Macitentan Teva

Package leaflet: Information for the user

Macitentan Teva 10 mg film-coated tablets

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

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

Macitentan Teva tablets contain the active substance macitentan, which belongs to a class of medicines called "endothelin receptor antagonists".
Macitentan Teva 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 may 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 Teva 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 progression of the disease.

2. What you need to know before taking Macitentan Teva

Do not take Macitentan Teva

• if you are allergic (hypersensitive) 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 pregnancy may occur 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. 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 Teva.
You will need to have blood tests as directed by your doctor
Your doctor will prescribe blood tests before starting treatment with Macitentan Teva 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
• tiredness/malaise/weakness
• increased heart rate, palpitations
• paleness

If you notice any of these signs, speak with your doctor.
Signs of impaired liver function include:

• nausea
• vomiting
• fever
• stomach (abdominal) pain
• yellowing of the skin or 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 notice any of these signs, inform your doctor immediately.
If you have kidney problems, inform your doctor before using Macitentan Teva. Macitentan may cause a reduction in blood pressure and lower haemoglobin levels in patients with kidney problems.
In patients with pulmonary veno-occlusive disease (obstruction of the pulmonary veins), the use of medicines for the treatment of pulmonary arterial hypertension, including Macitentan Teva, may lead to pulmonary oedema. If you experience signs of pulmonary oedema while taking Macitentan Teva, such as a sudden and significant worsening of breathing difficulty and reduced oxygen levels, speak with 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 its efficacy and safety have not been established.
Other medicines and Macitentan Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Macitentan Teva can affect other medicines.
If you take Macitentan Teva together with other medicines, including those listed below, the effect of Macitentan Teva 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 (used to treat high blood pressure or certain heart conditions).

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

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

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

3. How to take Macitentan Teva

Macitentan Teva 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 Teva is one 10 mg tablet once daily. Swallow the
tablet whole with a glass of water, without chewing or breaking the tablet. You may take
Macitentan Teva with or without food. It is preferable to take the tablet at the same time
each day.
For children weighing less than 40 kg, macitentan is available in lower-dose dispersible tablets under different brand names.
If you take more Macitentan Teva than you should
If you have taken more tablets than you were told to take, you may experience headache,
nausea, and vomiting. Contact your doctor for advice.
If you forget to take Macitentan Teva
If you forget to take Macitentan Teva, take a dose as soon as you remember, then continue
taking your tablets at the usual time. Do not take a double dose to make up for the forgotten
tablet.
If you stop taking Macitentan Teva
Macitentan Teva is a treatment that you must continue taking to control pulmonary arterial
hypertension. Do not stop treatment with Macitentan Teva 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 everybody gets them.
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, contact 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 side effects commonly observed in children include upper respiratory tract infection (infection of the sinuses or throat), rhinitis (itchy, runny or blocked nose), and gastroenteritis (inflammation of the stomach and intestines).
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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister or bottle after "Exp.". The expiry date refers to the last day of that month.
Blister packs: Store below 30 °C.
Bottles: 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 Teva contains

• The active substance is macitentan. Each film-coated tablet contains 10 mg of macitentan.
• The other components are: tablet core: mannitol, microcrystalline cellulose, povidone K-30, sodium starch glycolate (type A), magnesium stearate. Film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), PEG 3350 (E1521), talc (E533b).

Description of the appearance of Macitentan Teva and package contents
White, round, film-coated tablet, marked with "TV" on one side and "J7" on the opposite side.
The diameter of the tablets is approximately 5 mm.
Macitentan Teva is available in blisters containing 30, 60 or 120 film-coated tablets, in perforated, divisible unit-dose blisters containing 30 x 1 film-coated tablets, or in a bottle (with desiccant) containing 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia s.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano, Italy

Manufacturer
Balkanpharma-Dupnitsa AD
3, Samokovsko Shosse Str.,
2600 Dupnitsa, Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Macitentan ratiopharm 10 mg Filmtabletten
Belgium: Macitentan Teva 10 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Bulgaria: Мацитентан Тева 10 mg филмирани таблетки (Macitentan Teva 10 mg film-coated tablets)
Croatia: Macitentan Teva 10 mg filmom obložene tablete
Denmark: Macitentan Teva
Germany: Macitentan-ratiopharm 10 mg Filmtabletten
Ireland: Macitentan Teva 10 mg film-coated tablets
Iceland: Macitentan Teva
Italy: Macitentan Teva
Luxembourg: Macitentan-ratiopharm 10 mg Filmtabletten
Norway: Macitentan Teva
Netherlands: Macitentan Teva 10 mg, filmomhulde tabletten
Poland: Macitentan Teva
Portugal: Macitentano Teva
Romania: Macitentan Teva 10 mg comprimate filmate
Czech Republic: Macitentan Teva
Spain: Macitentan Teva 10 mg comprimidos recubiertos con pelicula EFG
Sweden: Macitentan Teva
Slovakia: Macitentan Teva 10 mg
Hungary: Macitentan Teva 10 mg filmtabletta