Hetlioz

Posology Dose and timing The recommended dose is 20 mg (1 capsule) tasimelteon per day taken one hour before bedtime, at the same time every night. HETLIOZ is intended for chronic use. 2). 2). 2). Tasimelteon has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing tasimelteon to patients with severe hepatic impairment.

Paediatric population The safety and efficacy of tasimelteon in children and adolescents aged 0 to 18 years have not been established. No data are available. Method of administration Oral use. Hard capsules should be swallowed whole. Avoid breaking as the powder has an unpleasant taste.

2).

1%). The most frequently reported adverse reactions were mostly mild to moderate in severity and transient in nature. 3% of tasimelteon-treated patients. 17%). Tabulated list of adverse reactions The following are adverse reactions that were reported in tasimelteon-treated adult patients, derived from patient trials in 1772 patients treated with tasimelteon.

The following terms and frequencies are applied and presented by MedDRA System Organ Class: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1:

Summary of Adverse Drug Reactions System Organ Class Very common Common Uncommon Psychiatric disorders Sleep disorder, insomnia, abnormal dreams Nightmare Nervous system disorders Headache Somnolence, dizziness Dysguesia Ear and labyrinth disorders Tinnitus Gastrointestinal disorders Dyspepsia, nausea, dry mouth Renal and urinary disorders Pollakiuria General disorders and administrative site conditions Fatigue Foggy feeling in head Investigations Alanine aminotransferase increased Aspartate aminotransferase increased, gamma-glutamyl transferase increased Reporting of suspected adverse reactions 6 Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

After taking tasimelteon, patients should limit their activity to preparing for going to bed. 5). 5). Patients should be instructed to initiate tasimelteon treatment without regard to circadian phase. Physicians should evaluate patient response to tasimelteon 3 months after treatment initiation utilising a clinician interview to assess their overall functioning with an emphasis on sleep-wake complaints.

Excipients HETLIOZ hard capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. HETLIOZ hard capsules contain the azo colouring agent Orange Yellow S (E110), which may cause allergic reactions.

This medicinal product contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.

1.