pitolisant: package leaflet

Ozawade is a medicine that contains the active substance pitolisant.

Ozawade is used in adults with obstructive sleep apnoea to treat excessive daytime sleepiness. It is used when sleepiness occurs despite treatment with continuous positive airway pressure (CPAP) or in patients who have not tolerated CPAP.

Obstructive sleep apnoea (OSA) is a condition that causes you to stop breathing for at least 10 seconds during sleep. This can lead to excessive daytime sleepiness and a tendency to suddenly fall asleep in inappropriate situations (sleep attacks).

The active substance, pitolisant, works on receptors (targets) on cells in the brain that are involved in stimulating alertness. This effect helps to reduce daytime sleepiness and tiredness.

Do not take Ozawade if you

• Are allergic to pitolisant or any of the other ingredients of this medicine (listed in section 6).
• Have severe liver problems, as pitolisant is normally broken down in the liver and high levels may build up in patients whose liver function is severely reduced.
• Are breastfeeding.

Warnings and precautions

Talk to your doctor before taking Ozawade if any of the following apply to you:
- You have ever had anxiety or depression with suicidal thoughts.
- You have liver or kidney problems, as your dose may need to be adjusted.
- You have a gastric ulcer or you take medicines that can irritate your stomach such as medicines to reduce inflammation, since gastric reactions can occur with Ozawade.

• You are very overweight or underweight, as your weight may increase or decrease while you are taking Ozawade.
• You have heart problems. Your doctor will need to check this regularly while you are taking Ozawade.
• You have severe epilepsy.

If any of these apply to you, talk to your doctor or pharmacist before taking Ozawade.

Ozawade does not replace your OSA primary treatment such as CPAP. You should continue to use such treatment as well as Ozawade.

Children and adolescents

Ozawade should not be taken by children or adolescents.

Other medicines and Ozawade

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

Tell your doctor or pharmacist if you are taking any of the following medicines:
- antidepressant medicines such as clomipramine, duloxetine, fluoxetine, imipramine, mirtazapine, paroxetine and venlafaxine
- bupropion, used either as an antidepressant or an aid to help stop smoking
- medicines for treating allergies called antihistamines such as pheniramine maleate, chlorpheniramine, diphenhydramine, promethazine, mepyramine, doxylamine
- rifampicin, an antibiotic used for treating tuberculosis and some other infections
- epilepsy medicines (to prevent fits) such as carbamazepine, phenobarbital and phenytoin
- heart medicines such as digoxin and quinidine
- St John’s Wort (Hypericum perforatum), a herbal remedy for depression
- cinacalcet used for treating disorders of the parathyroid gland
- terbinafine, used for treating fungal infections
- diabetes medicines such as metformin and repaglinide
- medicines for treating cancer such as docetaxel and irinotecan
- cisapride, used for treating gastric reflux
- pimozide, used for treating some mental disorders
- halofantrine, used for treating malaria
- efavirenz, an antiviral medicine to treat HIV infection
- morphine, used for treating severe pain
- paracetamol, used for treating pain
- anticoagulant medicines (medicines that prevent blood clots) such as dabigatran and warfarin
- probenecid, used for treating gout
- medicines for treating pain, inflammation and fever such as acetylsalicylic acid (aspirin), diclofenac, ibuprofen, meloxicam and naproxen
- hormonal contraceptive (birth control medicine), see also under ‘Pregnancy’, below.

Pregnancy and breast-feeding

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

Pregnancy

You should not take Ozawade during pregnancy unless you and your doctor decide that you need to take it. There is not enough information on the risk of taking Ozawade during pregnancy. If you are a

woman, you have to use effective birth control during your treatment with Ozawade and for at least 21 days after stopping treatment. As Ozawade may reduce the effectiveness of a hormonal contraceptive (birth control medicine), an alternative method of effective contraception has to be used.

Breast-feeding

You must stop breastfeeding when you start taking Ozawade. Ozawade passes into milk in animals.

Driving and using machines

You may feel sleepy or your ability to concentrate may be impaired. Take care with activities that require attention such as driving a car and handling machinery. Talk to your doctor or your pharmacist if you are unsure about how your condition affects your ability to drive.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Treatment is normally started with a dose of 4.5 mg once per day, and gradually increased over three weeks to the most appropriate dose. At any time, your doctor can increase or decrease your dose depending on how well the medicine works for you and how well you tolerate it. The maximum daily dose is 36 mg.

