Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I using OPSUMIT?
OPSUMIT contains the active ingredient macitentan. OPSUMIT is used to treat pulmonary
arterial hypertension (PAH). It can be used on its own or with other drugs to treat
PAH.
2. What should I know before I use OPSUMIT?
Do not use if you have ever had an allergic reaction to macitentan, soya or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. Women of childbearing potential must use reliable birth control (contraception) during
and for at least 3 months after you stop taking it.
3. What if I am taking other medicines?
Some medicines may interfere with OPSUMIT and affect how it works.
4. How do I use OPSUMIT?
The recommended dose of OPSUMIT for adults and children over 12 years and weighing
more than 40 kg is one 10 mg tablet once a day with or without food.
5. What should I know while using OPSUMIT?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using OPSUMIT.
You must use at least two reliable forms of birth control (contraception) while taking
OPSUMIT and for 3 months after you stop taking it.
Tell your doctor immediately if you notice any of the following: become pregnant or
trying to become pregnant, have signs of pulmonary oedema, such as a sudden, important
increase in breathlessness and low oxygen.
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Things you should not do
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Do not stop taking this medicine unless your doctor tells you to.
Do not breast feed while you are taking OPSUMIT.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how OPSUMIT
affects you.
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Looking after your medicine
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Keep tablets in the original pack, in a cool, dry place where the temperature stays
below 30°C.
Keep out of reach of children.
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6. Are there any side effects?
The common but less serious side effects you may experience include low number of
red blood cells (anaemia), swelling caused by fluid buildup in the body, infection
of nose or throat. The serious side effects that require medical attention include
severe allergic reaction.
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WARNING: OPSUMIT may cause birth defects (harm to unborn babies). Do not take OPSUMIT
if you are pregnant or plan to become pregnant.
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Active ingredient(s): macitentan (ma-SEE-ten-tan)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using OPSUMIT. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using OPSUMIT.
Where to find information in this leaflet:
1. Why am I using OPSUMIT?
OPSUMIT contains the active ingredient macitentan. OPSUMIT belongs to a group of medicines called endothelin receptor antagonists (ERA).
OPSUMIT is used to treat pulmonary arterial hypertension (PAH). It can be used on
its own or with other drugs to treat PAH.
PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry
blood from the heart to the lungs. 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.
2. What should I know before I use OPSUMIT?
Warnings
Do not use OPSUMIT if:
you are allergic to macitentan, soya or any of the other ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Symptoms of an allergic reaction may be mild or severe. They usually include some
or all of the following:
wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash
(hives) or fainting.
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).
you have serious liver disease or very high levels of liver enzymes in your blood.
Check with your doctor if you:
have an intolerance to lactose or any other sugars. OPSUMIT film-coated tablets contain
small amounts of a sugar called lactose.
have anaemia (low number of red blood cells)
have liver or kidney problems
have pulmonary veno-occlusive disease (obstruction of the lung veins)
have low blood pressure
are 75 years or older
Your doctor will order blood test before you start treatment and also during treatment
with OPSUMIT to check if you have anaemia (low number of red blood cells) or if your
liver is working properly.
Signs that your liver may not be working properly include:
nausea (urge to vomit)
vomiting
fever (high temperature)
pain in your stomach
jaundice (yellowing of your skin or the whites of your eyes)
dark-coloured urine
itching of your skin
lethargy or fatigue (unusual tiredness or exhaustion)
flu-like syndrome (joint and muscle pain with fever)
If you notice any of these signs, tell your doctor immediately.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take OPSUMIT if you or your partner are pregnant or planning to become pregnant
as it may harm unborn babies conceived before, during or soon after treatment.
Do not become pregnant for at least 3 months after stopping OPSUMIT.
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.
If it is possible you could become pregnant, use at least two reliable forms of birth
control (contraception) while you are taking OPSUMIT. You must continue to use contraception
for at least 3 months after stopping OPSUMIT. Talk to your doctor about this.
If you become pregnant or think that you may be pregnant while you are taking OPSUMIT,
or shortly after stopping OPSUMIT (up to three month), see your doctor immediately.
It is not known if OPSUMIT is transferred to breast milk. Do not breastfeed while you are taking OPSUMIT
. Talk to your doctor the best way to feed your baby if you take OPSUMIT.
Male fertility
If you are a male you should avoid exposing your partner to your semen by use of appropriate
contraception.
OPSUMIT may lower your sperm count. Talk to your doctor if you have any questions
or concerns about this.
Children and adolescents
OPSUMIT should not be used in children under the age of 12 years. The safety of OPSUMIT
and how effective it is have not been studied in this age group.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with OPSUMIT and affect how it works. You must tell you
doctor if you are taking:
rifampicin, clarithromycin, ciprofloxacin, erythromycin (antibiotics used to treat
infections)
ritonavir (a medicine for HIV infections)
ketoconazole (except shampoo), itraconazole, voriconazole, fluconazole, miconazole
(medicines used against fungal infections)
phenytoin (a medicine used to treat seizures)
carbamazepine (a medicine used to treat depression and epilepsy)
amiodarone (medicines to treat irregular heartbeat)
ciclosporin (medicine used to prevent organ rejection after transplant)
diltiazem, verapamil (medicine used to treat high blood pressure or specific heart
problems)
St. John’s Wort (a herbal medicine used to support healthy mood balance)
piperine (a herbal dietary supplement)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect OPSUMIT.
