InfoCons Consumer Protection informs you – Macitentan AccordPharma – Package Leaflet

Before anything else

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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Macitentan Accord Pharma is and what it is used for

Macitentan Accord Pharma contains the active substance macitentan , which belongs to the class of medicines called “endothelin receptor antagonists”.

Macitentan Accord Pharma is used for the long -term treatment of pulmonary arterial hypertension (PAH) :

• in adults of WHO Functional Class (FC) II to III
• in children under 18 years and body weight of at least 40 kg with WHO Functional Class (FC) II to III It can be used on its own or with other medicines for PAH. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to feel tired, dizzy, and short of breath.

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

⚠️ 2. What you need to know before you take Macitentan Accord Pharma

Do not take Macitentan Accord Pharma

• if you are allergic to macitentan, soya or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception). See section ‘Pregnancy and breastfeeding’.
• if you are breastfeeding. See section ‘Pregnancy and breastfeeding’.

32 • 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.

If any of these apply to you, please tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Macitentan Accord Pharma .

You will need blood tests, as indicated by your doctor:

Your doctor will take blood test before you start treatment with Macitentan Accord Pharma and during treatment to test:

• whether you have anaemia (a reduced number of red blood cells)
• whether your liver is working properly If you have anaemia (a reduced number of red blood cells), you may have the following signs:
• dizziness
• fatigue/malaise/weakness
• fast heart rate, palpitations
• pallor If you notice any of these signs, tell your doctor.

Signs that your liver may not be working properly include:

• feeling sick (nausea)
• vomiting
• fever
• pain in your stomach (abdomen)
• yellowing of your skin or the whites of your eyes (jaundice)
• dark- coloured urine
• itching of your skin
• unusual tiredness or exhaustion (lethargy or fatigue)
• flu-like syndrome (joint and muscle pain with fever) If you notice any of these signs, tell your doctor immediately.

If you have kidney problems, talk to your doctor before using Macitentan Accord Pharma . Macitentan may lead to more reduction of blood pressure and decrease in haemoglobin in patients with kidney problems.

In patients with pulmonary veno- occlusive disease (obstruction of the lung veins), the use of medicines for treatment of PAH, including Macitentan Accord Pharma , may lead to pulmonary oedema. If you have signs of pulmonary oedema when using Macitentan Accord Pharma , such as a sudden, important increase in breathlessness and low oxygen, tell your doctor immediately . Your doctor may perform additional tests, and will determine what treatment regimen is most suitable for you.

Children and adolescent s Do not give this medicine to children below 2 years of age because efficacy and safety have not been established.

Other medicines and Macitentan Accord Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

Macitentan Accord Pharma can affect other medicines.

33 If you take Macitentan AccordPharma together with other medicines including those listed below, the effects of Macitentan Accord Pharma or the other medicines might be altered. Please talk to 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 to treat seizures)
• carbamazepine (used to treat depression and epilepsy)
• St. John’s Wort (an herbal preparation used to treat depression)
• ritonavir, saquinavir (used to treat HIV infections)
• nefazodone (used to treat depression)
• ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used against fungal infections)
• amiodarone (to control the heartbeat)
• cyclosporine (used to prevent organ rejection after transplant)
• diltiazem, verapamil (to treat high blood pressure or specific heart problems)

Macitentan Accord Pharma with food

If you are taking piperine as a dietary supplement, this may alter how the body responds to some medicinal products, including Macitentan AccordPharma . Please talk to your doctor or pharmacist should this be the case.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Macitentan Accord Pharma may harm unborn babies conceived before, during or soon after treatment.

• If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you are taking Macitentan Accord Pharma . Talk to your doctor about this.
• Do not take Macitentan Accord Pharma if you are pregnant or planning to become pregnant.
• If you become pregnant or think that you may be pregnant while you are taking Macitentan AccordPharma, or shortly after stopping Macitentan AccordPharma (up to 1 month), see your doctor immediately.

If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Macitentan AccordPharma and regularly (once a month) while you are taking Macitentan Accord Pharma .

It is not known if m acitentan is transferred to breast milk. Do not breastfeed while you are taking Macitentan Accord Pharma . Talk to your doctor about this.

