MACITENTAN STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Macitentan Stada 10 mg film-coated tablets EFG

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.

Contents of the pack

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

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

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

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

• in adults classified as functional class (FC) II to III by the WHO
• in children under 18 years of age with a body weight of at least 40 kg classified as functional class (FC) II to III.

It can be used alone or with other medicines for PAH. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arteries). In people with PAH, these arteries can become narrowed, so the heart has to work harder to pump blood through them. As a result, those affected feel tired, dizzy, and have difficulty breathing.

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

2. What you need to know before you take Macitentan Stada

Do not take Macitentan Stada

• if you are allergic to macitentan or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or planning to become pregnant, or if you could become pregnant because you are not using a reliable method of contraception. See section "Pregnancy and breast-feeding".
• if you are breast-feeding. See section "Pregnancy and breast-feeding".
• if you have liver disease or if you have very high levels of liver enzymes in your blood. Consult your doctor, who will decide if the medicine is suitable for you.

If you meet any of the above points, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take macitentan.

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

Your doctor will perform blood tests before you start treatment with macitentan and during treatment to determine:

• if you have anemia (reduced number of red blood cells)
• if your liver is working properly

If you have anemia (reduced number of red blood cells), you may have the following signs:

• dizziness
• fatigue/general malaise/weakness
• rapid heart rate, palpitations
• paleness

If you experience any of these signs, talk to your doctor.

Signs that your liver may not be working properly are:

• nausea
• vomiting
• fever
• stomach pain (abdomen)
• yellowing of the skin or the whites of the eyes (jaundice)
• dark-colored urine
• itching of the skin
• unusual tiredness or exhaustion (lethargy or fatigue)
• pseudo-flu syndrome (joint or muscle pain with fever)

If you experience any of these signs, inform your doctor immediately.

If you have kidney problems, talk to your doctor before using macitentan. Macitentan may cause a greater reduction in blood pressure and a decrease in hemoglobin in patients with kidney problems.

The use of medicines for the treatment of PAH, including macitentan, in patients with pulmonary veno-occlusive disease (obstruction of the pulmonary veins) may cause pulmonary edema. If you experience signs of pulmonary edema during treatment with macitentan, such as a sudden and significant increase in shortness of breath and oxygen, talk to your doctor immediately.Your doctor may perform additional tests and determine the most suitable treatment for you.

Children and adolescents

Do not give this medicine to children under 2 years of age because the efficacy and safety have not been established.

Other medicines and Macitentan Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Macitentan may affect other medicines.

If you take macitentan with other medicines, including those listed below, the effects of macitentan or other medicines may be affected. 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 (medicine used to treat seizures)
• carbamazepine (used to treat depression and epilepsy)
• St. John's Wort (herbal medicine used to treat depression)
• ritonavir, saquinavir (used to treat HIV infection)
• nefazodone (used to treat depression)
• ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used to treat fungal infections)
• amiodarone (to control heartbeats)
• cyclosporin (used to prevent organ rejection after a transplant)
• diltiazem, verapamil (to treat high blood pressure or specific heart problems)

Taking Macitentan Stada with food

If you take piperine as a dietary supplement, it may alter the way your body responds to some medicines like macitentan. Talk to your doctor or pharmacist if this is the case.

Pregnancy and breast-feeding

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

Macitentan may harm fetuses conceived before, during, or shortly after treatment.

• If you can become pregnant, use a reliable method of contraception while taking macitentan. Talk to your doctor about this.
• Do not take macitentan if you are pregnant or planning to become pregnant.
• If you become pregnant or think you may have become pregnant during treatment with macitentan, or shortly after stopping treatment (up to 1 month), consult your doctor immediately.

If you are a woman of childbearing age, your doctor will ask you to have a pregnancy test before starting to take macitentan and periodically (once a month) during treatment.

It is not known if macitentan passes into breast milk. Do not breast-feed during treatment with macitentan. Talk to your doctor about this.

Fertility

If you are a man taking macitentan, this medicine may decrease your sperm count. Talk to your doctor if you have any questions or concerns about this.

Driving and using machines

Macitentan may cause side effects such as headaches and hypotension (indicated in section 4) and the symptoms of the disease can also make you less fit to drive or use machines.

Macitentan Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Macitentan Stada

Macitentan should only be prescribed by a doctor with experience in the treatment of pulmonary arterial hypertension.

Follow exactly the instructions of administration indicated by your doctor. If you are unsure, consult your doctor again.

Adults and children under 18 years of age with a minimum weight of 40 kg

The recommended dose of macitentan is one 10 mg tablet once a day. Swallow the tablet whole, with a glass of water, and do not chew or break it. Macitentan can be taken with or without food. It is best to take the tablet at the same time each day.

For children who weigh less than 40 kg, other brands of macitentan are available in dispersible tablets with a lower dose.

If you take more Macitentan Stada than you should

If you take more tablets than indicated, you may experience headache, nausea, or vomiting. Seek advice from your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Macitentan Stada

If you forget to take macitentan, take a dose as soon as you remember and, from then on, continue to take the tablets at the usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking Macitentan Stada

Macitentan is a treatment that you should continue to take to control PAH. Do not stop taking macitentan 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.

Serious side effects, uncommon(may affect up to 1 in 100 people)

• Allergic reactions (inflammation around the eyes, face, lips, tongue, or throat, itching and/or skin rash).

If you experience any of these signs, talk to your doctor immediately.

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

• Anemia (reduced number of red blood cells) or decreased hemoglobin
• Headache
• Bronchitis (inflammation of the airways)
• Nasopharyngitis (inflammation of the throat and nasal passages)
• Edema (swelling), especially in the ankles and feet

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

• Pharyngitis (inflammation of the throat)
• Flu
• Urinary tract infection (infection of the bladder)
• Hypotension (low blood pressure)
• Nasal congestion (stuffy nose)
• Increased liver tests
• Leukopenia (reduced white blood cell count)
• Thrombocytopenia (reduced platelet count)
• Flushing (redness of the face)
• Increased uterine bleeding

Side effects in children and adolescents

The side effects listed above can also be observed in children. Other very common side effects in children are upper respiratory tract infections (infection of the nose, sinuses, or throat) and gastroenteritis (inflammation of the stomach and intestine). Rhinitis (itching, discharge, or blockage of the nose) was also commonly observed in children.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Macitentan Stada

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and other information

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

The other ingredients are maltodextrin (E1400), polysorbate 80 (E433), mannitol (E421), pregelatinized starch (from corn), sodium croscarmellose (E468), magnesium stearate (E572), poly(vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate, type I, sodium lauryl sulfate (E487).

Appearance of the product and contents of the pack

Macitentan Stada is presented as film-coated tablets.

White to off-white, round, biconvex film-coated tablets, approximately 5.6 mm in diameter.

Macitentan Stada 10 mg is available in PVC/PE/PVdC-Al blisters containing 15 or 30 film-coated tablets or unit-dose blisters of PVC/PE/PVdC-Al containing 15x1 or 30x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Stada Arzneimittel AGStadastrase 2-1861118 Bad VilbelGermany

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel

E91 D768 Co. Tipperary

Ireland

or

Stada Arzneimittel GmbHMuthgasse 36/21190 ViennaAustria

or

Centrafarm Services B.V.Van de Reijtstraat 31 E4814 NE BredaNetherlands

Date of last revision of this leaflet:July 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)