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 taking ZIAGEN tablets?
ZIAGEN tablets contains the active ingredient abacavir which belongs to a group of
medicines called antiretrovirals. ZIAGEN 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).
2. What should I know before I take ZIAGEN tablets?
Do not use if you have ever had an allergic reaction to ZIAGEN tablets 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.
3. What if I am taking other medicines?
Some medicines may interfere with ZIAGEN tablets and affect how it works.
4. How do I take ZIAGEN tablets?
Follow the instructions provided and use ZIAGEN tablets until your doctor tells you
to stop.
If you are giving ZIAGEN tablets to a child, follow the doctor's instructions.
5. What should I know while taking ZIAGEN tablets?
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Things you should do
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Tell your doctor if, for any reason, you have not taken your medicine exactly as directed
Remind any doctor, dentist or pharmacist you visit that you are taking ZIAGEN tablets
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Things you should not do
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Do not give this medicine to anyone else, even if their symptoms seem similar to yours
Do not use ZIAGEN tablets to treat any other complaints unless your doctor tells you
to
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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 ZIAGEN
tablets affects you
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Looking after your medicine
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Store below 30°C
Store in the original pack
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6. Are there any side effects?
Side effects which have been reported include headache, nausea & vomiting, diarrhoea,
fever/high temperature, fatigue/tiredness, anorexia/loss of appetite, rash, abdominal
discomfort and pain, cough, ear, nose & throat infection, insomnia, muscular pain,
reduced white blood cell count (neutropenia), pancreatitis, and changes in the immune
system. Serious side effects include lactic acidosis, allergic reaction, flare up
of old infections, and fat loss or gain.
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WARNING:
PATIENTS TAKING ZIAGEN tablets, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY
REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH
ZIAGEN IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD
STOP TAKING ZIAGEN tablets 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 ZIAGEN tablets NEVER TAKE
ZIAGEN tablets, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA, TRIUMEQ,)
AGAIN AS YOU MAY DEVELOP A LIFE-THREATENING REACTION WHICH CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ZIAGEN tablets 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 ZIAGEN tablets.
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Active ingredient: abacavir (as sulfate)
Consumer Medicine Information (CMI)
This leaflet provides important information about using ZIAGEN tablets. 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 ZIAGEN tablets.
Where to find information in this leaflet:
1. Why am I taking ZIAGEN tablets?
1. Why am I taking ZIAGEN tablets?
ZIAGEN tablets contains the active ingredient abacavir which belongs to a group of
medicines called antiretrovirals.
ZIAGEN tablets 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).
ZIAGEN tablets does not cure AIDS or kill the HIV virus, but prevents further damage
to the immune system by stopping the 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.
While taking ZIAGEN 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.
2. What should I know before I take ZIAGEN tablets?
Warnings
Do not take ZIAGEN tablets if:
you are allergic to abacavir, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine
if you develop any of the symptoms of allergy or hypersensitivity, tell your doctor
immediately. If an allergy or hypersensitivity is suspected then your doctor will
stop your ZIAGEN tablets treatment
YOU MUST NOT TAKE ZIAGEN tablets, OR ANY OTHER MEDICINE CONTAINING ABACAVIR (KIVEXA,
TRIUMEQ) AGAIN
Special warning
ZIAGEN tablets 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 ZIAGEN tablets. If
your doctor is not available you must urgently seek other medical advice (e.g. the
Emergency Department 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 ZIAGEN 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 ZIAGEN tablets, NEVER take ZIAGEN tablets,
or any other medicine containing abacavir (KIVEXA, TRIUMEQ) 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 ZIAGEN
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 ZIAGEN tablets was
re-started in patients who had no symptoms of hypersensitivity before stopping.
If you have stopped taking ZIAGEN 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 ZIAGEN tablets, or any other medicine containing abacavir
(KIVEXA, TRIUMEQ) again. It is important that you follow this advice.
If you are hypersensitive to ZIAGEN tablets you should return all of your unused medicine
to your pharmacist for proper disposal.
Check with your doctor if you:
have any other medical conditions/illness such as:
liver problems, e.g. jaundice, hepatitis, virus affecting the liver, enlarged liver
or liver scarring (cirrhosis) or if you have any risk factors for liver problems
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.
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 ZIAGEN tablets and affect how it works.
Tell your doctor if you are taking riociguat (a medicine used to treat high blood
pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart
to the lungs). Your doctor may need to reduce your riociguat dose, as abacavir (the
active substance in ZIAGEN tablets) may increase riociguat blood levels.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ZIAGEN tablets.
