Macitentan Glenmark

Patient Information Leaflet

Macitentan Glenmark 10 mg film-coated tablets

Macitentan
Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Macitentan Glenmark contains the active substance macitentan, which belongs to a class of
medicines called "endothelin receptor antagonists".
Macitentan Glenmark is used in adults 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 may be used alone or in combination with other medicines for the treatment of pulmonary arterial
hypertension. Pulmonary arterial hypertension is characterized by high blood 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 become narrowed, making it harder for the heart to pump blood
through them. This leads to feelings of fatigue, dizziness, and shortness of breath.
Macitentan Glenmark 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 progression of the disease.

2. What you should know before taking Macitentan Glenmark

Do not take Macitentan Glenmark

• if you are allergic to macitentan, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, planning to become pregnant, or if you may become pregnant because you are not using an effective method of contraception. See section “Pregnancy and breastfeeding”;
• if you are breastfeeding. See section “Pregnancy and breastfeeding”;
• if you have liver disease or very high levels of liver enzymes in your blood. Talk to your doctor, who will decide whether 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 Glenmark.
You will need to have blood tests as directed by your doctor
Your doctor will prescribe blood tests before starting treatment with Macitentan Glenmark and during treatment to check:

• whether you have anaemia (reduced number of red blood cells)
• whether your liver is functioning properly

If you have anaemia (reduced number of red blood cells), the following symptoms 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 your liver is not working properly:

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

If you experience any of these symptoms, contact your doctor immediately.
If you have kidney problems, inform your doctor before using Macitentan Glenmark. Macitentan may lead to a reduction in blood pressure and decreased haemoglobin levels in patients with kidney problems.
In patients with pulmonary veno-occlusive disease (obstruction of the pulmonary veins), treatment with medicines for pulmonary arterial hypertension, including Macitentan Glenmark, may lead to pulmonary oedema. If you develop signs of pulmonary oedema while taking Macitentan Glenmark, such as a sudden and significant worsening of breathlessness and reduced oxygen levels, contact your doctor immediately. Your doctor may carry out further tests to determine the most appropriate treatment regimen for you.
Children and adolescents
Do not give this medicine to children under 2 years of age, as efficacy and safety have not been established.
Other medicines and Macitentan Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Macitentan Glenmark may affect other medicines.
If you take Macitentan Glenmark together with other medicines, including those listed below, the effect of Macitentan Glenmark or the other medicines may be altered. Inform 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 epileptic seizures),
• carbamazepine (used for depression and epilepsy),
• St John’s wort (a herbal preparation used for depression),
• ritonavir, saquinavir (used in HIV infection),
• nefazodone (used for depression),
• ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used to treat fungal infections),
• amiodarone (to control heart rhythm),
• cyclosporine (used to prevent organ rejection after transplantation),
• diltiazem, verapamil (used to treat high blood pressure or certain heart conditions).

Macitentan Glenmark with food
If you take piperine as a dietary supplement, it may alter how your body responds to certain medicines, including Macitentan Glenmark. Inform your doctor or pharmacist if this applies to you.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Macitentan Glenmark may harm the unborn child conceived before, during, or shortly after treatment.

• If you could become pregnant, use an effective method of birth control (contraception) during treatment with Macitentan Glenmark. Discuss this with your doctor.
• Do not take Macitentan Glenmark if you are pregnant or planning to become pregnant.
• If you become pregnant or suspect you are pregnant during treatment with Macitentan Glenmark or shortly after stopping Macitentan Glenmark (within one month), contact your doctor immediately.

If you are a woman of childbearing potential, your doctor will require you to take a pregnancy test before starting Macitentan Glenmark and then repeat it regularly (once a month) during treatment with Macitentan Glenmark.
It is not known whether Macitentan Glenmark passes into breast milk. Do not breastfeed during treatment with Macitentan Glenmark. Inform your doctor immediately if you are breastfeeding.
Fertility
If you are a man taking Macitentan Glenmark, this medicine may reduce sperm count. Talk to your doctor if you have any questions or concerns about this.
Driving and using machines
Macitentan Glenmark may cause side effects such as headache and hypotension (listed in section 4). Additionally, symptoms of the disease itself may impair your ability to drive or operate machinery.
Macitentan Glenmark contains lactose and soy lecithin
Macitentan Glenmark contains a sugar called lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Macitentan Glenmark contains lecithin derived from soy. If you are allergic to peanuts or soy, do not use this medicine (see section 2 “Do not take Macitentan Glenmark”).

3. How to take Macitentan Glenmark

Macitentan Glenmark may only be prescribed by a physician experienced in the treatment of pulmonary arterial hypertension.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

Adults and children under 18 years of age weighing at least 40 kg
The recommended dose of macitentan is one 10 mg tablet once daily. Swallow the tablet whole with a glass of water, without chewing or breaking the tablet. Macitentan Glenmark may be taken on an empty stomach or with food. It is preferable to take the tablet at the same time each day.

For children weighing less than 40 kg, a lower dose of macitentan is available in the form of dispersible tablets marketed under other brand names.

If you take more Macitentan Glenmark than you should
If you have taken more tablets than prescribed, you may experience headache, nausea, and vomiting. Seek advice from your doctor.

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

If you stop taking Macitentan Glenmark
Macitentan Glenmark is a treatment that you must continue taking to control pulmonary arterial hypertension. Do not stop treatment with Macitentan Glenmark unless agreed upon with your doctor.

If you have any doubts about how to use this medicine, consult 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 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)

• Anaemia (reduced number of red blood cells) or reduced haemoglobin concentration
• Headache
• Bronchitis (inflammation of the airways)
• Nasopharyngitis (inflammation of the throat and nasal passages)
• Oedema (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 (blocked nose)
• Abnormal liver function tests
• Leucopenia (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 may also occur in children. Additional 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 (inflammation of the stomach and intestines).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Glenmark

Keep this medicine out of the sight and reach of children.
Do not use Macitentan Glenmark after the expiry date stated on the carton and 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Macitentan Glenmark contains

• The active substance is macitentan. Each film-coated tablet contains 10 mg of macitentan.
• The other components are: monohydrate lactose (see section 2 "Macitentan Glenmark contains lactose and soy lecithin"), microcrystalline cellulose PH 101, crospovidone Type A, povidone K 30, polysorbate 80 (E433), magnesium stearate (E572), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), lecithin (soy) (E322) (see section 2 "Macitentan Glenmark contains lactose and soy lecithin") and xanthan gum (E415).

Description of the appearance of Macitentan Glenmark and contents of the pack
Macitentan Glenmark 10 mg tablets are white to off-white, biconvex, round, film-coated tablets with a diameter of 6 mm, marked with "10" on one side.
Macitentan Glenmark film-coated tablets are available in blister packs containing 30 film-coated tablets.
Macitentan Glenmark film-coated tablets are also available in unit-dose divisible blister packs containing 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31, 82194 Gröbenzell,
Germany
Manufacturer
KeVaRo Group Ltd.
9 Tzaritza Elenora Str., Office 23,
Sofia 1618, Bulgaria

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
IS Macitentan Glenmark
DK Macitentan Glenmark
SE Macitentan Glenmark
NO Macitentan Glenmark
DE Macitentan Glenmark 10 mg Filmtabletten
IT Macitentan Glenmark
FI Macitentan Glenmark
NL Macitentan Glenmark 10 mg filmomhulde tabletten
PT Macitentan Glenmark 10 mg comprimidos revestidos por película
ES Macitentan Glenmark 10 mg comprimidos recubiertos con película EFG