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HSA Approval

SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG

SIN16335P

SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG

SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG

September 27, 2021

SYNERRV (S) PTE. LTD.

SYNERRV (S) PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSYNERRV (S) PTE. LTD.
Licence HolderSYNERRV (S) PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

Solifenacin Succinate

5.0mg

Solifenacin

Documents

Package Inserts

SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG.pdf

Approved: February 11, 2022

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SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG - HSA Approval | MedPath