RETROVIR™

Zidovudine capsules 100mg, oral solution 10mg/mL, IV infusion 10mg/mL

What is in this leaflet

Please read this leaflet carefully before you start taking RETROVIR capsules
or oral solution, or are given RETROVIR by IV infusion.

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

All medicines have risks and benefits. Your doctor has weighed the risks of
you taking RETROVIR 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.

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

What RETROVIR is used for

RETROVIR contains the active ingredient zidovudine, which belongs to a group
of medicines called antiretrovirals.

Please note that the active ingredient in RETROVIR, zidovudine, is also
available as a combination medicine, Combivir™, along with lamivudine, another
antiretroviral.

RETROVIR capsules and oral solution are used, in combination with other
antiretrovirals, for the long term treatment of HIV infected adults and
children. RETROVIR slows down the progression of human immunodeficiency virus
(HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS)
and other related illnesses, such as AIDS-related Complex (ARC).

RETROVIR IV infusion is used for short term treatment of these conditions in
people who cannot take RETROVIR capsules or oral solution. RETROVIR IV infusion
is also used during childbirth in HIV-infected mothers to reduce the risk of HIV
transmission to the baby.

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

RETROVIR 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 body secretions which carry the HIV virus. You should continue to take
all the appropriate precautions.

While taking RETROVIR and/or any other therapy for HIV disease, you may
continue to develop further infections and other complications of HIV disease.
You should keep in regular contact with your doctor.

Your doctor may have prescribed RETROVIR for another reason. Ask your doctor
if you have any questions about why RETROVIR has been prescribed for you.

RETROVIR is not addictive.

Use in children

RETROVIR may be used in children. The RETROVIR oral solution is particularly
suitable for younger children. RETROVIR IV infusion may also be used in newborn
babies to reduce their risk of contracting the HIV virus during delivery.

Before you take RETROVIR

When you must not take it

• Do not take RETROVIR capsules or oral solution, or have an IV infusion of
  RETROVIR, if you have ever had an allergic (hypersensitivity) reaction to
  zidovudine (RETROVIR.
  
  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 RETROVIR capsules or oral solution, or have an IV infusion of
  RETROVIR, if you have ever had an allergic reaction to any of the other
  ingredients in the formulations listed at the end of this leaflet.
• If you have certain blood disorders, your doctor may advise that you take
  a lower dose of RETROVIR or that you take a break from RETROVIR. Ask your
  doctor if you are not sure whether you should take RETROVIR.
• Do not take or use RETROVIR after the expiry date (EXP) on the packaging.
  If you take this medicine after the expiry date has passed it may not work as
  well.
• Do not take or use RETROVIR if the packaging is torn or shows signs of
  tampering, if the capsules look discoloured or damaged, if the oral solution
  looks lumpy or discoloured, if the solution for IV infusion looks cloudy or
  discoloured, or has been premixed for your infusion more than 48 hours
  earlier.

If you're not sure whether you should be taking RETROVIR capsules or oral
solution, or be given an IV infusion of RETROVIR, talk to your doctor.

Before you start to take RETROVIR

You must tell your doctor if:

• You are allergic to any foods, dyes, preservatives or any other medicines.
• You are taking or have recently taken any other medicines.
• You have, or ever have had, liver problems.
• You have kidney disease.
• You are pregnant or planning to become pregnant.
  

  It is not known if RETROVIR is harmful to an unborn baby in the early stages
  of pregnancy. It is not recommended that this medicine be used by women until
  they are more than 14 weeks pregnant. If you are prescribed RETOVIR earlier
  than 14 weeks, your doctor will have weighed up the expected benefits to you
  against any possible risks to your unborn baby.
  
  Note that while use of RETROVIR during pregnancy can reduce the chance that
  your baby will get HIV, some may get it even with this treatment.

• You are breastfeeding or are planning to breastfeed.
  
  RETROVIR passes into breast milk, so it is recommended that mothers taking
  this medicine do not breastfeed. Breastfeeding may also increase the risk of
  passing on the HIV virus to the baby.

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.

