Trizivir™ Tablets

Lamivudine 150mg, zidovudine 300mg and abacavir (as sulphate) 300mg tablets

If you have had a hypersensitivity (allergic) reaction to
Trizivir or Ziagen, NEVER take Trizivir or Ziagen again as you may develop a
life threatening reaction which has caused death. See more details under
Side Effects.

What is in this leaflet?

Please read this leaflet carefully before you start taking Trizivir tablets

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

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of
you taking Trizivir tablets against the benefits this medicine is expected to
have for you.

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

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

What Trizivir tablets are used for

Trizivir contains abacavir, lamivudine and zidovudine which all belong to a
group of medicines called antiretrovirals.

Please note that these medicines are also available separately: abacavir is
Ziagen (tablets), lamivudine is 3TC™, (tablets and oral solution) and zidovudine
is Retrovir™ (capsules and syrup).

Trizivir is used, alone or 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).

Trizivir does not cure AIDS or HIV infection, but slows production of human
immunodeficiency virus. In this way it stops ongoing damage to the body's immune
system, which fights infection.

Trizivir does not reduce your risk of passing HIV infection to others. You
will still be able to pass on the HIV virus by sexual activity or by passing on
blood or bodily secretions which carry the HIV virus. You should continue to
take all appropriate precautions.

While taking Trizivir 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 your doctor.

The long-term risks and benefits of taking Trizivir are not known. Trizivir
is not addictive.

Before you take Trizivir tablets

When you must not take them

• Do not take Trizivir tablets if you have ever had an allergic reaction to
  abacavir (trade name Ziagen), lamivudine (trade name 3TC) or zidovudine (trade
  name Retrovir), or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may be mild or severe. They usually include
some or all of the following: wheezing, swelling of the lips/mouth, difficulty
in breathing, hay fever, lumpy rash ("hives") or fainting.

• Do not take Trizivir tablets if you are pregnant, trying to become
  pregnant or breastfeeding, unless your doctor says you should.

Your doctor should discuss with you the risks and benefits of using Trizivir
tablets if you are pregnant or breastfeeding.

Do not take Trizivir if you have:

• kidney disease
• liver disease or reduced liver function
• reduced red blood cell count (anaemia),
• reduced white blood cell count (neutropenia).

If you have certain health conditions, your doctor may advise that you take a
lower dose of lamivudine and/or zidovudine, the active ingredients in Trizivir
tablets. The separate products should be used in these cases. Ask your doctor if
you are not sure whether you should take Trizivir.

• Do not take Trizivir tablets after the expiry date (EXP) printed on the
  pack.

If you take them after the expiry date has passed, they may not work as well.

• Do not take Trizivir tablets if the packaging is torn or shows signs of
  tampering.

If you're not sure whether you should be taking Trizivir tablets, talk to
your doctor.

Before you start to take Trizivir

You must tell your doctor if:

• you are allergic to foods, dyes, preservatives or any other medicines.
• you had a previous allergic reaction to Ziagen (abacavir) containing
  products.
• you have, or have ever had, liver problems, for example jaundice,
  hepatitis, virus affecting the liver, enlarged liver or liver scarring
  (cirrhosis) or if you have any risk factors for liver problems, e.g. excessive
  alcohol intake, illegal intravenous drug use with shared equipment, iron or
  copper storage disorders.
• you have any other illness, including those that you think are not related
  to HIV infection.
• you are taking or have taken any other medicines.

When you stop taking Trizivir Tablets

If you have a long-standing viral infection of your liver (hepatitis B) it
may flare up. This can cause serious illness particularly if your liver is
already not working very well. If you have both HIV and hepatitis B, when you
stop taking your Trizivir tablets, your doctor is likely to arrange tests from
time to time to check how well your liver is working and to measure virus
levels.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines
you buy without a prescription from a pharmacy, supermarket or health food shop.

