Ozawade

Treatment should be initiated by a healthcare professional experienced in the treatment of OSA and cardiovascular risk. OSA disease should be annually reassessed. Ozawade is not a therapy for the underlying airway obstruction in patients with OSA.

Primary OSA therapy should be maintained or periodically rechallenged in patients not tolerating primary OSA therapy. 5 mg tablet) per day. 5 mg tablets) per day. 5 mg tablet) per day. 5 mg per day) or increased (up to 18 or 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 individual response and tolerance. 8). Renal impairment In patients with renal impairment, the maximum daily dose should be 18 mg. Hepatic impairment No dosage adjustment is required in patients with mild hepatic impairment.

2). 3). Paediatric population There is no relevant use of Ozawade in the paediatric population in Obstructive Sleep Apnoea (OSA). 8-fold) is observed in CYP2D6 ultra-rapid metabolizers. No differences in systemic exposure is observed between CYP2D6 extensive and intermediate metabolizers.

2). Furthermore, no dose recommendation can currently be given for CYP2D6 ultra-rapid metabolizers taking a CYP3A inducer, because the PK is currently unknown in this subpopulation. Method of administration For oral use.

7%. 0%) more frequently in women (headache and insomnia) and in elderly (insomnia) patients. 2). Dosing should be adjusted accordingly. 5% of the patients receiving pitolisant. Higher rates of nausea are reported in women. These effects were mostly mild to moderate.

If they persist, a corrective treatment with proton pump inhibitor could be initiated. Patients with low/normal Body Mass Index (BMI) (<25) Headache, insomnia, nausea and anxiety have been reported in higher rates in patients with low/normal BMI.

Dosing should be adjusted accordingly. 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 4 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. 5). 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 (6-12-times the therapeutic dose, that is 108 mg to 216 mg) produced mild to moderate prolongation of QTc interval (10-13 ms).

5). 3). In clinical studies, 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). Drug abuse, rebound effect In a specific study, pitolisant showed no or very low signal suggestive of abuse at the current therapeutic dose of 36 mg and at doses up to 216 mg; consequently, potential for drug abuse or recreational drug with pitolisant is very low.

No rebound effect was reported during clinical studies. However, treatment discontinuation should be monitored. 5

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