatment of OAB in the pediatric population. **Special populations:** _Patients with renal impairment:_ No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance >30 ml/min). Patients with severe renal impairment (creatinine clearance ≤30 ml/min) should be treated with caution and receive no more than 5 mg once daily. _Patients with hepatic impairment:_ No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh B) should be treated with caution and receive no more than 5 mg once daily. Solifenacin Succinate is not recommended for patients with severe hepatic impairment (Child-Pugh C). _Co-medication:_ The maximum dose of Solifenacin Succinate should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4-inhibitors e.g. ritonavir, nelfinavir, itraconazole, cyclosporin, macrolide antibiotics (see also INTERACTIONS WITH OTHER MEDICINAL PRODUCTS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration:** Solifenacin Succinate should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.
ORAL
Medical Information
**INDICATIONS:** Solifenacin Succinate is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.
**CONTRAINDICATIONS:** **Solifenacin is contraindicated in** - patients with urinary retention. - patients with uncontrolled narrow-angle glaucoma. - patients who have demonstrated hypersensitivity to the drug substance or other components of the product. - severe gastro-intestinal condition (including toxic megacolon and gastric retention). - myasthenia gravis. - patients undergoing haemodialysis. - patients with severe hepatic impairment. - patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole.
G04BD08
solifenacin
Manufacturer Information
SYNERRV (S) PTE. LTD.
UMEDICA LABORATORIES PVT LTD
Active Ingredients
Documents
Package Inserts
SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG.pdf
Approved: February 11, 2022