MACITENTAN 10 mg Tabletki Powlekane

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1. Macitentan Glenmark 10 mg film-coated tablets
   1. What is Macitentan Glenmark 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. Package contents and other information

Macitentan Glenmark 10 mg film-coated tablets

Macitentan

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Macitentan Glenmark and what it is used for

Macitentan Glenmark contains the active substance macitentan, which belongs to the category 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 can be used alone or with other medicines for the treatment of pulmonary arterial hypertension. Pulmonary arterial hypertension is characterized by high pressure in the blood vessels (pulmonary arteries) that carry blood from the heart to the lungs. In people with
pulmonary arterial hypertension, these arteries narrow, making it harder for the heart to pump
blood through them. This results in a feeling of fatigue, dizziness and difficulty breathing.
Macitentan Glenmark widens the pulmonary arteries, making it easier for the heart to pump
blood into the arteries. This lowers blood pressure in the
pulmonary circulation, relieves symptoms and improves the course of the disease.

2. What you need to know before taking Macitentan Glenmark

Do not take Macitentan Glenmark

• if you are allergic to macitentan, peanuts, soya or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, if you are planning a pregnancy, or if there is a possibility that you might become pregnant unless you are using effective contraception (contraceptive). See section “Pregnancy and breastfeeding”;
• if you are breastfeeding. See section “Pregnancy and breastfeeding”;
• if you have a liver disease, if you have very high levels of liver enzymes in your blood. Talk to your doctor, he will decide if 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 undergo blood tests as directed by your doctor
Your doctor will prescribe blood tests before starting treatment with Macitentan
Glenmark and during treatment to check:

• if you suffer from anemia (low red blood cell count)
• if your liver is functioning properly

If you suffer from anemia (low red blood cell count) the following symptoms may occur:

• dizziness, weakness/malaise/feeling unwell
• increased heart rate, palpitations
• paleness

If you notice any of these signs, talk to your doctor.
The following symptoms may indicate that the liver may not be functioning properly:

• nausea
• vomiting
• fever
• stomach (abdominal) pain
• yellowing of the skin and the white of your eyes (jaundice) dark urine
• skin itching
• unusual tiredness or fatigue (lethargy or exhaustion)
• flu-like syndrome (joint and muscle pain with fever).

If you observe any of these symptoms, tell your doctor immediately.
If you have kidney problems tell your doctor before using Macitentan Glenmark. Macitentan may
lead to a reduction in blood pressure and a decrease in hemoglobin in patients with
kidney problems.
In patients with pulmonary veno-occlusive disease (obstruction of the pulmonary veins), the use of
medicines for the treatment of pulmonary arterial hypertension, including Macitentan Glenmark,
may lead to pulmonary edema. If you experience signs of pulmonary edema when using Macitentan
Glenmark, such as a sudden and significant increase in difficulty breathing and a decrease in
oxygen, talk to your doctor immediately. The doctor may perform further tests to
determine which treatment regimen is most appropriate for you.

Children and adolescents
Do not give this medicine to children under 2 years of age, because 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 medicine.
Macitentan Glenmark can 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. Tell 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 seizures),
• carbamazepine (used for depression and epilepsy),
• St John's wort (herbal remedy used for depression),
• ritonavir, saquinavir (used in HIV infection),
• nefazodone (used in depression),
• ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used against fungal infections),
• amiodarone (to control heartbeat),
• cyclosporine (used in preventing organ rejection after a transplant),
• diltiazem, verapamil (for the treatment of high blood pressure or certain heart problems).

Macitentan Glenmark with food
If you take piperine as a dietary supplement, this may alter the way the body
responds to some medicines, including Macitentan Glenmark. Tell your doctor or pharmacist if
this is the case.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
Macitentan Glenmark can harm the unborn child who has been conceived before, during or immediately after
treatment.

• If there is a possibility that you might become pregnant, use an effective method of birth control (contraception) during treatment with Macitentan Glenmark. Talk to your doctor.
• Do not take Macitentan Glenmark if you are pregnant or planning a pregnancy.
• If you become pregnant or suspect you are pregnant during treatment with Macitentan Glenmark or shortly after stopping taking Macitentan Glenmark (within one month), contact your doctor immediately.

If you are a woman of childbearing potential, your doctor will ask you to take a pregnancy test before starting
to take Macitentan Glenmark and then have others at regular intervals (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. Tell your doctor immediately if you are breastfeeding.

Fertility
If you are a man and are 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 can cause side effects such as headache and hypotension (listed in
section 4), also the symptoms of the disease may make you less able to drive or
use machines.

Macitentan Glenmark contains lactose and soya lecithin
Macitentan Glenmark contains a sugar called lactose.
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before
taking this medicine.
Macitentan Glenmark contains lecithin derived from soya. If you are allergic to peanuts or soya do
not use this medicine (see section 2 “Do not take Macitentan Glenmark”).

3. How to take Macitentan Glenmark

Macitentan Glenmark can only be prescribed by a doctor experienced in the treatment of
pulmonary arterial hypertension.
Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor.
Adults and children over 18 years of age weighing at least 40 kg
The recommended dose of macitentan is one 10 mg tablet, once a day. Swallow
the entire tablet with a glass of water, without chewing or breaking the tablet. Macitentan
Glenmark can 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 dosage of macitentan is available, in the form of
dispersible tablets marketed under other brands.

If you take more Macitentan Glenmark than you should
If you have taken more tablets than you were told to take, you may experience headache,
nausea and vomiting. Ask your doctor for advice.

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

If you stop taking Macitentan Glenmark
Macitentan Glenmark is a treatment that you must continue to take to control pulmonary
arterial hypertension. Do not stop taking Macitentan Glenmark unless you have
agreed this with your doctor.
If you have any further questions on the use of this medicine, ask 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)

• Anemia (reduced number of red blood cells) or reduced hemoglobin concentration
• Headache
• Bronchitis (inflammation of the airways)
• Nasopharyngitis (inflammation of the throat and nasal passages)
• Edema (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 (stuffy nose)
• Abnormal liver function tests
• Leukopenia (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 can also affect children. Further 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 (inflamed stomach and
intestines).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and on the 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 any medicine in 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 ingredient is macitentan. Each film-coated tablet contains 10 mg of macitentan.
• The other ingredients are: lactose monohydrate (see section 2 “Macitentan Glenmark contains lactose and soya 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 (soya) (E322) (see section 2 “Macitentan Glenmark contains lactose and soya lecithin”) and xanthan gum (E415).

Description of the appearance of Macitentan Glenmark and package contents
Macitentan Glenmark 10 mg tablets are film-coated tablets, white to off-white in colour,
biconvex, round, with a diameter of 6 mm, and imprinted 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 available in divisible blister packs
for unit dose containing 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

MAH
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 with 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