10 mg film-coated tablets
macitentan
What Opsumit is and what it is used for
Opsumite contains the active substance macitentan and belongs to a group of medicines called “endothelin receptor antagonists”.
Opsumite is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults. It can be used alone or in combination with other drugs
for PAH. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arteries). In people with PAH, these arteries become narrower and the heart has to work harder to pump blood through them. It makes you feel tired, dizzy, and out of breath.
Opsumite dilates the pulmonary arteries and makes it easier for the heart to pump blood through them. Blood pressure is lowered, symptoms are relieved and the disease develops more favorably.
What you need to know before you take Opsumit
Do not take Opsumit:
- 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 could become pregnant because you are not using a reliable contraceptive. See section “Pregnancy and breast-feeding”.
- if you are breast-feeding. See section “Pregnancy and breast-feeding”.
- 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 if this medicine is right for you.
Tell your doctor if any of these apply to you.
Warnings and cautions
Talk to your doctor or pharmacist before taking Opsumit.
Your doctor will decide on certain blood tests:
Blood samples will be taken before and after treatment with Opsumit to check
- if you have anemia (decreased red blood cell count )
- if your liver function is normal
The following may be signs of anemia (ie decreased red blood cell count ):
- dizziness
- fatigue / feeling of illness / weakness
- fast pulse , palpitations
- pallor
If you notice any of these signs, tell your doctor.
Signs that your liver may not be functioning normally may be:
- nausea
- vomiting
- fever
- abdominal / abdominal pain
- yellowing of the skin and whites of the eyes (jaundice)
- dark-colored urine
- itchy skin
- unusual fatigue or exhaustion (hibernation or fatigue)
- flu-like symptoms (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 a further decrease in blood pressure and a decrease in hemoglobin in patients with kidney problems.
In patients with venous occlusive lung disease ( obstruction of the pulmonary veins), the use of drugs against PAHs, e.g. Opsumite, leads to pulmonary edema. If you get signs of pulmonary edema while using Opsumit, e.g. sudden and severe shortness of breath and lack of oxygen, tell your doctor immediately. The doctor can do more tests and then decide which treatment is best for you.
Children and young people
Do not give this medicine to children or adolescents under 18 years of age. Opsumit has not been tested in children.
Older
Experience with Opsumit treatment in patients older than 75 years is limited. Opsumite should be used with caution in this age group.
Other medicines and Opsumit
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Opsumite can affect other medicines.
If you are taking Opsumit with other medicines, including those mentioned below, the effect of Opsumit or other medicines may change. 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 to treat seizures)
- carbamazepine (used to treat depression and epilepsy )
- St. John’s wort (a traditional herbal medicine used to treat depression)
- ritonavir, saquvinavir (used to treat HIV infections )
- nefazodone (used to treat depression)
- ketoconazole (excluding shampoos ), fluconazole , itraconazole, miconazole , voriconazole (medicines used to treat fungal infections)
- amiodarone (to control heart rhythm)
- cyclosporine (used to prevent organ rejection after a transplant)
- diltiazem , verapamil (to treat high blood pressure or specific heart problems).
Summarize with food
Taking piperine as a dietary supplement may change the way your body responds to certain medicines, including Opsumit. Talk to your doctor or pharmacist if this applies to you.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Opsumit can harm the fetus if you become pregnant before, during, or shortly after treatment.
- If you can get pregnant, use a reliable contraceptive 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 you may be pregnant while you are taking Opsumit, or shortly after you stop taking Opsumit (up to one month), contact your doctor immediately.
If you are a woman and could become pregnant, your doctor will want to do a pregnancy test before you start taking Opsumit and at regular intervals (once a month) while you are taking Opsumit.
It is unknown whether Opsumit is excreted in human milk. You should not breast-feed while taking Opsumit. Talk to your doctor about this.
Driving and using machines
Opsumite can cause side effects such as headaches and low blood pressure (see section 4) and the symptoms of your condition may also make you less fit to drive.
Opsumite contains lactose, soy lecithin and sodium
Opsumite contains the sugar lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Opsumite contains lecithin from soy. Do not take this medicine if you are allergic to soy, (see section 2, “Do not take Opsumit”).
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. is almost “sodium-free”.
How to take Opsumit
Opsumit should only be prescribed by doctors who have experience in the treatment of pulmonary arterial hypertension.
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
The recommended dose of Opsumit is one 10 mg tablet once a day. Swallow the tablet whole with a glass of water. The tablet must not be chewed or shared. You can take Opsumit with or without food. It is best if you take the tablet at the same time each day.
If you take more Opsumit than you should
If you take more tablets than you should, you may experience headaches, nausea, or vomiting. Consult your doctor.
If you forget to take Opsumit
If you forget to take Opsumit, take your dose as soon as you remember. Then continue to take the tablets at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Opsumit
Opsumit is a treatment that you need to take all the time to keep your PAH under control. Do not stop taking Opsumit unless you have agreed to do so with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 rash)
If you notice any of these signs, tell your doctor immediately.
Very common side effects ( may affect more than 1 user in 10)
- Anemia (low red blood cell count ) or decreased hemoglobin value
- Headache
- Bronchitis ( inflammation of the trachea)
- Nasopharyngitis ( inflammation of the nose and throat)
- Edema (swelling), especially in the ankles and feet
Common side effects ( may affect up to 1 in 10 people)
- Pharyngitis ( inflammation of the pharynx)
- Influenza
- Urinary tract infection
- Hypotension (low blood pressure )
- Nasal congestion
- Elevated liver values
- Leukopenia (decreased white blood cell count )
- Thrombocytopenia (decreased platelet count)
How to store Opsumit
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 expiration date is the last day of the specified month.
Do not store above 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is macitentan. Each tablet contains 10 mg of macitentan.
- The other ingredients are lactose monohydrate (see section 2 “Opsumit contains lactose , soy lecithin and sodium”), microcrystalline cellulose (E460i), povidone, sodium starch glycolate type A (see section 2 “Opsumit contains lactose , soy lecithin and sodium (E5), magnesium5”, E72). polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soy lecithin (E322) (see section 2 “Opsumite contains lactose , soy lecithin and sodium”) and xanthan gum (E415).
What the medicine looks like and contents of the pack
Opsumit 10 mg tablets are white to off-white, biconvex, round, film-coated tablets debossed with “10” on both sides.
Opsumite is supplied as 10 mg film-coated tablets, packaged in blister cards of 15 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium