KIVEXA™ tablets

abacavir (as sulfate) and lamivudine

What is in this leaflet?

Please read this leaflet carefully before you start Kivexa tablets.

This leaflet answers some common questions about Kivexa tablets. It does
not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist (also
known as a chemist). All medicines have benefits and risks. Your doctor has
weighed the expected benefits of you taking Kivexa tablets against the
risks this medicine could have for you.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the tablets. You may need to read it again.

What Kivexa tablets are used for

Kivexa tablets contain abacavir and lamivudine which belong to a group of
medicines called antiretrovirals. These are also available as separate
medicinal products: Ziagen (abacavir) and 3TC (lamivudine).

Kivexa 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
(eg AIDS-related Complex or ARC).

Kivexa tablets do not cure AIDS or kill the HIV virus, but delays further
damage to the immune system by stopping production of new viruses.

Kivexa tablets do 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 Kivexa 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.

Kivexa tablets are not addictive.

Before you take Kivexa tablets

Do not take if:

You must not take Kivexa tablets if:

• you have ever had an allergic reaction to abacavir, which is also
  included in medicines called Trizivir and Ziagen
• if you are allergic to the active ingredient lamivudine or any of the
  other ingredients listed toward the end of this leaflet.
• if you have a serious liver disease Kivexa may not be suitable for you.

You must not take Kivexa tablets if:

• you had a previous allergic reaction to Kivexa tablets or other abacavir
  containing products (Ziagen & Trizivir).
• you are pregnant, think you may be pregnant or are breastfeeding, unless
  your doctor tells you to.
• the expiry date (EXP.) printed on the pack has passed.
• the packaging is torn or shows signs of tampering.

You must tell your doctor if:

• you are allergic to foods, dyes, preservatives or any other medicines.
• you have any other illness.
• you are taking any other medicines, including medicines you buy without
  a prescription from a supermarket or health food shop.

Abacavir or lamivudine in Kivexa tablets may interact with certain other
medicines.

Kivexa tablets should not be taken with zalcitabine (also known as Hivid).

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.

How do I take Kivexa tablets?

How much to take

Take Kivexa tablets as directed by your doctor or pharmacist. The normal
dose for adults and adolescents is one tablet once a day. Your doctor may
prescribe a different dosage.

How to take them

Kivexa tablets should be swallowed whole with water. Kivexa tablets do not
have to be taken with food.

How long to take them for

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 Kivexa
tablets or change the dose without first talking to your doctor.

What do I do if I take too much? (Overdose)

If you think you or anyone else may have taken too many Kivexa tablets,
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.

While you are taking Kivexa tablets

Things you must 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.

If you forget to take them

It is important to take this medicine as prescribed to ensure you get
maximum benefit. If you forget to take a dose, take it as soon as you
remember, and then continue as before.

Do not take more than one tablet to make up for the doses you have missed.

If you have stopped taking them

If you have stopped taking Kivexa 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 Kivexa tablets where medical care can be
readily accessed by yourself or others.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem
similar to yours.

Do not use Kivexa tablets to treat any other complaints unless your
doctor tells you to.

If you have hepatitis B infection, you should not stop Kivexa tablets
without instructions from your doctor, as you may have a recurrence of your
hepatitis. This may occur due to you suddenly stopping lamivudine.

Things to be careful of

Be careful driving or operating machinery until you know how Kivexa tablets
affect you.

No studies on the effects of Kivexa 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 Kivexa tablets before
considering driving or using machines.

What are the side-effects?

Check with your doctor as soon as possible if you think you are
experiencing any side-effects or allergic reactions while taking Kivexa
tablets, even if the problem is not listed in this leaflet.

Like all medicines, Kivexa tablets 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.

Hypersensitivity Reaction

A hypersensitivity reaction (serious allergic reaction) has been reported
in about five in every hundred patients who have been treated with Kivexa
tablets. This is described in the section "Special warning" under
"Before you take Kivexa tablets", of this leaflet. It is important that
you read and understand the information about this serious reaction.

As Kivexa tablets contains both abacavir and lamivudine, the side effects
reported for each of these have been combined.

The most common side-effects (could affect at least one to ten in every 100
people) are:

• nausea, vomiting
• diarrhoea
• upper abdominal pain
• headache
• high temperature
• lethargy, fatigue, loss of appetite
• hair loss
• joint and muscle pain
• abacavir hypersensitivity
• skin rash (without any other illness).

Uncommon side-effects (could affect less than one in every 100 people) are:

• increases in enzymes produced by the liver
• anaemia (low red blood cell count)
• neutropenia (low white blood cell count)
• reduction in the number of platelets (blood cells important for blood
  clotting).

If the production of red blood cells is reduced, you may have symptoms of
tiredness or breathlessness.

A reduction in your white blood cell count can make you more prone to
infection. If you have a low platelet count, you may notice that you bruise
more easily.

Rare side-effects (could affect less than one in every 1,000 people) are:

• breakdown of muscle tissue, increases of an enzyme called amylase
• inflammation of the pancreas (pancreatitis).

Very rare side-effects (could affect less than one in every 10,000 people)
are:

• serious skin reactions
• severe anaemia.

Changes in fat distribution have been reported in association with
antiretroviral medicines. These may include:

• loss of fat from legs, arms and face
• increased fat in the abdomen (belly) and other internal organs, breasts
  and back of the neck.

Changes in the amounts of fatty substances and glucose in the blood have
also been reported.

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.

In babies and infants exposed to Nucleoside Reverse Transcriptase
Inhibitors (NRTIs) during pregnancy or labour small temporary increases in
blood levels of a substance called lactate have been observed. Additionally
there have been very rare reports of diseases that affect the nervous system
such as a delayed development and seizures. Overall, in children whose mothers
took NRTIs during pregnancy, the benefit from the reduced chance of being
infected with HIV is likely to be greater than the risk of suffering from side
effects.

Call your doctor IMMEDIATELY if you notice any of the following. The
doctor will tell you whether you should stop taking Kivexa tablets and what
you should do:

• Lactic Acidosis
  
  If you become very sick, with fast breathing you may have a condition known
  as "lactic acidosis". The fast breathing is due to high acid levels in the
  blood. This can be
  
  life-threatening. This illness occurs more often in women than men.
• Allergic (anaphylactic) reaction
  

  The symptoms of an allergic (anaphylactic) reaction which may occur soon
  after starting Kivexa include wheezing, swelling of the lips/mouth,
  difficulty in breathing, hayfever, lumpy rash (hives) or fainting.

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.

How do I store Kivexa tablets?

Keep this medicine where children cannot reach it, such as a locked
cupboard.

Keep Kivexa tablets in a cool, dry place where it stays below 30°C.

Do not store the tablets, or any other medicine, in a bathroom or near a
sink.

Do not leave them in the car or on window sills.

Keep your Kivexa tablets in their pack until you take them.

If your doctor tells you to stop taking Kivexa tablets, or the tablets have
passed their expiry date, return any unused or expired medicine to your
pharmacist.

Product description

What Kivexa tablets look like

The tablets are orange, film-coated, capsule shaped, engraved with GS FC2
on one side.

Kivexa tablets are supplied in blister packs containing 30 tablets.

Ingredients

Kivexa tablets contain 600 mg of abacavir as the sulfate salt and 300mg of
lamivudine.

Your tablets also contain the following inactive ingredients:

magnesium stearate, microcrystalline cellulose, sodium starch glycollate.
Tablet Coating Opadry Orange YS-1-13065-A
containing: hypromellose, titanium dioxide CI 77891, macrogol 400, polysorbate
80, sunset yellow FCF CI 15985 aluminium lake.