Tell your doctor if you are taking any of the following:

• Phenytoin (Dilantin™), a medicine used to treat epilepsy
• Rifampicin (Rifadin™, Rifinah™), a strong antibiotic used for several
  serious infections.
• Other antiretrovirals, such as lamivudine (3TC™) or stavudine (Zerit™)
• Probenecid (Benemid™), a medicine used to treat gout
• Non-steroidal anti-inflammatory medicines to reduce pain, stiffness and
  inflammation, including:
  • aspirin (Aspec™, Aspro™, Aspro Clear™, Cardiprin™, Cartia™, Disprin™,
    Ecotrin™, Alka-Seltzer™, Solprin™, Codral Forte™, Pirophen™)
  • indomethacin (Arthrexin™, Indocid™, Indocid R™, Rheumacin™, Rheumacin
    SR™)
  • ketoprofen (, Orudis™, Oruvail™)
  • naproxen (Naprosyn™, Naprosyn SR™, Apo-Naproxen™, Naxen™, Noflam™,
    Noflam™, Naprogesic™, Synflex™)
• Some types of medicines used to produce calmness or help you sleep, such
  as oxazepam (Benzotran™, Ox-Pam™, Serepax™) or lorazepam (Ativan™, Lorapam™,
  Lorzem™)
• Cimetidine (Apo-Cimetidine™, Cytine™, , Tagamet™), a medicine used to
  treat stomach ulcers.
• Narcotic painkillers, such as morphine (RA Morph Mix™, Kapanol™, LA
  Morph™, MST Continus™, RMS™, Sevredol™)
• codeine (Alpha-Codeine Phosphate™, Codral Forte™, , Pirophen™,
  Apo-Paracodeine™, Panadeine™, Mersyndol™, Codral Cold and Flu™, Nurofen Plus™)
• methadone (Biodone™, Methaforte™, Pallidone™)
• Clofibrate (Atromid™) a medicine for lowering blood cholesterol levels
• Pyrimethamine a medicine for malaria
• Certain other medicines likely to be used in the treatment of HIV
  infection, AIDS and ARC, including:
  • Pentamidine (Pentacarinat™)
  • Co-trimoxazole (Bactrim™, Septrin™, Trimel™, Trisul™)
  • Amphotericin (Fungilin™, Fungizone™)
  • Flucytosine (Alcobon™)
  • Ganciclovir (Cymevene™)
  • Aciclovir (Zovirax™)
  • Interferon (Intron-A, Roferon-A, Wellferon™, Betaferon™, Imukin™)
  • Dapsone (Dapsone™), used for leprosy
• Some medicines used to treat cancer, including: Vincristine (Vincristine™)
  Vinblastine (Velbe™) Doxorubicin (Adriamycin™).

Your doctor or pharmacist will be able to tell you what to do when taking
RETROVIR capsules or oral solution, or when you are given a RETROVIR IV
infusion, while you are taking other medicines.

How to take RETROVIR

Your doctor will tell you how many RETROVIR capsules or how much RETROVIR
oral solution to take and how often. You will also find this information on the
labelling of your medicine.

Do not take or give extra RETROVIR medicine. Do not take RETROVIR or any
medicine more often than you have been told.

If you have been prescribed RETROVIR IV infusion, it will be given to you in
hospital by a slow drip into a vein by a doctor or nurse.

How much to take

For adults and children over 12 years of age:

RETROVIR capsules and oral solution: The usual total daily dose is
500mg to 600mg, taken in smaller doses two to three times during the day, e.g.
200mg three times a day.

RETROVIR IV infusion: The usual dose is 1mg to 2mg per kilogram of body
weight, given every four hours.

For children aged three months to 12 years:

RETROVIR capsules and oral solution: The recommended dose is 360 to 480mg per
square metre of body surface area (the area of skin the child has). The daily
dose of RETROVIR will be calculated by your child's doctor.

RETROVIR IV infusion: Your doctor will calculate how much to give your child.

In pregnant women from 14 weeks of pregnancy:

RETROVIR capsules or oral solution: The recommended total daily dose is
500mg, 100mg five times daily.

During labour and delivery:

RETROVIR IV infusion: The usual dose is 2mg per kilogram of body weight over
the first hour, then continuous infusion at a rate of 1mg per kilogram per hour,
until the time that the umbilical cord is cut. Alternatively, capsules have been
given by mouth with a higher dose from 36 weeks gestation then higher again
during labour.

