abacavir (as sulfate) and lamivudine
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING ABACAVIR/LAMIVUDINE MYLAN, WHICH CONTAINS ABACAVIR, MAY DEVELOP A
HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING
IF TREATMENT WITH ABACAVIR/LAMIVUDINE MYLAN IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY
FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE MYLAN IF:
1) YOU GET A SKIN RASH OR
2) YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING GROUPS:
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 MYLAN
TABLETS, NEVER TAKE ABACAVIR/LAMIVUDINE MYLAN, 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 MYLAN 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
What is in this leaflet
Please read this leaflet carefully before you start ABACAVIR/LAMIVUDINE MYLAN tablets.
This leaflet answers some common questions about ABACAVIR/LAMIVUDINE MYLAN 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
All medicines have benefits and risks. Your doctor has weighed the expected benefits
of you taking ABACAVIR/LAMIVUDINE MYLAN 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 ABACAVIR/ LAMIVUDINE MYLAN tablets are used for
ABACAVIR/LAMIVUDINE MYLAN tablets contain abacavir and lamivudine which belong to
a group of medicines called antiretrovirals.
These are also available as separate medicinal products.
ABACAVIR/LAMIVUDINE MYLAN 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).
ABACAVIR/LAMIVUDINE MYLAN tablets do not cure AIDS or kill the HIV virus, but delays
further damage to the immune system by stopping production of new viruses.
ABACAVIR/LAMIVUDINE MYLAN 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
While taking ABACAVIR/LAMIVUDINE MYLAN 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.
ABACAVIR/LAMIVUDINE MYLAN tablets are not addictive.
Before you take ABACAVIR/ LAMIVUDINE MYLAN tablets
Do not take if:
You must not take ABACAVIR/LAMIVUDINE MYLAN tablets if:
you have ever had an allergic reaction to abacavir
you are allergic to the active ingredient lamivudine or any of the other ingredients
listed toward the end of this leaflet.
you have a serious liver disease ABACAVIR/LAMIVUDINE MYLAN may not be suitable for
ABACAVIR/LAMIVUDINE MYLAN 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
MYLAN 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
MYLAN 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 MYLAN tablets, NEVER
take ABACAVIR/LAMIVUDINE MYLAN 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
MYLAN 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
MYLAN tablets were restarted in patients who had no symptoms of hypersensitivity before
If you have stopped taking ABACAVIR/LAMIVUDINE MYLAN 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 MYLAN tablets
again. It is important that you follow this advice.
If you are hypersensitive to ABACAVIR/LAMIVUDINE MYLAN tablets you should return all
of your unused ABACAVIR/LAMIVUDINE MYLAN tablets to your doctor or pharmacist for
You must not take ABACAVIR/LAMIVUDINE MYLAN tablets if:
you had a previous allergic reaction to ABACAVIR/LAMIVUDINE MYLAN tablets or other
abacavir containing products
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 ABACAVIR/LAMIVUDINE MYLAN tablets may interact with certain
other medicines. ABACAVIR/LAMIVUDINE MYLAN tablets should not be taken with emtricitabine.
Some medicines may affect how ABACAVIR/LAMIVUDINE MYLAN works, or make it more likely
that you'll have side effects. These medicines include:
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).
Tell your doctor or pharmacist if you are taking any of these.
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 ABACAVIR/ LAMIVUDINE MYLAN tablets?
How much to take
Take ABACAVIR/LAMIVUDINE MYLAN 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
ABACAVIR/LAMIVUDINE MYLAN tablets should be swallowed whole with water. ABACAVIR/LAMIVUDINE
MYLAN 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 ABACAVIR/LAMIVUDINE MYLAN 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 ABACAVIR/LAMIVUDINE MYLAN
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 ABACAVIR/ LAMIVUDINE MYLAN 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
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
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 ABACAVIR/LAMIVUDINE MYLAN 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 MYLAN 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 ABACAVIR/LAMIVUDINE MYLAN tablets to treat any other complaints unless
your doctor tells you to.
If you have hepatitis B infection, you should not stop ABACAVIR/LAMIVUDINE MYLAN 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 ABACAVIR/LAMIVUDINE MYLAN
tablets affect you.
No studies on the effects of ABACAVIR/LAMIVUDINE MYLAN 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 MYLAN 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 ABACAVIR/LAMIVUDINE MYLAN tablets, even if the
problem is not listed in this leaflet.
Like all medicines, ABACAVIR/LAMIVUDINE MYLAN 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.
ABACAVIR/LAMIVUDINE MYLAN 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 "Before you take
ABACAVIR/LAMIVUDINE MYLAN tablets", of this leaflet.
It is important that you read and understand the information about this serious reaction.
As ABACAVIR/LAMIVUDINE MYLAN 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)
upper abdominal pain
lethargy, fatigue, loss of appetite
joint and muscle pain
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
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
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 (e.g. 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 ABACAVIR/LAMIVUDINE MYLAN tablets and what you
Some people taking ABACAVIR/LAMIVUDINE MYLAN, 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
Signs of lactic acidosis include:
deep, rapid, difficult breathing
numbness or weakness in the limbs
feeling sick (nausea), being sick (vomiting)
Allergic (anaphylactic) reaction
The symptoms of an allergic (anaphylactic) reaction which may occur soon after starting
ABACAVIR/LAMIVUDINE MYLAN include wheezing, swelling of the lips/mouth, difficulty
in breathing, hayfever, lumpy rash (hives) or fainting.
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.
Fat gain and loss
Fat gain and loss 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.
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
How do I store ABACAVIR/ LAMIVUDINE MYLAN tablets?
Keep this medicine where children cannot reach it, such as a locked cupboard.
Keep ABACAVIR/LAMIVUDINE MYLAN tablets in a cool, dry place where it stays below 25°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 ABACAVIR/LAMIVUDINE MYLAN tablets in their pack until you take them.
If your doctor tells you to stop taking ABACAVIR/LAMIVUDINE MYLAN tablets, or the
tablets have passed their expiry date, return any unused or expired medicine to your
What ABACAVIR/LAMIVUDINE MYLAN tablets look like
The tablets are white, film-coated, modified capsule shaped, biconvex tablet debossed
with AL12 on one side of the tablet and M on the other side.
ABACAVIR/LAMIVUDINE MYLAN tablets are supplied in blister packs containing 30 tablets.
ABACAVIR/LAMIVUDINE MYLAN tablets contain 600 mg of abacavir as the sulfate salt and
300 mg of lamivudine.
The tablets also contain the following inactive ingredients:
silicified microcrystalline cellulose
tablet coating OPADRY II complete film coating system 13B58894 White (ARTG No. 13119)
containing: hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.
ABACAVIR/LAMIVUDINE MYLAN tablets contain sorbates.
ABACAVIR/LAMIVUDINE MYLAN tablets are supplied by:
Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Australian registration numbers:
ABACAVIR/LAMIVUDINE MYLAN 600 mg/300 mg tablet blister pack: AUST R 266516
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