Macitentan Tecnigen

Patient Information Leaflet

Macitentan Tecnigen 10 mg film-coated tablets

macitentan
Read all of this leaflet carefully before 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 their symptoms are the same as yours, as 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 Tecnigen is and what it is used for
2. What you need to know before taking Macitentan Tecnigen
3. How to take Macitentan Tecnigen
4. Possible side effects
5. How to store Macitentan Tecnigen
6. Contents of the pack and other information

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

Macitentan Tecnigen tablets contain macitentan, which belongs to a class of
medicines known as "endothelin receptor antagonists".
Macitentan Tecnigen 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 with a body weight of 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 feelings of fatigue, dizziness, and difficulty
breathing.
Macitentan Tecnigen 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 need to know before taking Macitentan Tecnigen

Do not take Macitentan Tecnigen

• 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 you may become pregnant 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 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 Tecnigen.
You will need to have blood tests as directed by your doctor
Your doctor will prescribe blood tests before starting treatment with Macitentan Tecnigen
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 signs 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:

• nausea,
• vomiting,
• fever,
• stomach (abdominal) pain,
• yellowing of the skin and whites of the eyes (jaundice),
• dark-coloured urine,
• skin itching,
• unusual tiredness or lethargy (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 Tecnigen. Macitentan may
cause a drop in blood pressure and reduce 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 Tecnigen,
may lead to pulmonary oedema. If you develop signs of pulmonary oedema while taking Macitentan
Tecnigen, such as a sudden and significant worsening of breathlessness 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 administer this medicine to children under 2 years of age, as efficacy and safety have not been established.
Other medicines and Macitentan Tecnigen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Macitentan Tecnigen may affect other medicines.
If you take Macitentan Tecnigen together with other medicines, including those listed below, the effect of Macitentan Tecnigen or of 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 (herbal remedy 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 Tecnigen with food
If you take piperine as a dietary supplement, it may alter how your body responds to certain medicines, including Macitentan Tecnigen. Inform your doctor or pharmacist if this applies to you.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Macitentan Tecnigen 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 Tecnigen. Discuss this with your doctor.
• Do not take Macitentan Tecnigen if you are pregnant or planning to become pregnant.
• If you become pregnant or suspect you are pregnant during treatment with Macitentan Tecnigen or within one month after stopping Macitentan Tecnigen, contact your doctor immediately.

If you are a woman of childbearing potential, your doctor will require a pregnancy test before
starting Macitentan Tecnigen and will repeat the test regularly (once a month) during treatment with Macitentan Tecnigen.
It is not known whether Macitentan Tecnigen passes into breast milk. Do not breastfeed during treatment
with Macitentan Tecnigen. Inform your doctor immediately if you are breastfeeding.
Fertility
If you are a man taking Macitentan Tecnigen, this medicine may reduce sperm count. Talk to your doctor if you have any questions or concerns about this.
Driving and using machines
Macitentan Tecnigen 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.
Macitentan Tecnigen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Macitentan Tecnigen

Macitentan Tecnigen 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 with a body weight of at least 40 kg
The recommended dose of Macitentan Tecnigen is one 10 mg tablet once daily.
Swallow the tablet whole with a glass of water, without chewing or breaking the tablet.
Macitentan Tecnigen can be taken either on an empty stomach or with food. It is preferable to take the tablet at the same time each day.
If you take more Macitentan Tecnigen than you should
If you have taken more tablets than prescribed, you may experience headache, nausea, and vomiting. Seek advice from your doctor.
If you forget to take Macitentan Tecnigen
If you forget to take Macitentan Tecnigen, take a dose as soon as you remember, and then continue taking the tablets at your regular times. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Macitentan Tecnigen
Macitentan Tecnigen is a treatment that you must continue taking to control pulmonary arterial hypertension. Do not stop treatment with Macitentan Tecnigen unless agreed with your doctor.
If you have any questions about 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 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 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 (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 infections (sinus or throat infections), 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 . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Macitentan Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use Macitentan Tecnigen after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of that month.
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 need. These measures will help protect the environment.

6. Package contents and other information

What Macitentan Tecnigen contains

• The active substance is macitentan. Each tablet contains 10 mg of macitentan.
• The other components are:
  Tablet core: mannitol (type 160C), microcrystalline cellulose (type 101), crospovidone (type A), povidone (type K25), polysorbate 80, microcrystalline cellulose (type 302), magnesium stearate.
  Tablet coating (Opadry AMB 88A180040 white): polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate type I, sodium lauryl sulfate.

Description of the appearance of Macitentan Tecnigen and contents of the pack
The 10 mg tablets of Macitentan Tecnigen are white, film-coated, round tablets.
Macitentan Tecnigen is available as 10 mg film-coated tablets in blister packs containing 30 tablets.

Marketing Authorisation Holder
Farmoz – Sociedade Técnico Medicinal, S.A.
Rua da Tapada Grande 2, Abrunheira, 2710-228 Sintra, Portugal.

Manufacturer
Tecnimede - Sociedade Técnico-Medicinal S.A.
Quinta da Cerca, Caixaria, 2565-187 Dois Portos, Portugal.

This medicinal product is authorised in the EEA Member States under the following names:
Italy: Macitentan Tecnigen.
Portugal: Macitentano Tecnigen.
Spain: Macitentan Tecnigen 10 mg comprimidos recubiertos con película EFG.

This Patient Information Leaflet was last reviewed on