- 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 HEALTHCARE PTE LTD
- Licence Holder
- NOVEM PHARMA PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Adults (including the Elderly)</u><br>
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.</p>
<p><u>Use in Children</u><br>
Safety and effectiveness in children have not yet been established.</p>
<p><u>Use in Impaired Renal Function</u><br>
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired renal function <strong>(see Section 4.4 – Special Warnings and Precautions for Use</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><strong>).</strong></p>
<p><u>Use in Impaired Hepatic Function</u><br>
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired hepatic function <strong>(see Section 4.4 – Special Warnings and Precautions for Use</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><strong>).</strong></p>
<p><u>Use with Potent CYP3A4 Inhibitors</u><br>
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 <strong>(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</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><strong>).</strong></p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Hypersensitivity to the active substance or to any of the excipients</li>
<li>Urinary retention</li>
<li>Uncontrolled narrow angle glaucoma</li>
<li>Myasthenia gravis</li>
<li>Severe ulcerative colitis</li>
<li>Toxic megacolon</li>
</ul>
- Atc Code
- G04BD07
- Atc Item Name
- tolterodine
- Pharma Manufacturer Name
- NOVEM PHARMA PRIVATE LIMITED
