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  4. CIRCADIN™ PROLONGED RELEASE TABLETS 2MG [SIN13954P]

CIRCADIN™ PROLONGED RELEASE TABLETS 2MG [SIN13954P]

Active ingredients: CIRCADIN™ PROLONGED RELEASE TABLETS 2MG

Last updated 26 October 2025

Product Info

CIRCADIN™ PROLONGED RELEASE TABLETS 2MG

[SIN13954P]

Product information

Active Ingredient and Strength

MELATONIN - 2 MG

Dosage Form

TABLET, EXTENDED RELEASE

Manufacturer and Country

SWISSCO SERVICES AG - SWITZERLAND
IBERFAR-INDÚSTRIA FARMACÊUTICA, S.A. - PORTUGAL

Registration Number

SIN13954P

Licence Holder

DKSH SINGAPORE PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

N05CH01

Indications
Monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

Dosage and Administration
Oral use. Tablets should be swallowed whole to maintain prolonged release properties. Crushing or chewing should not be used to facilitate swallowing.

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.

Paediatric use
The safety and efficacy of Circadin in children aged 0 to 18 years has not yet been established.
No data are available.

Renal insufficiency
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.

Hepatic impairment
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.

Contra-indications
Circadin prolonged release tablets are contraindicated in patients with a known hypersensitivity to any ingredient of the product (see DESCRIPTION – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).