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HSA Approval

TOLTERODINE MEVON SR CAPSULE 2 MG

SIN16433P

TOLTERODINE MEVON SR CAPSULE 2 MG

TOLTERODINE MEVON SR CAPSULE 2 MG

February 28, 2022

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

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_ **).**

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** Tolterodine is contraindicated in patients with: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ - Urinary retention - Uncontrolled narrow angle glaucoma

G04BD07

tolterodine

Manufacturer Information

NOVEM PHARMA PRIVATE LIMITED

PHARMATHEN INTERNATIONAL S.A

Active Ingredients

Tolterodine Tartrate

2 mg

Tolterodine

Documents

Package Inserts

Tolterodine Mevon SR Capsule PI.pdf

Approved: February 28, 2022

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TOLTERODINE MEVON SR CAPSULE 2 MG - HSA Approval | MedPath