REYATAZ® Capsules

Atazanavir

What is in this leaflet

Read this leaflet carefully before taking Reyataz. This leaflet answers some
common questions about Reyataz.

It does not contain all 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 Reyataz against the benefits they expect it will 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 Reyataz is used for

Reyataz is a trade name (manufacturer's name) for the medicine, atazanavir.
Reyataz belongs to a group of medicines protease inhibitors.

Reyataz is used to treat adults and children infected with Human
lmmunodeficiency Virus (HIV).

What is HIV: HIV is a virus that kills important cells in the immune
system over time (e.g. CD4 cells). When HIV has killed enough of the immune
cells, your body becomes prone to certain types of infections. Some infections
are the cause of "AIDS-defining" illnesses. This is when someone is said to have
developed the Acquired lmmunodeficiency Syndrome or AIDS. AIDS is a serious
condition and can lead to death.

How Reyataz Works

When HIV infects cells in the immune system, it takes over part of the cell's
internal workings and uses contents of the cells to produce new viruses.

When HIV infects a healthy cell, Reyataz can stop the virus from processing
the cell's proteins into viral proteins, stopping HIV from producing more
viruses. Interfering with the production of new viruses helps to reduce the
total amount of HIV in the body and slows down the damage to the immune system.

Reyataz is not a cure for HIV infection. Taking it will not necessarily
prevent the illnesses that commonly occur in people with HIV infection or AIDS.
You can still infect other people with HIV while you are taking this medicine.

It is not known how safe Reyataz is when it is used for long periods.

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

Reyataz is not addictive. This medicine is available only with a doctor's
prescription.

Before you take Reyataz

It is important that you check the information below before you take Reyataz.

When you must not take Reyataz

Do not take Reyataz if you have an allergy to it or to any other ingredients
in the formulation listed at the end of this leaflet.

Do not take Reyataz if you have severe liver disease.

Do not take Reyataz if you are currently taking any of these medicines:

Rifampicin - a medicine used to treat tuberculosis
Medicine used to treat some cancers (irinotecan)
Medicine used to treat gastric reflux (cisapride)
Medicines used to treat stomach ulcers (or other stomach disorders), such
as cimetidine or omeprazole
Cholesterol reducing medicines (lovastatin, simvastatin)
Sleeping tablets containing midazolam ot triazolam
Medicine to treat psychotic problems (pimozide)
Medicines to treat migraine or severe headaches which contain ergotamine
Herbal products which contain St Johns wort (Hypericum perforatum)

If you are not sure if any of these medicines are in the products you are
taking, talk to your doctor or pharmacist.

Do not use Reyataz after the expiry date printed on the back of the pack. If
this medicine is taken after the expiry date has passed, it may not work as
well.

Do not take Reyataz if the packaging is torn or shows signs of tampering.

Before you start to take Reyataz

Tell your doctor if you:

have allergies to:
- other medicines that are called 'protease inhibitor'
- any other medicines you have been given or purchased
- substances such as foods, preservatives or dyes.
Symptoms of an allergic reaction may include:

swelling of the face, lips, tongue or throat which may cause difficulty in
swallowing or breathing, or severe and sudden onset of pinkish, itchy
swellings on the skin, also called hives;
are pregnant or intend to become pregnant. Experience is limited with the
use of Reyataz in pregnant women. Therefore, it should not be used during
pregnancy unless it is clearly needed. If there is an urgent need to consider
Reyataz during pregnancy, your doctor will discuss with you the benefits and
risks of taking it;
are breast feeding or planning to breast-feed. It is not known whether
Reyataz passes into breast milk. Therefore to avoid possible side effects in
the nursing infant, mothers should stop breast-feeding if they are taking
Reyataz (breast-feeding can also transfer HIV to babies);
currently experience or have experienced any medical conditions
especially:
- liver problems including hepatitis, yellowing of the skin or eyes
  (jaundice) or prior use of medicines toxic to the liver. Liver problems may
  cause higher levels of Reyataz in the blood, increasing the chance of side
  effects
- haemophilia, haemaphiliac patients may experience increased bleeding
  when taking Reyataz
- any problems with irregular heart beat
- diabetes or impaired glucose tolerance

If you have not told your doctor about any of the above, tell them before
you use Reyataz.

