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 ZIAGEN oral solution?
ZIAGEN oral solution contains the active ingredient abacavir which belongs to a group
of medicines called antiretrovirals. ZIAGEN 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).
2. What should I know before I use ZIAGEN oral solution?
Do not use if you have ever had an allergic reaction to ZIAGEN oral solution 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 oral solution and affect how it works.
4. How do I use ZIAGEN oral solution?
Follow the instructions provided and use ZIAGEN oral solution until your doctor tells
you to stop.
If you are giving ZIAGEN oral solution to a child, follow the doctor's instructions.
5. What should I know while using ZIAGEN oral solution?
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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 using ZIAGEN oral
solution
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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 oral solution 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
oral solution affects you
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Looking after your medicine
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Store below 25°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 oral solution, 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 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 oral solution NEVER
TAKE ZIAGEN oral solution, 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 oral solution 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 USE ZIAGEN
oral solution.
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Active ingredient(s):
abacavir (as sulfate)
Consumer Medicine Information (CMI)
This leaflet provides important information about using ZIAGEN oral solution. 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 oral solution.
Where to find information in this leaflet:
1. Why am I using ZIAGEN oral solution?
1. Why am I using ZIAGEN oral solution?
ZIAGEN oral solution contains the active ingredient abacavir which belongs to a group
of medicines called antiretrovirals.
ZIAGEN oral solution 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 oral solution 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 oral solution 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 use ZIAGEN oral solution?
Warnings
Do not use ZIAGEN oral solution 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 oral solution treatment
YOU MUST NOT TAKE ZIAGEN oral solution OR ANY OTHER ABACAVIR CONTAINING PRODUCTS (KIVEXA,
TRIZIVIR), AGAIN
Special warning
ZIAGEN oral solution 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 oral solution.
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 oral solution.
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 oral solution, NEVER take ZIAGEN,
or any other abacavir containing products (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
oral solution 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 oral solution
was re-started in patients who had no symptoms of hypersensitivity before stopping.
If you have stopped taking ZIAGEN oral solution 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 oral solution or any other abacavir containing products
(KIVEXA, TRIUMEQ) again. It is important that you follow this advice.
If you are hypersensitive to ZIAGEN oral solution 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
hereditary fructose intolerance
this medicine contains the sweetener sorbitol, which occasionally may cause stomach
pain and diarrhoea. Medicines containing sorbitol should not be taken if you have
a hereditary fructose intolerance
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 oral solution 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 oral solution) 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 oral solution.
4. How do I use ZIAGEN oral solution?
How much to take
the normal dose in adults and children weighing at least 25 kg is 15 mL (300 mg) twice
a day.
your doctor may prescribe a different dose.
follow the instructions provided and use ZIAGEN oral solution until your doctor tells
you to stop.
if you are giving ZIAGEN oral solution to a child, follow the doctor's instructions.
How to take ZIAGEN oral solution
To measure your dose of ZIAGEN oral solution accurately use the dosing syringe supplied
as follows:
1. Remove the plastic wrap from the syringe/adapter
3. Remove the plastic adapter from the syringe
4. Push the plastic adapter into the neck of the bottle, while holding the bottle firmly
5. Insert the syringe firmly into the adapter
6. Turn the bottle upside down
7. Pull out syringe plunger until the correct amount is withdrawn
8. Turn the bottle the correct way up and remove the syringe from the adapter
9. Replace and tighten the bottle cap
10. Administer the dose into the mouth by placing the tip of the syringe against the inside
of the cheek. Slowly depress the plunger, allowing time to swallow. Forceful squirting
to the back of the throat may cause choking
After use the syringe and adapter must not be left in the bottle. They should be washed
thoroughly in clean water.
When to use ZIAGEN oral solution
because your medicine helps to control your condition, but does not cure it, you will
need to use the oral solution every day. Do not stop using ZIAGEN oral solution or
change the dose without first talking to your doctor.
If you forget to use ZIAGEN oral solution
ZIAGEN oral solution should be used 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 use too much
If you think that you have used 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 using ZIAGEN oral solution
If you have stopped taking ZIAGEN oral solution 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 oral solution 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
oral solution again.
5. What should I know while using ZIAGEN oral solution?
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 using ZIAGEN oral
solution.
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 oral solution 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
oral solution affects you.
Looking after your medicine
store below 25°C
store in the original pack
Follow the instructions on the carton on how to take care of your medicine properly.
Keep your ZIAGEN oral solution in the bottle with the cap tightly closed until you
need to take it. Shake the bottle before use.
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 oral solution 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 use ZIAGEN oral solution? 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
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 oral solution 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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sorbitol solution (70%)
saccharin sodium
sodium citrate dihydrate
citric acid
methyl hydroxybenzoate
propyl hydroxybenzoate
propylene glycol
artificial strawberry
artificial banana flavour
purified water
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Do not take this medicine if you are allergic to any of these ingredients.
What ZIAGEN oral solution looks like
ZIAGEN oral solution is a clear to yellowish solution which may turn into a brown
colour over time with strawberry/banana flavour. Each 1 mL of solution contains 20
mg of abacavir as the sulfate salt (AUST R 66879).
ZIAGEN oral solution is supplied in a white polyethylene bottle with a polypropylene
or polyethylene child-resistant closure. The bottle contains 240 mL of solution for
oral use only and is packed in a carton.
The pack includes an oral dosing syringe and syringe-adapter.
ZIAGEN is also available as tablets (300 mg abacavir).
Who distributes ZIAGEN oral solution
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.