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.
1. Why am I taking EDURANT?
EDURANT contains the active ingredient rilpivirine. EDURANT in combination with other
HIV medicines is used to treat adults who are infected by HIV and who have not used
other anti-HIV medicines before.
2. What should I know before I take EDURANT?
Do not use if you have ever had an allergic reaction to EDURANT or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you are 65 years or older, or have problems with your liver,
or symptoms of infection or inflammation. Tell your doctor if you take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with EDURANT and affect how it works.
4. How do I take EDURANT?
The usual dose of EDURANT is one tablet taken once daily with a meal.
5. What should I know while taking EDURANT?
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Things you should do
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Call your doctor straight away if you become pregnant while taking EDURANT
Remind any doctor, dentist or pharmacist you visit that you are taking EDURANT.
If you are undergoing anaesthesia, tell your anaesthetist that you are taking EDURANT.
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Things you should not do
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Do not stop using this medicine without taking to your doctor first.
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Looking after your medicine
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Store EDURANT tablets below 30°C.
Store EDURANT tablets in the original bottle. Keep the bottle tightly closed in order
to protect from moisture and light.
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6. Are there any side effects?
The side effects you may experience include: skin rash, stomach pain, nausea, depression,
sleep disorders, decreased appetite, tiredness, changes in your routine liver tests,
and headache.
Active ingredient(s):
rilpivirine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using EDURANT. 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 EDURANT.
Where to find information in this leaflet:
1. Why am I taking EDURANT?
EDURANT contains the active ingredient rilpivirine. EDURANT is a medicine used for the treatment of Human Immunodeficiency Virus (HIV)
infection. It belongs to a group of anti-HIV medicines called non-nucleoside reverse
transcriptase inhibitors (NNRTIs).
EDURANT in combination with other HIV medicines is used to treat adults who are infected
by HIV and who have not used other anti-HIV medicines before.
EDURANT must be taken in combination with other anti-HIV medicines. Your doctor will
discuss with you which combination of medicines is best for you.
EDURANT works by reducing the amount of HIV in your body. This will improve your
immune system and reduce the risk of developing illnesses linked to HIV infection.
2. What should I know before I take EDURANT?
Warnings
Do not take EDURANT if:
you are allergic to rilpivirine, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can take this medicine.
Do not combine EDURANT with any of the following medicines:
carbamazepine, oxcarbazepine, phenobarbital, phenytoin (to treat epilepsy or prevent
seizures)
non-nucleoside reverse transcriptase inhibitors (NNRTIs) (HIV medicines)
rifampicin, rifapentine (to treat some infections such as tuberculosis)
products that contain St John's wort (Hypericum perforatum) (a herbal product used
for depression)
omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole (to treat gastrointestinal
ulcers, heartburn or acid reflux disease)
dexamethasone (a corticosteroid used in a variety of conditions such as inflammation
and allergic reactions)
If you are taking any of these, ask your doctor for advice.
Take special care with EDURANT
EDURANT is not a cure for HIV infection. It is part of a treatment reducing the amount
of virus in the blood.
EDURANT does not reduce the risk of passing HIV to others through sexual contact or
blood contamination. Therefore, you must continue to use appropriate precautions (a
condom or other barrier method) to lower the chance of sexual contact with any body
fluids such as semen, vaginal secretions or blood.
People taking EDURANT may still develop infections or other illnesses associated with
HIV infection. You must keep in regular contact with your doctor to monitor your health
while taking EDURANT.
EDURANT is not for use in children or adolescents.
EDURANT has only been used in a limited number of patients aged 65 years or older.
If you belong to this age group, discuss the use of EDURANT with your doctor.
Check with your doctor if you:
have or have had any medical conditions, especially the following:
Problems with your liver.
Including hepatitis B and/or C. Your doctor may need to evaluate how severe your liver
disease is before deciding if you can take EDURANT.
Symptoms of infection or inflammation.
In some patients with advanced HIV infection, signs and symptoms of infection or inflammation
may occur after HIV treatment is started. It is believed that these symptoms are due
to an improvement in the body's immune response.
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
Check with your doctor if you are pregnant or intend to become pregnant.
During pregnancy you should not take EDURANT, unless it is specifically approved by
your doctor.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
HIV infected mothers must not breast-feed, as there is a possibility of infecting
the baby with HIV.
3. What if I am taking other medicines?
EDURANT might interact with 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.
EDURANT can be combined with most other anti-HIV medicines belonging to another class.
However, some combinations are not recommended. In other cases, increased monitoring
and/or a change in the dose of the medicine may be needed. Therefore, always tell
your doctor which other anti-HIV medicines you take. Carefully follow your doctor's
instructions, on which medicines can be combined.
EDURANT may interfere with and affect how some medicines work.
methadone (strong pain killer also used in drug dependence programs)
Medicines that may
increase
the effect of EDURANT include:
clarithromycin, erythromycin, troleandomycin (antibiotics)
Medicines that may
reduce
the effect of EDURANT include:
rifabutin (a medicine to treat some bacterial infections). If you take this medicine
while taking EDURANT, please carefully read Section
4. How do I take EDURANT?
cimetidine, famotidine, nizatidine, ranitidine (antihistamines used to treat stomach
or intestinal ulcers or used to relieve heartburn from acid reflux)
antacids (for example, aluminium / magnesium hydroxide, calcium carbonate)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect EDURANT.