Taking other medicines

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

Medicines for HIV:

Reyataz will be given with other anti-HIV medicines, some of these anti-HIV
medicines may affect the way Reyataz works, and Reyataz may affect the way some
other anti-HIV medicines work. Your doctor has all the current information on
the effects these medicines have on one another and will discuss with you the
combination of medicines that you should be taking.

Medicines for other conditions:

You should also tell your doctor if you are taking any of the following
medicines:

macrolide antibiotics (clarithromycin, roxithromycin, erythromycin, or
azithromycin) used to treat various infections
sildenafil (Viagra) - used to treat impotence
amiodarone, bepridil, lignocaine, quinidine, or tricyclic antidepressants
- if you take any of these medicines, your doctor may ask you to have blood
tests just to make sure that Reyataz and the other medicine are not affecting
the way each medicine works.
Calcium channel blockers (such as diltiazem, felodipine, nifedipine or
nicardipine) - medicines used to treat high blood pressure
Antacids and buffered medicines reduce the absorption of Reyataz. These
medicines should be taken one hour before or two hours after Reyataz.

Medicines that must not be taken when you are taking Reyataz, are listed
in the section When you must not take Reyataz.

Your doctor and pharmacist may have more information on medicines to be
careful with, or to avoid while taking Reyataz.

How to take Reyataz

Reyataz should be given only when prescribed by your doctor. Follow all
directions given to you by your doctor or pharmacist carefully. They may differ
from the information contained in this leaflet.

How much to take

The recommended dose of Reyataz is 400mg (2 x 200 mg capsules) once a day
with food.

How to take it

Swallow the capsules whole with a drink such as a glass of water or fruit
juice. The dose of Reyataz should be taken with food.

When to take Reyataz

You may take Reyataz Capsules at any time. It is recommended, however, that
you take your medicine at about the same time each day. Taking Reyataz at the
same time each day will have the best effect. It will also help you remember
when to take the capsules.

Talk to your doctor or pharmacist to work out when it is best for you to take
your doses of Reyataz.

How long to take it

Reyataz helps control your condition but does not cure it. Therefore you must
take Reyataz every day as directed by your doctor. Continue taking Reyataz for
as long as your doctor tells you to.

Do not stop taking Reyataz unless your doctor tells you to - even if you feel
better.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take
the next dose when you are meant to.

Otherwise take it as soon as you remember, and then go back to taking it as
you would normally.

Do not take a double dose to make up for the dose you missed. This may
increase the chance of you getting an unwanted side effect. If you are not sure
what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your
pharmacist for some hints and inform your doctor that you have missed a dose. It
is very important not to miss your doses of Reyataz. If you miss doses the virus
may become resistant to your HIV medicines.

If you take too much (overdose)

Immediately call your doctor or the Poisons Information Centre on 03 474 7000, or go to the Accident and Emergency Centre at your nearest hospital if you
or anyone else takes too much Reyataz. Do this even if there are no signs of
discomfort or poisoning.

While you are using Reyataz

Things you must do

If you become pregnant while taking Reyataz, tell your doctor immediately.
Pregnant women have experienced serious side effects when taking atazanavir
(the active ingredient in Reyataz) in combination with Videx^®
(didanosine) and Zerit^® (stavudine).
If you are about to start taking any new medicines, tell your doctor and
pharmacist that you are taking Reyataz. Reyataz may interfere with the
medicine you are taking.
If you are about to have any medical tests, tell your doctor that you are
taking Reyataz. Reyataz may interfere with the results of these tests.
If you plan to have surgery, tell your doctor or dentist that you are
taking Reyataz. You may wish to discuss disclosure issues with your doctor
about who should know you are taking Reyataz.
You should have your liver functions and blood tested when your doctor
advises on a regular basis to ensure that your body chemistry is functioning
normally and that Reyataz is working.

