Macitentan stada

Package leaflet: Information for the user

Macitentan Stada, 10 mg, film-coated tablets
Macitentanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

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

• in adults in World Health Organization (WHO) functional class (FC) II to III
• in children under 18 years of age with 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 the treatment of PAH. PAH is high blood pressure in the blood vessels that carry 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 Stada works by widening the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers blood pressure, reduces symptoms, and improves the course of the disease.

2. Important information before taking Macitentan Stada

When not to take Macitentan Stada

• 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, plans to become pregnant, or could 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. The patient should inform their doctor – the doctor will decide whether this medicine is suitable for them.

If any of the above contraindications apply to the patient, they should inform their doctor.

Warnings and precautions

Before starting treatment with Macitentan Stada, the patient should discuss this with their doctor or pharmacist.

Blood tests must be performed as directed by the doctor:

The doctor will order blood tests before starting treatment with Macitentan Stada and during treatment to check:

• whether the patient has anaemia (reduced number of red blood cells)
• whether the liver is functioning properly

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

• dizziness
• fatigue/poor well-being/weakness
• rapid heartbeat, palpitations
• paleness

The patient should inform their 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-coloured urine
• skin itching
• unusual tiredness or exhaustion (lethargy or fatigue)
• flu-like symptoms (joint and muscle pain with fever).

The patient should contact their doctor immediately if any of the above symptoms are observed.

If the patient has kidney disease, they should inform their doctor before starting treatment with Macitentan Stada. Macitentan may cause a greater decrease in blood pressure and haemoglobin levels in patients with kidney disease.

In patients with pulmonary veno-occlusive disease (PVOD), treatment with drugs for PAH, including Macitentan Stada, may lead to pulmonary oedema.

If symptoms of pulmonary oedema occur during treatment with Macitentan Stada, such as sudden worsening of breathlessness and low oxygen levels, the patient should contact their doctor immediately. The doctor may perform additional tests and decide on the most appropriate treatment for the patient.

Children and adolescents

This medicine should not be given to children and adolescents under 2 years of age, as the efficacy and safety have not been established.

Macitentan Stada and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Macitentan Stada may affect the action of other medicines.

When taking Macitentan Stada together with other medicines, including those listed below, the effect of Macitentan Stada or other medicines may change. The patient should inform their doctor or pharmacist if they 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 (a herbal remedy used to treat depression),
• ritonavir and saquinavir (used in the treatment of HIV infection),
• nefazodone (used to treat depression),
• ketoconazole (except 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 problems).

Macitentan Stada and food

If the patient takes piperine as a dietary supplement, it may alter the body's response to certain medicines, including Macitentan Stada. In such a case, the patient should consult their doctor or pharmacist.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.

Macitentan Stada may cause birth defects in unborn children conceived before, during, or shortly after treatment.

• If the patient could become pregnant, she must use an effective method of birth control (contraception) during treatment with Macitentan Stada. Discuss this with the doctor.
• Do not take Macitentan Stada if the patient is pregnant or plans to become pregnant.
• If the patient becomes pregnant during treatment with Macitentan Stada, suspects she may be pregnant, or becomes pregnant within one month after stopping treatment with Macitentan Stada, she should contact her doctor immediately.

If the patient is of childbearing age, the doctor will request a pregnancy test before starting treatment with Macitentan Stada and regular repeat tests (once a month) during treatment.

It is not known whether macitentan passes into human breast milk. Breastfeeding is not recommended during treatment with Macitentan Stada. Discuss this with the doctor.

Fertility

In men, taking Macitentan Stada may result in a reduced sperm count. The patient should consult their doctor if they have any questions or concerns in this regard.

Driving and operating machinery

Macitentan Stada may cause side effects such as headache and low blood pressure (mentioned in section 4). The symptoms of the disease may also reduce the ability to drive or operate machinery.

Macitentan Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Macitentan Stada

Macitentan Stada may only be prescribed by a doctor experienced in the treatment of pulmonary arterial hypertension.

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, the patient should consult their doctor.

