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 OPSYNVI?
OPSYNVI is a single tablet that contains two medicines, macitentan and tadalafil.
OPSYNVI is used for the treatment for pulmonary arterial hypertension in adults.
2. What should I know before I use OPSYNVI?
Do not use if you have ever had an allergic reaction to OPSYNVI or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, such as heart problems,
liver problems, 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 OPSYNVI and affect how it works. Do not take OPSYNVI
if you are currently taking any nitrates or amyl nitrate.
4. How do I use OPSYNVI?
The recommended dose is one tablet, once a day. More instructions can be found in
Section
4. How do I use OPSYNVI? in the full CMI.
5. What should I know while using OPSYNVI?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using OPSYNVI.
If you are about to be started on any new medicine, especially nitrates (medicines
used for the treatment of angina ["chest pain"] or other heart condition), remind
your doctor or pharmacist
Tell your doctor immediately if you notice any of the following: become pregnant or
are trying to become pregnant, have sudden decrease or loss of vision, have sudden
decrease or loss of hearing, have signs of pulmonary oedema such as a sudden, important
increase in breathlessness and low oxygen
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Driving or using machines
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OPSYNVI can cause dizziness and affect your vision. Be careful driving or operating
machinery until you know how OPSYNVI affects you.
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Drinking alcohol
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When taking OPSYNVI with large amounts of alcohol, you may experience dizziness.
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Looking after your medicine
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Store below 30°C. Store in original package.
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, headache or migraine, flushing, sweating, nausea, indigestion,
back pain, arm or leg pain and muscle pain. The serious side effects that require
medical attention include severe allergic reaction, chest pain, increase, fast or
uneven heart rate, prolonged and painful erection and sudden decrease or loss of vision.
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WARNING: OPSYNVI may cause birth defects (harm to unborn babies). Do not take OPSYNVI
if you are pregnant or plan to become pregnant.
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Active ingredients:
macitentan and tadalafil
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using OPSYNVI. 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 OPSYNVI.
Where to find information in this leaflet:
1. Why am I using OPSYNVI?
OPSYNVI is a single tablet that contains two medicines, macitentan and tadalafil. Macitentan belongs to the class of medicines called endothelin receptor antagonists
(ERA). Tadalafil belongs to the class of medicines called phosphodiesterase type 5
(PDE5) inhibitors. You should only switch to OPSYNVI, after you have been on stable
doses of macitentan and tadalafil as separate tablets, as instructed by your doctor.
OPSYNVI is used for the treatment of pulmonary arterial hypertension (PAH) in adults.
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.
OPSYNVI widens the pulmonary arteries, making it easier for the heart to pump blood
through them. This lowers the blood pressure in the blood vessels that carry blood
from the heart to the lungs (pulmonary arteries) and may improve some of your symptoms.
2. What should I know before I use OPSYNVI?
Warnings
Do not use OPSYNVI if:
you are allergic to macitentan, tadalafil or any of the ingredients listed at the
end of this leaflet. Always check the ingredients to make sure you can use this medicine.
you are pregnant, 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’.
You have a serious liver problems or if you have very high levels of liver enzymes
in your blood.
you are taking any form of nitrates such as amyl nitrite, used in the treatment of
angina ("chest pain"). Tadalafil has been shown to increase the effects of these medicines.
If you are taking any form of nitrate or are unsure, tell your doctor.
you have ever had loss of vision – a condition described as “stroke of the eye” (non-arteritic
anterior ischemic optic neuropathy - NAION).
you have had a heart attack in the last 3 months.
you have severe low blood pressure.
you have heart problems such as angina, arrhythmias (changes in rhythm or rate of
the heartbeat), uncontrolled high blood pressure, or a stroke in the last 6 months.
you are taking guanylate cyclase stimulators such as riociguat to treat pulmonary
arterial hypertension (i.e., high blood pressure in the arteries of the lungs) or
chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the arteries
of the lungs secondary to blood clots that could block blood flow). PDE5 inhibitors,
such as tadalafil, have been shown to increase the hypotensive effects of this medicine.
If you are taking riociguat or are unsure, tell your doctor.
Check with your doctor if you:
have any of the following medical conditions:
pulmonary veno-occlusive disease (obstruction of the lung veins)
heart problems other than your pulmonary hypertension
problems with your blood pressure
blood vessel problems
any hereditary eye disease
an abnormality of red blood cells (sickle cell anaemia)
cancer of the bone marrow (multiple myeloma)
cancer of the blood cells (leukaemia)
any deformation of your penis, or unwanted or persistent erections lasting more than
4 hours
liver or kidney problems
have an intolerance to lactose or some sugars. OPSYNVI contains lactose.
take any medicines for any other condition.
You will need blood tests, as indicated by your doctor. Your doctor will order some blood tests before you start treatment with OPSYNVI 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
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
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 OPSYNVI if you are pregnant or planning to become pregnant as it may harm
unborn
babies conceived before, during or soon after treatment.
You must not become pregnant for at least 3 months after stopping OPSYNVI.
If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy
test before you start taking OPSYNVI and regularly (once a month) while you are taking
OPSYNVI.
If it is possible you could become pregnant, use at least two reliable forms of birth
control (contraception) while you are taking OPSYNVI. 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 OPSYNVI,
or shortly after stopping OPSYNVI (up to three month), see your doctor immediately.
It is not known if OPSYNVI is transferred to breast milk. Do not breastfeed while you are taking OPSYNVI. Talk to your doctor the best way to feed your baby if you take OPSYNVI.
Male fertility
If you are a male you should avoid exposing your partner to your semen by use of appropriate
contraception. OPSYNVI may lower sperm count in men. Tell your doctor if being able
to have children is important to you.
