Macitentan Olpha

Package leaflet: Information for the user

Macitentan Olpha 10 mg film-coated tablets

macitentan
Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

• in adults in WHO functional class II or III
• in children under 18 years of age and weighing at least 40 kg in WHO functional class II or III.

It can be used alone or in combination with other medicines for the treatment of the disease. Pulmonary arterial hypertension is characterized by high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In people with pulmonary arterial hypertension, these arteries become narrowed, making it harder for the heart to pump blood through them. This leads to symptoms such as fatigue, dizziness, and difficulty breathing.

Macitentan Olpha widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers blood pressure in the pulmonary circulation, relieves symptoms, and improves the course of the disease.

2. What you should know before taking Macitentan Olpha

Do not take Macitentan Olpha

• if you are allergic to macitentan, soy, or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, planning to become pregnant, or if you may become pregnant because you are not using an effective method of contraception. See section “Pregnancy and breastfeeding”;
• if you are breastfeeding. See section “Pregnancy and breastfeeding”;
• if you have liver disease or if you have very high levels of liver enzymes in your blood. Speak with your doctor, who will decide whether this medicine is suitable for you.

Inform your doctor if any of these situations apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Macitentan Olpha.
You will need to have blood tests as directed by your doctor:
Your doctor will prescribe blood tests before starting treatment with Macitentan Olpha and during treatment to check:

• whether you have anaemia (reduced number of red blood cells)
• whether your liver is functioning properly

If you have anaemia (reduced number of red blood cells), the following symptoms may occur:

• dizziness
• fatigue/malaise/weakness
• increased heart rate, palpitations
• paleness

If you notice any of these signs, talk to your doctor.
The following symptoms may indicate that your liver is not functioning properly:

• nausea
• vomiting
• fever
• stomach (abdominal) pain
• yellowing of the skin and whites of the eyes (jaundice)
• dark-coloured urine
• skin itching
• unusual tiredness or weakness (lethargy or fatigue)
• flu-like symptoms (joint and muscle pain with fever)

If you experience any of these symptoms, contact your doctor immediately.
If you have kidney problems, inform your doctor before using Macitentan Olpha. Macitentan may cause a reduction in blood pressure and lower haemoglobin levels in patients with kidney problems.
In patients with pulmonary veno-occlusive disease (blockage of the pulmonary veins), treatment with medicines for pulmonary arterial hypertension, including Macitentan Olpha, may lead to pulmonary oedema. If you develop signs of pulmonary oedema while taking Macitentan Olpha, such as a sudden and significant worsening of breathing difficulty and reduced oxygen levels, contact your doctor immediately. Your doctor may perform further tests to determine the most appropriate treatment for you.
Children and adolescents
Do not administer this medicine to children under 2 years of age, as efficacy and safety have not been established.
Other medicines and Macitentan Olpha
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Macitentan Olpha may affect other medicines.
If you take Macitentan Olpha together with other medicines, including those listed below, the effect of Macitentan Olpha or the other medicines may be altered. Inform your doctor or pharmacist if you are taking any of the following medicines:

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

Macitentan Olpha with food
If you take piperine as a dietary supplement, it may alter how your body responds to certain medicines, including Macitentan Olpha. Inform your doctor or pharmacist if this applies to you.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Macitentan Olpha may harm the unborn child conceived before, during, or shortly after treatment.

• If you may become pregnant, use an effective method of birth control (contraception) during treatment with Macitentan Olpha. Discuss this with your doctor.
• Do not take Macitentan Olpha if you are pregnant or planning to become pregnant.
• If you become pregnant or suspect you are pregnant during treatment with Macitentan Olpha or shortly after stopping (within one month), contact your doctor immediately.

