4.5 mg and 18 mg film-coated tablets
pitolisant respectively
What Wakix is and what it is used for
Wakix contains the active substance pitolisant. It is a drug used to treat adult patients with narcolepsy, with or without cataplexy.
Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks). Cataplexy is a sudden muscle weakness or paralysis without loss of consciousness in response to a sudden emotional reaction, e.g. anger, fear, joy, laughter, or surprise.
The active substance, pitolisant, attacks the receptors on the cells in the brain that stimulate wakefulness. This helps combat daytime sleepiness and cataplexy and promotes alertness.
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, pitolisant is normally broken down in the liver and high levels may accumulate in patients whose liver function is severely impaired.
- If you are breastfeeding.
Warnings and precautions
Talk to your doctor before taking Wakix if any of the situations below apply to you:
- You have ever had anxiety or depression with suicidal thoughts?
- You have liver or kidney problems, and your dose may need to be adjusted.
- You have a stomach ulcer or are taking medicines that can irritate the stomach, e.g. medicines against inflammation, as side effects in the gastrointestinal tract have been reported with Wakix.
- You suffer from obesity or anorexia, as your body weight may change (increase or decrease) when taking Wakix.
- You have heart problems. Your doctor must check this regularly while you are taking Wakix.
- You have severe epilepsy.
Talk to your doctor or pharmacist before taking Wakix if any of these apply to you.
Other things to talk to your doctor or pharmacist about:
Some people with mental illnesses have been reported to have 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 ask a family member or close friend to help you spot signs of depression or other changes in your behavior.
Children and young people
Wakix should not be taken by children and adolescents.
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 how Wakix works. The doctor may need to adjust your dose.
In particular, you should be careful if you take Wakix together with certain antidepressants (eg imipramine, clomipramine, and mirtazapine) and certain medicines for the treatment of allergic conditions ( antihistamines, eg pheniramine maleate, chlorpheniramine, diphenhydramine, 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 (anti-depressant), St. John ‘s wort ( Hypericum perforatum ) a natural remedy for mild depression and mild anxiety, bupropion (an anti-depressant or smoking cessation agent), cinacalcet (used to treat parathyroid disorders), terbinafine (used to treat fungal infections ),metformin , repaglinide (used to treat diabetes ), docetaxel, irinotecan (used to treat cancer), cisapride (used to treat acid reflux), pimozide (used to treat certain mental illnesses), halofantrine (used to treat malaria ) , efavirenz (antiviral medicine to treat HIV ), morphine, paracetamol (used to treat pain), dabigatran (used to treat problems with the veins), warfarin (used to treat heart disease), probenecid (used to treat gout and gouty arthritis ). Pitolisant can be used with modafinil and sodium oxybate.
Wakix can reduce the effectiveness of hormonal contraceptives and therefore an alternative effective contraceptive must be used (see section “Pregnancy”).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 prescribed by the doctor. There is not enough information to determine whether there are any particular risks associated with the use of Wakix during pregnancy. If you are a woman, you must use contraception during your treatment with Wakix and for at least another 21 days after treatment. As Wakix can reduce the effectiveness of hormonal contraceptives, an alternative effective contraceptive must be used.
Breast-feeding
Wakix is excreted in the breast milk of animals. Patients taking Wakix must stop breastfeeding.
Driving ability and use of machinery
You should be careful with activities that require attention, e.g. driving vehicles and using machines. Talk to your doctor if you are not sure whether your condition hurts your ability to drive.
How to take Wakix
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Treatment normally starts with a dose of 9 mg once a day and is gradually increased over three weeks to a suitable dose. Your doctor may increase or decrease your dose at any time depending on how well the medicine works for you and how well you tolerate it.
It may take a few days before you notice any effect of the medicine, and the greatest effect usually appears after a few weeks.
Do not change the dose of Wakix on your own. Any change in dosage must be prescribed and supervised by a physician.
For a 4.5 mg dose, take one 4.5 mg tablet.
