MedPath
HSA Approval

TOLTERODINE MEVON IR FILM-COATED TABLET 2 MG

SIN16313P

TOLTERODINE MEVON IR FILM-COATED TABLET 2 MG

TOLTERODINE MEVON IR FILM-COATED TABLET 2 MG

August 31, 2021

NOVEM PHARMA PRIVATE LIMITED

NOVEM PHARMA PRIVATE LIMITED

Regulatory Information

NOVEM PHARMA PRIVATE LIMITED

NOVEM PHARMA PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**4.2 Posology and method of administration** Adults (including the Elderly) The recommended total daily dose is 4 mg. Dosage with tolterodine tablets is 2 mg twice 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 tablets 1 mg twice 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 tablets 1 mg twice 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 tablets 1 mg twice 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_ **).**

ORAL

Medical Information

**4.1 Therapeutic indications** Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.

**4.3 Contraindications** - Hypersensitivity to the active substance or to any of the excipients - Urinary retention - Uncontrolled narrow angle glaucoma - Myasthenia gravis - Severe ulcerative colitis - Toxic megacolon

G04BD07

tolterodine

Manufacturer Information

NOVEM PHARMA PRIVATE LIMITED

PHARMATHEN S.A.

Active Ingredients

Tolterodine Tartrate

2.00 mg

Tolterodine

Documents

Package Inserts

Tolterodine Mevon Package Insert.pdf

Approved: August 31, 2021

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

TOLTERODINE MEVON IR FILM-COATED TABLET 2 MG - HSA Approval | MedPath