Wakix (pitolisant) 4.5mg and 18mg film-coated tablets (United Kingdom and Ireland)

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Wakix (pitolisant) 4.5mg and 18mg film-coated tablets (United Kingdom and Ireland)

Wakix (pitolisant) is indicated in adults for the treatment of narcolepsy with or without cataplexy.  Pitolisant is a potent, orally active histamine H3-receptor antagonist/inverse agonist which, via its blockade of histamine auto-receptors enhances the activity of brain histaminergic neurons, a major arousal system with widespread projections to the whole brain. Pitolisant also modulates various neurotransmitter systems, increasing acetylcholine, noradrenaline and dopamine release in the brain.  Treatment should be initiated by a physician experienced in the treatment of sleep disorders. Further information regarding Wakix can be viewed in the SPC below.

Wakix is a presciption-only medication.

 

For Medical Information in the UK: 0300 1003684 or directly from Lincoln Medical Ltd.

For Medical Information in Ireland: (01) 676 4971

4.5mg/18mg combined SPC: https://www.medicines.org.uk/emc/medicine/32397

Adverse events should be reported via the following methods: In the UK In Ireland    

Prescribing Information

Wakix 4.5 mg Film-coated Tablets Wakix 18 mg Film-coated Tablets Please refer to the Summary of Product Characteristics (SmPC) before prescribing Wakix. 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. Indication: Treatment of narcolepsy in adults, with or without cataplexy. Dosage and administration: For oral use. Treatment should be initiated by a physician experienced in the treatment of sleep disorders. Use at the lowest effective dose, up to a maximum 36 mg/day. Start at 9 mg/day in week 1 and titrate depending on dose response. Dose may be increased to 18 mg/day in week 2 and 36 mg/day in week 3. Dose may be adjusted at any time between 4.5 to 36 mg/day. 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), 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, 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. Interactions: Avoid combination with oral contraceptives. Pitolisant efficacy may be impaired by tri- or tetra-cyclic antidepressants, antihistamines. See also warnings on drugs affecting QT interval and repolarisation. Enzyme inducers and CYP2D6 inhibitors may affect pitolisant metabolism. Pitolisant may affect the metabolism of CYP3A4, CYP2B6 and OCT1 substrates. 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 undesirable effects: Insomnia, headache, nausea, anxiety, irritability, dizziness, depression, tremor, sleep disorders, fatigue, vomiting, vertigo, dyspepsia, weigh increase and upper abdominal pain. 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 MA Holder: Bioprojet Pharma, 9, rue Rameau, 75002 Paris, France UK Distributor: Lincoln Medical Ltd, Unit B Stanley Court, Glenmore Business Park, Wilton, Telford Road, Salisbury SP2 7GH, UK Full SmPC available from the UK Distributor. Date of preparation: February 2017 Unique ID LINWAKAPI-130616