For a 9 mg dose, take two 4.5 mg tablets.
For an 18 mg dose, take one 18 mg tablet.
For a 36 mg dose, take two 18 mg tablets.
Take Wakix once a day by mouth, in the morning with breakfast.
Do not take a dose of Wakix in the afternoon, as it may make it difficult to sleep.
If you have taken too much Wakix
If you have taken too many Wakix tablets, immediately contact the emergency department of the nearest hospital or tell your doctor or pharmacist. You may get a headache, abdominal pain, and feel nauseous, 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 a missed dose.
If you stop taking Wakix
You should continue to take Wakix as long as your doctor has instructed. Do not suddenly stop taking Wakix on your own.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
This medicine can cause side effectslike all medicines, although not everybody gets them. Contact a doctor if you experience any side effects.
Common side effects ( may affect up to 1 in 10 users):
- Difficulty sleeping, anxiety, irritation, depression, sleep problems
- Headache, a feeling of “spinning” (dizziness), poor balance, tremors
- Nausea, vomiting, digestive problems
- Fatigue (exhaustion)
Uncommon side effects ( may affect up to 1 in 100 users):
- Sweating
- Decreased or increased appetite
- Edema
- Jerking, nervousness, seeing or hearing things that aren’t there
- Alternating emotional states
- Abnormal dreams
- Voltage
- Difficulty falling asleep at the beginning of the night or in the middle of the night or towards the end of the night, difficulty staying asleep, extensive sleepiness, morbid fatigue ( somnolence )
- State of indifference with a lack of emotions
- Nightmares
- Restlessness and inability to stay still
- Panic reaction
- Suicidal thoughts
- Changed or increased interest in sex
- Sudden and transient episodes of muscle weakness, uncontrollable muscle twitching or movement in one leg
- Attention deficit disorder
- Migraine
- Epilepsy
- Weakness
- Movement disorder, slow body movements
- A sensation of tingling, tickling, stinging, or burning in the skin
- Sudden and unpredictable phases of mobility and immobility
- A feeling of being unsteady
- Decreased visual acuity, abnormal contractions, or twitching of the eyelids
- Hearing sounds when there are no external sounds
- Abnormal heartbeats, slow or fast heart rate, increased or decreased blood pressure, hot flashes
- Yawns
- Dry mouth
- Diarrhea, abdominal pain, discomfort or pain in the stomach (abdomen), constipation, heartburn, stomach pain and discomfort, inflammation of the lining of the stomach ( gastritis ), high acidity in the gastrointestinal tract
- Itching, a facial skin condition where the nose and cheeks are unusually red, profuse sweating
- Joint pain, back pain, muscle stiffness, muscle weakness, pain in muscles and bones, pain in toes and fingers
- Abnormal urination
- Irregular bleeding from the uterus
- Loss of strength or extreme tiredness, chest pain, malaise, edema
- Weight gain, weight loss, abnormal ECG values for the heart, abnormal blood values related to liver function.
Rare side effects ( may affect up to 1 in 1,000 users):
- Decreased appetite, increased appetite
- Abnormal behavior, confusion, low mood, irritability, emotional and mental discomfort, a feeling of seeing or hearing things that are not there while sleeping
- Unconsciousness, tension headaches, memory problems, poor sleep quality
- Abdominal discomfort, difficulty swallowing or pain when swallowing, flatulence, inflammation of the digestive system
- Skin infection, abnormally high sensitivity to sunlight
- Neck pain, chest pain
- Spontaneous abortion
- Pain, night sweats, heaviness
- High blood levels of the enzyme creatinine phosphokinase, abnormal general condition, altered electrical recording of the heart ( ECG )
How to store Wakix
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is pitolisant.
Wakix 4.5 mg tablet
Each tablet contains pitolisant hydrochloride, equivalent to 4.45 mg pitolisant
Wakix 18 mg tablet
Each tablet contains pitolisant hydrochloride, equivalent to 17.8 mg pitolisant
Other ingredients are microcrystalline cellulose, crospovidone (type A), talc, magnesium stearate, colloidal anhydrous silica, poly(vinyl alcohol), titanium dioxide
Appearance and package sizes of the medicine
Wakix 4.5 mg is a white, round, coated tablet of 3.7 mm, biconvex, and marked with “5” on one side.
