Ozawade

Package leaflet: Information for the patient

Ozawade 4.5 mg film-coated tablets, 18 mg film-coated tablets

pitolisant
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Ozawade is and what it is used for

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 involving interruption of breathing for at least 10 seconds during sleep. This can lead to excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks).
The active substance, pitolisant, acts on receptors (targets) located on brain cells involved in promoting wakefulness. This effect helps reduce daytime sleepiness and fatigue.

2. What you should know before taking Ozawade

Do not take Ozawade

• if you are allergic to pitolisant or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver problems, as pitolisant is usually metabolized in the liver and excessive levels may accumulate in patients with severely impaired liver function;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor before taking Ozawade if any of the following apply to you:

• You have experienced 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 are taking medicines that may irritate the stomach, such as anti-inflammatory medicines, as gastric reactions related to Ozawade intake may occur.
• You are significantly overweight or underweight, as weight may increase or decrease during treatment with Ozawade.
• You have heart problems. Your doctor will carry out regular checks while you are taking Ozawade.
• You suffer from severe epilepsy.

If any of the above conditions apply to you, consult your doctor or pharmacist before taking Ozawade.
Ozawade does not replace primary treatment for OSA such as CPAP. You must continue to use this treatment alongside Ozawade.
Children and adolescents
Ozawade must not be taken by children or adolescents.
Other medicines and Ozawade
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ozawade may affect how other medicines work, and other medicines may affect how Ozawade works. Your doctor may need to adjust the dose.
Inform your doctor or pharmacist if you are taking any of the following medicines:

• antidepressants such as clomipramine, duloxetine, fluoxetine, imipramine, mirtazapine, paroxetine and venlafaxine;
• bupropion, used as an antidepressant or to help stop smoking;
• allergy medicines called antihistamines such as maleate pheniramine, chlorpheniramine, diphenhydramine, promethazine, mepyramine, doxylamine;
• rifampicin, an antibiotic used to treat tuberculosis and some other infections;
• medicines for epilepsy (to prevent seizures) 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 to treat parathyroid gland disorders;
• terbinafine, used to treat fungal infections;
• diabetes medicines such as metformin and repaglinide;
• anticancer medicines such as docetaxel and irinotecan;
• cisapride, used to treat gastric reflux;
• pimozide, used to treat certain mental disorders;
• halofantrine, used to treat malaria;
• efavirenz, an antiviral medicine used to treat HIV infection;
• morphine, used to treat severe pain;
• paracetamol, used to treat pain;
• anticoagulant medicines (medicines that prevent blood clots) such as dabigatran and warfarin;
• probenecid, used to treat gout;
• medicines for pain, inflammation and fever such as acetylsalicylic acid (aspirin), diclofenac, ibuprofen, meloxicam and naproxen;
• hormonal contraceptives (birth control medicines), see also section "Pregnancy".

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not take Ozawade during pregnancy unless you and your doctor decide it is necessary. There is insufficient information available on the risk associated with using Ozawade during pregnancy. If you are a woman, you must use an effective method of contraception during treatment with Ozawade and for at least 21 days after stopping treatment. Since Ozawade may reduce the effectiveness of hormonal contraceptives (birth control medicines), an adequate alternative method of contraception must be used.
Breastfeeding
You must stop breastfeeding when starting Ozawade. Ozawade passes into breast milk in animals.
Driving and using machines
You may feel sleepy or your concentration may be reduced. Caution is advised in activities requiring alertness, such as driving vehicles or operating machinery. Consult your doctor or pharmacist if you have any doubts about how your condition may affect your ability to drive.

3. How to take Ozawade

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Treatment is usually started at a dose of 4.5 mg once daily, gradually
increased over a period of three weeks to the most appropriate dose. At any
time, your doctor may increase or decrease the dose depending on how the medicine works for you and how well you tolerate it. The maximum daily dose is 36 mg.
It may take several days before the medicine starts to work, while the full
benefit is usually felt after a few weeks.
Do not change the dose of Ozawade on your own. Any dosage adjustment 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 daily by mouth in the morning with breakfast.
Do not take a dose of Ozawade in the afternoon, as this may cause difficulty sleeping.
If you take more Ozawade than you should
If you take too many Ozawade tablets, go to the nearest emergency room or contact your
doctor or pharmacist immediately. You may experience headache, stomach ache, a feeling
of discomfort or irritability. You may also have difficulty sleeping. Bring 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 your usual time. Do not take a
double dose to make up for the forgotten tablet.
If you stop taking Ozawade
You must continue taking Ozawade for as long as your doctor has instructed. Do not stop
taking Ozawade suddenly on your own.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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, sleep disorders, feeling of anxiety
• Dizziness
• Feeling unwell, abdominal discomfort

