Macitentan olpha

Macitentan Olpha, 10 mg, film-coated tablets
Macitentanum
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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, 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 Olpha is and what it is used for
2. Important information before taking Macitentan Olpha
3. How to take Macitentan Olpha
4. Possible side effects
5. How to store Macitentan Olpha
6. Contents of the pack and other information

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

Macitentan Olpha contains the active substance macitentan, which belongs to a group of medicines called "endothelin receptor antagonists".
Macitentan Olpha 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 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 Olpha widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure, decreases disease symptoms, and improves disease progression.

2. Important information before taking Macitentan Olpha

When not to take Macitentan Olpha

• if the patient is allergic to macitentan, soy, 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 effective 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 levels of liver enzymes in the blood. The patient should inform the doctor – the doctor will decide whether this medicine is suitable.

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

Warnings and precautions

Before starting treatment with Macitentan Olpha, discuss this with your doctor or pharmacist.

Blood tests are required as directed by the doctor:

The doctor will order blood tests before starting treatment with Macitentan Olpha 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 the 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;
• itching of the skin;
• unusual tiredness or exhaustion (lethargy or fatigue);
• flu-like symptoms (joint and muscle pain with fever).

The patient should immediately inform the doctor if any of the above symptoms occur.

If the patient has kidney disease, they should inform the doctor before starting treatment with Macitentan Olpha. Macitentan may cause a greater drop in blood pressure and a decrease in hemoglobin levels in patients with kidney disease.

In patients with pulmonary veno-occlusive disease (PVOD), treatment with PAH therapies, including Macitentan Olpha, may lead to pulmonary edema. If symptoms of pulmonary edema occur during treatment with Macitentan Olpha, such as sudden worsening of breathlessness and low oxygen levels, the patient should immediately inform the 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 Olpha 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 Olpha may affect the action of other medicines.

When Macitentan Olpha is taken together with other medicines, including those listed below, the effect of Macitentan Olpha or the other medicines may be altered. The patient should inform the 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 Olpha with food

If the patient takes piperine as a dietary supplement, it may alter the body's response to certain medicines, including Macitentan Olpha. In such a case, the patient should speak with their doctor or pharmacist.

Pregnancy, breastfeeding, and effects on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Macitentan Olpha may cause birth defects in unborn children conceived before, during, or shortly after treatment.

• If the patient may become pregnant, effective contraception must be used during treatment with Macitentan Olpha. Discuss this with the doctor.
• Macitentan Olpha should not be taken if the patient is pregnant or planning to become pregnant.
• If the patient becomes pregnant during treatment with Macitentan Olpha, suspects she may be pregnant, or becomes pregnant within one month after stopping Macitentan Olpha, she should contact her doctor immediately.

If the patient is of childbearing age, the doctor will require a pregnancy test before starting Macitentan Olpha and regular monthly tests during treatment.

It is not known whether macitentan passes into human milk. Breastfeeding is not recommended during treatment with Macitentan Olpha. Discuss this with the doctor.

Fertility

In men, taking Macitentan Olpha may result in reduced sperm count. Discuss any questions or concerns with the doctor.

Driving and using machines

Macitentan Olpha may cause adverse effects such as headache and low blood pressure (listed in section 4). Additionally, symptoms of the disease may also reduce the ability to drive or operate machinery.

Macitentan Olpha contains lactose, soy lecithin, and sodium

Macitentan Olpha contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before starting this medicine.

Macitentan Olpha contains lecithin derived from soy. If the patient is allergic to soy, this medicine must not be used (see section 2 "When not to take Macitentan Olpha").

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 Olpha

Macitentan Olpha may be prescribed only by a physician experienced in the treatment of
pulmonary arterial hypertension.
This medicine should always be taken exactly as the doctor has instructed. If in doubt,
consult the doctor.
Adults and children under 18 years of age with body weight of at least 40 kg
The recommended dose of Macitentan Olpha is one 10 mg tablet once daily. Swallow the tablet whole
with a glass of water; do not chew or split the tablet. Macitentan Olpha may be taken with or without food. It is best to take the tablets at the same time each day.
For children with body weight below 40 kg, oral suspension tablets with lower strength are available. The physician will recommend the appropriate dosage.
Taking more Macitentan Olpha than prescribed
If more tablets than recommended have been taken, symptoms such as headache, nausea, or
vomiting may occur. Contact the doctor immediately.
Missing a dose of Macitentan Olpha
If a dose of Macitentan Olpha is missed, take it as soon as remembered, then continue taking the tablets at the usual time. Do not take a double dose to make up for a missed tablet.
Stopping Macitentan Olpha
Macitentan Olpha is a medicine that should be taken continuously to reduce symptoms of PAH.
Do not stop taking Macitentan Olpha without consulting the doctor.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Uncommon serious adverse effects (may occur in no more than 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 effects (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), especially in the ankles and feet.

Common adverse effects (may occur in no more than 1 in 10 people):

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

Adverse effects in children and adolescents
The adverse effects listed above may also occur in children. Additional adverse effects very commonly observed in children include: upper respiratory tract infection (sinus or throat infection) and gastroenteritis (inflammation of the stomach and intestines). Nasal mucosal inflammation (itching, runny or blocked nose) has been frequently observed in children.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects may also be reported to the responsible entity.

5. How to store Macitentan Olpha

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the blister
after "EXP". The expiry date refers to the last day of the stated month.
There are no special storage requirements for this medicinal product.
Medicines must not be disposed of via the sewage system or in household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the
environment.

6. Contents of the package and other information

What Macitentan Olpha contains

• The active substance is macitentan. Each tablet contains 10 mg of macitentan.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, povidone, sodium starch glycolate (type A), magnesium stearate, polyvinyl alcohol (E1203), calcium carbonate (E170), talc (E553b), soy lecithin (E322) and xanthan gum (E415).

What Macitentan Olpha looks like and contents of the pack
Macitentan Olpha 10 mg film-coated tablets are white or almost white, round, biconvex,
film-coated tablets, embossed with the number "10" on one side and smooth on the other.
Macitentan Olpha 10 mg film-coated tablets are available in blister packs containing 15 or 30
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]
Manufacturer
Genepharm S.A.,
18th km Marathonos Avenue,
Pallini, 153 51,
Greece

This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names: