- Approval Id
- c7553fe24ea99e97
- Drug Name
- DALISOON F.C. TABLETS 5MG
- Product Name
- DALISOON F.C. TABLETS 5MG
- Approval Number
- SIN16679P
- Approval Date
- 2023-01-18
- Registrant
- NOVEM HEALTHCARE PTE LTD
- Licence Holder
- NOVEM HEALTHCARE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p><em>Adults, including the elderly</em><br>
The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to a maximum of 10 mg solifenacin succinate once daily.</p>
<p><em>Children and adolescents</em><br>
Solifenacin succinate is not indicated for treatment of OAB in the pediatric population.</p>
<p><strong>Special populations</strong></p>
<p><em>Patients with renal impairment</em><br>
No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance >30 ml/min). Patients with severe renal impairment (creatinine clearance ≤30 ml/min) should be treated with caution and receive no more than 5 mg once daily.</p>
<p><em>Patients with hepatic impairment</em><br>
No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh B) should be treated with caution and receive no more than 5 mg once daily. Dalisoon is not recommended for patients with severe hepatic impairment (Child-Pugh C).</p>
<p><em>Co-medication</em><br>
The maximum dose of Dalisoon should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4- inhibitors e.g. ritonavir, nelfinavir, itraconazole, cyclosporin, macrolide antibiotics (see also INTERACTIONS WITH OTHER DRUGS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Method of administration</strong></p>
<p>Dalisoon should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong></p>
<p>Dalisoon is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>Solifenacin is contraindicated in</p>
<ul class="dash">
<li>patients with urinary retention</li>
<li>patients with uncontrolled narrow-angle glaucoma</li>
<li>patients who have demonstrated hypersensitivity to the drug substance or other components of the product</li>
<li>severe gastro-intestinal condition (including toxic megacolon and gastric retention)</li>
<li>myasthenia gravis</li>
<li>patients undergoing haemodialysis</li>
<li>patients with severe hepatic impairment</li>
<li>patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole</li>
</ul>
- Atc Code
- G04BD08
- Atc Item Name
- solifenacin
- Pharma Manufacturer Name
- NOVEM HEALTHCARE PTE LTD
- Company Detail Path
- /organization/novem-healthcare-pte-ltd
