Macitentan sandoz

Macitentan Sandoz, 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, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
• If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Macitentan Sandoz is and what it is used for
2. Important information 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 (FC) II to III
• in children under 18 years of age with a 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 to treat PAH. PAH is high blood pressure in the blood vessels that carry 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 Sandoz dilates the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure, alleviates symptoms, and improves disease progression.

2. Important information before taking Macitentan Sandoz

When not to take Macitentan Sandoz

• if the patient is allergic to macitentan, soya, 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 liver enzyme activity in the blood. The patient should inform their doctor – the doctor will decide whether this medicine is suitable for them.

If any of the above contraindications apply to the patient, they should
inform their doctor.
Warnings and precautions
Before starting treatment with Macitentan Sandoz, discuss this with your doctor or
pharmacist.
Blood tests must be performed as recommended by the doctor:
Your doctor will order blood tests before starting treatment with Macitentan Sandoz
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/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-coloured 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 are observed.
If the patient has kidney disease, they should inform their doctor before starting treatment with
Macitentan Sandoz. Macitentan may cause a greater drop in blood pressure
and reduced haemoglobin levels in patients with kidney disease.
In patients with pulmonary veno-occlusive disease (PVOD), treatment with PAH medicines, including Macitentan Sandoz, may
lead to pulmonary oedema.
If symptoms of pulmonary oedema occur during treatment with Macitentan Sandoz, such as sudden worsening of breathlessness and low oxygen levels, the patient should 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 Sandoz 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 Sandoz may affect the action of other medicines.
When taking Macitentan Sandoz together with other medicines, including those listed below, the effect of Macitentan Sandoz 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 medicine used to treat depression),
• ritonavir and saquinavir (used in HIV therapy),
• 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 Sandoz with food If the patient takes piperine as a dietary supplement, it may alter the body's response to certain medicines, including Macitentan Sandoz. 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 child, she should consult her doctor before taking this medicine.
Macitentan Sandoz may cause birth defects in unborn children conceived before, during,
or shortly after completion of therapy.

• If the patient may become pregnant, she must use an effective method of contraception during treatment with Macitentan Sandoz.
  Discuss this with the doctor.

• Do not take Macitentan Sandoz if the patient is pregnant or planning to have a child.

• If the patient becomes pregnant during treatment with Macitentan Sandoz, suspects she may be pregnant, or becomes pregnant shortly after stopping Macitentan Sandoz (within one month), she should immediately contact her doctor.

If the patient is of childbearing age, the doctor will request a pregnancy test before starting Macitentan Sandoz and regular repeat tests (once a month) during treatment with Macitentan Sandoz.
It is not known whether Macitentan Sandoz passes into human milk. Breastfeeding is not recommended during treatment with Macitentan Sandoz. Discuss this with the doctor.
Fertility
In men, taking Macitentan Sandoz may result in reduced sperm count. Discuss any questions or concerns with the doctor.
Driving and operating machinery
Macitentan Sandoz may cause adverse effects such as headache and low blood pressure (listed in section 4). Symptoms of the disease may also impair the ability to drive or operate machinery.
Macitentan Sandoz contains lactose, soya lecithin, and sodium
Macitentan Sandoz contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before starting this medicine.
Macitentan Sandoz contains lecithin derived from soya. If the patient is allergic to soya or peanuts, this medicine must not be used (see section 2 "When not to take Macitentan Sandoz").
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit, meaning the medicine is considered "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.
This medicine should always be taken exactly as directed by the physician. If in doubt, consult your doctor.

Adults and children under 18 years of age with body weight of at least 40 kg
The recommended dose of Macitentan Sandoz is one 10 mg tablet once daily. The whole tablet should be swallowed with a glass of water; do not chew or split the tablet.
If a patient is unable to swallow the tablets whole, alternative commercially available pharmaceutical forms containing macitentan should be used.
Macitentan Sandoz can 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, lower-strength tablets for oral suspension are available under different trade names.

Taking more Macitentan Sandoz than recommended
If more tablets than recommended are taken, headache, nausea or vomiting may occur. Contact your doctor immediately.

If you forget to take Macitentan Sandoz
If a dose of Macitentan Sandoz 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 the missed tablet.

Stopping Macitentan Sandoz
Macitentan Sandoz is a medicine that must be taken continuously to reduce symptoms of PAH. Do not stop taking Macitentan Sandoz 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 they do not occur in everyone.
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 affect more than 1 in 10 people)

• anaemia (low number of red blood cells) or decreased haemoglobin concentration
• headache
• bronchitis (inflammation of the airways)
• nasopharyngitis (inflammation of the nasal and throat mucous membranes)
• oedema (swelling), especially in the ankle joints and feet.

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

• pharyngitis (inflammation of the throat)
• influenza (flu)
• 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)
• 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 very commonly observed in children are: upper respiratory tract infection (infection of the nose, sinuses or throat) 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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 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 stated on the carton and blister after "EXP". The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Package contents and other information

What the medicine contains
Macitentan Sandoz

• The active substance is macitentan. Each coated tablet contains 10 mg of macitentan.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, poloxamer, povidone K-30, sodium stearyl fumarate, polyvinyl alcohol partially hydrolysed, titanium dioxide (E 171), talc, soya lecithin and xanthan gum.

What Macitentan Sandoz looks like and contents of the pack
Macitentan Sandoz 10 mg film-coated tablets are round, biconvex, white to off-white film-coated tablets, embossed with "L" on one side and "11" on the other side. Diameter approximately 5.4 mm.
Macitentan Sandoz is available in blisters in cardboard boxes containing 15 or 30 tablets, or in perforated unit-dose blisters in cardboard boxes containing 15 x 1 or 30 x 1 tablet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
Tel. 22 209 70 00
Manufacturer/Importer
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben
Germany
This medicine is authorised in the European Economic Area countries under the following names:
AT Macitentan Sandoz 10 mg – Filmtabletten
BE Macitentan Sandoz 10 mg filmomhulde tabletten / Macitentan Sandoz 10 mg comprimés / Macitentan Sandoz 10 mg Filmtabletten
CY Macitentan Sandoz
DE Macitentan - 1 A Pharma 10 mg Filmtabletten
DK Macitentan Sandoz
EL Macitentan/Sandoz
ES Macitentan Sandoz 10 mg comprimidos recubiertos con película EFG
FI Macitentan Sandoz 10 mg tabletti kalvopäällysteinen
HU Macitentan Sandoz 10 mg filmtabletta
IE Macitentan Rowex 10 mg film-coated tablets
IT Macitentan Sandoz
MT Macitentan Sandoz 10 mg film-coated tablets
NL Macitentan Sandoz 10 mg, filmomhulde tabletten
NO Macitentan Sandoz
PL Macitentan Sandoz
PT Macitentano Sandoz 10 mg Comprimido revestido por película
SE Macitentan Sandoz