Fertility

If you are a man taking Macitentan Accord Pharma , it is possible that this medicine may lower your sperm count. Talk to your doctor if you have any questions or concerns about this.

Driving and using machines

Macitentan Accord Pharma can cause side effects such as headaches and hypotension (listed in section 4), and the symptoms of your condition can also make you less fit to drive or use machines.

Macitentan Accord Pharma contains lactose, lecithin from soya and sodium

Macitentan Accord Pharma contains a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

34 Macitentan Accord Pharma contains lecithin derived from soya. If you are allergic to soya, do not use this medicine (see section 2 ‘Do not take Macitentan AccordPharma ’).

This medicine conta ins less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium – free’.

💊 3. How to take Macitentan Accord Pharma

Macitentan Accord Pharma should only be prescribed by a doctor experienced in the treatment of pulmonary arterial hypertension.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Adults and children aged less than 18 years weighing at least 40 kg The recommended dose of Macitentan Accord Pharma is one 10 mg tablet, once a day. Swallow the whole tablet, with a glass of water, do not chew or break the tablet. You can take Macitentan Accord Pharma with or without food. It is best to take the tablet at the same time each day.

For children weighing less than 40 kg other products must be used.

If you take more Macitentan Accord Pharma than you should

If you have taken more tablets than you have been told to take, you may experience headache, nausea, or vomiting. Ask your doctor for advice.

If you forget to take Macitentan Accord Pharma

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

If you stop taking Macitentan Accord Pharma

Macitentan Accord Pharma is a treatment that you will need to keep on taking to control your PAH. Do not stop taking Macitentan Accord Pharma unless you have agreed this with your doctor.

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.

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

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

• Pharyngitis (inflammation of the throat) 35 • Influenza (flu)
• Urinary tract infection (bladder infection)
• Hypotension (low blood pressure)
• Nasal congestion (blocked nose)
• Elevated liver tests
• Leukopenia (decreased white blood cell counts)
• Thrombocytopenia (decreased blood platelet counts)
• Flushing (redness of the skin)
• Increased uterine bleeding Side effects in children and adolescents The side effects listed above may also be seen in children. Additional side effects very commonly seen in children include upper respiratory tract infection (infected nose sinuses, or throat) and gastroenteritis (inflamed stomach and gut). Rhinitis (itchy, runny, or blocked nose) was seen commonly in children.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Macitentan Accord Pharma

Keep this medicine out of the sight and reach of children.

Do not use Macitentan Accord Pharma after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicinal product 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 require. These measures will help to protect the environment.

📦 6. Contents of the pack and other information

What Macitentan Accord Pharma contains

The active substance is macitentan. Each film- coated tablet contains 10 mg of macitentan.

• The other ingredients are Lactose monohydrate, Microcrystalline cellulose (E460) , Sodium Starch Glycolate, Poloxamer 188, Povidone K- 30 and Magnesium stearate.
• Coating: Polyvinyl Alcohol (E1203) , Titanium Dioxide (E171) , Talc (E553b) , Lecithin [Soya] (E322), and Xanthan Gum (E415).

What Macitentan Accord Pharma looks like and contents of the pack

Macitentan Accord Pharma 10 mg tablets are White to off -white, round, biconvex, film -coated tablets debossed with ‘NL’ on one side and plain on the other side.

Macitentan Accord Pharma is supplied as 10 mg film -coated tablets in Clear PVC/PE/PVDC blister pack or clear PVC/PVDC blister pack in cartons containing 15 or 30 film-coated tablets and 15×1 or 30×1 film- coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est, 6 a Planta, 08039 Barcelona, Spain

Manufacturer

Accord Healthcare Polska Sp. z.o.o. ul.Lutomierska 50, 95-200, Pabianice, Poland Pharmadox Healthcare Limited KW20A Kordin Industrial Park, Paola PLA 3000, Malta Accord Healthcare B.V.

Winthontlaan 200, 3526 KV Utrecht, Netherlands Accord Healthcare Single Member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Macitentan AccordPharma (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1971).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.