Wakix 18 mg is a white, round, coated tablet of 7.5 mm, biconvex, and marked with “20” on one side.
Wakix is supplied in a jar of 30 or 90 tablets.
Wakix 4.5 mg: Available in packs of 1 jar of 30 tablets.
Wakix 18 mg: Available in packs of 1 jar of 30 tablets or packs of 1 jar of 90 tablets, or multipacks of 90 (3 jars of 30) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bio project Pharma
9, rue Rameau
75002 Paris
France
Manufacturer
Wakix 18 mg
Pharmacy
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
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienBioproject Benelux0032(0)78050202info@bioprojet.be | LithuaniaAOP Orphan Pharmaceuticals GmbH00370 672 12222office@aoporphan.com |
| BulgariaAOP Orphan Pharmaceuticals GmbH00359 88 6666096office@aoporphan.com | Luxembourg/Luxemburg Bioproject Benelux0032(0)78050202info@bioprojet.be |
| Czech RepublicAOP Orphan Pharmaceuticals GmbH00420 251 512 947office@aoporphan.com | MagyarországAOP Orphan Pharmaceuticals GmbH0036 1 3192633office@aoporphan.com |
| DenmarkAOP Orphan Pharmaceuticals GmbH0046 70578 61 00office@aoporphan.com | MaltaBioproject Pharma0033 (0)1 47 03 66 33contact@bioprojet.com |
| DeutschlandBioprojet Deutschland GmbH030/3465 5460-0info@bioprojet.de | The NetherlandsBioprojet Benelux NV088 34 34 100info@bioprojet.nl |
| EstoniaAOP Orphan Pharmaceuticals GmbH00370 672 12222office@aoporphan.com | NorwayAOP Orphan Pharmaceuticals GmbH0046 70578 61 00office@aoporphan.com |
| GreeceBioproject Pharma0033 (0)1 47 03 66 33contact@bioprojet.com | AustriaAOP Orphan Pharmaceuticals GmbH0043 1 503 72 44office@aoporphan.com |
| SpainBioproject Pharma0033 (0)1 47 03 66 33contact@bioprojet.com | PolishAOP Orphan Pharmaceuticals GmbH0048 22 542 81 80office@aoporphan.com |
| FranceBioproject Pharma0033 (0)1 47 03 66 33contact@bioprojet.com | PortugalBioproject Pharma0033 (0)1 47 03 66 33contact@bioprojet.com |
| HrvatskaAOP Orphan Pharmaceuticals GmbH0043 1 503 72 44office@aoporphan.com | RomaniaAOP Orphan Pharmaceuticals GmbH00407 303 522 42office@aoporphan.com |
| IrelandLincoln Medical Ltd.0330 1003684info@lincolnmedical.co.uk | SlovenijaAOP Orphan Pharmaceuticals GmbH0043 1 503 72 44office@aoporphan.com |
| IcelandBioproject Pharma0033 (0)1 47 03 66 33contact@bioprojet.com | Slovenian RepublicAOP Orphan Pharmaceuticals GmbH00421 902 566 333office@aoporphan.com |
| ItalyBioprojet Italia srl+39 02 84254830info@bioprojet.it | Finland/FinlandAOP Orphan Pharmaceuticals GmbH0046 70578 61 00office@aoporphan.com |
| CyprusBioproject Pharma0033 (0)1 47 03 66 33contact@bioprojet.com | SwedenAOP Orphan Pharmaceuticals GmbH0046 70578 61 00office@aoporphan.com |
| LatviaAOP Orphan Pharmaceuticals GmbH00370 672 12222office@aoporphan.com | United KingdomLincoln Medical Ltd.0330 1003684info@lincolnmedical.co.uk |