It might take a few days before you feel the medicine starting to work and you may usually feel the maximum benefit after a few weeks.

Do not change the Ozawade dose on your own. Any change in dosage must be prescribed and monitored 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.

Take Ozawade once a day by mouth, in the morning with your breakfast.
Do not take a dose of Ozawade in the afternoon since you may have difficulty sleeping.

If you take more Ozawade than you should

If you take too many tablets of Ozawade, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. You may experience headaches, stomach pain or feel sick or irritable. You may also have difficulty sleeping. Take this leaflet and any remaining tablets with you.

If you forget to take Ozawade

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

If you stop taking Ozawade

You should continue to take Ozawade for as long as instructed by your doctor. Do not stop taking Ozawade suddenly on your own.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):
- Headache
- Difficulty sleeping, sleeping problems, feeling anxious
- Feeling of “spinning” (vertigo)
- Feeling sick, abdominal (belly) discomfort

Uncommon side effects (may affect up to 1 in 100 people):
- Viral upper respiratory tract infection (common cold), cold sores
- Change in bleeding analyses, abnormal blood values related to the function of the liver, raised blood pressure, increase of cholesterol level in the blood
- Alcohol intolerance, increased appetite, low blood sugar level, body weight change
- Irritability, confusional state, fear, panic reaction, altered or increased sexual interest, feeling depressed, feeling nervous
- Loss of balance, trouble of sleep rhythm, impairment of the taste, sudden and unpredictable phases of mobility and immobility, migraine, sleep paralysis, loss of the ability to perform physical activities
- Swelling of eyelid, dry eye, presence of flashes of light or floaters in the vision
- Ringing or buzzing in the ear
- Irregular heart rhythm, palpitation, fast heart rate, abnormal heart rate
- Hot flush, high blood pressure, sudden rise in blood pressure
- Yawning, cough, difficulty to breath at night
- Diarrhoea, constipation, dry mouth, disorders of the digestive tract, inflammation of the digestive tract, discoloration of the faeces, odour of the breath, flatulence, rectal bleeding, high secretion of saliva
- Skin eruption, itching of the face, redness of the skin, cold sweats, excessive sweating, sweating at night, abnormal high sensitivity of the skin to sunlight
- Discomfort of arms and legs, spasms of muscles, pain of the muscles, joint pain, pain of the tendons
- Frequent urination
- Pain and discomfort, tiredness (fatigue), feeling hot, feeling thirsty, oedema of legs or hands

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ozawade contains

The active substance is pitolisant.

Ozawade 4.5 mg tablet
Each tablet contains pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant.

Ozawade 18 mg tablet
Each tablet contains pitolisant hydrochloride, equivalent to 17.8 mg of pitolisant.

The other ingredients are microcrystalline cellulose, crospovidone, talc, magnesium stearate, colloidal anhydrous silica, poly(vinyl alcohol), titanium dioxide, macrogol 3350.

What Ozawade looks like and contents of the pack

Ozawade 4.5 mg comes in a white, round, film-coated tablet of 3.7 mm, biconvex marked with “5” on one side.
Ozawade 18 mg comes in a white, round, film-coated tablet of 7.5 mm, biconvex marked with “20” on one side.

Ozawade is available in a bottle (30 tablets or 90 tablets) or in blisters (28 tablets, 30 or 90 tablets).
Ozawade 4.5 mg – Available in:
- packs containing 1 bottle of 30 tablets
- packs containing 1 bottle of 90 tablets
- packs containing blisters of 28 tablets (2 blisters of 14 tablets)
- packs containing blisters of 30 tablets (2 blisters of 15 tablets).
Ozawade 18 mg – Available in:
- packs containing 1 bottle of 30 tablets
- packs containing 1 bottle of 90 tablets
- packs containing blisters of 28 tablets (2 blisters of 14 tablets)
- packs containing blisters of 30 tablets (2 blisters of 15 tablets)
- packs containing blisters of 90 tablets (6 blisters of 15 tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bioprojet Pharma
115, rue d’Aboukir
75002 Paris
France

Manufacturer

Bottle:

Ozawade 18 mg
Athena IPS
ZI N°2 de Prouvy-Rouvignies
1 rue Nungesser
59121 Prouvy
France

