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.
Why am I using ABACAVIR/LAMIVUDINE VIATRIS?
ABACAVIR/LAMIVUDINE VIATRIS contains the active ingredients abacavir and lamivudine.
ABACAVIR/LAMIVUDINE VIATRIS is used together with other antiretrovirals to slow down
the progression of human immunodeficiency virus (HIV) infection, which can lead to
Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS-related
Complex or ARC).
For more information, see Section
1. Why am I using ABACAVIR/ LAMIVUDINE VIATRIS? in the full CMI.
What should I know before I use ABACAVIR/LAMIVUDINE VIATRIS?
Do not use if you have ever had an allergic reaction to abacavir or lamivudine 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.
What if I am taking other medicines?
Some medicines may interfere with ABACAVIR/LAMIVUDINE VIATRIS and affect how it works.
How do I use ABACAVIR/LAMIVUDINE VIATRIS?
The normal dose for adults and adolescents is one tablet once a day.
ABACAVIR/LAMIVUDINE VIATRIS tablets should be swallowed whole with water and do not
have to be taken with food.
What should I know while using ABACAVIR/ LAMIVUDINE VIATRIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ABACAVIR/LAMIVUDINE
VIATRIS.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
For as long as you're taking ABACAVIR/LAMIVUDINE VIATRIS, your doctor will arrange
regular blood tests to check for side effects.
Keep in contact with your doctor, and don't stop taking KIVEXA without your doctor's
advice.
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Things you should not do
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Do not take ABACAVIR/LAMIVUDINE VIATRIS to treat any other complaints unless your
doctor tells you to.
Do not stop taking ABACAVIR/LAMIVUDINE VIATRIS tablets or change the dose without
first talking to your doctor.
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Driving or using machines
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Don't drive or operate machinery unless you are sure you are not affected.
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Looking after your medicine
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Keep your tablets in cool, dry place where it stays below 25°C
Keep your ABACAVIR/LAMIVUDINE VIATRIS tablets in their pack until you take them.
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Are there any side effects?
The most common side effects are feeling sick (nausea), diarrhoea, being sick (vomiting),
stomach pain (abdominal pain), headache and rash. Tell your doctor or pharmacist if
you notice anything that is making you feel unwell.
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PATIENTS TAKING ABACAVIR/LAMIVUDINE VIATRIS, WHICH CONTAINS ABACAVIR, MAY DEVELOP
A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING
IF TREATMENT WITH ABACAVIR/LAMIVUDINE VIATRIS IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY
FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE VIATRIS IF:
1) YOU GET A SKIN RASH OR
2) YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING GROUPS:
FEVER
SHORTNESS OF BREATH, SORE THROAT OR COUGH
NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN
SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO ABACAVIR/LAMIVUDINE VIATRIS
TABLETS, NEVER TAKE ABACAVIR/LAMIVUDINE VIATRIS, OR ANY OTHER MEDICINAL PRODUCT CONTAINING
ABACAVIR AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR/LAMIVUDINE VIATRIS PACK, TO REMIND
YOU AND MEDICAL STAFF ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED
FROM THE PACK AND KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE
ABACAVIR/LAMIVUDINE VIATRIS.
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Active ingredient(s):
abacavir (as sulfate) and lamivudine
Consumer Medicine Information (CMI)
This leaflet provides important information about using ABACAVIR/LAMIVUDINE VIATRIS.
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 ABACAVIR/LAMIVUDINE VIATRIS.
Where to find information in this leaflet:
Why am I using ABACAVIR/ LAMIVUDINE VIATRIS?
ABACAVIR/LAMIVUDINE VIATRIS contains the active ingredients
abacavir and lamivudine. ABACAVIR/ LAMIVUDINE VIATRIS belong to a group of medicines called antiretrovirals.
These are also available as separate medicinal products.
ABACAVIR/LAMIVUDINE VIATRIS is used to treat human immunodeficiency virus (HIV) infection.
ABACAVIR/LAMIVUDINE VIATRIS tablets do not cure AIDS or kill the HIV virus, but delays
further damage to the immune system by stopping production of new viruses.
You can still pass on HIV when taking this medicine, although the risk is lowered
by effective antiretroviral therapy. You will still be able to pass on the HIV virus
by sexual activity or by contamination with infected blood. You should still use proper
precautions to prevent this. Discuss with your doctor the precautions needed to avoid
infecting other people.
ABACAVIR/LAMIVUDINE VIATRIS tablets are used together with other antiretrovirals to
slow down the progression of human immunodeficiency virus (HIV) infection, which can
lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g.
AIDS-related Complex or ARC).
What should I know before I use ABACAVIR/LAMIVUDINE VIATRIS?
Warnings
Do not use ABACAVIR/LAMIVUDINE VIATRIS if:
you have ever had an allergic reaction to abacavir.
you are allergic to the active ingredient lamivudine, 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 have a serious liver disease ABACAVIR/ LAMIVUDINE VIATRIS may not be suitable
for you.
you have severe kidney disease.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
have allergies to any other medicines, foods, preservatives or dyes .