Children and adolescents
Do not give OPSYNVI to children or young people below 18 years of age because it
has not been tested in children.
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.
Please talk to your doctor or pharmacist if you are taking any of the following medicines:
rifampicin, clarithromycin, 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 to support healthy mood balance),
ritonavir (used to treat HIV infections),
ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole
(medicines used against fungal infections),
amiodarone (to control the heartbeat),
ciclosporin (used to prevent organ rejection after transplant),
piperine (a herbal preparation),
nitrates, medicines such as glyceryl trinitrate, used to treat angina (chest pain)
and other heart conditions,
bosentan, sildenafil (other treatments for pulmonary arterial hypertension),
alpha blockers used to treat high blood pressure or prostate problems,
diltiazem, verapamil (to treat high blood pressure or specific heart problems),
medicines used to treat high blood pressure,
tablets for erectile dysfunction (PDE5 inhibitors),
grapefruit juice,
large amount of alcohol.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect OPSYNVI.
4. How do I use OPSYNVI?
How much to take
The recommended dose of OPSYNVI is one tablet, once a day.
Follow the instructions provided and use OPSYNVI until your doctor tells you to stop.
When to take OPSYNVI
You can take OPSYNVI with or without food.
Take the tablet at the same time each day.
How to take OPSYNVI
Swallow the whole tablet, with a glass of water. Do not chew or break the tablet.
If you forget to use OPSYNVI
OPSYNVI should be used regularly at the same time each day. If you miss your dose
at the usual time, 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 the dose you missed.
If you use too much OPSYNVI
If you think that you have used too much OPSYNVI, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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 OPSYNVI?
Things you should do
Call your doctor straight away if you:
become pregnant or are trying to become pregnant.
have signs of pulmonary oedema when using OPSYNVI, 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
OPSYNVI, may cause a build-up of fluid in your lungs (pulmonary oedema).
have sudden decrease or loss of vision in one or both eyes.
have sudden decrease or loss of hearing or hearing problems such as ringing in the
ears, dizziness.
are about to be started on any new medicine, especially nitrates (medicines used for
the treatment of angina ["chest pain"] or other heart condition), remind your doctor
and pharmacist who treat you that you are taking OPSYNVI.
have not used your medicine exactly as prescribed.
Things you should not do
Do not stop using this medicine suddenly, unless you have agreed this with your doctor.
OPSYNVI is a treatment that you will need to keep on taking to control your PAH.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how OPSYNVI
affect you.
OPSYNVI may cause dizziness and affects your vision.
Drinking alcohol
Tell your doctor if you drink alcohol.
When taking OPSYNVI with large amount of alcohol, you may experience dizziness.
Looking after your medicine
Store below 30°C.
Keep your tablets in the original pack until it is time to take them.
Follow the instructions in the carton on how to take care of your medicine properly.
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:
indigestion
nausea
vomiting
stomach discomfort or pain
heartburn
diarrhoea
inflammation of stomach and gut that may cause diarrhoea, abdominal pain, vomiting
irritable bowel syndrome (stomach pain and bloating with diarrhoea or constipation)
haemorrhoids
Liver:
increased level of liver enzymes in the blood
gallstones
Nervous system:
headache or migraine
dizziness
fainting
Musculoskeletal:
back pain
muscle pain
arm or leg pain
joint 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
Skin related:
sweating
ulcer or sore on the skin
Vascular:
facial flushing
redness of the skin
bleeding nose
low blood pressure
Infection:
infection of the nose, sinuses or throat including nasal congestion, blocked sinuses,
itchy, runny or blocked nose
flu
irritated or inflamed throat
cough
bronchitis (inflammation of the airways)
respiratory tract infection
increased sensitivity of the airways in the lungs, causing narrowing and difficulty
breathing
Eye related:
red eyes, eye pain, swelling of
eyelids
blurred vision
conjunctivitis (inflammation of the eye)
General:
swelling caused by fluid buildup in the body
face swelling
fever
Blood related:
thrombocytopenia (low number of platelets (cells that help blood to clot))
decreased level of hemoglobin or haematocrit in the blood
anaemia (low number of red blood cells)
increased level of urea in the blood
decreased or increased level of potassium in blood
Mental health:
difficulty sleeping
depression
Urogenital:
increased or abnormal uterine bleeding
long or heavy menstrual period
cyst in the ovary
enlarged breasts in men
urinary tract infection
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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
*Sudden loss or decrease in hearing and seizures have been reported in people taking
tadalafil. It is not possible to determine whether these events are related directly
to OPSYNVI, to other diseases or medications, to other factors, or to a combination
of factors.
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
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
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 OPSYNVI contains
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Active ingredient
(main ingredient)
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macitentan
tadalafil
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Other ingredients
(inactive ingredients)
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Tablet core
Hyprolose
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Polysorbate 80
Povidone
Sodium starch glycollate
Sodium lauryl sulfate
Film coating
Opadry II Complete Film Coating System 30K580008 White, ARTG PI No. 146235
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Potential allergens
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Lactose monohydrate
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Do not take this medicine if you are allergic to any of these ingredients.
What OPSYNVI looks like
OPSYNVI 10 mg/40 mg is a white to almost-white, oblong, film-coated tablet debossed
with “1040” on one side and “MT” on the other side. It is supplied in blister pack
containing 30 tablets (AUST R 420130).
Who distributes OPSYNVI
Janssen-Cilag Pty Ltd
1-5 Khartoum Road Macquarie Park NSW 2113
Telephone: 1800 226 334
This leaflet was prepared on 16 September 2024.