- Approval Id
- 58354d96da7ebb06
- Drug Name
- TOLTERODINE MEVON IR FILM-COATED TABLET 1 MG
- Product Name
- TOLTERODINE MEVON IR FILM-COATED TABLET 1 MG
- Approval Number
- SIN16314P
- Approval Date
- 2021-08-31
- Registrant
- NOVEM PHARMA PRIVATE LIMITED
- Licence Holder
- NOVEM PHARMA PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **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_ **).**
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.
- Contraindications
- **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
- Atc Code
- G04BD07
- Atc Item Name
- tolterodine
- Pharma Manufacturer Name
- NOVEM PHARMA PRIVATE LIMITED
- Company Detail Path
- /organization/66db3ea384434852/novem-pharma-private-limited