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You must not take ABACAVIR/LAMIVUDINE VIATRIS tablets if you are pregnant, think you
may be pregnant or are breastfeeding, unless your doctor tells you to.
Symptoms of infection and inflammation
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely
to develop serious infections (opportunistic infections). When these people start
treatment, the immune system becomes stronger, so that the body starts to fight these
infections.
Symptoms of infection and inflammation may develop, caused by either:
old, hidden infections flaring up against as the body fights them
the immune system attacking healthy body tissue (autoimmune disorders).
The symptoms of autoimmune disorders may develop many months after you start taking
medicine to treat your HIV infection.
Symptoms may include:
muscle weakness and/or muscle pain
joint pain or swelling
weakness beginning in the hands feet and moving towards the trunk of the body
palpitations or tremor
hyperactivity (excessive restlessness and movement).
If you get any symptoms of infection or if you notice any of the symptoms above tell
your doctor immediately. Don’t take other medicines for the infection without your
doctors' advice.
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.
Abacavir or lamivudine in ABACAVIR/LAMIVUDINE VIATRIS tablets may interact with certain
other medicines. ABACAVIR/LAMIVUDINE VIATRIS tablets should not be taken with emtricitabine.
Some medicines may interfere with ABACAVIR/ LAMIVUDINE VIATRIS and affect how it works.
sorbitol-containing medicines (usually liquids) used regularly
trimethoprim-sulphamethoxazole (also known as co-trimoxazole), (an antibiotic used
to treat PCP - Pneumocystis jiroveci pneumonia (often referred to as PCP) or toxoplasmosis).
If you are taking methadone, your doctor may need to adjust your methadone dose, as
abacavir increases the rate at which methadone leaves your body. This is unlikely
to affect most methadone users.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ABACAVIR/ LAMIVUDINE VIATRIS.
How do I use ABACAVIR/ LAMIVUDINE VIATRIS?
How much to take
The normal dose for adults and adolescents is one tablet once a day.
Follow the instructions provided and use ABACAVIR/ LAMIVUDINE VIATRIS until your doctor
tells you to stop.
When to take ABACAVIR/LAMIVUDINE VIATRIS
ABACAVIR/ LAMIVUDINE VIATRIS should be used swallowed whole with water. ABACAVIR/LAMIVUDINE
VIATRIS tablets do not have to be taken with food.
If you forget to take ABACAVIR/LAMIVUDINE VIATRIS
ABACAVIR/LAMIVUDINE VIATRIS should be used regularly at the same time each day. If
you miss your dose at the usual time, take it as soon as you remember, and then continue
as before.
If 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 take too much ABACAVIR/LAMIVUDINE VIATRIS
If you think that you have used too much ABACAVIR/ LAMIVUDINE VIATRIS, you may need
urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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.
What should I know while using ABACAVIR/LAMIVUDINE VIATRIS?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ABACAVIR/LAMIVUDINE VIATRIS tablets.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
If you have stopped taking ABACAVIR/LAMIVUDINE VIATRIS tablets for any reason, it
is important that you contact your doctor before restarting. This is especially so
if you think you are having side-effects or have another illness. In some cases your
doctor will ask you to restart ABACAVIR/LAMIVUDINE VIATRIS tablets where medical care
can be readily accessed by yourself or others.
You will need regular blood tests
For as long as you're taking ABACAVIR/LAMIVUDINE VIATRIS, your doctor will arrange
regular blood tests to check for side effects.
Stay in regular contact with your doctor
ABACAVIR/LAMIVUDINE VIATRIS helps to control your condition, but does not cure HIV
infection, you will need to take the tablets every day to stop your illness from getting
worse. While taking ABACAVIR/LAMIVUDINE VIATRIS tablets and/or any other therapy for
HIV disease, you may continue to develop other infections and other complications
of HIV infection.
You should keep in regular contact with the doctor who is looking after you.
Do not stop taking ABACAVIR/LAMIVUDINE VIATRIS tablets or change the dose without
first talking to your doctor.
Things you should not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use ABACAVIR/LAMIVUDINE VIATRIS tablets to treat any other complaints unless
your doctor tells you to.
If you have hepatitis B infection, you should not stop ABACAVIR/LAMIVUDINE VIATRIS
tablets without instructions from your doctor, as you may have a recurrence of your
hepatitis. This may occur due to you suddenly stopping lamivudine.
Hypersensitivity reaction
ABACAVIR/LAMIVUDINE VIATRIS contains abacavir. Abacavir can cause a serious allergic
reaction known as a hypersensitivity reaction, which can be life-threatening if treatment
with abacavir containing products is not stopped.
Research has found that people with a gene called HLA-B (type 5701) are more likely
to have a hypersensitivity reaction to abacavir. However, even if you do not have
this gene type it is still possible for you to get this reaction. If you know you
have this gene type, be sure to tell your doctor before you take abacavir.
