Macitentan teva

Macitentan Teva, 10 mg, film-coated tablets
macitentan

Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Macitentan Teva is and what it is used for
2. Important information 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 contains the active substance macitentan, which belongs to a group 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 (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 carrying 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 Teva widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers blood pressure, reduces symptoms and improves disease progression.

2. Important information before taking Macitentan Teva

When not to take Macitentan Teva

• 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 may become pregnant because she is not using effective contraception. See information in the section “Pregnancy and breastfeeding”;
• if the patient is 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.

Tell your doctor – your doctor will decide whether this medicine is suitable for you.
If any of the above contraindications apply to you, inform your doctor.
Warnings and precautions
Before starting treatment with Macitentan Teva, discuss this with your doctor or pharmacist.
Blood tests must be performed as directed by your doctor.
Your doctor will order blood tests before starting treatment with Macitentan Teva 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/malaise/weakness
• rapid heartbeat, palpitations
• paleness

Inform your 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 (apathy or fatigue)
• flu-like symptoms (joint and muscle pain with fever)

Contact your doctor immediately if any of the above symptoms are observed.
If the patient has kidney disease, inform the doctor before starting treatment with Macitentan Teva. Macitentan may cause a more pronounced drop in blood pressure and reduced haemoglobin levels in patients with kidney disease.
In patients with pulmonary veno-occlusive disease (PVOD), treatment with PAH therapies, including Macitentan Teva, may lead to pulmonary oedema.
If symptoms of pulmonary oedema occur during treatment with Macitentan Teva, such as sudden worsening of breathlessness and low oxygen levels, contact your doctor immediately. Your doctor may perform additional tests and decide which treatment is most appropriate for the patient.
Children and adolescents
This medicine should not be given to children under 2 years of age, as efficacy and safety have not been established.
Macitentan Teva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Macitentan Teva may affect the action of other medicines.
When taking 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 the patient is 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 (an herbal preparation used to treat depression)
• ritonavir, 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)

Taking Macitentan Teva with food
If the patient takes piperine as a dietary supplement, it may alter the body’s response to certain medicines, including Macitentan Teva. In such a case, consult your 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 using this medicine.
Macitentan Teva may cause birth defects in unborn children conceived before, during, or shortly after treatment.

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

If the patient is of childbearing age, the doctor will request a pregnancy test before starting Macitentan Teva and regular repeat tests (once a month) during treatment.
It is not known whether Macitentan Teva passes into breast milk. Breastfeeding is not recommended during treatment with Macitentan Teva. Discuss this with your doctor.
Fertility
In men, taking Macitentan Teva may result in reduced sperm count. Discuss any questions or concerns with your doctor.
Driving and using machines
Macitentan Teva may cause adverse effects such as headache and low blood pressure (listed in section 4). Also, symptoms of the disease may impair the ability to drive or operate machinery.
Macitentan Teva 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 Teva

Macitentan Teva may only be prescribed by a physician experienced in the treatment of pulmonary arterial hypertension.
This medicine should always be taken exactly as directed by the physician. If in doubt, consult the physician.

Adults and children under 18 years of age with body weight of 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; do not chew or split the tablet. Macitentan Teva may be taken with or without food. It is best to take the medicine at the same time each day.

For children with body weight below 40 kg, macitentan is available as orally disintegrating tablets with lower strength under different brand names.

If you take more Macitentan Teva than prescribed
If you take more tablets than prescribed, symptoms such as headache, nausea, or vomiting may occur. Contact your doctor immediately.

If you forget to take Macitentan Teva
If a dose of Macitentan Teva is missed, take the next dose as soon as you remember, then continue taking the tablets at your usual time. Do not take a double dose to make up for the missed tablet.

Stopping Macitentan Teva
Macitentan Teva is a medicine that must be taken continuously to reduce symptoms of PAH. Do not stop taking Macitentan Teva without consulting your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Uncommon adverse reactions (may affect no more than 1 in 100 people)

• Hypersensitivity reactions [swelling around the eyes, face, lips, tongue or throat, itching and/or rash]. If any of these symptoms occur, contact your doctor immediately.

Very common adverse reactions (may affect more than 1 in 10 people)

• Anaemia (low number of red blood cells) or decreased 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 adverse reactions (may affect no more than 1 in 10 people)

• Pharyngitis (inflammation of the throat)
• Influenza
• Urinary tract infection (bladder infection)
• Hypotension (low blood pressure)
• Nasal mucosal oedema (nasal congestion)
• Elevated liver function test results
• Leukopenia (reduced number of white blood cells)
• Thrombocytopenia (reduced number of platelets)
• Flushing, particularly of the face (skin redness)
• Increased uterine bleeding

Adverse reactions in children and adolescents
The adverse reactions listed above may also occur in children. Additional adverse reactions commonly observed in children include: upper respiratory tract infection (infection of the nose, sinuses or throat), rhinitis (nasal mucosal inflammation – itching, runny or blocked nose), and gastritis/enteritis (inflammatory condition of the stomach and intestines).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 the stated month.
Blister: Store below 30°C.
Bottle: No special requirements for storage.
Medicines must 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 Teva contains

• The active substance is macitentan. Each coated tablet contains 10 mg of macitentan.
• The other ingredients are: tablet core: mannitol, microcrystalline cellulose (type 101), povidone K-30, sodium carboxymethyl starch (type A), microcrystalline cellulose (type 102), magnesium stearate. Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E533b).

What Macitentan Teva looks like and contents of the pack
White, round, film-coated tablet, engraved with "TV" on one side and "J7" on the other side.
The diameter of the tablet is approximately 5 mm.
Macitentan Teva is available in blister packs containing 30, 60 or 120 film-coated tablets,
perforated unit dose blisters containing 30x1 film-coated tablets, or in a bottle (with a desiccant) containing 30 film-coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00
Manufacturer
Balkanpharma Dupnitsa AD
Samokovsko Shosse 3
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
Czech Republic Macitentan Teva
Denmark Macitentan Teva
Spain Macitentan Teva 10 mg comprimidos recubiertos con pelicula EFG
Netherlands Macitentan Teva 10 mg, filmomhulde tabletten
Ireland Macitentan Teva 10 mg film-coated tablets
Iceland Macitentan Teva
Luxembourg Macitentan-ratiopharm 10 mg Filmtabletten
Germany Macitentan-ratiopharm 10 mg Filmtabletten
Norway Macitentan Teva
Poland Macitentan Teva
Portugal Macitentano Teva
Romania Macitentan Teva 10 mg comprimate filmate
Sweden Macitentan Teva
Slovakia Macitentan Teva 10 mg
Hungary Macitentan Teva 10 mg filmtabletta
Italy Macitentan Teva