Ozawade - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Ozawade 4.5 mg film-coated tablets

Ozawade 18 mg film-coated tablets

pitolisant

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 signs of illness 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.

What is in 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 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 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.

2. What you need to know before you take Ozawade

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 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.

3. How to take Ozawade

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 18 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.

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.

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people):

• – Headache

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

• – Difficulty sleeping, sleeping problems, feeling anxious

• – Feeling of “spinning” (vertigo)

• – High blood pressure

• – Feeling sick, abdominal (belly) discomfort, diarrhoea

• – Pain and 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

• – 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

• – Yawning, cough, difficulty to breath at night

• – 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

• – Tiredness (fatigue), feeling hot, feeling thirsty

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 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.

6. Contents of the pack and other information

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 of 30 tablets or 90 tablets.

Ozawade 4.5 mg: Available in packs containing 1 bottle of 30 tablets or packs containing 1 bottle of 90 tablets.

Ozawade 18 mg: Available in packs containing 1 bottle of 30 tablets or packs containing 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Bioprojet Benelux 0032(0)78050202	Lietuva Bioprojet Pharma 0033 (0)1 47 03 66 33
Efc^rapufl Bioprojet Pharma 0033 (0)1 47 03 66 33	Luxembourg/Lu­xemburg Bioprojet Benelux 0032(0)78050202
Česká republika Bioprojet Pharma 0033 (0)1 47 03 66 33	Magyarorszag Bioprojet Pharma 0033 (0)1 47 03 66 33
Danmark Bioprojet Pharma 0033 (0)1 47 03 66 33	Malta Bioprojet Pharma 0033 (0)1 47 03 66 33
Deutschland Bioprojet Deutschland GmbH 030/3465 5460–0	Nederland Bioprojet Benelux N.V. 088 34 34 100
Eesti Bioprojet Pharma 0033 (0)1 47 03 66 33	Norge Bioprojet Pharma 0033 (0)1 47 03 66 33
EMába Bioprojet Pharma 0033 (0)1 47 03 66 33	Österreich Bioprojet Pharma 0033 (0)1 47 03 66 33
España Bioprojet Pharma 0033 (0)1 47 03 66 33	Polska Bioprojet Pharma 0033 (0)1 47 03 66 33
France Bioprojet Pharma 0033 (0)1 47 03 66 33	Portugal Bioprojet Pharma 0033 (0)1 47 03 66 33
Hrvatska Bioprojet Pharma 0033 (0)1 47 03 66 33	Romania Bioprojet Pharma 0033 (0)1 47 03 66 33
Ireland Lincoln Medical Ltd. 0330 1003684	Slovenija Bioprojet Pharma 0033 (0)1 47 03 66 33

Slovenská republika

Bioprojet Pharma

0033 (0)1 47 03 66 33

Suomi/Finland

Bioprojet Pharma

0033 (0)1 47 03 66 33

Sverige

Bioprojet Pharma

0033 (0)1 47 03 66 33

United Kingdom (Northern Ireland)

Lincoln Medical Ltd.

0330 1003684

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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

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