Ozawade 4.5 mg
Patheon France

40 Boulevard de Champaret
38300 Bourgoin-Jallieu
France

Blisters:

Patheon France
40 Boulevard de Champaret
38300 Bourgoin-Jallieu
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Bioprojet Benelux
0032(0)78050202 info@bioprojet.be
Lietuva
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

България
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Luxembourg/Luxemburg
Bioprojet Benelux
0032(0)78050202 info@bioprojet.be

Česká republika
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Magyarország
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Danmark
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800 contact@zambongroup.com

Malta
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Deutschland
Bioprojet Deutschland GmbH
030/3465 5460-0 info@bioprojet.de

Nederland
Bioprojet Benelux N.V.
088 34 34 100 info@bioprojet.nl
Eesti
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Norge
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800 contact@zambongroup.com

Ελλάδα
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Österreich
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

España
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Polska
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

France
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Portugal
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Hrvatska
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Ireland
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
România
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Slovenija
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Ísland
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Slovenská republika
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Italia
Bioprojet Italia srl
+39 02 84254830 info@bioprojet.it
Suomi/Finland
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Κύπρος
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Sverige
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800 contact@zambongroup.com

Latvija
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

This leaflet is available in all EU/EAA languages on the European Medicines Agency website.

Wakix contains the active ingredient pitolisant. It is a medicine used to treat adults, adolescents and children over the age of 6 years with narcolepsy, with or without cataplexy.

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

The active substance, pitolisant, attaches to receptors on cells in the brain that are involved in stimulating alertness. This helps to combat daytime sleepiness and cataplexy and promote wakefulness.

Do not take Wakix if you

• Are allergic to pitolisant or any of the other ingredients of this medicine (listed in section 6).
• Have severe liver problems, as pitolisant is normally broken down in the liver and excess levels may build up in patients whose liver function is severely reduced.
• Are breastfeeding.

Warnings and precautions

Talk to your doctor before taking Wakix if any of the situations mentioned below apply to you:

• You ever had anxiety or depression with suicidal thoughts.
• You have liver or kidney problems, as your dose may need to be adjusted.
• You have a gastric ulcer or you take medicines that can irritate your stomach such as medicines against inflammations, since gastric reactions have been reported with Wakix.
• You are obese or anorexic, as you may have change of your body weight (increase or decrease) while taking Wakix.
• You have heart problems. Your doctor will need to check this regularly while you are taking Wakix.
• You have severe epilepsy.

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

Other things to talk to your doctor or pharmacist about:

Some people with history of psychiatric disorders have reported having suicidal thoughts while taking this medicine. Tell your doctor straight away if you notice that you are becoming depressed or have suicidal thoughts (see section 4). You may want to consider asking a family member or close friend to help you look out for signs of depression or other changes in your behaviour.

Children

Wakix should not be taken by children less than 6 years old.

Other medicines and Wakix

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

In particular, you should be cautious if you take Wakix together with some antidepressants (e.g.
imipramine, clomipramine and mirtazapine) and some medicines to treat allergic conditions (anti- histamines, e.g. pheniramine maleate, chlorpheniramine, diphenydramine, promethazine, mepyramine, doxylamine).

Tell your doctor or pharmacist if you are taking any of the following medicines: rifampicin (an antibiotic), phenytoin, carbamazepine and phenobarbital (mainly used to control seizures), quinidine, digoxin (used to treat abnormal heart rhythms), paroxetine, fluoxetine, venlafaxine, duloxetine (antidepressants), St John’s Wort (Hypericum perforatum) a herbal remedy for depression, bupropion (antidepressant or aid to smoking cessation), cinacalcet (for treatment of disorders of the parathyroid gland), terbinafine (used to treat fungal infections), metformin, repaglinide (used to treat diabete), docetaxel, irinotecan (used to treat cancer), cisapride (used to treat gastric reflux), pimozide (used to treat some mental disorders), halofantrine (to treat malaria), efavirenz (antiviral medicine to treat HIV), morphine, paracetamol (used to treat pain), dabigatran (used to treat problems of the veins), warfarin (used to treat heart diseases), probenecid (used to treat gout and gouty arthritis).Pitolisant can be used with modafinil or sodium oxybate.

