Package leaflet: Information for the user

Macitentan Onkogen, 10 mg, film-coated tablets
macitentan
Please read all of 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 further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

What Macitentan Onkogen is and what it is used for
What you need to know before taking Macitentan Onkogen
How to take Macitentan Onkogen
Possible side effects
How to store Macitentan Onkogen
Contents of the pack and other information

1. What Macitentan Onkogen is and what it is used for

Macitentan Onkogen contains the active substance macitentan, which belongs to a group of medicines called endothelin receptor antagonists.
Macitentan Onkogen is used for the long-term treatment of pulmonary arterial hypertension (PAH):

in adults in WHO functional class (FC) II to III
in children under 18 years of age with a body weight of at least 40 kg in WHO functional class (FC) II to III. It may be used alone or in combination with other medicines used in PAH therapy. PAH is high blood pressure in the blood vessels carrying blood from the heart to the lungs (pulmonary arteries). In patients with PAH, these arteries become narrowed, causing the heart to work harder to pump blood through them. This leads to fatigue, dizziness, and shortness of breath.

Macitentan Onkogen widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure, alleviates symptoms, and improves disease progression.

2. Important information before using Macitentan Onkogen

When not to use Macitentan Onkogen

if the patient is allergic to macitentan or any of the other ingredients of this medicine (listed in section 6);
if the patient is pregnant, planning to become pregnant, or may become pregnant and is not using an effective method of birth control (contraception). See information in the section "Pregnancy and breastfeeding";
during breastfeeding; please read the information in the section "Pregnancy and breastfeeding";
if the patient has liver disease or very high levels of liver enzymes in the blood. Inform the doctor about this – the doctor will decide whether this medicine is suitable for the patient.

If any of the above contraindications apply to the patient, inform the
treating physician.
Warnings and precautions
Before starting treatment with Macitentan Onkogen, discuss this with your doctor or pharmacist.
Blood tests must be performed as directed by the physician:
Your doctor will order blood tests before starting treatment with Macitentan Onkogen and during treatment to check:

whether the patient has anemia (reduced number of red blood cells)
whether the liver is functioning properly. If the patient has anemia (reduced number of red blood cells), the following symptoms may occur:
dizziness
fatigue/feeling unwell/weakness
rapid heartbeat, palpitations
pallor. Inform the doctor if any of these symptoms occur. Symptoms of abnormal liver function include:
nausea
vomiting
fever
abdominal pain
yellowing of the skin or whites of the eyes (jaundice)
dark-colored urine
skin itching
unusual fatigue or exhaustion (apathy or tiredness)
flu-like symptoms (joint and muscle pain with fever).

Contact the treating physician immediately if any of the above symptoms occur.
If the patient has kidney disease, inform the doctor before starting treatment with Macitentan Onkogen. Macitentan may cause a greater drop in blood pressure and reduced hemoglobin levels in patients with kidney disease.
In patients with pulmonary veno-occlusive disease (PVOD), treatment with drugs for PAH, including Macitentan Onkogen, may lead to pulmonary edema.
If symptoms of pulmonary edema occur during treatment with Macitentan Onkogen, such as sudden worsening of shortness of breath and low oxygen levels, contact the doctor immediately. The doctor may perform additional tests and decide which treatment is most appropriate for the patient.
Children and adolescents
Do not give this medicine to children under 2 years of age, as efficacy and safety have not been established.
Macitentan Onkogen and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Macitentan Onkogen may affect the action of other medicines.
When taking Macitentan Onkogen together with other medicines, including those listed below, the effect of Macitentan Onkogen or other medicines may change. Inform your doctor or pharmacist if the patient is taking any of the following medicines:

rifampicin, clarithromycin, telithromycin, ciprofloxacin, erythromycin (antibiotics used to treat infections),
phenytoin (used to treat seizures),
carbamazepine (used to treat depression and epilepsy),
St. John's wort (herbal preparation used to treat depression),
ritonavir and saquinavir (used in the treatment of HIV infection),
nefazodone (used to treat depression),
ketoconazole (except in shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used to treat fungal infections),
amiodarone (used to control heart rhythm),
cyclosporine (used to prevent organ rejection after transplantation),
diltiazem, verapamil (used to treat high blood pressure or certain heart conditions).

Macitentan Onkogen with food and drink
If the patient takes piperine as a dietary supplement, it may affect how the body reacts to certain medicines, including Macitentan Onkogen. In such a case, consult your doctor or pharmacist.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
Macitentan Onkogen may cause birth defects in unborn children conceived before, during, or shortly after treatment.