Adults and children under 18 years of age weighing at least 40 kg

The recommended dose of Macitentan Stada is one 10 mg tablet once daily. Swallow the whole tablet with a glass of water. Do not chew or break the tablet to avoid damaging the coating. Macitentan Stada can be taken with or without food. It is best to take the medicine at the same time each day.

For children weighing less than 40 kg, macitentan is available as orally disintegrating tablets of lower strength under other brand names.

Taking more Macitentan Stada than recommended

If the patient takes more tablets than recommended, symptoms such as headache, nausea, or vomiting may occur. The patient should contact their doctor.

Missing a dose of Macitentan Stada

If a dose of Macitentan Stada is missed, the patient should take it as soon as they remember, then continue taking the tablets at the usual time. Do not take a double dose to make up for the missed tablet.

Stopping Macitentan Stada

Macitentan Stada is a medicine that must be taken continuously to reduce PAH symptoms. Do not stop taking Macitentan Stada without consulting the doctor.

If the patient has any further questions about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Uncommon serious side effects (may occur in no more than 1 in 100 people)

• hypersensitivity reactions [swelling of the eye area, face, lips, tongue or throat, itching and/or rash]. If such symptoms occur, contact your doctor immediately.

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

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

Common side effects (may occur in no more than 1 in 10 people)

• pharyngitis (inflammation of the throat)
• influenza (flu)
• urinary tract infection (bladder infection)
• hypotension (low blood pressure)
• nasal mucosal inflammation (nasal congestion)
• elevated liver function test results
• leukopenia (reduced number of white blood cells)
• thrombocytopenia (reduced number of platelets)
• erythema (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 very commonly observed in children are: upper respiratory tract infection (infection of the nose, sinuses or throat) and gastroenteritis (inflammation of the stomach and intestines). Nasal mucosal inflammation (itching, runny or blocked nose) has been frequently observed in children.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Macitentan Stada

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

Do not use this medicine after the expiry date stated on the outer carton and blister pack following "EXP". The expiry date refers to the last day of the stated month.

No special storage conditions apply.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Macitentan Stada contains
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 corn starch, sodium croscarmellose (E468), magnesium stearate (E572),
polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaproyl
ester, type I, sodium lauryl sulfate (E487).

What Macitentan Stada looks like and contents of the pack
Macitentan Stada is a film-coated tablet.
White to off-white, round, biconvex film-coated tablets with a diameter of approximately 5.6 mm.
Macitentan Stada 10 mg is available in PVC/PE/PVdC-Aluminium foil blisters containing 15 or 30
film-coated tablets in cardboard boxes, or in PVC/PE/PVdC-Aluminium foil blisters containing
15x1 or 30x1 film-coated tablets in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
Dortelweil
61118 Bad Vilbel
Germany
Clonmel Healthcare Limited
Waterford Road
Gurtnafleur
E91 D768 Clonmel
Co. Tipperary
Ireland
Stada Arzneimittel GmbH
Muthgasse 36/2
Doebling
1190 Vienna
Austria
Centrafarm Services B.V.
Van de Reijtstraat 31 E
4814 NE Breda
The Netherlands

For further information about this medicine, please contact the local representative of the marketing authorisation holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Austria Macitentan STADA 10 mg Filmtabletten
Belgium Macitentan EG 10 mg filmomhulde tabletten
Denmark Macitentan STADA
Finland Macitentan STADA 10 mg kalvopäällysteiset tabletit
Spain Macitentan STADA 10 mg comprimidos recubiertos con película EFG
The Netherlands Macitentan CF 10 mg, filmomhulde tabletten
Ireland Macitentan Clonmel 10 mg film-coated tablets
Iceland Macitentan STADA 10 mg filmuhúðaðar töflur
Luxembourg Macitentan EG 10 mg comprimés pelliculés
Malta Macitentan Clonmel 10 mg film-coated tablets
Germany Macitentan STADA 10 mg Filmtabletten
Norway Macitentan STADA
Portugal Macitentano Stada
Romania Macitentan Stada 10 mg comprimate filmate
Slovakia Macitentan STADA 10 mg filmom obalené tablety
Sweden Macitentan STADA
Hungary Macitentan Stada 10 mg filmtabletta
Italy Macitentan EG