- Approval Id
- 1400132972db2862
- Drug Name
- CIRCADIN™ PROLONGED RELEASE TABLETS 2MG
- Product Name
- CIRCADIN™ PROLONGED RELEASE TABLETS 2MG
- Approval Number
- SIN13954P
- Approval Date
- 2011-05-04
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, EXTENDED RELEASE
- Dosage
- <p><strong>Dosage and Administration</strong><br>
Oral use. Tablets should be swallowed whole to maintain prolonged release properties. Crushing or chewing should not be used to facilitate swallowing.</p>
<p>The recommended dose is 2 mg once daily, 1–2 hours before bedtime and after food. This dosage may be continued for up to thirteen weeks.</p>
<p><em><strong>Paediatric use</strong></em><br>
The safety and efficacy of Circadin in children aged 0 to 18 years has not yet been established.<br>
No data are available.</p>
<p><em><strong>Renal insufficiency</strong></em><br>
The effect of any stage of renal insufficiency on melatonin pharmacokinetics has not been studied. Caution should be used when melatonin is administered to such patients.</p>
<p><em><strong>Hepatic impairment</strong></em><br>
There is no experience of the use of Circadin in patients with liver impairment. Published data demonstrates markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment. Therefore, Circadin is not recommended for use in patients with hepatic impairment.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong><br>
Monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.</p>
- Contraindications
- <p><strong>Contra-indications</strong><br>
Circadin prolonged release tablets are contraindicated in patients with a known hypersensitivity to any ingredient of the product (see DESCRIPTION – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- N05CH01
- Atc Item Name
- melatonin
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/dksh-singapore-pte-ltd
