ZIAGEN oral solution contains 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 (eg AIDS-related Complex or ARC).
ZIAGEN does not cure AIDS or kill the HIV virus, but prevents further damage to the immune system by stopping production of new viruses.
ZIAGEN does not reduce the risk of passing the infection to others. 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.
While taking ZIAGEN 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.
ZIAGEN oral solution is not addictive.
You must not take ZIAGEN oral solution if:
Hypersensitivity reaction (serious allergic reaction): About 5 in every 100 patients, who are treated with ZIAGEN, develop a hypersensitivity reaction to the active ingredient abacavir.
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. If your doctor is not available you must urgently seek other medical advice (eg 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 or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with ZIAGEN. 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, NEVER take ZIAGEN, or any other abacavir containing products (KIVEXA, TRIZIVIR), 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 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 was re-started in patients who had no symptoms of hypersensitivity before stopping.
If you have stopped taking ZIAGEN 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 or any other abacavir containing products (KIVEXA, TRIZIVIR) again. It is important that you follow this advice.
If you are hypersensitive to ZIAGEN you should return all of your unused ZIAGEN to your doctor or pharmacist for proper disposal.
You must not take ZIAGEN oral solution if:
You must tell your doctor if:
Take ZIAGEN oral solution as directed by your doctor or pharmacist. The normal dose in adults and adolescents over 12 years of age is 15 mL (300 mg) twice a day. Your doctor may prescribe a different dosage.
If you are giving Ziagen oral solution to a child, follow the doctor's instructions.
To measure your dose of Ziagen oral solution accurately use the dosing syringe supplied as follows:
1. Remove the bottle cap.
2. Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.
3. Insert the syringe firmly into the adapter.
4. Turn the bottle upside down.
5. Pull out syringe plunger until the correct amount is withdrawn.
6. Turn the bottle the correct way up and remove the syringe from the adapter.
7. Replace and tighten the bottle cap.
8. 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.
Because your medicine helps to control your condition, but does not cure it, you will need to take the oral solution every day. Do not stop taking ZIAGEN oral solution or change the dose without first talking to your doctor.
If you think you or anyone else may have taken too much ZIAGEN oral solution immediately telephone your doctor or Poisons Information Centre (In Australia telephone 131126. In New Zealand telephone 0800 POISON). Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you are not sure what to do, contact your doctor or pharmacist.
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.
If you have forgotten to take a dose of your medicine 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 that you missed.
If you have stopped taking ZIAGEN 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 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 again.
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.
This medicine contains the sweetener sorbitol, which occasionally may cause stomach pain and diarrhoea. Medicines containing sorbitol should not be taken if you have hereditary fructose intolerance.
Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions while taking ZIAGEN oral solution, even if the problem is not listed in this leaflet.
Like all medicines, ZIAGEN oral solution can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and may need medical attention.
An important side effect called a hypersensitivity reaction (serious allergic reaction) has been reported in about five every hundred patients who have been treated with ZIAGEN. This is described in the section "Special warning" under "Before you take ZIAGEN oral solution", of this leaflet.
It is important that you read and understand the information about this serious reaction.
The most commonly reported side effects include:
Other side effects that have been reported include:
Changes in fat distribution have been reported in association with combination antiretroviral therapy. These may include:
Changes in your immune system.
A condition called Immune Reconstitution Syndrome can happen when you start taking HIV medicines. Your immune system may get stronger and could begin to fight infections that have been hidden in your body such as pneumonia, herpes virus or tuberculosis. Tell your doctor if you develop new symptoms after starting your HIV medicines.
Within the first few weeks of treatment with anti-HIV medicines, some people, particularly those that have been HIV positive for some time, may develop inflammatory reactions (eg pain, redness, swelling, high temperature) which may resemble an infection and may be severe. It is thought that these reactions are caused by a recovery in the body's ability to fight infections, previously suppressed by HIV. If you become concerned about any new symptoms, or any changes in your health after starting HIV treatment, please discuss with your doctor immediately.
On very rare occasions serious skin reactions have been reported.
Call your doctor IMMEDIATELY if you notice any of the following. The doctor will tell you whether you should stop taking ZIAGEN oral solution and what you should do:
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Do not be alarmed by this list of possible side-effects. You may not experience any of them.
Keep this medicine where children cannot reach it such as a locked cupboard.
Keep ZIAGEN oral solution in a cool, dry place where it stays below 30°C.
Do not store the oral solution, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Keep your ZIAGEN oral solution in the bottle with the cap tightly closed until you need to take it.
If your doctor tells you to stop taking ZIAGEN oral solution, or the oral solution has passed its expiry date, return any unused or expired medicine to your pharmacist.
The oral solution is a clear to yellowish solution with strawberry/banana flavour. Each 1 mL of solution contains 20 mg of abacavir as the sulfate salt.
ZIAGEN oral solution is supplied in a white polyethylene bottle with a cap. 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 oral solution contains 20 mg per mL of abacavir as the sulfate salt. Your oral solution also contains the following inactive ingredients:
Sorbitol (34%), saccharin sodium, sodium citrate, anhydrous citric acid, methyl hydroxybenzoate, propyl hydroxybenzoate, propylene glycol, artificial strawberry and banana flavour and purified water.