OZAWADE 4.5 MG Фильм-coated таблетки

Содержание инструкции

1. Ozawade 4.5 mg film-coated tablets, 18 mg film-coated tablets
   1. What is Ozawade and what is it 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

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

pitolisant

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Ozawade and what is it used for

Ozawade is a medicine that contains the active substance pitolisant.
Ozawade is used in adults with obstructive sleep apnea 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 apnea (OSA) is a condition that involves the 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) that are located on brain cells that
are involved in stimulating wakefulness. This effect helps to reduce daytime sleepiness and
fatigue.

2. What you need to know before taking Ozawade

Do not take Ozawade

• 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 metabolised in the liver and excessive levels may accumulate in patients with severely reduced liver function;
• if you are breastfeeding.

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

• You have experienced anxiety or depression with suicidal thoughts.
• You have problems with your liver or kidneys, as a dose adjustment may be necessary.
• You have a stomach ulcer or are taking medicines that can irritate the stomach, such as medicines that reduce inflammation, as gastric reactions related to taking Ozawade may occur.
• You are very overweight or underweight, as weight may increase or decrease during the intake of Ozawade.
• You have heart problems. Your doctor will subject you to regular check-ups during the intake of Ozawade.
• You suffer from severe epilepsy.

If any of the above conditions apply to you, talk to your doctor or pharmacist before taking
Ozawade.
Ozawade does not replace the primary treatment for OSA such as CPAP. You must continue to use
this treatment together with Ozawade.

Children and adolescents
Ozawade must 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. It may be necessary for your doctor
to adjust the dose.
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 as an antidepressant or as aid to stop smoking;
• medicines for the treatment of allergies called antihistamines such as pheniramine maleate, chlorpheniramine, diphenhydramine, promethazine, mepyramine, doxylamine;
• rifampicin, an antibiotic used to treat tuberculosis and some other infections;
• medicines for epilepsy (to prevent convulsions) such as carbamazepine, phenobarbital and phenytoin;
• medicines for the heart such as digoxin and quinidine;
• St John's wort ( Hypericum perforatum), a herbal remedy for depression;
• cinacalcet used for the treatment of disorders of the parathyroid gland;
• terbinafine, used for the treatment of fungal infections;
• medicines for diabetes such as metformin and repaglinide;
• anticancer medicines such as docetaxel and irinotecan;
• cisapride, used for the treatment of heartburn;
• pimozide, used for the treatment of some mental disorders;
• halofantrine, used for the treatment of malaria;
• efavirenz, an antiviral medicine for the treatment of HIV infection;
• morphine, used for the treatment of severe pain;
• paracetamol, used for the treatment of pain;
• anticoagulant medicines (medicines that prevent blood clots) such as dabigatran and warfarin;
• probenecid, used for the treatment of gout;
• medicines for the treatment of pain, inflammation and fever such as acetylsalicylic acid (aspirin), diclofenac, ibuprofen, meloxicam and naproxen;
• hormonal contraceptives (contraceptive medicines), see also the section "Pregnancy".

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not take Ozawade during pregnancy unless your doctor decides that it is
necessary to take it. There is not enough information on the risk associated with the use of
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. Because
Ozawade may reduce the effectiveness of hormonal contraceptives (contraceptive medicines), an
adequate alternative method of contraception must be used.
Breastfeeding
You must stop breastfeeding when you start taking Ozawade. Ozawade passes into
the breast milk of animals.

Driving and using machines
You may feel sleepy or your ability to concentrate may be reduced. Caution is
recommended when performing activities that require attention such as driving and using machines. If
you have any doubts about how your condition affects your ability to drive, ask your
doctor or pharmacist.