If the patient may become pregnant, she must use an effective method of birth control (contraception) during treatment with Macitentan Onkogen. Discuss this with your doctor.
Do not take Macitentan Onkogen if the patient is pregnant or planning to become pregnant.
If the patient becomes pregnant during treatment with Macitentan Onkogen, suspects she may be pregnant, or becomes pregnant within one month after stopping treatment with Macitentan Onkogen, she should contact her doctor immediately. If the patient is of childbearing age, the doctor will request a pregnancy test before starting Macitentan Onkogen and regular testing (once a month) during treatment.

It is not known whether Macitentan Onkogen passes into human milk. Breastfeeding is not recommended during treatment with Macitentan Onkogen. Discuss this with your doctor.
Fertility
In men, taking Macitentan Onkogen may result in reduced sperm count. Discuss any questions or concerns with your doctor.
Driving and operating machinery
Macitentan Onkogen may cause side effects such as headache and hypotension (listed in section 4), and symptoms of the disease may also affect the ability to drive or operate machinery.
Macitentan Onkogen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to take Macitentan Onkogen
Macitentan Onkogen may only be prescribed by a physician experienced in the treatment of pulmonary arterial hypertension.
Always take this medicine exactly as prescribed by your doctor. In case of doubt, consult your doctor.
Adults and children under 18 years of age weighing at least 40 kg
The recommended dose of Macitentan Onkogen is one 10 mg tablet once daily. Swallow the tablet whole with a glass of water; do not chew or break the tablet. Macitentan Onkogen can be taken with or without food. It is best to take the tablets at the same time each day.
Taking more Macitentan Onkogen than recommended
If more tablets are taken than recommended, headache, nausea, or vomiting may occur. Contact your doctor.
Missing a dose of Macitentan Onkogen
If a dose of Macitentan Onkogen is missed, take it as soon as remembered, then continue taking the tablets at the usual time. Do not take a double dose to make up for a missed tablet.
Stopping Macitentan Onkogen
Macitentan Onkogen is a medicine that should be taken continuously to reduce PAH symptoms. Do not stop taking Macitentan Onkogen without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.

Uncommon serious adverse reactions (may occur in up to 1 in 100 people)

hypersensitivity reactions [swelling around the eyes, face, lips, tongue or throat, itching and (or) rash]. If such symptoms occur, contact your doctor immediately.

Very common adverse reactions (may occur in more than 1 in 10 people)

anaemia (low number of red blood cells) or decreased haemoglobin concentration
headache
bronchitis (inflammation of parts of the respiratory tract)
nasopharyngitis (inflammation of the mucous membranes of the nose and throat)
oedema (swelling), especially in the ankle joints and feet.

Common adverse reactions (may occur in up to 1 in 10 people)

pharyngitis (inflammation of the throat)
influenza (flu)
urinary tract infection (bladder infection)
hypotension (low blood pressure)
nasal mucosal oedema (nasal congestion)
elevated liver function test results
leukopenia (reduced number of white blood cells)
thrombocytopenia (reduced number of platelets)
redness, especially of the face (skin flushing)
increased uterine bleeding.

Adverse reactions in children and adolescents
The adverse reactions listed above may also occur in children. Additional adverse reactions very commonly observed in children include: upper respiratory tract infection (sinus or throat infection), and gastritis and enteritis (inflammatory condition of the stomach and intestines).
Nasal mucosal inflammation (itching, runny or blocked nose) has been frequently observed in children.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Macitentan Onkogen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and cardboard container
after: EXP. The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Macitentan Onkogen contains

The active substance is macitentan. Each tablet contains 10 mg of macitentan.
The other ingredients are:

Tablet core:
Mannitol (type 160 C)
Microcrystalline cellulose (type 101)
Crospovidone (type A)
Povidone (type K25)
Polysorbate 80
Microcrystalline cellulose (type 302)
Magnesium stearate

Film-coated tablet contains (Coating Opadry AMB 88A180040 white):
Polyvinyl alcohol
Talc
Titanium dioxide (E171)
Glyceryl monooctanoate/caprylocaproyl glycerides
Sodium lauryl sulfate

What Macitentan Onkogen looks like and contents of the pack
Macitentan Onkogen 10 mg film-coated tablets are white, round, film-coated tablets.
Macitentan Onkogen 10 mg film-coated tablets are supplied in blister packs containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Onkogen Kft.
Bécsi út 77-79
1037 Budapest
Hungary
Email: [email protected]

Manufacturer
Tecnimede-Sociedade Técnico-Medicinal, S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal

This medicinal product is authorised in the European Economic Area under the following names:
Hungary: Macitentan Onkogen 10 mg filmtabletta
Poland: Macitentan Onkogen
Portugal: Macitentano Onkogen