Product Dossier
MELOTIN
Product Dossier for MELOTIN (melatonin 2 mg, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: melatonin 2 mg
- Therapeutic area: Psychiatry
- Related brand: RESTIN
- Same area: REXULTI
- Same area: NICORETTE
What it is
MELOTIN capsules contain 2 mg, 3 mg or 5 mg of melatonin. MELOTIN oral solution contains 1 mg/mL of melatonin. Melatonin is a hormone and antioxidant.
Approved indications
— Short-term treatment of jet lag in adults aged 18 and over. — Sleep disorders in children and adolescents aged 6 to 18 with neurodevelopmental disorders including autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been insufficient.
Dosing overview
It is recommended that MELOTIN is administered on an empty stomach and food is not consumed 1 hour before and 1 hour after intake of MELOTIN.
Key safety warnings
Melatonin may cause daytime drowsiness, and MELOTIN should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety. MELOTIN is not recommended prior to driving and using machines until the effects are known. Melatonin may increase seizure frequency in patients experiencing seizures such as epileptic patients, and patients suffering from seizures must be informed about this possibility before using melatonin. There is no data concerning the use of melatonin in patients with autoimmune diseases, and MELOTIN is not recommended in patients with autoimmune diseases. Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, and the use of melatonin in combination with these drugs is not recommended.
Contraindications
MELOTIN is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. MELOTIN is not recommended for patients with hepatic impairment or renal impairment. Patients with hereditary fructose intolerance should not take MELOTIN oral solution. Use in pregnant women and by women intending to become pregnant is not recommended. Breast-feeding is not recommended in women under treatment with melatonin.
Regulatory history
MELOTIN melatonin 2 mg modified release tablet was first listed on the ARTG on 4 April 2017.