WAKIX 18 mg FILM-COATED TABLETS

Introduction

Package Leaflet: 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 allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Wakix and what is it used for
2. What you need to know before you take Wakix
3. How to take Wakix
4. Possible side effects
5. Storing Wakix
6. Contents of the pack and other information

1. What is Wakix and what is it used for

Wakix contains the active substance pitolisant. It is a medicine used to treat adult, adolescent, and child patients older than 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 starts 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 substance, pitolisant, binds to receptors in brain cells that are involved in stimulating the state of alertness. This helps to combat daytime sleepiness and cataplexy, and to promote the state of wakefulness.

2. What you need to know before you take Wakix

Do not take Wakix:

• If you are allergic to pitolisant or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver problems, as pitolisant is usually broken down in the liver and may build up to excessive levels in patients with severely impaired liver function.
• If you are breast-feeding (lactation period).

Warnings and precautions

Talk to your doctor before taking Wakix if you are in any of the following situations:

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

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

Other aspects you should discuss with your doctor or pharmacist:

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

Children

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

Using Wakix with other medicines

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

In particular, be cautious if you take Wakix with certain antidepressants (such as imipramine, clomipramine, and mirtazapine) and certain medicines for treating allergic diseases (antihistamines such as maleate of feniramine, chlorpheniramine, diphenhydramine, promethazine, mepiramine, and doxylamine).

Talk to your doctor or pharmacist if you are taking any of the following medicines: rifampicin (antibiotic), phenytoin, carbamazepine, and phenobarbital (mainly used to control convulsions), quinidine, digoxin (used to treat arrhythmia), paroxetine, fluoxetine, venlafaxine, duloxetine (antidepressants), St. John's Wort (Hypericum perforatum) a herbal medicine for depression, bupropion (antidepressant or aid to stop 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 esophageal reflux), pimozide (used to treat certain mental disorders), halofantrine (used to treat malaria), efavirenz (antiviral for treating HIV), morphine, paracetamol (used as pain relief), 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 you should use another safe contraceptive method (see section "Pregnancy").

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breast-feeding

In animals, Wakix passes into breast milk. Patients taking Wakix must stop breast-feeding.

Driving and using machines

Be cautious when performing activities that require attention, such as driving cars and using machines. If you are not sure if your condition has a negative effect on your ability to drive, talk to your doctor.

3. How to take Wakix

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

Adults

Treatment usually starts 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, your doctor may increase or decrease the dose based on the patient's response and tolerance to the medicine.

It may take several days before the benefits of the medicine are noticed, and the maximum benefit is usually seen after several weeks of treatment.

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

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

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

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

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

Adolescents and children over 6 years of age

Treatment usually starts 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 by mouth, 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 emergency department of the nearest hospital or talk to your doctor or pharmacist immediately. You may experience headache, stomach pain, nausea, or irritability. You may also have difficulty sleeping. Bring this leaflet and the remaining tablets with you.

If you forget to take Wakix

If you forget to take the medicine, take the next dose at the usual time, do not take a double dose to make up for the forgotten dose.

If you stop taking Wakix

You should keep 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, talk to your doctor.

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

• Difficulty sleeping, feeling anxious, feeling irritable, feeling depressed, sleep problems
• Headaches, feeling dizzy (vertigo), loss of balance, tremors
• Nausea, vomiting, indigestion
• Fatigue (tiredness)

Uncommon 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
• State of indifference with lack of emotion
• Nightmares
• Feeling restless and unable to stay still
• Panic attack
• Suicidal thoughts
• Altered or increased sexual interest
• Sudden and transient episode of muscle weakness, uncontrolled muscle spasms, or movements of a leg
• Attention disorder
• Migraine
• Epilepsy
• Weakness
• Lack of coordination, slow body movements
• Feeling of tingling, prickling, or burning of the skin
• Sudden and unpredictable phases of mobility and immobility
• Feeling of instability
• Reduced visual acuity, contraction or abnormal spasm of the eyelid
• Hearing sounds that do not exist
• Abnormal heartbeat, rapid or slow heart rate, increased or decreased blood pressure, flushing
• Yawning
• Dry mouth
• Diarrhea, abdominal discomfort or pain, constipation, heartburn, stomach discomfort or pain, gastritis, excess acidity of the digestive tract
• Itching, skin disease where the nose and cheeks are unusually reddened, excessive sweating
• Joint pain, lower back pain, muscle stiffness, muscle weakness, muscle and bone pain, pain in the fingers and toes
• Abnormal urination
• Irregular uterine bleeding
• Loss of strength or extreme 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, confusion, depressive state, excitability, feeling of emotional and mental unease, 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 when swallowing, flatulence, inflammation of the digestive tract
• Skin infection, abnormally high sensitivity to sunlight
• Neck pain and chest pain
• Spontaneous abortion
• Pain, night sweats, feeling of oppression
• Elevated level in the blood of the enzyme creatine phosphokinase, general abnormal physical condition, alteration of the heart's electrical recording (ECG)

Reporting of side effects

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Wakix

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Wakix Composition

The active ingredient is pitolisant.

Wakix 4.5 mg tablets

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

Wakix 18 mg tablets

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

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

Product Appearance and Package Contents

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

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

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

Wakix 4.5 mg: Available in packs of 1 bottle of 30 tablets.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Bioprojet Pharma

9, rue Rameau

75002 Paris

France

Manufacturer

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website:

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

On the European Medicines Agency website, this leaflet can be found in all languages of the European Union/European Economic Area.