The newborn baby is then given RETROVIR oral solution at a recommended dose
of 2mg per kilogram of body weight every six hours, starting within 12 hours of
birth, until the baby is six weeks old. If a newborn baby cannot or will not
swallow medicine, RETROVIR IV infusion is given, at a recommended dose of 1.5mg
per kilogram of body weight, infused over 30 minutes every six hours until the
baby is six weeks old. Your doctor will work this out.

Kidney or liver disease or blood changes

The recommended dose for RETROVIR is reduced in people with kidney or liver
disease and depends on how well these organs are working. It may also be reduced
if the blood cells are low.

How to take it

RETROVIR capsules should be swallowed with a drink of water.

RETROVIR oral solution should be swallowed. A 10ml oral dosing syringe is
provided with the oral solution, so you can measure your dose correctly.

RETROVIR capsules and oral solution can be taken with or without food.

RETROVIR IV infusion is given by a slow drip into a vein in hospital by a
doctor or nurse.

How long to take it

RETROVIR helps to control your condition but does not cure it. If you have
been prescribed capsules or oral solution you will need to take it every day. Do
not stop taking your medicine without first talking to your doctor.

If you are being given RETROVIR IV infusion, your doctor will decide how many
infusions you need.

If you forget to take it

If it is almost time for your next dose of RETROVIR capsules or oral
solution, 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 one that you missed.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre
(03-474-7000) or go to the accident and emergency department at your nearest
hospital, if you think that you or anyone else may have taken too much RETROVIR.
Do this even if there are no signs of poisoning or discomfort. You may need
urgent medical attention.

Keep telephone numbers for these places handy.

An overdose of RETROVIR may cause symptoms similar to those listed under the
Side Effects" heading, especially vomiting, headache and tiredness. It could
also have serious effects on your red and white blood cell counts.

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

While you are taking RETROVIR

Things you must do

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

Other medicines might affect the way that RETROVIR works. You must tell your
doctor or pharmacist that you are taking RETROVIR before you start taking any
medicines you buy from a pharmacy, health food shop or supermarket.

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

If you are taking RETROVIR capsules or oral solution, tell your doctor if,
for any reason, you have not taken your medicine exactly as prescribed.
Otherwise your doctor may think that it is not working for you and change your
medicine unnecessarily.

Things you must not do

If you are taking RETROVIR capsules or oral solution, do not stop taking your
medicine 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 RETROVIR capsules or oral solution to treat any other complaints
unless your doctor says to.

Things to be careful of

Be careful driving or operating machinery until you know how treatment with
RETROVIR affects you. As with many other medicines, RETROVIR may cause headache
and tiredness in some people.

Side-Effects

Check with your doctor as soon as possible if you have any problems while
taking RETROVIR capsules or oral solution, or when you are given RETROVIR IV
infusion even if you do not think the problems are connected with the medicine
or are not listed in this leaflet.

Like many other medicines, RETROVIR capsules, oral solution and IV infusion
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.

It is not known whether many of these side effects are due to taking RETROVIR
alone or taking RETROVIR with other medicines. Some of these symptoms may also
occur as part of HIV infection, AIDS or AIDS-related Complex (ARC).

The side effects listed below have been reported:

Common and Mild

• Nausea, vomiting, stomach pain, diarrhoea
• Tiredness, generally feeling unwell
• Headache, dizziness
• Aching muscles
• Changes in blood tests for liver enzymes or bilirubin

These side effects are common but not usually serious. Contact your doctor if
they concern you. They will normally improve over the first few weeks.

Uncommon

• Tingling or numbness of the hands or feet
• Anxiety, depression
• Trouble sleeping, feeling sleepy, loss of mental clarity
• Cough
• Feeling short of breath
• Loss of appetite, change in taste
• Excessive air in the stomach or bowel (wind), feeling uncomfortable in the
  stomach (indigestion)
• Colour changes in nails, skin or inside the mouth
• Skin rash, itchy skin, sweating
• Passing urine more often
• Breast enlargement in men
• Muscle problems, loss of strength
• Chest pain
• Fever, chills, symptoms similar to the 'flu

These side effects are uncommon or rare but not usually serious. Contact your
doctor or pharmacist if they concern you.

