RENAXIN FILM-COATED TABLETS 5MG [SIN17559P]

Product Info

RENAXIN FILM-COATED TABLETS 5MG

[SIN17559P]

Indication

4.1. Therapeutic indications

Renaxin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Dosing

4.2. Posology and method of administration

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 is not recommended for patients with severe hepatic impairment (Child-Pugh C).

Co-medication
The maximum dose of Solifenacin 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 section 4.5 Interaction with other medicinal products and other forms of interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
Solifenacin should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.

Contraindications

4.3. 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).
– patients with 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.