3. How to take Ozawade

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Treatment is normally started with a dose of 4.5 mg once a day, gradually
increased to the most appropriate dose over three weeks. At any time, the doctor
may increase or decrease the dose depending on how the medicine works on you and how well you
tolerate it. The maximum daily dose is 36 mg.
It may take a few days before the medicine starts to work, while the
maximum benefit is usually felt after a few weeks.
Do not change the dose of Ozawade on your own. Any change in dosage must be prescribed and
monitored by the 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 breakfast.
Do not take a dose of Ozawade in the afternoon as it may cause you to have difficulty sleeping.

If you take more Ozawade than you should
If you take too many Ozawade tablets, go to the nearest emergency room or inform
your doctor or pharmacist immediately. You may experience headache, stomach upset, a feeling
of unwellness or irritability. You may also have difficulty sleeping. Bring this leaflet and all the
remaining tablets with you.

If you forget to take Ozawade
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 missed tablet.

If you stop taking Ozawade
You must continue to take Ozawade for the time indicated by your doctor. Do not suddenly stop
taking Ozawade on your own.
If you have any further questions on 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.

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

• Headache
• Difficulty sleeping, sleep problems, feeling anxious
• Feeling dizzy
• Feeling unwell, abdominal discomfort (stomach ache)

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

• Viral infection of the upper respiratory tract (common cold), cold sores
• Changes in coagulation tests, abnormal blood values related to liver function, increased blood pressure, increased cholesterol levels in the blood
• Intolerance to alcohol, increased appetite, low blood sugar levels, change in body weight
• Irritability, confused state, fear, panic reaction, altered or increased sexual desire, feeling of depression, feeling nervous
• Loss of balance, sleep rhythm disorders, altered taste, sudden and unpredictable phases of mobility and immobility, headache, sleep paralysis, loss of ability to perform physical activities
• Swelling of the eyelid, dry eyes, flashes of light or floating objects in the field of vision
• Whistling or ringing in the ear
• Irregular heartbeat, palpitations, fast heartbeat, abnormal heartbeat
• Hot flashes, high blood pressure, sudden increase in blood pressure
• Yawning, coughing, difficulty breathing during the night
• Diarrhea, constipation, dry mouth, digestive tract disorders, inflammation of the digestive tract, change in stool color, bad breath, flatulence, rectal bleeding, increased saliva production
• Skin rash, itching on the face, redness of the skin, cold sweat, excessive sweating, night sweats, excessive skin sensitivity to sunlight
• Discomfort in arms and legs, muscle spasms, muscle pain, joint pain, tendon pain
• Frequent urination
• Pain and discomfort, fatigue, feeling hot, feeling thirsty, swelling of the legs or hands

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is 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 any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ozawade contains
The active ingredient 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, colloidal
anhydrous silica, polyvinyl alcohol, titanium dioxide, macrogol 3350.

Description of the appearance of Ozawade and contents of the pack
Ozawade 4.5 mg is available as film-coated tablets, white, round and biconvex, with a diameter of
3.7 mm, bearing the inscription “5” on one side.
Ozawade 18 mg is available as film-coated tablets, white, round and biconvex, with a diameter of
7.5 mm, bearing the inscription “20” on one side.
Ozawade is available in a bottle 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 Authorisation 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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Bioprojet Benelux
0032(0)78050202
[email protected]

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

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

Luxembourg/Luxemburg
Bioprojet Benelux
0032(0)78050202
[email protected]

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

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

Danmark
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800
[email protected]

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

Deutschland
Bioprojet Deutschland GmbH
030/3465 5460-0
[email protected]

Nederland
Bioprojet Benelux N.V.
088 34 34 100
[email protected]

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

Norge
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800
[email protected]

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

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

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

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

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

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

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

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

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

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

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

Italia
Bioprojet Italia srl
+39 02 84254830
[email protected]

Suomi/Finland
Bioprojet Pharma
0033 (0)1 47 03 66 33
[email protected]

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

Sverige
Zambon Sweden, filial of Zambon Nederland
B.V.
+46 (0)10 33 50 800
[email protected]

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

Other 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 website of the European Medicines Agency.