MACITENTAN 10 mg Film-Coated Tablets

Зміст інструкції

1. Macitentan Tecnigen 10 mg film-coated tablets
   1. What is Macitentan Tecnigen and what it is used for
   2. What you need to know before taking Macitentan Tecnigen
   3. How to take Macitentan Tecnigen
2. Macitentan Tecnigen can only be prescribed by a doctor experienced in the treatment
   1. Possible side effects
   2. How to store Macitentan Tecnigen
   3. Contents of the pack and other information

Macitentan Tecnigen 10 mg film-coated tablets

macitentan

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Macitentan Tecnigen and what it is used for

Macitentan Tecnigen tablets contain macitentan which belongs to the category of
medicines called “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 and weighing at least 40 kg in WHO functional class II or III.

It can be used alone or with other medicines for the treatment of the disease.
Pulmonary arterial hypertension is characterized by high 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 narrow and the heart has to work harder to
pump blood through them. This results in a feeling of fatigue, dizziness and difficulty
breathing.
Macitentan Tecnigen 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 course of the disease.

2. What you need to know before taking Macitentan Tecnigen

Do not take Macitentan Tecnigen

• if you are allergic to macitentan or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, planning a pregnancy, or if there is a possibility of becoming pregnant as you are not using effective contraception (contraceptive). See section “Pregnancy and breastfeeding”;
• if you are breastfeeding. See section “Pregnancy and breastfeeding”;
• if you have a liver disease, or if you have very high levels of liver enzymes in your blood. Talk to your doctor, who will decide if 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 undergo blood tests as directed by your doctor
Your doctor will prescribe blood tests before starting treatment with Macitentan Tecnigen
and during treatment to check:

• if you suffer from anemia (low red blood cell count);
• if your liver is functioning properly.

If you suffer from anemia (low red blood cell count), 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 the liver may not be functioning properly:

• nausea,
• vomiting,
• fever,
• stomach (abdominal) pain,
• yellowing of the skin and the whites of the eyes (jaundice),
• dark urine,
• skin itching,
• unusual fatigue or exhaustion (lethargy or fatigue)
• flu-like syndrome (joint and muscle pain with fever)

If you observe any of these symptoms, inform your doctor immediately.
If you have kidney problems, inform your doctor before using Macitentan Tecnigen. Macitentan can
lead to a reduction in blood pressure and a decrease in hemoglobin 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,
can lead to pulmonary edema. If you experience signs of pulmonary edema when using Macitentan
Tecnigen, such as a sudden and significant increase in difficulty breathing and a decrease in
oxygen levels, talk to your doctor immediately.
The doctor may perform further tests to determine which treatment regimen is most
suitable for you.

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

Other medicines and Macitentan Tecnigen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. Macitentan Tecnigen can affect other medicines.
If you take Macitentan Tecnigen together with other medicines, including those listed below, the effect of
Macitentan Tecnigen or the other medicines may be altered. Tell 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 seizures),
• carbamazepine (used for depression and epilepsy),
• St. John's wort (herbal preparation used for depression),
• ritonavir, saquinavir (used in HIV infection),
• nefazodone (used in depression),
• ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used against fungal infections),
• amiodarone (to control heartbeat),
• cyclosporine (used in preventing organ rejection after a transplant),
• diltiazem, verapamil (for the treatment of high blood pressure or certain heart problems).

Macitentan Tecnigen with food
If you are taking piperine as a dietary supplement, this may alter the way
the body responds to some medicines, including Macitentan Tecnigen. Tell your doctor or
pharmacist if this is the case.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
Macitentan Tecnigen can harm the unborn child who has been conceived before, during or immediately after
treatment.

• If there is a possibility of becoming pregnant, use an effective method of birth control (contraception) during treatment with Macitentan Tecnigen. Talk to your doctor.
• Do not take Macitentan Tecnigen if you are pregnant or planning a pregnancy.
• If you become pregnant or suspect you are pregnant during treatment with Macitentan Tecnigen or shortly after stopping taking Macitentan Tecnigen (within one month), contact your doctor immediately.

If you are a woman of childbearing potential, your doctor will ask you to take a pregnancy test before
starting to take Macitentan Tecnigen and then have further tests at regular intervals (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 and are taking Macitentan Tecnigen, it is possible that this medicine may reduce
sperm count. Talk to your doctor if you have any questions or concerns about this.

Driving and operating machinery
Macitentan Tecnigen can cause side effects such as headache and hypotension (listed in
section 4), and also the symptoms of the disease may make you less fit to drive.

Macitentan Tecnigen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say
essentially "sodium-free".

3. How to take Macitentan Tecnigen

Macitentan Tecnigen can only be prescribed by a doctor experienced in the treatment

of pulmonary arterial hypertension.
Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor.

Adults and children aged under 18 years with a body weight of at least 40 kg
The recommended dose of Macitentan Tecnigen is one 10 mg tablet, once a day.
Swallow the entire tablet with a glass of water, without chewing or breaking the tablet.
Macitentan Tecnigen can be taken 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 you were told to take, you may experience headache,
nausea and vomiting. Ask your doctor for advice.

If you forget to take Macitentan Tecnigen
If you forget to take Macitentan Tecnigen, take a dose as soon as you remember and then
take the tablets at the usual times. Do not take a double dose to make up for a
missed tablet.

If you stop taking Macitentan Tecnigen
Macitentan Tecnigen is a treatment that you must continue to take to control pulmonary
arterial hypertension. Do not stop taking Macitentan Tecnigen unless this has been
agreed 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.

Rare serious side effects(may affect 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)

• Anemia (reduced number of red blood cells) or reduced hemoglobin concentration.
• 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 1 in 10 people)

• Pharyngitis (inflammation of the throat).
• Influenza.
• Urinary tract infection (bladder infection).
• Hypotension (low blood pressure).
• Nasal congestion (stuffy nose).
• Abnormal liver tests.
• Leukopenia (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 can also be observed in children. Further side effects commonly
observed in children include upper respiratory tract infections (sinus or throat infection), rhinitis
(itchy, runny or stuffy nose) and gastroenteritis (inflammation of the stomach and intestines).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use Macitentan Tecnigen after the expiry date which is stated on the package and on the blister
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 any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer need. These measures will help protect
the environment.

6. Contents of the pack and other information

What Macitentan Tecnigen contains

• The active ingredient is macitentan. Each tablet contains 10 mg of macitentan.
• The other ingredients 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), glyceryl monocaprylocaprate type I, sodium lauryl sulfate.

Description of the appearance of Macitentan Tecnigen and contents of the pack
Macitentan Tecnigen 10 mg tablets are round, film-coated tablets,
white.
Macitentan Tecnigen is available in 10 mg film-coated tablets in blisters of 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 Member States of the EEA under the following denominations:
Italy: Macitentan Tecnigen.
Portugal: Macitentano Tecnigen.
Spain: Macitentan Tecnigen 10 mg film-coated tablets EFG.