Opsumit
macitentan
macitentan
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Opsumit is and what it is used for
What you need to know before you take Opsumit
How to take Opsumit
Possible side effects
How to store Opsumit
Contents of the pack and other information
Opsumit contains the active substance macitentan, which belongs to the class of medicines called “endothelin receptor antagonists”.
Opsumit is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults; it can be used on its own or with other medicines for PAH. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to feel tired, dizzy, and short of breath.
Opsumit widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure, relieves the symptoms and improves the course of the disease.
if you are allergic to macitentan, soya or any of the other ingredients of this medicine (listed in section 6).
if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception). See section ‘Pregnancy and
breastfeeding’.
if you are breastfeeding. See section ‘Pregnancy and breastfeeding’.
if you have liver disease or if you have very high levels of liver enzymes in your blood. Talk to your doctor, who will decide whether this medicine is suitable for you.
If any of these apply to you, please tell your doctor.
Talk to your doctor or pharmacist before taking Opsumit.
Youwillneedbloodtests,asindicatedbyyourdoctor:
Your doctor will take blood test before you start treatment with Opsumit and during treatment to test:
whether you have anaemia (a reduced number of red blood cells)
whether your liver is working properly
If you have anaemia (a reduced number of red blood cells), you may have the following signs:
dizziness
fatigue/malaise/weakness
fast heart rate, palpitations
pallor
If you notice any of these signs, tell your doctor.
Signs that your liver may not be working properly include:
feeling sick (nausea)
vomiting
fever
pain in your stomach (abdomen)
yellowing of your skin or the whites of your eyes (jaundice)
dark-coloured urine
itching of your skin
unusual tiredness or exhaustion (lethargy or fatigue)
flu-like syndrome (joint and muscle pain with fever)
If you notice any of these signs, tell your doctor immediately.
If you have kidney problems, talk to your doctor before using Opsumit. Macitentan may lead to more reduction of blood pressure and decrease in haemoglobin in patients with kidney problems.
In patients with pulmonary veno-occlusive disease (obstruction of the lung veins), the use of medicines for treatment of PAH, including Opsumit, may lead to pulmonary oedema. If you have signs of pulmonary oedema when using Opsumit, such as a sudden, important increase in breathlessness and low oxygen, tell your doctor immediately. Your doctor may perform additional tests, and will determine what treatment regimen is most suitable for you.
Do not give this medicine to children and adolescents below 18 years because Opsumit has not been tested in children.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Opsumit can affect other medicines.
If you take Opsumit together with other medicines including those listed below, the effects of Opsumit or the other medicines might be altered. Please talk to 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 to treat seizures),
carbamazepine (used to treat depression and epilepsy),
St. John’s Wort (an herbal preparation used to treat depression),
ritonavir, saquinavir (used to treat HIV infections),
nefazodone (used to treat depression),
ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used against fungal infections)
amiodarone (to control the heartbeat)
cyclosporine (used to prevent organ rejection after transplant)
diltiazem, verapamil (to treat high blood pressure or specific heart problems)
If you are taking piperine as a dietary supplement, this may alter how the body responds to some medicinal products, including Opsumit. Please talk to your doctor or pharmacist should this be the case.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Opsumit may harm unborn babies conceived before, during or soon after treatment.
If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you are taking Opsumit. Talk to your doctor about this.
Do not take Opsumit if you are pregnant or planning to become pregnant.
If you become pregnant or think that you may be pregnant while you are taking Opsumit, or shortly after stopping Opsumit (up to 1 month), see your doctor immediately.
If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Opsumit and regularly (once a month) while you are taking Opsumit.
It is not known if Opsumit is transferred to breast milk. Do not breastfeed while you are taking Opsumit. Talk to your doctor about this.
If you are a man taking Opsumit, it is possible that this medicine may lower your sperm count. Talk to your doctor if you have any questions or concerns about this.
Opsumit can cause side effects such as headaches and hypotension (listed in section 4), and the symptoms of your condition can also make you less fit to drive.
Opsumit contains a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Opsumit contains lecithin derived from soya. If you are allergic to soya, do not use this medicine (see section 2 ‘Do not take Opsumit’).
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Opsumit should only be prescribed by a doctor experienced in the treatment of pulmonary arterial hypertension.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The recommended dose of Opsumit is one 10 mg tablet, once a day. Swallow the whole tablet, with a glass of water, do not chew or break the tablet. You can take Opsumit with or without food. It is best to take the tablet at the same time each day.
If you have taken more tablets than you have been told to take, you may experience headache, nausea, or vomiting. Ask your doctor for advice.
If you forget to take Opsumit, take a dose as soon as you remember, then continue to take your tablets at the usual times. Do not take a double dose to make up for a forgotten tablet.
Opsumit is a treatment that you will need to keep on taking to control your PAH. Do not stop taking Opsumit 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (swelling around the eyes, face, lips, tongue or throat, itching and/or rash) If you notice any of these signs, tell your doctor immediately.
Anaemia (low number of red blood cells) or reduced haemoglobin
Headache
Bronchitis (inflammation of the airways)
Nasopharyngitis (inflammation of the throat and nasal passages)
Oedema (swelling), especially of the ankles and feet
Pharyngitis (inflammation of the throat)
Influenza (flu)
Urinary tract infection (bladder infection)
Hypotension (low blood pressure)
Nasal congestion (blocked nose)
Elevated liver tests
Leukopenia (decreased white blood cell counts)
Thrombocytopenia (decreased blood platelet counts)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem listedinAppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Opsumit 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.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help to protect the environment.
The active substance is macitentan. Each tablet contains 10 mg macitentan.
The other ingredients are lactose monohydrate (see section 2 “Opsumit contains lactose, lecithin from soya and sodium”), microcrystalline cellulose (E460i), povidone, sodium starch glycolate Type A (see section 2 “Opsumit contains lactose, lecithin from soya and sodium”), magnesium stearate (E572), polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soya bean lecithin (E322) (see section 2 “Opsumit contains lactose, lecithin from soya and sodium”) and xanthan gum (E415).
Opsumit 10 mg tablets are white to off-white, biconvex, round, film-coated tablets with “10” on both sides.
Opsumit is supplied as 10 mg film-coated tablets in blister packs of 15 or 30 tablets. Not all pack sizes may be marketed.
B-2340 Beerse Belgium
Janssen Pharmaceutica NV Turnhoutseweg 30
B-2340 Beerse
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88
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AM MANGION LTD Tel: +356 2397 6000
Janssen-Cilag GmbH Tel: +49 2137 955 955
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Janssen-Cilag Pharma GmbH Tel: +43 1 610 300
Janssen-Cilag, S.A. Tel: +34 91 722 81 00
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Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600
Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700
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Janssen_safety_slo@its.jnj.com
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Sími: +354 535 7000
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
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Puh/Tel: +358 207 531 300
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Janssen-Cilag AB Tfn: +46 8 626 50 00
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Janssen Sciences Ireland UC Tel: +44 1 494 567 444