MACITENTAN 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Macitentan Teva 10 mg film-coated tablets
   1. What is Macitentan Teva 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

Macitentan Teva 10 mg film-coated tablets

Generic medicine

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 they have the same symptoms as you, 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 Teva is and what it is used for
• 2. What you need to know before you take 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 is Macitentan Teva and what it is used for

Macitentan Teva tablets contain the active substance macitentan, which belongs to the
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 can be used alone or with other medicines to treat 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, making it harder for the heart to pump blood through them.
This causes 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 course of the disease.

2. What you need to know before taking Macitentan Teva

Do not take Macitentan Teva

• 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 it is possible you could become pregnant unless you are using effective contraception (contraceptive). 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 if this medicine is suitable for you.

In any of these cases, tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Macitentan Teva.

You will need to undergo blood tests as directed by your doctor
Your doctor will prescribe blood tests before you start treatment with Macitentan Teva 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 symptoms may occur:

• dizziness
• tiredness/weakness/feeling unwell
• increased heart rate, palpitations
• paleness

If you notice any of these signs, talk to your doctor.
The signs of impaired liver function are:

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

If you observe any of these signs, tell your doctor immediately.
If you have kidney problems, tell your doctor before using Macitentan Teva. 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 Teva, can
lead to pulmonary edema. If you experience signs of pulmonary edema while using Macitentan Teva, such as
a sudden and significant increase in difficulty breathing and a decrease in oxygen, talk to your
doctor immediately. Your doctor may perform further tests to determine which
treatment regimen is most appropriate 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 Teva
Tell 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. 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 for depression),
• ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used against fungal infections),
• amiodarone (to control heartbeat),
• cyclosporine (used to prevent organ rejection after a transplant),
• diltiazem, verapamil (for the treatment of high blood pressure or certain heart problems).

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor for advice before taking this medicine.
Macitentan Teva can harm a developing baby who was conceived before, during or immediately after
treatment.

• If it is possible you could become pregnant, use effective contraception (birth control) during treatment with Macitentan Teva. Talk to your doctor.
• Do not take Macitentan Teva if you are pregnant or planning a pregnancy.
• If you become pregnant or suspect you may be pregnant while taking Macitentan Teva or shortly after stopping Macitentan Teva (within one month), contact your doctor immediately.

If you are a woman of childbearing potential, your doctor will ask you to have a pregnancy test before starting
to take Macitentan Teva and then have further tests at regular intervals (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. Talk to your doctor.

Fertility
If you are a man and are taking Macitentan Teva, this medicine may reduce sperm count. Talk to your doctor if you have any questions or concerns.

Driving and using machines
Macitentan Teva can cause side effects such as headache and hypotension (listed in section
4), and also the symptoms of the disease may make you less able to drive or operate
machinery.

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

3. How to take Macitentan Teva

Macitentan Teva can only be prescribed by a doctor experienced in the treatment of pulmonary arterial hypertension.
Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor.
Adults and children aged under 18 years weighing at least 40 kg
The recommended dose of Macitentan Teva is one 10 mg tablet, once a day. Swallow
the entire tablet with a glass of water, without chewing or breaking the tablet. You can take
Macitentan Teva with or without food. It is preferable to take the tablet at the same time of
day.
For children weighing less than 40 kg, macitentan is available in the form of dispersible tablets
at lower dosages with other 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. Ask 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 and then continue to
take the tablets at the usual time. Do not take a double dose to make up for a missed
tablet.

If you stop taking Macitentan Teva
Macitentan Teva is a treatment that you must continue to take to control pulmonary
arterial hypertension. Do not stop taking Macitentan Teva unless it 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.

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, 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 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 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 affect children. Further 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 (inflamed stomach and
intestines).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister or the
bottle after “Exp.”. The expiry date refers to the last day of that month.
Blisters: Store at a temperature below 30 °C.
Bottles: This medicine does not require any special storage conditions.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Macitentan Teva contains

• The active ingredient is macitentan. Each film-coated tablet contains 10 mg of macitentan.
• The other ingredients 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 Macitentan Teva and contents of the pack
Round, film-coated tablet of white color, with “TV” imprinted 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 blisters divisible for single doses 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

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Macitentan ratiopharm 10 mg Filmtabletten
Belgium: Macitentan Teva 10 mg film-coated tablets/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