SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG [SIN16335P]

Product Info

SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG

[SIN16335P]

INDICATIONS:
Solifenacin Succinate is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

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.

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.