Wakix

Treatment should be initiated by a physician experienced in the treatment of sleep disorders. 5 mg tablets) per day. 5 mg tablet) per day. 3 - Week 3: the dose may be increased to 36 mg (two 18 mg tablets) per day. 5 mg per day) or increased (up to 36 mg per day) according to the physician assessment and the patient’s response.

The total daily dose should be administered as a single dose in the morning during breakfast. 1), the continued efficacy of treatment should be regularly evaluated by the physician. Special populations Elderly Limited data are available in elderly.

Therefore, dosing should be adjusted according to their renal and hepatic status. Renal impairment In patients with renal impairment, the maximum daily dose should be 18 mg. 2). 3). No dosage adjustment is required in patients with mild hepatic impairment.

Paediatric population Wakix should be used at the optimal dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day (18 mg/day in children weighing less than 40 kg).

5 mg tablet) per day. 5mg tablets) per day. - Week 3: the dose may be increased to 18 mg (one 18 mg tablet) per day. - Week 4: in children weighing 40 kg and above, the dose may be increased to 36 mg (two 18 mg tablets) per day. 5 mg per day) or increased (up to 36 mg per day in children weighing 40 kg and above or 18 mg per day in children weighing less than 40 kg) according to the physician assessment and the patient’s response.

The total daily dose should be administered as a single dose in the morning during breakfast. Poor metabolizers By comparison to CYP2D6 extensive metabolisers, higher systemic exposure (up to 3 fold) is observed in CYP2D6 poor metabolisers.

In the up-titration scheme, dose increment should take into account this higher exposure. Method of administration For oral use.

9%). 09%). 4%). Most of these adverse reactions were mild to moderate. If symptoms persist a reduced daily dose or discontinuation should be considered. 5% of the patients receiving pitolisant. These effects were mostly mild to moderate.

If they persist a corrective treatment with proton pump inhibitor could be initiated. Paediatric population (Age 6 to 17) The paediatric population has been studied in a double-blind multicentre randomized placebo- controlled trial; a total of 73 children and adolescents with narcolepsy with or without cataplexy were treated with pitolisant for 8 weeks.

Frequency, type and severity of adverse reactions in children and adolescents were similar to that of adults. 7%). Reporting of suspected adverse reactions 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.

Psychiatric disorders Pitolisant should be administered with caution in patients with history of psychiatric disorders such as severe anxiety or severe depression with suicidal ideation risk. Suicidal ideation has been reported in patients with psychiatric history treated with pitolisant.

2. 8) or when co-administered with gastric irritants such as corticosteroids or NSAID. 8). In case of significant weight change, treatment should be re-evaluated by the physician. Cardiac disorders In two dedicated QT studies, supra-therapeutic doses of pitolisant (3-6-times the therapeutic dose, that is 108 mg to 216 mg) produced mild to moderate prolongation of QTc interval (10-13 ms).

In clinical trials, no specific cardiac safety signal was identified at therapeutic doses of pitolisant. 5). 3). In clinical trials, one epilepsy aggravation was reported in one epileptic patient. Caution should be taken for patients with severe epilepsy.

Women of childbearing potential Women of childbearing potential have to use effective contraception during treatment and at least up to 21 days after treatment discontinuation (based on pitolisant/metabolites half-life). Pitolisant may reduce the effectiveness of hormonal contraceptives.

6). 5). Rebound effect 5 No rebound effect was reported during clinical trials. However, treatment discontinuation should be monitored. Drug abuse Pitolisant showed absence or low abuse potential according to clinical data (specific human abuse potential study at doses from 36 up to 216 mg in adults and observed abuse-related adverse effects in phase 3 studies).

1. Severe hepatic impairment (Child-Pugh C). 6).