If you are a woman of childbearing potential, your doctor will require you to undergo a pregnancy test before starting Macitentan Olpha and then repeat it regularly (once a month) during treatment with Macitentan Olpha.
It is not known whether macitentan passes into breast milk. Do not breastfeed during treatment with Macitentan Olpha. Discuss this with your doctor.
Fertility
If you are a man taking Macitentan Olpha, this medicine may reduce sperm count. Talk to your doctor if you have any questions or concerns about this.
Driving and using machines
Macitentan Olpha may cause side effects such as headache and hypotension (listed in section 4). Additionally, symptoms of the disease itself may also impair your ability to drive or operate machinery.
Macitentan Olpha contains lactose, soy lecithin, and sodium
Macitentan Olpha contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Macitentan Olpha contains lecithin derived from soy. If you are allergic to soy, do not use this medicine (see section 2 “Do not take Macitentan Olpha”).
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Macitentan Olpha

Macitentan Olpha may only be prescribed by a physician experienced in the treatment of pulmonary arterial hypertension.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

Adults and children under 18 years of age weighing at least 40 kg
The recommended dose of Macitentan Olpha is one 10 mg tablet once daily. Swallow the tablet whole with a glass of water, without chewing or breaking it. Macitentan Olpha can be taken either on an empty stomach or with food. It is preferable to take the tablet at the same time each day.

For children weighing less than 40 kg, dispersible tablets with a lower dosage are available. Your doctor will prescribe the correct dose.

If you take more Macitentan Olpha than you should
If you have taken more tablets than prescribed, you may experience headache, nausea, and vomiting. Seek advice from your doctor.

If you forget to take Macitentan Olpha
If you forget to take Macitentan Olpha, take a dose as soon as you remember, then continue taking your tablets at your usual time. Do not take a double dose to make up for the missed tablet.

If you stop taking Macitentan Olpha
Macitentan Olpha is a treatment that you must continue taking to control pulmonary arterial hypertension. Do not stop treatment with Macitentan Olpha unless agreed with your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• Allergic reactions (swelling around the eyes, face, lips, tongue or throat, itching and/or skin rash). If you notice any of these signs, tell your doctor immediately.

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

• Anaemia (reduced number of red blood cells) or reduced haemoglobin concentration
• Headache
• Bronchitis (inflammation of the airways)
• Nasopharyngitis (inflammation of the throat and nasal passages)
• Oedema (swelling), especially in the ankles and feet

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

• Pharyngitis (inflammation of the throat)
• Influenza
• Urinary tract infection (bladder infection)
• Hypotension (low blood pressure)
• Nasal congestion (blocked nose)
• Abnormal liver function tests
• Leucopenia (low white blood cell count)
• Thrombocytopenia (low platelet count)
• Flushing (reddening of the skin)
• Increased uterine bleeding

Side effects in children and adolescents
The side effects listed above may also occur in children. Additional very common side effects observed in children include upper respiratory tract infection (infection of the sinuses or throat) and gastroenteritis (inflammation of the stomach and intestines). Rhinitis (itchy, runny or blocked nose) has been commonly observed in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Macitentan Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP/SCAD. 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 Macitentan Olpha contains

• The active substance is macitentan. Each tablet contains 10 mg of macitentan.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium starch glycolate Type A, magnesium stearate, polyvinyl alcohol (E1203), calcium carbonate (E170), talc (E553b), lecithin (soy) (E322), and xanthan gum (E415).

Description of the appearance of Macitentan Olpha and package contents
The 10 mg film-coated tablets of Macitentan Olpha are white to off-white, round, biconvex, with the number "10" engraved on one side and smooth on the other.
Macitentan Olpha is available as 10 mg film-coated tablets in blister packs containing 15 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Genepharm S.A.,
18th km Marathonos Avenue,
Pallini, 15351,
Greece
or
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

This medicinal product is authorized in the European Economic Area countries under the following names:
Sweden Macitentan Olpha
Estonia Macitentan Olpha
Lithuania Macitentan Olpha 10 mg plėvele dengtos tabletės
Latvia Macitentan Olpha 10 mg apvalkotās tabletes
Slovakia Macitentan Olpha 10 mg filmom obalené tablety
Spain Macitentan Olpha 10 mg comprimidos recubiertos con película EFG
France MACITENTAN OLPHA 10 mg, comprimé pelliculé
Czech Republic Macitentan Olpha
Italy Macitentan Olpha
Poland Macitentan Olpha
Germany Macitentan Olpha 10 mg Filmtabletten