Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**v. Recommended Dosage:** _Adults, including the elderly_ The recommended dose is 5 mg Solifenacin succinate once daily. If needed, the dose may be increased to a maximum of 10 mg Solifenacin succinate 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 Tablet is not recommended for patients with severe hepatic impairment (Child-Pugh C). _Co-medication_ The maximum dose of Solifenacin Succinate Tablet 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.
ORAL
Medical Information
**iv. Therapeutic Indication:** Solifenacin Succinate Tablet is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.
**vii. Contraindication:** 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
ACCORD HEALTHCARE PRIVATE LIMITED
Intas Pharmaceuticals Limited
Active Ingredients
Documents
Package Inserts
Solicin-5 Film Coated Tablets 5 mg PI.pdf
Approved: June 9, 2022