4. How do I use OPSUMIT?
How much to take
The recommended dose of OPSUMIT for adults and children over 12 years and weighing
more than 40 kg is one 10 mg tablet, once a day. Follow the instructions provided
and take OPSUMIT until your doctor tells you to stop. Swallow the whole tablet, with
a glass of water. Do not chew or break the tablet.
When to take OPSUMIT
OPSUMIT can be taken with or without food.
It is best to take the tablet at the same time each day.
If you forget to take OPSUMIT
OPSUMIT should be taken regularly at the same time each day.
If you miss your dose at the usual time and it is almost time for your next dose,
skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much OPSUMIT
If you think that you have used too much OPSUMIT, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre (in Australia telephone 13 11 26 and in New Zealand telephone 0800 POISON or 0800 764 766), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using OPSUMIT?
Things you should do
If it is possible you could become pregnant, use at least two reliable forms of birth
control (contraception) while you are taking OPSUMIT. You must continue to use contraception
for at least 3 months after stopping OPSUMIT. Talk to your doctor about this.
Call your doctor straight away if you:
if you become pregnant or are trying to become pregnant.
have signs of pulmonary oedema when using OPSUMIT, such as a sudden, important increase
in breathlessness and low oxygen. In patients with pulmonary veno-occlusive disease
(obstruction of the lung veins), the use of medicines for treatment of PAH, including
OPSUMIT, may cause a build-up of fluid in your lungs (pulmonary oedema).
Remind any doctor, dentist or pharmacist you visit that you are using OPSUMIT.
Things you should not do
Do not stop taking this medicine without talking to your doctor. OPSUMIT is a treatment
that you will need to keep on taking to control your PAH.
Do not breastfeed while you are taking OPSUMIT.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use OPSUMIT to treat any other complaints unless your doctor says to.
Driving or using machines
OPSUMIT may cause headaches in some people.
Be careful before you drive or use any machines or tools until you know how OPSUMIT
affects you.
Looking after your medicine
Store below 30°C. Keep tablets in the original pack.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Allergic reaction:
including skin rash, swelling of the face and hives, itching
Gastrointestinal:
diarrhoea
stomach pain
inflammation of stomach and gut that may cause diarrhoea, abdominal pain, vomiting
irritable bowel syndrome (stomach pain and bloating with diarrhoea or constipation)
haemorrhoids
General:
oedema (swelling), especially of the ankle, feet or hands
fever
Infection:
infection of the nose, sinuses or throat including nasal congestion, blocked sinuses,
itchy, runny or blocked nose
flu
irritated or inflamed throat
bronchitis (inflammation of the airways)
respiratory tract infection
increased sensitivity of the airways in the lungs, causing narrowing and difficulty
breathing
Liver:
increased level of liver enzymes in the blood
gallstones
Mental health:
difficulty sleeping
depression
Musculoskeletal:
joint and muscle pain
systemic sclerosis (problem with immune system that causes a build-up of scar tissue
in the skin and internal organ)
inflamed tissue (cartilage) in the rib cage which may cause chest pain
Nervous system:
headache or migraine
Skin related:
ulcer or sore on the skin
pruritus (severe itching of the skin)
eczema (itchy skin rash)
Vascular:
flushing
hypotension (low blood pressure)
Urogenital:
increased or abnormal uterine bleeding
long or heavy menstrual period
cyst in the ovary
enlarged breasts in men
urinary tract infection (bladder infection)
Blood related:
anaemia (low number of red blood cells
thrombocytopenia (low number of platelets (cells that help blood to clot))
decreased level of hemoglobin or haematocrit in the blood
increased level of urea in the blood
decreased or increased level of potassium in blood
Eye related:
conjunctivitis (inflammation of the eye
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What OPSUMIT contains
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Active ingredient (main ingredient)
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macitentan
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
sodium starch glycollate type A
povidone
magnesium stearate
polysorbate 80
The film-coating contains:
polyvinyl alcohol
titanium dioxide
talc
soya lecithin
xanthan gum
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Potential allergens
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lactose
soya lecithin
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Do not take this medicine if you are allergic to any of these ingredients.
What OPSUMIT looks like
OPSUMIT 10 mg tablets are white to off white, round, biconvex, film-coated tablets
with "10" on both sides, supplied in blister packs of 9 or 30 tablets. (AUST R 205624)
Who distributes OPSUMIT?
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113 Australia
Telephone: 1800 226 334
NZ Office: Auckland New Zealand
Telephone: 0800 800 806
This CMI was prepared on 17 January 2025.