Macitentan Sandoz

Package leaflet: Information for the patient

Macitentan Sandoz 10 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 pass it on 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Macitentan Sandoz contains the active substance macitentan, which belongs to a group of medicines called "endothelin receptor antagonists".
Macitentan Sandoz 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 may be used alone or in combination with other medicines for the treatment of the disease. 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 Sandoz widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure in the pulmonary circulation, relieves symptoms, and improves the course of the disease.

2. What you should know before taking Macitentan Sandoz

Do not take Macitentan Sandoz:

• if you are allergic to macitentan, 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 could become pregnant because you are not using an effective method of birth control (contraception). See section “Pregnancy and breastfeeding”;
• if you are breastfeeding. See section “Pregnancy and breastfeeding”;
• if you have liver disease or have 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 Sandoz:
You will need to have blood tests as directed by your doctor:
Your doctor will prescribe blood tests before starting treatment with Macitentan Sandoz and during treatment to check:

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

If you suffer from anaemia (low 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 functioning 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 exhaustion (lethargy or 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 Sandoz. Macitentan may cause a reduction in blood pressure and lower haemoglobin levels in patients with kidney problems.
In patients with pulmonary veno-occlusive disease (blockage of the pulmonary veins), the use of medicines for the treatment of pulmonary arterial hypertension, including Macitentan Sandoz, may lead to pulmonary oedema. If you develop signs of pulmonary oedema while taking Macitentan Sandoz, 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 administer this medicine to children under 2 years of age, as efficacy and safety have not been established.
Other medicines and Macitentan Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Macitentan Sandoz may affect other medicines.
If you take Macitentan Sandoz together with other medicines, including those listed below, the effect of Macitentan Sandoz 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 (for treatment of high blood pressure or certain heart conditions).

Macitentan Sandoz with food
If you take piperine as a dietary supplement, it may alter how your body responds to certain medicines, including Macitentan Sandoz. Inform your doctor or pharmacist if this applies to you.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Macitentan Sandoz 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 Sandoz. Discuss this with your doctor.
• Do not take Macitentan Sandoz if you are pregnant or planning to become pregnant.
• If you become pregnant or suspect you are pregnant during treatment with Macitentan Sandoz or shortly after stopping it (within one month), contact your doctor immediately. If you are a woman of childbearing potential, your doctor will require a pregnancy test before starting Macitentan Sandoz and will repeat it regularly (once a month) during treatment.

It is not known whether macitentan passes into breast milk. Do not breastfeed while taking Macitentan Sandoz. Inform your doctor if you are breastfeeding.
Fertility
If you are a man taking Macitentan Sandoz, this medicine may reduce sperm count. Talk to your doctor if you have any questions or concerns about this.
Driving and using machines
Macitentan Sandoz 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 Sandoz contains lactose, soy lecithin, and sodium
Macitentan Sandoz contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Macitentan Sandoz contains lecithin derived from soy. If you are allergic to soy or peanuts, do not use this medicine (see section 2 “Do not take Macitentan Sandoz”).
This medicine contains less than 1 mmol of sodium (23 mg) per dosage unit, i.e., essentially “sodium-free”.

3. How to take Macitentan Sandoz

Macitentan Sandoz 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 Sandoz is one 10 mg tablet once daily. Swallow the whole tablet with a glass of water, without chewing or breaking the tablet. If you are unable to swallow the tablets whole, you should use other macitentan-containing pharmaceutical forms available on the market.

Macitentan Sandoz 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, dispersible macitentan tablets with lower dosage strengths under different brand names are available.

If you take more Macitentan Sandoz than you should
If you have taken more tablets than instructed, you may experience headache, nausea, or vomiting. Seek advice from your doctor.

If you forget to take Macitentan Sandoz
If you forget to take Macitentan Sandoz, take a 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 forgotten tablet.

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

If you have any questions about the use of 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.
Serious 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)

• 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 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)
• Changes in 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 very common side effects observed in children include upper respiratory tract infection (infection of the sinuses or throat) and gastroenteritis (inflammation of the stomach and intestines). Rhinitis (itchy, runny or blocked nose) has been commonly observed in children.
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 Sandoz

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 carton and blister after "Exp.".
The expiry date refers to the last day of that month.
This medicine requires no 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 Sandoz contains

• The active substance is macitentan. Each film-coated tablet contains 10 mg of macitentan.

The other components are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, poloxamer,
povidone, sodium stearyl fumarate, partially hydrolysed polyvinyl alcohol, titanium dioxide, talc, soya lecithin and xanthan gum.
Description of the appearance of Macitentan Sandoz and package contents
Macitentan Sandoz 10 mg tablets are film-coated tablets, white to off-white, round, biconvex, imprinted with “L” on one side and “11” on the other, with a diameter of approximately 5.4 mm.
Macitentan Sandoz is available in blisters of 15 or 30 film-coated tablets or in unit-dose divisible blisters of 15 x 1 or 30 x 1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Macitentan Sandoz 10 mg filmtabletten
Belgium Macitentan Sandoz 10 mg filmomhulde tabletten
Cyprus Macitentan Sandoz
Denmark Macitentan Sandoz
Finland Macitentan Sandoz 10 mg tabletti kalvopäällysteinen
Germany Macitentan - 1 A Pharma 10 mg filmtabletten
Greece Macitentan/Sandoz
Ireland Macitentan Rowex 10 mg film-coated tablets
Italy Macitentan Sandoz
Malta Macitentan Sandoz 10 mg film-coated tablets
Netherlands Macitentan Sandoz 10 mg, filmomhulde tabletten
Poland Macitentan Sandoz
Norway Macitentan Sandoz
Portugal Macitentano Sandoz 10 mg comprimido revestido por película
Spain Macitentan Sandoz 10 mg comprimidos recubiertos con película EFG
Sweden Macitentan Sandoz
Hungary Macitentan Sandoz 10 mg filmtabletta