Prospect: Information for the User

Wakix 4.5mg Film-Coated Tablets

Wakix 18mg Film-Coated Tablets

pitolisant

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Wakix contains the active ingredient pitolisant. It is a medication used for the treatment of adult, adolescent, and children over 6 years of age with narcolepsy, with or without cataplexy.

Narcolepsy is a disease that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks). Cataplexy usually begins with the sudden onset of muscle weakness or paralysis without loss of consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter, or surprise.

The active ingredient, pitolisant, binds to receptors in brain cells involved in the stimulation of the alert state. This helps to combat daytime sleepiness and cataplexy, and to promote wakefulness.

Do not take Wakix:

• If you are allergic to pitolisant or any of the other components of this medication (listed in section 6).
• If you have severe liver problems, as pitolisant is usually broken down in the liver and it is possible that excessive levels may increase in patients with severely impaired liver function.
• If you are breastfeeding (lactation period).

Warnings and precautions

Consult your doctor before starting to take Wakix if you are in any of the following situations:

• You have had anxiety or depression with suicidal thoughts at some point.
• You have liver or kidney problems, as your doctor may need to adjust the dose.
• You have a stomach ulcer or are taking a medication that can irritate the stomach (such as anti-inflammatory medications), as gastrointestinal reactions have been reported with Wakix.
• You have obesity or anorexia, as your weight may have changed (increased or decreased) while taking Wakix.
• You have heart problems. Your doctor will need to regularly check these aspects during treatment with Wakix.
• If you have severe epilepsy.

If you are in any of these situations, consult your doctor or pharmacist before taking Wakix.

Other aspects to discuss with your doctor or pharmacist:

Some people with a history of psychiatric disorders have reported suicidal thoughts while taking this medication. Inform your doctor immediately if you feel depressed or have suicidal thoughts (see section 4). Ask a close family member or friend to help you detect signs of depression or other changes in your behavior.

Children

Wakix should not be administered to children under 6 years of age.

Use of Wakix with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Wakix may affect how other medications work and other medications may affect how Wakix works. Your doctor may need to adjust the dose.

Particularly, be cautious if you take Wakix with some antidepressants (such as imipramine, clomipramine, and mirtazapine) and some medications for treating allergic diseases (antihistamines such as, for example, pheniramine maleate, chlorpheniramine, diphenhydramine, promethazine, mepiramine, and doxylamine).

Consult your doctor or pharmacist if you are taking any of the following medications: rifampicin (antibiotic), phenytoin, carbamazepine, and phenobarbital (mainly used to control seizures), quinidine, digoxin (used to treat arrhythmia), paroxetine, fluoxetine, venlafaxine, duloxetine (antidepressants), St. John's Wort (Hypericum perforatum) a plant-based medication for depression, bupropion (antidepressant or substance to help quit smoking), cinacalcet (used to treat parathyroid gland disorders), terbinafine (used to treat fungal infections), metformin, repaglinide (used to treat diabetes), docetaxel, irinotecan (used to treat cancer), cisapride (used to treat gastroesophageal reflux), pimozide (used to treat some mental disorders), halofantrine (used to treat malaria), efavirenz (antiviral to treat HIV), morphine, paracetamol (used as analgesic treatment), dabigatran (used to treat bleeding problems) and warfarin (used to treat heart conditions), probenecid (used to treat gout and gouty arthritis). Pitolisant can be used with modafinil and sodium oxybate.

Wakix may reduce the effectiveness of hormonal contraceptives, so another secure contraceptive method should be used (see section "Pregnancy").

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Wakix should not be used during pregnancy unless your doctor prescribes it. There is not enough information available to know if there are any specific risks associated with taking Wakix during pregnancy. Women should use contraceptive methods during treatment with Wakix, and at least 21 days after stopping treatment. Since Wakix may reduce the effectiveness of hormonal contraceptives, another secure contraceptive method should be used.

Lactation

In animals, Wakix passes into breast milk. Patients taking Wakix should stop breastfeeding.

Driving and operating machinery

You should be cautious when performing activities that require attention, such as driving cars and operating machinery. If you are unsure if your condition affects your ability to drive, consult your doctor.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

Treatment usually begins with a dose of 9 mg once a day, and is gradually increased over three weeks to reach the most suitable dose. At any time, the doctor may increase or decrease the dose based on the suitability and tolerance to the medication presented by the patient.

It may take several days before the benefits of the medication are perceived, and the maximum benefit is usually observed after several weeks of treatment.

Do not modify the doses of Wakix on your own. Any change in the dosage must be prescribed and supervised by your doctor.

To take a dose of 4.5 mg, take one 4.5 mg tablet.

To take a dose of 9 mg, take two 4.5 mg tablets.

To take a dose of 18 mg, take one 18 mg tablet.

To take a dose of 36 mg, take two 18 mg tablets.

Adolescents and children over 6 years of age

Treatment usually begins with a dose of 4.5 mg once a day and is gradually increased over three weeks to reach the most suitable dose (see above).

