Macitentan EG

Patient Information Leaflet: Information for the User

Macitentan EG 10 mg film-coated tablets

Generic medicine
Please read all of 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 give it to others, even if they have the same symptoms as you, because it could 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 EG is and what it is used for
2. What you need to know before taking Macitentan EG
3. How to take Macitentan EG
4. Possible side effects
5. How to store Macitentan EG
6. Contents of the pack and other information

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

Macitentan EG contains the active substance macitentan, which belongs to a class of medicines known as
"endothelin receptor antagonists".
Macitentan EG 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 PAH. 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 affected by pulmonary arterial hypertension, these arteries become narrowed, making it harder for the heart to pump blood through them. This leads to feelings of fatigue, dizziness, and difficulty breathing.

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

2. What you should know before taking Macitentan EG

Do not take Macitentan EG

• if you are allergic to macitentan or to 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 contraceptive method. 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. Talk to your doctor, who will decide whether this medicine is suitable for you.

In any of these cases, inform your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Macitentan EG.
You will need to have blood tests as directed by your doctor.
Your doctor will prescribe blood tests before starting treatment with Macitentan EG 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:

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

If you experience any of these symptoms, inform your doctor immediately.
If you have kidney problems, inform your doctor before using Macitentan EG. Macitentan may lead to a reduction in blood pressure and decreased haemoglobin levels in patients with kidney problems.
In patients with pulmonary veno-occlusive disease (obstruction of the pulmonary veins), treatment with medicines for pulmonary arterial hypertension, including Macitentan EG, may lead to pulmonary oedema. If you develop signs of pulmonary oedema while taking Macitentan EG, 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 regimen for you.
Children and adolescents
Do not give this medicine to children under 2 years of age, as efficacy and safety have not been established.
Other medicines and Macitentan EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Macitentan EG may affect other medicines.
If you take Macitentan EG together with other medicines, including those listed below, the effect of Macitentan EG 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 (an herbal preparation used for depression),
• ritonavir, saquinavir (used in HIV infection),
• nefazodone (used for depression),
• ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used to treat fungal infections),
• amiodarone (to control heart rhythm),
• cyclosporine (used to prevent organ rejection after transplantation),
• diltiazem, verapamil (for treatment of high blood pressure or certain heart conditions).

Macitentan EG with food
If you take piperine as a dietary supplement, it may alter how your body responds to certain medicines, including Macitentan EG. Inform your doctor or pharmacist if this applies to you.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Macitentan EG 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 EG. Discuss this with your doctor.
• Do not take Macitentan EG if you are pregnant or planning to become pregnant.
• If you become pregnant or suspect you are pregnant during treatment with Macitentan EG or shortly after stopping the medicine (within one month), contact your doctor immediately.

If you are a woman of childbearing potential, your doctor will ask you to undergo a pregnancy test before starting Macitentan EG and then repeat the test at regular intervals (once a month) during treatment with Macitentan EG.
It is not known whether Macitentan EG passes into breast milk. Do not breastfeed during treatment with Macitentan EG. Inform your doctor immediately if you are breastfeeding.
Fertility
If you are a man taking Macitentan EG, this medicine may reduce sperm count. Talk to your doctor if you have any questions or concerns about this.
Driving and using machines
Macitentan EG may cause side effects such as headache and hypotension (listed in section 4). Additionally, symptoms of the disease itself may impair your ability to drive or operate machinery.
Macitentan EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Macitentan EG

Macitentan EG may only be prescribed by a physician experienced in the treatment of pulmonary arterial hypertension.
Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.

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

For children weighing less than 40 kg, dispersible macitentan tablets with a lower dosage and other brand names are available.

If you take more Macitentan EG than you should
If you have taken more tablets than prescribed, you may experience headache, nausea, and vomiting. Contact your doctor for advice.

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

If you stop taking Macitentan EG
Macitentan EG is a treatment that you must continue taking to control pulmonary arterial hypertension. Do not stop treatment with Macitentan EG unless agreed upon 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 experiences them.

Serious uncommon 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 (redness of the skin);
• Increased uterine bleeding.

Side effects in children and adolescents
The side effects listed above may also occur in children. Additional side effects commonly observed in children include upper respiratory tract infection (sinus or throat infection) 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, talk to 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 EG

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. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Macitentan EG contains
The active substance is macitentan. Each film-coated tablet contains 10 mg of macitentan.
The other components are maltodextrin (E1400), polysorbate 80 (E433), mannitol (E421), pregelatinized starch (corn starch), sodium croscarmellose (E468), magnesium stearate (E572), polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprilocaprate, type I, sodium lauryl sulfate (E487).

Description of the appearance of Macitentan EG and contents of the pack
Macitentan EG is available as film-coated tablets.
The film-coated tablets are white to off-white, round, biconvex, with a diameter of approximately 5.6 mm.
Macitentan EG 10 mg is available in PVC/PE/PVdC-Al blisters containing 15 or 30 film-coated tablets, or in unit-dose divisible PVC/PE/PVdC-Al blisters containing 15x1 or 30x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milan, Italy

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria
Clonmel Healthcare Ltd, Waterford Road, Clonmel, E91 D768 Co. Tipperary, Ireland
Centrafarm Services B.V., Van de Reijtstraat 31 E, 4814NE Breda, The Netherlands

This medicinal product is authorized in the European Economic Area countries under the following names:
NL Macitentan CF 10 mg, filmomhulde tabletten
AT Macitentan STADA 10 mg Filmtabletten
BE Macitentan EG 10 mg filmomhulde tabletten
LU Macitentan EG 10 mg comprimés pelliculés
DE Macitentan STADA 10 mg Filmtabletten
DK Macitentan STADA
ES Macitentan STADA 10 mg comprimidos recubiertos con película EFG
FI Macitentan STADA 10 mg kalvopäällysteiset tabletit
HU Macitentan Stada 10 mg filmtabletta
IS Macitentan STADA 10 mg filmuhúðaðar töflur
IE Macitentan Clonmel 10 mg film-coated tablets
IT Macitentan EG
PL Macitentan Stada
PT Macitentano Stada
RO Macitentan Stada 10 mg comprimate filmate
SE Macitentan STADA
SK Macitentan STADA 10 mg filmom obalené tablety
NO Macitentan STADA
MT Macitentan Clonmel 10 mg film-coated tablets