Things you must not do

Do not give Reyataz to anyone else, even if they have the same condition
as you.
Do not use Reyataz to treat any other complaints unless your doctor tells
you to.
Do not stop taking Reyataz or lower the dosage without checking with your
doctor. Your doctor may gradually want to reduce the amount of Reyataz you are
taking before stopping completely.

Things to be careful of

Be careful driving or operating machinery until you know how Reyataz
affects you. Some patients taking Reyataz have experienced dizziness. It is
not known if this was caused by Reyataz. Make sure you know how you react to
Reyataz before you drive a car, operate machinery or do anything else that
could be dangerous if you are dizzy.
Make sure that you visit your doctor regularly throughout your entire
course of treatment with Reyataz.

Things that may help your condition

Things that may help your general health are suggested below:

exercise
healthy eating
stress reduction
counselling
regular visits to your doctor to monitor your health
good oral hygiene
support groups

Talk with your doctor about all of the above suggestions. You can also access
further information about HIV and services for people with HIV by contacting
your local AIDS Council, Positive Living Centre or PLWH/A organisation.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking Reyataz. Reyataz helps most people with HIV infection but
it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get some of the side
effects

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

nausea, diarrhoea, dyspepsia (upset stomach), flatulence (wind)
headache, fatigue
rash
dizziness, insomnia

These are the more common side effects of Reyataz.

Tell your doctor or pharmacist immediately if you notice any of the
following

tingling of the hands or feet
abdominal pain, abdominal distension or tenderness, vomiting
changes to the distribution of fat on your body
pain in the joints, muscle pain
ulcers in the mouth, oesophagus (pain or burning on swallowing) or stomach
(pain or indigestion)
kidney pain, blood in the urine, urinary tract infections
change in heart rhythm, fainting

These are serious side effects. You may need urgent medical attention or
hospitalisation

If any of the following happen, tell your doctor immediately, or go to the
Accident and Emergency Centre at your nearest hospital:

liver problems including yellowing of the skin or eyes, also called
jaundice; this may occur with vomiting, fever and dark coloured urine
lactic acidosis - symptoms include nausea, vomiting, unusual or unexpected
stomach discomfort, feeling very weak and tired, short of breath, or weakness
in arms and legs
allergic reaction - swelling of the face, lips, or throat which makes
breathing difficult

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

This is not a complete list of side effects, other side effects not listed
above may also occur in some patients. Tell your doctor if you notice
anything that is making you feel unwell. Do not be alarmed by this list of
possible side effects. You may not experience any of them or only some of them.

After using Reyataz

Storage

Store Reyataz capsules in a cool dry place where the temperature stays below
25°C.

Keep your capsules in the bottle until it is time to take them. If you take
the capsules out of the bottle they may not keep as well.

Do not store Reyataz or any other medicine in the bathroom or near the
kitchen sink. Do not leave it in the car. Heat and dampness can destroy some
medicines.

Keep Reyataz capsules where children cannot reach them. A locked cupboard at
least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

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

Product description

What it looks like

Reyataz Capsules come in three types of capsules:

Reyataz 100 mg capsules - blue and white capsules, marked BMS 100 mg in
white and 3623 in blue
Reyataz 150 mg capsules - blue and powder blue capsules, marked BMS 150 mg
in white and 3624 in blue
Reyataz 200 mg capsules - blue capsules, marked BMS 200 mg and 3631 in
white

Ingredients

Each capsule contains:

Active ingredients:

Reyataz 100 mg capsules - 100 mg of atazanavir as the sulfate per capsule
Reyataz 150 mg capsules - 150 mg of atazanavir as the sulfate per capsule
Reyataz 200 mg capsules - 200 mg of atazanavir as the sulfate per capsule

Other ingredients:

lactose monohydrate, crospovidone and magnesium stearate.

The capsule shell is made from gelatin, titanium dioxide and FD&C blue#2.

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