WIDE AWAKE AT
NIGHT ? Isolation and loneliness can affect our quality of sleep 1
Circadin ® 2mg ( prolonged-release melatonin ) Tablets Prescribing Information : Please refer to the Summary of Product Characteristics before prescribing . Presentation : Circadin 2mg prolonged-release tablets containing 2mg melatonin . Indication : Monotherapy for the short-term treatment of primary insomnia characterised by poor quality sleep in patients aged 55 or over . Dosage and administration : 2mg orally once daily , 1-2 hours before bedtime and after food . Swallow whole , do not crush or chew . This dosage may be continued for up to thirteen weeks . Children and adolescents (< 18 years ): Safety and efficacy not yet established . Contraindications : Hypersensitivity to the active substance or to any excipients . Special warnings and precautions for use : Use caution when administered to patients with renal insufficiency . Not recommended for use in patients with hepatic impairment . Circadin may cause drowsiness , therefore use with caution if the effects of drowsiness are likely to be associated with a risk to safety . Not recommended in patients with autoimmune diseases . Patients with rare hereditary problems of galactose intolerance , the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine . Fertility , pregnancy and lactation : Circadin use in pregnancy and in women intending to become pregnant is not recommended and breast-feeding is not recommended in women receiving melatonin . Driving : Circadin has moderate influence on the ability to drive and use machines . Interactions : Fluvoxamine should be avoided . Caution should be used in patients on 5- or 8-methoxypsoralen ( 5- and 8-MOP ), cimetidine and oestrogens . Cigarette smoking may decrease melatonin levels . CYP1A2 inhibitors such as quinolones may give rise to increased melatonin exposure . CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced melatonin exposure . Alcohol should not be taken with Circadin . Sedative properties of benzodiazepines and non-benzodiazepine hypnotics may be enhanced . Undesirable effects : In clinical trials the rate of patients with adverse events per
• Provides clinically meaningful improvements in quality of sleep and morning alertness 2
• Monotherapy for the short-term treatment of primary insomnia characterised by poor quality sleep in patients aged 55 or over 2
100 patient weeks was higher for Placebo than Circadin ( 5.743 placebo vs . 3.013 Circadin ). There are no very common ( ≥1 / 10 ) or common ( ≥1 / 100 to < 1 / 10 ) adverse reactions . Uncommon ( ≥1 / 1,000 to < 1 / 100 ) adverse reactions include hypertension , chest pain , migraine , headache , irritability , abnormal dreams , nightmares , dermatitis , menopausal symptoms , abdominal pain , abnormal liver function test and asthenia . Rare ( ≥1 / 10,000 to < 1 / 1,000 ) adverse reactions include loss of consciousness , angina , palpitations , depression , visual impairment , disorientation , vertigo , haematuria , leukopenia , thrombocytopenia and abnormal laboratory test . Prescribers should consult the full Summary of Product Characteristics for further information on adverse reactions . Legal category : POM . Packs and Prices : Circadin 2mg , 30 tablets , £ 15.39 . Marketing Authorisation number : EU / 1 / 07 / 392 / 003 . Marketing Authorisation holder : RAD Neurim Pharmaceuticals EEC SARL , 4 rue de Marivaux , 75002 Paris , France . Further information available from : Flynn Pharma Ltd . Hertlands House , Primett Road , Stevenage , Hertfordshire , SG1 3EE . Date of last revision of PI : March , 2019 .
Adverse events should be reported . Reporting forms and information can be found at https :// yellowcard . mhra . gov . uk /. Adverse events should also be reported to Flynn Pharma Ltd . Medical Information : Tel 01438 727822 .
Information about this product , including adverse reactions , precautions , contraindications and method of use can be found at http :// www . medicines . org . uk / emc /
References 1 . Simon , E . B . and Walker , M . P . ( 2018 ) Nature Communications 9 ; 3146 . 2 . Circadin SmPC August 2019 .
Date of preparation December 2020 UK / CIR / 2020 / 1307