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HSA Approval

SOLICIN-5 FILM COATED TABLET 5 MG

SIN16510P

SOLICIN-5 FILM COATED TABLET 5 MG

SOLICIN-5 FILM COATED TABLET 5 MG

June 9, 2022

ACCORD HEALTHCARE PRIVATE LIMITED

ACCORD HEALTHCARE PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantACCORD HEALTHCARE PRIVATE LIMITED
Licence HolderACCORD HEALTHCARE PRIVATE LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

Solifenacin Succinate

5 mg

Solifenacin

Documents

Package Inserts

Solicin-5 Film Coated Tablets 5 mg PI.pdf

Approved: June 9, 2022

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