PROGRAF™

Tacrolimus

1mg capsules

5mg capsules

5mg/1mL concentrated injection

What is in this leaflet

This leaflet answers some of the common questions about PROGRAF 1mg, 5mg
capsules and 5mg/1mL injection. It does not contain all of the available
information. It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about using PROGRAF, ask your doctor or pharmacist.
Your doctor and pharmacist have more information.

Keep this leaflet with your PROGRAF. You may need to read it again.

What PROGRAF is used for

PROGRAF is used for:

• You have been given a transplanted organ (eg, kidney, liver, heart,
  pancreas, lung) from another person because your own was no longer healthy.
  Your body recognises that this new organ is "foreign" and will try to fight it
  in much the same way that it would fight germs, infections that enter your
  body. This process is called rejection.
• PROGRAF is used to prevent rejection.
• PROGRAF is also used to treat rejection. If you have been taking other
  medicines to prevent rejection and they are not sufficiently effective, or are
  causing unmanageable side effects, your doctor will have changed your
  treatment by starting you on PROGRAF.
• PROGRAF is an immunosuppressant. It works by preventing your white blood
  cells from attacking your new organ.

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

Before you take PROGRAF

When you must not take it

Do not take PROGRAF if you know you are allergic to any of the ingredients.
(See the last section of this leaflet for a list of ingredients). Signs of
allergy include a skin rash, itching, shortness of breath and/or a swollen face.
Also, if you are allergic to antibiotics of the erythromycin family, do not take
PROGRAF.

Do not use PROGRAF if the packaging is torn or shows signs of tampering. Do
not use PROGRAF beyond the expiry date (month and year) printed on the pack.

Before you start to use it

Certain people must use PROGRAF with caution. Ask your doctor for advice.

Driving and Operating Machinery

PROGRAF may cause visual or nervous disturbances. If affected, do not drive a
car, or operate machinery.

You must tell your doctor if:

• you are pregnant or planning to become pregnant;
• you are breast feeding or wish to breastfeed;
• you are using oral contraceptives;
• you are receiving cyclosporin immunosuppressive therapy

If you have not told your doctor or pharmacist about any of the above, tell
them before you start taking or are given PROGRAF.

Your doctor will advise you whether or not to take PROGRAF or, if you need to
adjust the dose, or adapt your treatment.

Other medicines and alcohol

Tell your doctor or pharmacist if you are taking any other medicines,
including medicines you can buy from a pharmacy, supermarket or health food
shop. This is particularly important for PROGRAF because there are some
specific medicines that could alter PROGRAF's effectiveness and safety.

In particular, tell your doctor or pharmacist if you are taking any of the
following (either by mouth or by injection):

• Drugs used to treat fungal infections. The specific drugs are itraconazole
  (SPORANOX), fluconazole (DIFLUCAN), clotrimazole (CANESTEN, GYNE-LOTREMIN,
  LOTREMIN), ketoconazole (NIZORAL). (However, taking PROGRAF with other forms
  of these medicines - for example cream, lotion, vaginal ovules, shampoo - is
  not a problem)
• Certain drugs used to treat heart/blood pressure problems. The specific
  drugs are diltiazem (CARDIZEM, CARDIZEM CD, DILACOR XR, DILZEM SR) and
  nifedipine (ADALAT, ADALAT OROS, ADALAT RETARD)
• the herbal preparation St John's Wort (Hypericum perforatum)

Taking PROGRAF

How much to take

Adults and children

You can only get PROGRAF from your doctor. Your dose will be calculated
according to your weight, age, and medical condition. As your health and the
function of your transplanted organ can be affected by how much medicine you
take, it is normal that your doctor collects samples of blood and urine at
regular intervals. This is in order to test whether your medicine requires an
adjustment in dose.

The total daily amount should be divided and taken in two doses (eg. morning
and evening). Take the capsule from the blister pack and swallow it whole with
plenty of water. Do not use grapefruit juice, grapefruit juice contains
substances that interfere with the action of PROGRAF.