While you are taking RETROVIR, 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 (low red blood cell count) or
neutropenia (low white blood cell count), your doctor may reduce your RETROVIR
dose or stop treatment with RETROVIR, and recommend standard treatment for these
side effects. Your doctor may also perform tests to ensure that your liver is
working properly.

• Low red blood cell count (anaemia) can cause tiredness, headaches, being
  short of breath when exercising, dizziness and looking pale
• Low white blood cell count (neutropenia) can cause frequent infections
  such as fever, severe chills, sore throat or mouth ulcers.

If you think that RETROVIR is causing you to have an allergic
(hypersensitivity) reaction, TELL YOUR DOCTOR IMMEDIATELY. 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
• Hayfever
• Bumpy skin rash ("hives")
• Fainting.

If you have any of the following symptoms soon after starting to take your
medicine, do not take any more COMBIVIR 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 inflammation of the pancreas which is rare.

If you are on medication for HIV and become very sick, with fast breathing,
stop taking COMBIVIR 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. This can be life threatening but is rare.

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. It is
likely you will have to stop taking COMBIVIR tablets.

Other potentially serious side effects include:

• Low blood platelet count - bleeding or bruising more easily than usual
• Other blood effects
• Seizures (fits)
• a disease of the heart muscle. The muscle is weakened and therefore the
  heart does not beat as well as it could. The heart is then not able to pump
  enough blood through the body. It may cause fatigue, chest pain, and
  palpitations (fast or irregular heart beat)

Most of these effects are uncommon or rare but may be serious. Contact a
doctor promptly if you think you have any of these side effects.

Ask your doctor or pharmacist if you have any questions about the side
effects of RETROVIR.

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 something on this list.

Do not be alarmed by this list of side effects. You may not experience any of
them. Most tend to occur at higher doses of RETROVIR, and the more common ones
tend to become less troublesome after a few weeks of treatment. If anything
worries you, please talk to your doctor.

After taking RETROVIR

Storage

Keep this medicine where young children cannot reach it. A locked cupboard at
least one and a half metres off the ground is a good place to store medicines.

Keep RETROVIR capsules in a cool, dry place away from light where the
temperature stays below 30°C.

Keep your RETROVIR capsules in their pack until it is time to take them.

If you take RETROVIR capsules out of their pack they may not work as well.

Keep RETROVIR oral solution in a cool, dry place where the temperature stays
below 30°C.

If you are taking RETROVIR oral solution, always screw the lid on the bottle
after taking your medicine, otherwise it may not work as well.

RETROVIR IV infusion is stored in a hospital ward or pharmacy in a cool dry
place where the temperature stays below 30°C.

Disposal

If your doctor tells you to stop taking RETROVIR capsules or oral solution,
or your medicine has passed its expiry date, ask your pharmacist what to do with
any leftover medicine.

If you have been given RETROVIR IV infusion, hospital staff will dispose of
any solution left over after your infusion is finished.

Product description

What RETROVIR looks like

RETROVIR capsules are white with a dark blue band around the middle,
printed with WELLCOME 100 and coded Y9C. They come in bottles,
each containing 100 capsules.

RETROVIR oral solution is a clear, pale yellow, strawberry flavoured,
sugar-free liquid. It comes in a 200ml amber (brown) glass bottle. The pack
contains a 10ml oral dosing syringe which should be fitted to the bottle before
you use it, and closed with the cap provided.

RETROVIR IV infusion is a clear, almost colourless liquid. It comes in
a 20ml amber (brown) glass vial and is diluted before use.

Ingredients

RETROVIR capsules

Zidovudine, Starches, Titanium dioxide, Microcrystalline cellulose, Sodium
starch glycollate, Magnesium stearate, Gelatin, Indigo carmine, Aluminium lake,
Black iron oxide.

RETROVIR oral solution

Zidovudine, Hydrogenated glucose syrup, Glycerol, Citric acid, Sodium
benzoate, Saccharin sodium, Strawberry flavour, White sugar flavour, Purified
water.

RETROVIR IV infusion

Zidovudine, Hydrochloric acid, Sodium hydroxide, water.

RETROVIR for IV infusion is diluted with a weak glucose solution before use.