4. How do I take EDURANT?
How much to take
The usual dose of EDURANT is one tablet taken once daily with a meal.
Always take EDURANT exactly as your doctor has told you. You must check with your
doctor if you are not sure.
When to take EDURANT
It is important that you take EDURANT with a meal. A meal is important to get the
right drug levels in your body. A protein drink alone does not replace a meal.
If you take rifabutin (a medicine to treat some bacterial infections), take two tablets
of EDURANT once a day. When you stop taking rifabutin, take one tablet of EDURANT
once a day. Talk to your doctor or pharmacist if you are not sure.
If you take an antacid (a medicine to treat diseases related to the acid in the stomach
such as aluminium/magnesium hydroxide, calcium carbonate), take the antacid either
at least 2 hours before or at least 4 hours after EDURANT.
If you take an H2-receptor antagonist (medicines used for stomach ulcers, heartburn,
or acid reflux disease (such as cimetidine, famotidine, nizatidine or ranitidine),
take the H2-receptor antagonist at least 12 hours before or at least 4 hours after
EDURANT. Importantly, proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole,
pantoprazole, esomeprazole) also available for these conditions should not be taken
with EDURANT.
Make sure that you always have enough EDURANT available so that you don't run out.
For example in case you cannot return home, need to travel or stay in a hospital.
Removing the child resistant cap
The plastic bottle comes with a child resistant cap and should be opened as follows:
Push the plastic screw cap down while turning it counter-clockwise.
Remove the unscrewed cap.
If you forget to take EDURANT
If you notice within 12 hours of the time you usually take EDURANT, you must take
the tablet as soon as possible. Always take the tablet with a meal. Then take the
next dose as usual.
If you notice after 12 hours, 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 take too much EDURANT
If you think that you have taken too much EDURANT, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre:
Australia: 13 11 26
New Zealand: 0800 POISON or 0800 764 766
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 taking EDURANT?
Things you should do
Keep all your doctor's appointments so your progress can be checked.
Your doctor will want to do some blood and other tests from time to time to check
on your progress.
Follow your doctor's instructions about other medicines you should take, and other
things you should do.
Ask your doctor or pharmacist if you have any questions.
Call your doctor straight away if you:
Become pregnant while taking EDURANT
Remind any doctor, dentist or pharmacist you visit that you are using EDURANT.
If you are undergoing anaesthesia, tell your anaesthetist that you are taking EDURANT.
If you are about to be started on any new medicines, tell your doctor or pharmacist
that you are taking EDURANT.
Things you should not do
Do not stop taking EDURANT without talking to your doctor first
HIV therapy may increase your sense of well being. Even if you feel better, do not
stop taking EDURANT or your other anti-HIV medicines. Doing so could increase the
risk of the virus developing resistance. Talk to your doctor first.
Driving or using machines
EDURANT has no or negligible influence on the ability to drive and use machines.
Looking after your medicine
Store EDURANT tablets below 30°C.
Store EDURANT tablets in the original bottle. Keep the bottle tightly closed in order
to protect from moisture and light. 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.
When treating HIV infection, it is not always easy to identify what side effects are
caused by EDURANT, which are caused by other medicines you are taking, or which are
caused by the HIV infection itself.
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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stomach pain
nausea
vomiting
depression
difficulty falling asleep (insomnia)
abnormal dreams
sleep disorders
decreased appetite
tiredness
changes in your routine liver tests
headache
dizziness
Some side effects are typical for combination anti-HIV therapy. These are:
immune reconstitution syndrome
In some patients with advanced HIV infection (AIDS) and a history of opportunistic
infection, signs and symptoms of inflammation from previous infections may occur soon
after anti-HIV treatment is started, including EDURANT. In addition to the opportunistic
infections, autoimmune disorders (a condition that occurs when the immune system attacks
healthy body tissue) may also occur after you start taking medicines for the treatment
of your HIV infection. Autoimmune disorders may occur many months after the start
of treatment. It is believed that these symptoms are due to an improvement in the
body's immune response, enabling the body to fight infections that may have been present
with no obvious symptoms.
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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
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Serious side effects
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What to do
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skin rash
The rash is usually mild to moderate. In rare instances, rash can be potentially
life-threatening. It is therefore important to contact your doctor immediately if
you develop a rash.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
Your doctor will advise you how to deal with your symptoms or whether EDURANT must
be stopped.
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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 EDURANT contains
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Active ingredient
(main ingredient)
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rilpivirine (as hydrochloride)
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Other ingredients
(inactive ingredients)
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glycerol triacetate
silicified microcrystalline cellulose
magnesium stearate
hypromellose
croscarmellose sodium
lactose monohydrate
povidone
polysorbate 20
titanium dioxide
macrogol 3000
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Do not take this medicine if you are allergic to any of these ingredients.
What EDURANT looks like
EDURANT (AUST R 176666) tablets are white to off-white, film-coated, round, biconvex, with "TMC" on one side
and "25" on the other side.
Each plastic bottle contains 30 tablets.
Who distributes EDURANT
Janssen-Cilag Pty Ltd
1-5 Khartoum Road Macquarie Park NSW 2113
Telephone: 1800 226 334
NZ Office: Auckland New Zealand
Telephone: 0800 800 806
This leaflet was prepared in Aug 2023.