Wakix may reduce the effectiveness of hormonal contraceptives, an alternative method of effective contraception has to be used (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 says so. There is not enough information available to know whether any particular risk is associated with the use of Wakix during pregnancy. If you are a woman, you have to take a contraceptive during your treatment with Wakix and at least up to 21 days after treatment discontinuation. As Wakix may reduce the effectiveness of hormonal contraceptive, an alternative method of effective contraception has to be used.

Breast-feeding

Wakix passes into breast milk in animal. Patients taking Wakix must stop breastfeeding.

Driving and using machines

You should be cautious with activities that require attention such as driving a car and handling machinery. If you are unsure whether your condition has a negative effect on your ability to drive, talk to your doctor.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults
Treatment is normally started with a dose of 9 mg once per day, and gradually increased over three weeks to the most appropriate dose. At any time, your doctor can increase or decrease your dose depending on how well the medicine works for you and how well you tolerate it.

It might take a few days before you feel the benefit of the medicine and the maximum benefit is usually felt after a few weeks.
Do not change doses of Wakix on your own. Any change in dosage must be prescribed and monitored 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 the age of 6
Treatment is normally started with a dose of 4.5 mg once per day, and gradually increased over three to four weeks to the most appropriate dose (see above).
If your weight is less than 40 kg, you should not take more than 18 mg per day.

Take Wakix once a day by mouth, in the morning with your breakfast.
Do not take a dose of Wakix in the afternoon since you may have difficulty sleeping.

If you take more Wakix than you should

If you take too many tablets of Wakix, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. You may experience headaches, stomach pain, feeling sick or irritable. You may also have difficulty sleeping. Take this leaflet and any remaining tablets with you.

If you forget to take Wakix

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

If you stop taking Wakix

You should continue to take Wakix for as long as instructed by your doctor. Do not stop taking Wakix suddenly on your own.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Common side effects (may affect up to 1 in 10 people):
- Difficulty in sleeping, feeling anxious, feeling irritable, feeling depressed, sleeping problems
- Headaches, feeling of “spinning” (vertigo), loss of balance, trembling
- Feeling sick, vomiting, indigestion
- Tiredness (fatigue)

Uncommon side effects (may affect up to 1 in 100 people):
- Sweating
- Decrease or increase of appetite
- Oedema
- Feeling jittery, nervousness, seeing or hearing things that are not really there
- Changing emotions
- Abnormal dreams
- Tension
- Difficulty in falling asleep at the beginning of the night or in the middle of the night or at the end of the night, difficulty in staying asleep, excessive sleepiness, somnolence
- State of indifference with lack of emotion
- Nightmare
- Feeling restless and unable to keep still
- Panic reaction
- Suicidal thoughts
- Altered or increased sexual interest
- Sudden and transient episode of muscle weakness, uncontrollable muscle spasms or movement of one leg
- Disturbance in attention
- Migraine
- Epilepsy
- Weakness
- Movement disturbance, slow body movement
- Sensation of tingling, tickling, pricking, or burning of the skin
- Sudden and unpredictable phases of mobility and immobility
- Feeling unsteady
- Reduced visual acuity, abnormal contraction or twitch of the eyelid
- Hearing of sound when no external sound is present
- Abnormal heart beat, slow or fast heart rate, raised or decrease blood pressure, hot flush
- Yawning
- Dry mouth
- Diarrhoea, abdominal pain, discomfort or pain in the belly (abdomen), constipation, heartburn, stomach pain and discomfort, gastritis, excessive acidity of the gastrointestinal tract
- Itching, skin condition of the face where the nose and cheeks are unusually red, excessive sweating
- Joint pain, back pain, muscle rigidity, muscle weakness, pain of the muscle and the bones, pain in the toes and in the fingers
- Abnormal urination
- Irregular uterine bleeding

• Loss of strength or extreme tiredness, chest pain, malaise, oedema
• Weight increase, weight decrease, abnormal reading (ECG) of the heart, abnormal blood values related to the function of the liver.

Rare side effects (may affect up to 1 in 1000 people):
- Loss of appetite, increased appetite
- Abnormal behaviour, confusional state, depressed mood, excitability, feelings of emotional and mental discomfort, feeling of seeing or hearing things that are not really there when you sleep
- Loss of consciousness, tension headache, trouble of the memory, poor sleep quality
- Abdominal discomfort, difficulty or pain in swallowing, flatulence, inflammation of the digestive tract
- Infection of the skin, abnormally high sensitivity to sunlight
- Neck pain, chest pain
- Spontaneous abortion
- Pain, night sweats, sense of oppression
- High blood level of the enzyme creatinine phosphokinase, abnormal general physical condition, modification of the electrical registration of the heart (ECG)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Wakix contains

The active substance is pitolisant.

