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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

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantNOVEM PHARMA PRIVATE LIMITED
Licence HolderNOVEM PHARMA PRIVATE LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

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

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