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

• Viral upper respiratory tract infection (common cold), cold sores (herpes labialis)
• Changes in blood coagulation tests, abnormal blood liver function test results, increased blood pressure, increased blood cholesterol levels
• Alcohol intolerance, increased appetite, low blood sugar levels, change in body weight
• Irritability, confusion, fear, panic reaction, altered or increased sexual desire, feeling depressed, feeling nervous
• Loss of balance, sleep rhythm disorders, altered taste, sudden and unpredictable episodes of mobility and immobility, headache, sleep paralysis, loss of ability to perform physical activities
• Swelling of the eyelid, dry eyes, perception of flashes of light or moving spots in the visual field
• Ringing or buzzing in the ear (tinnitus)
• Irregular heartbeat, palpitations, fast heartbeat, abnormal heartbeat
• Hot flushes, high arterial pressure, sudden increase in blood pressure
• Yawning, cough, difficulty breathing during the night
• Diarrhoea, constipation, dry mouth, digestive disturbances, inflammation of the digestive tract, change in stool colour, bad breath, flatulence, rectal bleeding, excessive salivation
• Skin rash, facial itching, skin redness, cold sweating, excessive sweating, night sweats, increased skin sensitivity to sunlight
• Discomfort in arms and legs, muscle spasms, muscle pain, joint pain, tendon pain
• Frequent urination
• Pain and discomfort, fatigue (tiredness), feeling of warmth, feeling thirsty, swelling of the legs or hands

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

5. How to store Ozawade

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ozawade contains
The active substance is pitolisant.
Ozawade 4.5 mg tablets
Each tablet contains pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant.
Ozawade 18 mg tablets
Each tablet contains pitolisant hydrochloride, equivalent to 17.8 mg of pitolisant.
The other ingredients are microcrystalline cellulose, crospovidone, talc, magnesium stearate, anhydrous colloidal silica, polyvinyl alcohol, titanium dioxide, macrogol 3350.

Description of the appearance of Ozawade and package contents
Ozawade 4.5 mg is available as white, round, biconvex film-coated tablets, 3.7 mm in diameter, marked with the number “5” on one side.
Ozawade 18 mg is available as white, round, biconvex film-coated tablets, 7.5 mm in diameter, marked with the number “20” on one side.
Ozawade is available in bottles containing 30 tablets or 90 tablets.
Ozawade 4.5 mg: available in packs containing 1 bottle of 30 tablets or 1 bottle of 90 tablets.
Ozawade 18 mg: available in packs containing 1 bottle of 30 tablets or 1 bottle of 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Bioprojet Pharma
9, rue Rameau
75002 Paris
France

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

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Bioprojet Benelux Bioprojet Pharma
0032(0)78050202 0033 (0)1 47 03 66 33
[email protected] [email protected]

България Luxembourg/Luxemburg
Bioprojet Pharma Bioprojet Benelux
0033 (0)1 47 03 66 33 0032(0)78050202
[email protected] [email protected]

Česká republika Magyarország
Bioprojet Pharma Bioprojet Pharma
0033 (0)1 47 03 66 33 0033 (0)1 47 03 66 33
[email protected] [email protected]

Danmark Malta
Zambon Sweden, filial of Zambon Nederland Bioprojet Pharma
B.V. 0033 (0)1 47 03 66 33
+46 (0)10 33 50 800 [email protected]

Deutschland Nederland
Bioprojet Deutschland GmbH Bioprojet Benelux N.V.
030/3465 5460-0 088 34 34 100
[email protected] [email protected]

Eesti Norge
Bioprojet Pharma Zambon Sweden, filial of Zambon Nederland
0033 (0)1 47 03 66 33 B.V.
[email protected] +46 (0)10 33 50 800
[email protected]

Ελλάδα Österreich
Bioprojet Pharma Bioprojet Pharma
0033 (0)1 47 03 66 33 0033 (0)1 47 03 66 33
[email protected] [email protected]

España Polska
Bioprojet Pharma Bioprojet Pharma
0033 (0)1 47 03 66 33 0033 (0)1 47 03 66 33
[email protected] [email protected]

France Portugal
Bioprojet Pharma Bioprojet Pharma
0033 (0)1 47 03 66 33 0033 (0)1 47 03 66 33
[email protected] [email protected]

Hrvatska România
Bioprojet Pharma Bioprojet Pharma
0033 (0)1 47 03 66 33 0033 (0)1 47 03 66 33
[email protected] [email protected]

Ireland Slovenija
Bioprojet Pharma Bioprojet Pharma
0033 (0)1 47 03 66 33 0033 (0)1 47 03 66 33
[email protected] [email protected]

Ísland Slovenská republika
Bioprojet Pharma Bioprojet Pharma
0033 (0)1 47 03 66 33 0033 (0)1 47 03 66 33
[email protected] [email protected]

Italia Suomi/Finland
Bioprojet Italia srl Bioprojet Pharma
+39 02 84254830 0033 (0)1 47 03 66 33
[email protected] [email protected]

Κύπρος Sverige
Bioprojet Pharma Zambon Sweden, filial of Zambon Nederland
0033 (0)1 47 03 66 33 B.V.
[email protected] +46 (0)10 33 50 800
[email protected]

Latvija
Bioprojet Pharma
0033 (0)1 47 03 66 33
[email protected]

Further sources of information
More detailed information on this medicinal product 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 European Medicines Agency website.