TOLTERODINE MEVON SR CAPSULE 4 MG

NOVEM PHARMA PRIVATE LIMITED

NOVEM PHARMA PRIVATE LIMITED

Therapeutic

Prescription Only

CAPSULE, EXTENDED RELEASE

**4.2 Posology and method of administration** The extended-release capsules can be taken with or without food and must be swallowed whole **(see Section 5.2 – Pharmacokinetic Properties, Pharmacokinetic characteristics** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **).** Adults (including the Elderly) The recommended total daily dose is 4 mg. Dosage with tolterodine capsules is 4 mg once daily. The total daily dose may be reduced to 2 mg, based on individual tolerability. Use in Children Safety and effectiveness in children have not yet been established. Use in Impaired Renal Function The recommended total daily dose is 2 mg (i.e., tolterodine capsules 2 mg once daily) for patients with impaired renal function **(see Section 4.4 – Special Warnings and Precautions for Use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **).** Use in Impaired Hepatic Function The recommended total daily dose is 2 mg (i.e., tolterodine capsules 2 mg once daily) for patients with impaired hepatic function **(see Section 4.4 – Special Warnings and Precautions for Use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **).** Use with Potent CYP3A4 Inhibitors The recommended total daily dose is 2 mg (i.e., tolterodine capsules 2 mg once daily) for patients receiving concomitant ketoconazole or other potent CYP3A4 inhibitors **(see Section 4.4 – Special Warnings and Precautions for Use, CYP3A4 inhibitors, and Section 4.5 – Interactions 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_ **).**