Wakix 4.5 mg tablet
Each tablet contains pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant

Wakix 18 mg tablet
Each tablet contains pitolisant hydrochloride, equivalent to 17.8 mg of pitolisant.

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

What Wakix looks like and contents of the pack

Wakix 4.5 mg comes in a white, round, film-coated tablet of 3.7 mm, biconvex marked with “5” on one side.
Wakix 18 mg comes in a white, round, film-coated tablet of 7.5 mm, biconvex marked with “20” on one side.

Wakix is available in a bottle (30 tablets or 90 tablets) or in blisters (28 tablets, 30 or 90 tablets).
Wakix 4.5 mg is available in:
- packs containing 1 bottle of 30 tablets
- packs containing blisters of 28 tablets (2 blisters of 14 tablets)
- packs containing blisters of 30 tablets (2 blisters of 15 tablets).
Wakix 18 mg is available in:
- packs containing 1 bottle of 30 tablets
- packs containing 1 bottle of 90 tablets
- multi-packs containing 90 (3 bottles of 30) tablets
- packs containingblisters of 28 tablets (2 blisters of 14 tablets)
- packs containingblisters of 30 tablets (2 blisters of 15 tablets)
- packs containing blisters of 90 tablets (6 blisters of 15 tablets).
Not all pack sizes may be marketed.

Marketing Autorisation Holder

Bioprojet Pharma
115, rue d’Aboukir
75002 Paris
France

Manufacturer

Bottle:

Wakix 18 mg
Athena IPS
ZI N°2 de Prouvy-Rouvignies
1 rue Nungesser
59121 Prouvy
France

Wakix 4.5 mg
Patheon France
40 Boulevard de Champaret
38300 Bourgoin-Jallieu
France

Blister:

Patheon France
40 Boulevard de Champaret
38300 Bourgoin-Jallieu
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Bioprojet Benelux
Lietuva
UAB Norameda

0032(0)78050202 info@bioprojet.be
+370 5 2306499 info@norameda.com

България
GTS Solution
+40 21 528 02 92 info@gotosolution.com

Luxembourg/Luxemburg
Bioprojet Benelux
0032(0)78050202 info@bioprojet.be

Česká republika
BIOXA Therapeutics (Czech) s.r.o.
+420 606 501 778 info@bioxa.cz

Magyarország
UAB Norameda
+370 5 2306499 info@norameda.com
Danmark
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800 contact@zambongroup.com

Malta
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Deutschland
Bioprojet Deutschland GmbH
030/3465 5460-0 info@bioprojet.de

Nederland
Bioprojet Benelux N.V.
088 34 34 100 info@bioprojet.nl
Eesti
UAB Norameda Eesti filiaal
+372 514 2118 info@norameda.com

Norge
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800 contact@zambongroup.com

Ελλάδα
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Österreich
Bioprojet Deutschland GmbH
030/3465 5460-0 info@bioprojet.de

España
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Polska
Norameda Polska Sp. z o.o.
+48 504 278 778 info.pl@norameda.com

France
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Portugal
Ferrer Portugal, S.A
00351 214 449 600 geral-pt@ferrer.com

Hrvatska
Lenis farmacevtika d.o.o.
+386 1 23 50 700 info@lenis.si

Ireland
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

România
GTS Solution
+40 21 528 02 92 info@gotosolution.com

Slovenija
Lenis farmacevtika d.o.o.
+386 1 23 50 700 info@lenis.si

Ísland
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

Slovenská republika
BIOXA Therapeutics s.r.o.
+421 907 927 010 info@bioxa.sk

Italia
Bioprojet Italia srl
+39 02 84254830 info@bioprojet.it
Suomi/Finland
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800 contact@zambongroup.com

Κύπρος
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com
Sverige
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800 contact@zambongroup.com

Latvija
Norameda pārstāvniecība
+371 29272107 info@norameda.com
United Kingdom (Northern Ireland)
Bioprojet Pharma
0033 (0)1 47 03 66 33 contact@bioprojet.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.