There is little information about the way other medicines might affect the
way that Trizivir works, or how Trizivir affects other medicines. Particular
care is needed when taking the painkiller, paracetamol. Your doctor or
pharmacist will be able to tell you what to do when taking Trizivir with other
medicines.

Use in children

Trizivir is not recommended for use in children under 12 years of age.
Because it is a fixed dose combination tablet it cannot be adjusted according to
the size and weight of the patient.

How to take Trizivir tablets

Your doctor will tell you how many Trizivir tablets to take and how often to
take them. You will also find this information on the label of your medicine.

Do not take or give extra tablets. Do not take the tablets more often than
you have been told.

How much to take

The usual dosage of Trizivir tablets is one tablet, twice a day.

How to take them

Your Trizivir tablets should be swallowed with a drink of water.

When to take them

Your doctor or pharmacist will be able to tell you when you should take your
Trizivir tablets.

How long to take them

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 your medicine
without first talking to your doctor.

If you forget to take them

If 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 take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (0800 764
766) or go to accident and emergency at your nearest hospital, if you think you
or anyone else may have taken too many Trizivir tablets. Do this even if there
are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking Trizivir tablets

Things you must do

Tell your doctor or pharmacist that you are taking Trizivir tablets if you
are about to be started on any new medicines.

There is little information about the way other medicines might affect the
way that Trizivir works. You must tell your doctor or pharmacist that you are
taking Trizivir before you start taking medicines you buy from a pharmacy,
health food shop or supermarket. This is especially important regarding
medicines which might have an effect on the kidneys, liver, red or white blood
cells or other body cells.

Tell your doctor if you become pregnant or are trying to become pregnant.

Tell your doctor if, for any reason, you have not taken your medicine exactly
as prescribed.

Otherwise, your doctor may think that it was not effective and change your
treatment unnecessarily.

Things you must not do

Do not stop taking Trizivir tablets, or change the dose without first
checking with your doctor.

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

Do not use Trizivir tablets to treat any other complaints unless your doctor
says to.

Do not take Trizivir tablets again if you have had an allergic reaction to
them.

Do not give this medicine to children under 12 years of age. Because it is a
fixed dose combination tablet it cannot be adjusted according to the size and
weight of the patient.

Things to be careful of

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

Side-Effects

Check with your doctor as soon as possible if you have any problems while
taking Trizivir tablets, even if you do not think the problems are connected
with the medicine or are not listed in this leaflet.

Like other medicines, Trizivir tablets can cause some side-effects. If they
occur, they are most likely to be minor and temporary. However, some may be
serious and need medical attention.

Hypersensitivity Reaction:

A hypersensitivity reaction (serious allergic reaction) has been reported
in about 4 in every 100 patients who have been treated with abacavir (Ziagen) a
component of Trizivir. This is described in the section "Special
Warnings" under "Before you take your Trizivir
tablets", of this leaflet. It is important that you read and
understand the information about this serious reaction.

Other side-effects associated with Trizivir hypersensitivity include:

• Headache
• Nausea & vomiting
• Diarrhoea
• Fever/high temperature
• Fatigue/tiredness
• Anorexia/loss of appetite
• Rash, hives
• General feeling of unwellness
• Aching muscles.

If you have any of the above symptoms soon after starting to take your
medicine, DO NOT TAKE ANY MORE TRIZIVIR TABLETS and tell your doctor IMMEDIATELY
or go to the Accident and Emergency department at your nearest hospital.

These are very serious side effects. If you have them, you may have a serious
allergic reaction. You may need urgent medical attention or hospitalisation.

Other serious side-effects include:

• reduced red blood cell count (anaemia).
• reduced white blood cell count (neutropenia).

The frequency and severity of anaemia and neutropenia are greater in patients
with advanced HIV disease, or in patients who start taking Trizivir in later
stages of HIV disease.

While you are taking Trizivir, it is very important that your doctor keeps a
close check on your health and takes blood samples to monitor levels of red and
white blood cells. If you develop anaemia or neutropenia, your doctor may reduce
or stop the dose of Trizivir, or recommend standard treatment for these
conditions. Ask your doctor any questions you may have.

