Click here for Prescribing Information: Wakix▼(pitolisant) 4.5mg and 18mg film-coated tablets (United Kingdom)

Prescribing Information (Please refer to the Summary of Product Characteristics (SmPC) before prescribing Wakix.)

Wakix 4.5 mg Film-coated Tablets Wakix 18 mg Film-coated Tablets

Pitolisant: Each 4.5 mg tablet contains 5 mg pitolisant hydrochloride equivalent to 4.45 mg pitolisant. Each 18 mg tablet contains 20 mg pitolisant hydrochloride equivalent to 17.8 mg pitolisant.

Indications: Treatment of narcolepsy in adults, with or without cataplexy; improved wakefulness and reduced excessive daytime sleepiness in adult patients with obstructive sleep apnoea (OSA) not satisfactorily treated by primary OSA therapy.

Dosage and administration: For oral use. Treatment should be initiated by a physician experienced in the treatment of sleep disorders or OSA and cardiovascular risk. Wakix is not a therapy for the underlying airway obstruction in patients with OSA. Use at the lowest effective dose, up to a maximum 36 mg/day for narcolepsy or 18 mg/day for OSA. Dose may be initiated at 9 mg/day in narcolepsy or 4.5 mg/day in OSA and titrated depending on dose response. See SmPC for weekly titration regime. Total daily dose should be administered as a single dose in the morning. Renal impairment or moderate hepatic impairment: Maximum daily dose should not exceed 18mg.

Contraindications: Hypersensitivity to any of the ingredients, severe hepatic impairment (Child-Pugh C), breastfeeding.

Warnings and Precautions: Use caution in patients with a history of psychiatric disorders (e.g. severe anxiety, severe depression with suicidal ideation risk), patients with renal or moderate hepatic impairment, acid related gastric disorders or medicines causing gastric irritation, patients with significant weight change, severe obesity or severe anorexia. Carefully monitor in cases of severe epilepsy, cardiac disease, hypertension, at risk of major adverse cardiovascular events (MACE), or concomitant medication known to prolong the QT interval, increase the risk of repolarization disorders or increase plasma pitolisant. May reduce the effectiveness of hormonal contraceptives. Advise affected patients to use alternative methods of contraception. Avoid combination with CYP3A4 substrates or products with a narrow therapeutic margin. Monitor treatment discontinuation.

Pregnancy and lactation: May reduce the effectiveness of hormonal contraceptives. Advise affected patients to use alternative methods of contraception. Pregnancy: Do not use unless the benefits outweigh the potential risks. Breastfeeding: Contraindicated.

Effects on ability to drive and use machines: Caused dizziness, vertigo and tremor. Patients with excessive daytime sleepiness should avoid driving and other potentially dangerous activity.

Common and serious undesirable effects (refer to SmPC for full list of side effects): Very Common: Headache. Common: Insomnia, headache, nausea, anxiety, irritability, dizziness, depression, tremor, sleep disorder, fatigue, vomiting, vertigo, dyspepsia. Uncommon serious: Suicidal ideation, dyskinesia, cataplexy, dystonia, epilepsy, bradycardia, increased hepatic enzymes, ECG QT prolonged, atrioventricular block first degree, tachycardia, rectal haemorrhage. Rare serious: anorexia, depressed mood, loss of consciousness, enterocolitis, toxic skin eruption, spontaneous abortion, increased creatine phosphokinase, ECG repolarisation abnormality, ECG T wave inversion.

Legal Category: POM

Pack size: 4.5 mg: 1 bottle x30 tablets £310 18 mg: 1 bottle x30 tablets £310

MA Number: EU/1/15/1068/001-002, PLGB: 18813/0006-7

MA Holder: Bioprojet Pharma, 9, rue Rameau, 75002 Paris, France

UK Distributor: Bioprojet UK Ltd, Unit B Stanley Court, Glenmore Business Park, Telford Road, Salisbury SP2 7GH

Date of preparation: January 2024 Unique ID: WAK/UK/053/24

Adverse events should be reported. Reporting forms and information can be found at UK: http://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store and IE HPRA Pharmacovigilance Website: www.hpra.ie.. Adverse events should also be reported to Bioprojet UK on +44 (0) 1271 334609