The most common symptoms of this reaction include high temperature (fever) and a skin
rash. Other most frequently seen symptoms include nausea, vomiting, diarrhoea or abdominal
pain; severe tiredness or body aches or generally feeling ill; headache; shortness
of breath, sore throat or cough. If you develop any of these symptoms call your doctor
IMMEDIATELY WHO WILL ADVISE YOU WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE
VIATRIS tablets. If your doctor is not available you must urgently seek other medical
advice (e.g. the Accident and Emergency unit of the nearest hospital) before taking
the next dose.
Other symptoms may include joint or muscle pain, swelling of the neck or itchy skin.
Occasionally inflammation of the eye (conjunctivitis), ulcers in the mouth, tingling
or numbness of the hands or feet or low blood pressure may occur. The symptoms of
this allergic reaction can occur at any time during treatment with ABACAVIR/LAMIVUDINE
VIATRIS tablets. However they usually occur in the first six weeks of treatment, and
get worse with continued treatment.
If you have had this serious reaction to ABACAVIR/LAMIVUDINE VIATRIS tablets, NEVER
take ABACAVIR/LAMIVUDINE VIATRIS or any other medicinal product containing abacavir
again as within hours you may experience a life-threatening lowering of your blood
pressure or death.
Occasionally life threatening hypersensitivity reactions have occurred when ABACAVIR/LAMIVUDINE
VIATRIS tablets was restarted in patients who reported only one of the symptoms on
the Alert Card before stopping.
On very rare occasions, hypersensitivity has been reported when ABACAVIR/LAMIVUDINE
VIATRIS tablets were restarted in patients who had no symptoms of hypersensitivity
before stopping.
If you have stopped taking ABACAVIR/LAMIVUDINE VIATRIS tablets for any reason it is
important that you contact your doctor before restarting. This is especially so if
you think you are having side-effects from other medicines or have another illness.
Your doctor will check whether any symptoms you had before stopping may be related
to this hypersensitivity reaction. If your doctor thinks there is a possibility that
they were related, you may be told never to take ABACAVIR/LAMIVUDINE VIATRIS tablets
again. It is important that you follow this advice.
If you are hypersensitive to ABACAVIR/LAMIVUDINE VIATRIS tablets you should return
all of your unused ABACAVIR/LAMIVUDINE VIATRIS tablets to your doctor or pharmacist
for proper disposal.
Kidney disease
If you have moderate kidney disease you should be monitored as you are at higher risk
of some side effects. See additional information under Section
6. Are there any side effects?
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ABACAVIR/
LAMIVUDINE VIATRIS affects you.
No studies on the effects of ABACAVIR/LAMIVUDINE VIATRIS tablets on the ability to
drive and use machines have been performed. However, you should take into account
the state of your health and the possible side effects of ABACAVIR/LAMIVUDINE VIATRIS
tablets before considering driving or using machines.
Looking after your medicine
Keep your ABACAVIR/LAMIVUDINE VIATRIS tablets in their pack until you take them.
Store below 25°C.
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,
such as a locked cupboard.
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.
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.
Check with your doctor as soon as possible if you think you are experiencing any side-effects
or allergic reactions while taking ABACAVIR/LAMIVUDINE VIATRIS tablets, even if the
problem is not listed in this leaflet.
Hypersensitivity Reaction
ABACAVIR/LAMIVUDINE VIATRIS contains abacavir. Abacavir can cause a serious allergic
reaction known as a hypersensitivity reaction, which can be life-threatening if treatment
with abacavir containing products is not stopped. This is described in the section
5. What should I know while using ABACAVIR/ LAMIVUDINE VIATRIS?.
It is important that you read and understand the information about this serious reaction.
As ABACAVIR/LAMIVUDINE VIATRIS tablets contains both abacavir and lamivudine, the
side effects reported for each of these have been combined.
Less serious side effects
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
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.
Product details
This medicine is only available with a doctor's prescription.
What ABACAVIR/LAMIVUDINE VIATRIS contains
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Active ingredient
(main ingredient)
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600 mg of abacavir as the sulfate salt and 300 mg of lamivudine
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
crospovidone
magnesium stearate
silicified microcrystalline cellulose
colloidal
anhydrous silica
talc
OPADRY II complete film coating system 13B58894 White (ARTG PI No: 13119) containing:
hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.
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Potential allergens
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ABACAVIR/LAMIVUDINE VIATRIS tablets contain sorbates and sulfites.
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Do not take this medicine if you are allergic to any of these ingredients.
What ABACAVIR/ LAMIVUDINE VIATRIS looks like
ABACAVIR/ LAMIVUDINE VIATRIS is white, film-coated, modified capsule shaped, biconvex
tablet debossed with AL12 on one side of the tablet and M on the other side (AUST
R 266516).
ABACAVIR/LAMIVUDINE VIATRIS tablets are supplied in blister packs containing 30 tablets.
Who distributes ABACAVIR/ LAMIVUDINE VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis
or medical advice. Your doctor or pharmacist is the best person to give you the individual
advice you need. You may also be able to find out more information about your disease
from books, for example in public libraries.
Counselling is also available from your local AIDS council.
This leaflet was prepared in Jan 2023.
ABACAVIR/ LAMIVUDINE VIATRIS_cmi\Jan23/00