How to take it

• PROGRAF capsules should be taken at least 1 hour before a meal.
• If you receive PROGRAF by intravenous infusion it will be added to a
  larger volume of diluent and infused over a prolonged period of time (usually
  24 hours).
• You must never change the dose yourself even if you are feeling better. It
  is very important that you keep taking this medicine so that your body will
  not reject your new transplanted organ.
• If you accidentally take a larger dose than recommended, tell your doctor
  immediately.
• If you do not understand the instructions provided with this medicine, ask
  you doctor or pharmacist for help.

If you forget to take a dose

• Take your dose (the dose you missed) as soon as you remember, and then
  continue taking it as you would normally.
• If it is almost time for your next dose, skip the dose you missed and take
  your next dose when you are meant to.
• Do not take a double dose to make up for the one you missed.

If you have missed more than one dose, or are not sure what to do it is
important that you, check with your doctor or pharmacist, immediately.

If you have trouble remembering when to take your medicine, ask your
pharmacist for some hints.

If you have taken too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre,
or go to the Accident and Emergency Department at your nearest hospital
immediately if you think you or anybody else has taken too much PROGRAF.

Do this even if there are no signs of discomfort or poisoning. You
may need urgent medical attention.

You can contact the Poisons Information Centre by dialling 0800 POISON or
0800 764 766. This is a 24-hour a day service.

While you are taking PROGRAF

Things you must do

• Always follow your doctor's instructions carefully.
• Tell your doctor if you become pregnant while taking PROGRAF.
• If you are about to start taking a new medicine, tell your doctor and
  pharmacist that you are taking PROGRAF.

Things you must not do

• Do not use PROGRAF to treat any other complaint unless your doctor says
  so.
• Do not take more than the recommended amount.
• Do not give this medicine to anyone else, even if their symptoms seem
  similar to yours.

Side Effects

All medicines have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some side effects. Do
not be alarmed by this list of possible side effects. You may not experience any
of them.

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

Tell your doctor if you notice any of the following:

• Sleeping difficulties
• Nausea
• Loose bowel movements

Tell your doctor immediately if you notice any of the following as you may
need urgent medical care:

• Headache
• Pins and needles in your arms or legs

STOP taking PROGRAF and tell your doctor immediately or go to the Accident
and Emergency Department at your nearest hospital if any of the following
happen:

• you have an allergic reaction to PROGRAF (allergy can be recognised, for
  instance, by skin rash, itching, shortness of breath and/or a swollen face)

Other side effects not listed above may also occur in some people. Do not
hesitate to report any other side effects to your doctor or pharmacist.

After taking PROGRAF

Storage

• Use all the capsules within 12 months of opening the aluminium wrapper.
• Keep PROGRAF capsules in the blisters until it is time to take them.
• Keep PROGRAF capsules in a cool dry place where the temperature is below
  25°C.
• Keep your medicines where children cannot reach them. A locked cupboard at
  least one-and-a-half metres (1.5m) above the ground is a good place to store
  medicines.
• Do not store PROGRAF, or any other medicine, in the bathroom or near a
  sink. Do not leave medicines in the car or on windowsills. Heat and dampness
  can destroy some medicines.

Disposal

If your doctor tells you to stop taking PROGRAF, or your medicine has passed
its expiry date, ask your pharmacist what to do with any which may be left over.

Product Description

What it looks like

• PROGRAF 1mg capsules (AUST R 58930) are white, packed in blister sheets of
  ten capsules and sealed in an aluminium wrapper. (Pack size 100 capsules)
• PROGRAF 5mg capsules (AUST R 58931) are greyish-red. (Pack size 50
  capsules)
• PROGRAF concentrated injection (AUST R 58932) contains 5mg in a 1mL
  ampoule. (Pack size 10 ampoules)

Ingredients

• PROGRAF capsules contain hydroxypropylmethyl cellulose, croscarmellose
  sodium, lactose, and magnesium stearate.
• PROGRAF concentrated injection contains polyoxyethylene hydrogenated
  caster oil and ethanol.