It is not known whether many of these side effects are due to taking Trizivir
or taking Trizivir while taking other medicines. Some of these symptoms may
occur as part of HIV infection, AIDS or AIDS-related Complex.

The side effects listed below have been reported:

• sweating, chills, swelling of lips and/or tongue, flu-like symptoms,
  fever, increased sensitivity to pain, back pain, enlarged glands, chest pain,
  weakness, weight loss, generally feeling unwell.
• constipation, difficulty in swallowing, gas from stomach or bowel, mouth
  ulcers, heartburn, vomiting, loss or reduction in appetite, nausea.
• abdominal discomfort and pain.
• muscle aches or pains, muscle shaking or spasm or twitching, muscle
  disease, joint pain
• enlarged fatty liver, abnormal results of blood tests of liver function,
  inflammation of the pancreas.
• confusion, depression, nervousness, fainting, loss of mental clarity,
  dizziness, seizures, severe headache, sleeplessness, fatigue/tiredness.
• cough, sore throat, hay fever, sinus problems, hoarseness.
• itchiness, skin rash conjunctivitis.
• changes in nail, skin or mouth colour.
• passing too much urine, pain, difficulty or increased frequency of passing
  urine.
• reduction in all blood cells.
• increased bruising or bleeding.
• blood chemistry changes, with excess acidity of the blood.
• unusual feelings in any part of the body, such as numbness, burning,
  tingling or pins and needles.
• Convulsions

Ask your doctor or pharmacist any questions you may have. If you experience
any of these side-effects, and they concern you, see your doctor or pharmacist.

If you have any of the following symptoms soon after starting to take your
medicine, do not take any more Trizivir tablets and tell your doctor immediately
or go to the accident and emergency department at your nearest hospital.

• Severe stomach pain or cramps.
• Nausea.
• Vomiting.

These side effects may be due to a condition called pancreatitis.

If you are on medication for HIV and become very sick, with fast breathing,
stop taking Trizivir tablets and consult your doctor immediately. You may have a
condition known as "lactic acidosis". The fast breathing is due to high acid
levels in the blood. Your liver may not be working properly and gets big and
fatty. This can be life threatening. This illness occurs more often in women
than men.

See your doctor if you feel generally unwell with loss of appetite, nausea,
vomiting, itching, yellowness of the skin or eyes or dark coloured urine, or if
the blood tests of your liver function are abnormal. It is likely you will have
to stop taking Trizivir tablets.

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.

Side-effects may depend on whether you take Trizivir alone, or also have
taken other antiretroviral medication(s). Less is known about possible
side-effects of taking Trizivir with other antiretrovirals.

Tell your doctor if you notice anything else that is making you feel unwell,
even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side-effects. You may not
experience any of them.

After taking Trizivir tablets

Storage

Keep this medicine where young children cannot reach them.

A locked cupboard at least one-and-a half metres above the ground is a good
place to store medicines.

Keep Trizivir 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.

Heat and dampness can destroy some medicines.

Keep your Trizivir tablets in their pack until it is time to take them.

If you take Trizivir tablets out of their pack they may not keep well.

Disposal

If your doctor tells you to stop taking Trizivir tablets, or the tablets have
passed their expiry date, ask your pharmacist what to do with any tablets left
over.

Product description

What Trizivir tablets looks like

Trizivir tablets are blue/green capsule shaped film coated tablets with
"GXLL1" engraved on one side

Ingredients

Trizivir contains the active ingredients abacavir 300mg as abacavir sulphate,
lamivudine (150 mg) and zidovudine (300 mg).

Trizivir tablets also contain the following inactive ingredients:
microcrystalline cellulose, sodium starch glycollate, magnesium stearate, Opadry
green 03B11434, hypromellose, titanium dioxide, polyethylene glycol, indigo
carmine aluminium lake, iron oxide yellow.