If you weigh less than 40 kg, do not take more than 18 mg per day.

Wakix should be taken once a day orally, in the morning during breakfast.

Do not take a dose of Wakix in the afternoon, as the patient may have difficulty sleeping.

If you take more Wakix than you should

If you take too many Wakix tablets, contact the nearest hospital emergency service or consult immediately with your doctor or pharmacist. You may experience headaches, stomach pain, nausea, or irritability. You may also have difficulty sleeping. Carry this leaflet and the rest of the tablets with you.

If you forget to take Wakix

If you forget to take the medication, take the next dose at the usual time, do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Wakix

You must continue taking Wakix for the time prescribed by your doctor. Do not stop taking Wakix suddenly on your own.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. If you experience any side effects, consult your doctor.

Frequent side effects(may affect up to 1 in 10 people):

• Difficulty sleeping, feeling anxious, feeling irritable, feeling depressed, sleep problems
• Headaches, feeling like you're spinning (dizziness), loss of balance, tremors
• Nausea, vomiting, indigestion
• Fatigue (tiredness)

Less frequent side effects(may affect up to 1 in 100 people):

• Sweating
• Increased or decreased appetite
• Edema
• Feeling nervous, seeing or hearing things that are not real
• Emotional instability
• Abnormal dreams
• Tension
• Difficulty falling asleep at the beginning, middle, or end of the night, difficulty staying asleep, excessive sleepiness, sleepiness
• Lack of emotional response
• Nightmares
• Restlessness and unable to stay still
• Panic attack
• Suicidal thoughts
• Altered sex drive or increased sex drive
• Episodic and transient weakness, uncontrolled muscle spasms, or leg movements
• Attention alteration
• Migraine
• Epilepsy
• Weakness
• Lack of coordination of movement, slow body movements
• Feeling of tingling, pins and needles, or burning of the skin
• Episodes of unpredictable and sudden mobility and immobility
• Feeling of instability
• Decreased visual acuity, abnormal contraction or spasm of the eyelid
• Perceiving sounds that do not exist
• Abnormal heart rhythm, rapid or slow heart rate, increased or decreased blood pressure, dizziness
• Yawning
• Dry mouth
• Diarrhea, abdominal discomfort or pain, constipation, heartburn, abdominal discomfort or pain, gastritis, excessive stomach acid
• Pruritus, skin disease where the nose and cheeks are unusually red, excessive sweating
• Joint pain, back pain, muscle stiffness, muscle weakness, muscle and bone pain, pain in the fingers of the hands and feet
• Abnormal urination
• Irregular uterine bleeding
• Extreme weakness or fatigue, chest pain, discomfort, edema
• Weight gain, weight loss, abnormal electrocardiogram (ECG), abnormal blood values related to liver function.

Rare side effects(may affect up to 1 in 1000 people):

• Loss of appetite, increased appetite
• Abnormal behavior, state of confusion, depressive state, excitability, feeling of emotional and mental unease, feeling of seeing or hearing things that are not real during sleep
• Loss of consciousness, tension headache, memory disorder, poor quality sleep
• Abdominal discomfort, difficulty or pain swallowing, flatulence, inflammation of the digestive tract
• Skin infection, abnormally high sensitivity to sunlight
• Neck pain and chest pain
• Spontaneous abortion
• Pain, nocturnal sweating, feeling of oppression
• Elevated levels of creatine phosphokinase in the blood, abnormal physical condition, alteration of the heart's electrical activity (ECG)

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Wakix

The active ingredient is pitolisant.

Wakix 4.5mg tablets

Each tablet contains pitolisant hydrochloride equivalent to 4.45mg of pitolisant.

Wakix 18mg tablets

Each tablet contains pitolisant hydrochloride equivalent to 17.8mg of pitolisant.

The other components are microcrystalline cellulose, crospovidone type A, talc, magnesium stearate, anhydrous colloidal silica, polyvinyl alcohol, titanium dioxide (E 171), and macrogol 3350.

Appearance of the product and contents of the package

Wakix 4.5mg is presented in film-coated tablets, white, round, biconvex, 3.7mm in diameter, and marked with “5” on one side.

Wakix 18mg is presented in film-coated tablets, white, round, biconvex, 7.5mm in diameter, and marked with “20” on one side.

Wakix is marketed in a bottle of 30 or 90 tablets.

Wakix 4.5 mg:Available in packaging with1bottle of 30 tablets.

Wakix 18 mg:Available in packaging with 1 bottle of 30 tablets or packaging with 1 bottle of 90 tablets or multiple packaging of 90 (3 bottles of 30) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Bioprojet Pharma

9, rue Rameau

75002 Paris

France

Responsible for manufacturing

Wakix 18 mg

Inpharmasci

ZI N°2 de Prouvy-Rouvignies

1 rue Nungesser

59121 Prouvy

France

Wakix 4.5 mg

Patheon

40 Boulevard de Champaret

38300 Bourgoin-Jallieu

France

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:

http://www.ema.europa.eu.

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.