4. How do I take ZIAGEN tablets?
How much to take
the usual dose of ZIAGEN tablets in adults and in children weighing at least 25 kg
is 600 mg a day. This can be taken as 300 mg (one tablet) twice a day, or 600 mg (two
tablets) once a day, as advised by your doctor.
the usual dose of ZIAGEN tablets in children weighing at least 20 kg and less than
25 kg is 450 mg a day. This can be taken as 150 mg (half a tablet) in the morning
and 300 mg (one whole tablet) in the evening, or 450 mg (one and a half tablets) once
a day as advised by your doctor.
the usual dose of ZIAGEN tablets in children weighing at least 14 kg and less than
20 kg is 300 mg a day. This can be taken as 150 mg (half a tablet) twice a day, or
300 mg (one whole tablet) once a day, as advised by your doctor.
your doctor may prescribe a different dose.
follow the instructions provided and use ZIAGEN tablets until your doctor tells you
to stop.
if you are giving ZIAGEN tablets to a child, follow the doctor's instructions. ZIAGEN
oral solution is also available for younger patients, or those who cannot swallow
tablets.
How to take ZIAGEN tablets
ZIAGEN tablets should be swallowed whole, with water or another drink.
ZIAGEN does not need to be taken with food.
the tablets may be crushed and added to a small amount of semi-solid food or liquid,
all of which should be consumed immediately.
When to take ZIAGEN tablets
because your medicine helps to control your condition, but does not cure it, you will
need to take the tablets every day. Do not stop taking ZIAGEN tablets or change the
dose without first talking to your doctor
If you forget to take ZIAGEN tablets
ZIAGEN tablets 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.
Otherwise, take it as soon as you remember then go back to taking it as you would
normally.
Do not take a double dose to make up for the dose you missed.
If you take too much
If you think that you have taken too much ZIAGEN, 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.
If you have stopped taking ZIAGEN tablets
If you have stopped taking ZIAGEN 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 ZIAGEN tablets where medical care can be readily accessed by yourself or
others. If your doctor thinks that there is a possibility that your symptoms were
related to a hypersensitivity reaction, you may be told never to take ZIAGEN tablets
again.
5. What should I know while taking ZIAGEN tablets?
Things you should do
Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Remind any doctor, dentist or pharmacist you visit that you are taking ZIAGEN tablets.
Things you should not do
do not give this medicine to anyone else, even if their symptoms seem similar to yours
do not use ZIAGEN tablets to treat any other complaints unless your doctor tells you
to
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ZIAGEN
tablets affects you.
Looking after your medicine
store below 30°C
store in the original pack
Follow the instructions on 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.
Hypersensitivity Reaction
ZIAGEN tablets 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 "Special warning"
under
2. What should I know before I take ZIAGEN tablets? of this leaflet.
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
Serious side effects
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Serious side effects
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What to do
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Metabolism and nutrition disorders
lactic acidosis
Some people taking ZIAGEN tablets, or other medicines like it (NRTIs), develop a condition
called lactic acidosis, together with an enlarged liver.
Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if
it happens, it usually develops after a few months of treatment. It can be life-threatening,
causing failure of internal organs.
Lactic acidosis is more likely to develop in people who have liver disease, especially
in women.
Signs of lactic acidosis include:
deep, rapid, difficult breathing
drowsiness
numbness or weakness in the limbs
feeling sick (nausea), being sick (vomiting)
stomach pain
fat loss or fat gain
Fat loss or fat gain has been observed with combined antiretroviral therapy. A causal
relationship for this has not been established. Should any change in body shape be
noticed, seek medical advice.
Immune system disorders
allergic (anaphylactic) reaction
The symptoms of an allergic (anaphylactic) reaction which may occur soon after starting
ZIAGEN tablets include wheezing, swelling of the lips/mouth, difficulty in breathing,
hayfever, lumpy rash (hives) or fainting.
Infections and infestations
old infections may flare up
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, they may find that old, hidden infections flare up, causing signs and symptoms
of inflammation. These symptoms are probably caused by the body’s immune system becoming
stronger, so that the body starts to fight these infections.
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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.
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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 ZIAGEN tablets contains
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Active ingredient
(main ingredient)
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abacavir (as sulfate)
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
sodium starch glycollate
magnesium stearate
colloidal anhydrous silica
glycerol triacetate
hypromellose
titanium dioxide
polysorbate 80
iron oxide yellow
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Do not take this medicine if you are allergic to any of these ingredients.
What ZIAGEN tablets looks like
ZIAGEN tablets are scored film coated tablets that are yellow, biconvex, capsule shaped
and engraved with "GX 623" on both sides (AUST R 66878).
ZIAGEN tablets are supplied in a white polyvinyl chloride/foil blister pack or a polyvinyl
chloride/child resistant foil blister pack. The blister pack is in a carton containing
60 tablets.
Who distributes ZIAGEN tablets
ViiV Healthcare Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria, 3067
Phone: 1800 499 226
This leaflet was prepared in February 2025.
Version 11.0
Trade marks are owned by or licensed to the ViiV Healthcare group of companies.
© 2025 ViiV Healthcare group of companies or its licensor.