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SOLICIN-5 FILM COATED TABLET 5 MG [SIN16510P]
Active ingredients: SOLICIN-5 FILM COATED TABLET 5 MG
Last updated 26 October 2025
Product Info
SOLICIN-5 FILM COATED TABLET 5 MG
[SIN16510P]
Product information
Active Ingredient and Strength | SOLIFENACIN SUCCINATE - 5 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | INTAS PHARMACEUTICALS LIMITED - INDIA |
Registration Number | SIN16510P |
Licence Holder | ACCORD HEALTHCARE PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | G04BD08 |
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.
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.
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