Macitentan tzf

Macitentan TZF, 10 mg, film-coated tablets
Macitentanum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If in doubt, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

1. What Macitentan TZF is and what it is used for
2. Important information before taking Macitentan TZF
3. How to take Macitentan TZF
4. Possible side effects
5. How to store Macitentan TZF
6. Contents of the pack and other information

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

Macitentan TZF contains the active substance macitentan, which belongs to a group of medicines called "endothelin receptor antagonists".
Macitentan TZF 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 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 PAH therapy. 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 TZF dilates the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure, alleviates symptoms, and improves the course of the disease.

2. Important information before taking Macitentan TZF

When not to take Macitentan TZF

• 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, planning to become pregnant, or may become pregnant because she is not using an effective method of birth control (contraception). See information in the section "Pregnancy and breastfeeding";
• during breastfeeding; please read the information in the section "Pregnancy and breastfeeding";
• if the patient has liver disease or very high liver enzyme activity in the blood. The patient should inform their doctor – the doctor will decide whether this medicine is suitable for the patient.

If any of the above contraindications apply to the patient, they must inform their doctor.
Warnings and precautions

Before starting treatment with Macitentan TZF, 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 TZF and during treatment to check:

• whether the patient has anemia (reduced number of red blood cells)
• whether the liver is functioning properly.

If the patient has anemia (reduced number of red blood cells), the following symptoms may occur:

• dizziness
• fatigue/poor well-being/weakness
• rapid heartbeat, palpitations
• paleness.

The patient should inform their 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-colored urine
• skin itching
• unusual tiredness or exhaustion (apathy or fatigue)
• flu-like symptoms (joint and muscle pain with fever).

The patient should immediately inform their doctor if any of the above symptoms occur.
If the patient has kidney disease, they must inform their doctor before starting treatment with Macitentan TZF. Macitentan may cause a greater drop in blood pressure and a decrease in hemoglobin concentration in patients with kidney disease.
In patients with pulmonary veno-occlusive disease (PVOD), treatment with PAH therapies, including Macitentan TZF, may lead to pulmonary edema.
If symptoms of pulmonary edema occur during treatment with Macitentan TZF, such as sudden worsening of breathlessness and low oxygen levels, the patient must immediately inform their doctor. The 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 TZF 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 TZF may affect the action of other medicines.
If Macitentan TZF is taken together with other medicines, including those listed below, the effect of Macitentan TZF or other medicines may change. The patient should inform their doctor or pharmacist if they are 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 and 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 conditions).

Taking Macitentan TZF with food
If the patient takes piperine as a dietary supplement, it may alter the body’s response to certain medicines, including Macitentan TZF. In such a case, the patient should consult their doctor or pharmacist.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before taking this medicine.
Macitentan TZF 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 birth control (contraception) during treatment with Macitentan TZF. Discuss this with the doctor.
• Macitentan TZF must not be taken if the patient is pregnant or planning to become pregnant.
• If the patient becomes pregnant during treatment with Macitentan TZF, suspects she may be pregnant, or becomes pregnant within one month after stopping treatment with Macitentan TZF, she should immediately contact her doctor.

If the patient is of childbearing age, the doctor will request a pregnancy test before starting Macitentan TZF and will require regular testing (once a month) during treatment with Macitentan TZF.
It is not known whether Macitentan TZF passes into human breast milk. Breastfeeding is not recommended during treatment with Macitentan TZF. Discuss this with the doctor.
Fertility
In men, taking Macitentan TZF may result in a reduced sperm count. Discuss any questions or concerns with the doctor.
Driving and operating machinery
Macitentan TZF may cause adverse effects such as headache and low blood pressure (listed in section 4). Additionally, symptoms of the disease may also impair the ability to drive or operate machinery.
Macitentan TZF contains lactose and sodium
Macitentan TZF contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Macitentan TZF

Macitentan TZF may only be prescribed by a physician experienced in the treatment of pulmonary arterial hypertension.
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, consult your doctor.

Adults and children under 18 years of age with body weight of at least 40 kg
The recommended dose of Macitentan TZF is one 10 mg tablet once daily. Swallow the tablet whole with a glass of water; do not chew or split the tablet. Macitentan TZF can be taken with or without food. It is best to take the medicine at the same time each day.

For children weighing less than 40 kg, other pharmaceutical formulations may be available. Your doctor will recommend the appropriate dosage.

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

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

Stopping Macitentan TZF
Macitentan TZF is a medicine that must be taken continuously to reduce PAH symptoms. Do not stop taking Macitentan TZF 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 everyone will experience them.
Uncommon serious adverse reactions (may occur in up to 1 in 100 people)

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

Very common adverse reactions (may occur in 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)
• pharyngitis (inflammation of the mucous membranes of the nose and throat)
• oedema (swelling), particularly in the ankle joints and feet.

Common adverse reactions (may occur in up to 1 in 10 people)

• sore throat
• influenza
• urinary tract infection (bladder infection)
• hypotension (low blood pressure)
• nasal mucosal oedema (nasal congestion)
• elevated liver function test results
• leucopenia (reduced number of white blood cells)
• thrombocytopenia (reduced number of platelets)
• redness, especially of the face (skin flushing)
• increased uterine bleeding.

Adverse reactions in children and adolescents
The adverse reactions listed above may also occur in children. Additional adverse reactions frequently observed in children include: upper respiratory tract infection (infection of the nose, sinuses or throat), rhinitis (nasal itching, runny or blocked nose), and gastritis and enteritis (inflammation 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 Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 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 TZF

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the blister after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Macitentan TZF contains

• The active substance is macitentan. Each tablet contains 10 mg of macitentan.
• The other ingredients are: lactose monohydrate (see section 2 “Macitentan TZF contains lactose and sodium”), microcrystalline cellulose (E460i), sodium carboxymethyl starch (type A), povidone (K29/32), polysorbate 80 (E433), magnesium stearate (E572), Opadry White, polyvinyl alcohol (partially hydrolysed) (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type I) and sodium lauryl sulphate.

What Macitentan TZF looks like and contents of the pack
Macitentan TZF 10 mg film-coated tablets are white to off-white, round tablets,
with the imprint “C” on one side and “1S” on the other side.
Macitentan TZF 10 mg film-coated tablets are supplied in blisters containing 30 tablets
or in unit dose blisters containing 30 x 1 tablets.
Marketing Authorisation Holder
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: (22) 811-18-14
Manufacturer
Coripharma ehf.
Reykjavikurvegur 78-80
220 Hafnarfjörður
Iceland
This medicinal product is authorised in the European Economic Area member states under the following names:
Iceland Macitentan TZF
Poland Macitentan TZF
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder: