- Approval Id
- 8dbbefd466c4c64e
- Drug Name
- TOLTERODINE MEVON SR CAPSULE 4 MG
- Product Name
- TOLTERODINE MEVON SR CAPSULE 4 MG
- Approval Number
- SIN16432P
- Approval Date
- 2022-02-28
- Registrant
- NOVEM PHARMA PRIVATE LIMITED
- Licence Holder
- NOVEM PHARMA PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
The extended-release capsules can be taken with or without food and must be swallowed whole <strong>(see Section 5.2 – Pharmacokinetic Properties, Pharmacokinetic characteristics</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>Adults (including the Elderly)</u><br>
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.</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 capsules 2 mg once 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 capsules 2 mg once 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 capsules 2 mg once 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></p>
<p>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>
<p>Tolterodine is contraindicated in patients with:</p>
<ul class="dash">
<li>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em></li>
<li>Urinary retention</li>
<li>Uncontrolled narrow angle glaucoma</li>
</ul>
- Atc Code
- G04BD07
- Atc Item Name
- tolterodine
- Pharma Manufacturer Name
- NOVEM PHARMA PRIVATE LIMITED
- Company Detail Path
- /organization/novem-pharma-private-limited
