Consumer Medicine Information
What is in this leaflet If you have been taking other • you are pregnant or planning to
medicines for this purpose, but are become pregnant
This leaflet answers some common still feeling unwell, your doctor may • you are using oral contraceptives
questions about PROGRAF-XL change your treatment and begin
giving you PROGRAF-XL. • you are breast feeding
Prolonged-Release Capsules. It does
not contain all the available PROGRAF-XL contains the active • you are receiving cyclosporin
information. It does not take the ingredient tacrolimus, which is an immunosuppressive therapy
place of talking to your doctor or immunosuppressive agent. If you have not told your doctor or
pharmacist. Your doctor may have prescribed pharmacist about any of the above,
tell them before you start taking or
All medicines have risks and PROGRAF-XL for another reason.
benefits. Your doctor has weighed Ask your doctor if you have any are given PROGRAF-XL.
the risks of you taking PROGRAF- questions about why this medicine Your doctor will advise you whether
XL against the benefits this medicine has been prescribed for you. or not to take PROGRAF-XL or if
is expected to have for you. you need to adjust the dose or adapt
If you have any concerns about using
PROGRAF-XL ask your doctor or
pharmacist. Before you use Taking other medicines:
Keep this leaflet with your medicine.
PROGRAF-XL Tell your doctor or pharmacist if you
You may need to read it again. are taking any other medicines,
When you must not use it including medicines you can buy
without a prescription from a
Do not use PROGRAF-XL if
pharmacy, supermarket or health
• you have an allergy to tacrolimus, food shop.
What PROGRAF-XL is other macrolides (these are
used for antibiotics of the erythromycin
This is particularly important for
PROGRAF-XL because there are
family - trade names are Eryc,
You have been given a new some specific medicines that could
EES, Klacid, Zithromax, Rulide
transplanted liver or kidney, lung or alter PROGRAF-XL's effectiveness
and Biaxsig) or any of the
heart from another person because and safety.
ingredients contained in the
your own was no longer healthy. Among these medicines is the herbal
capsules. See Product
Your body recognises that this new preparation St John's Wort
Description at the end of this
organ is different from your organs (Hypericum perforatum) which is
leaflet for a list of ingredients.
and will try to reject it by attacking it capable of decreasing tacrolimus
in the same way that it would attack Do not use PROGRAF-XL if the
germs that enter your body. This packaging is torn or shows signs of
tampering. Do not use PROGRAF- Your doctor or pharmacist can tell
could make you become ill again.
XL beyond the expiry date (month you what to do if you are taking any
PROGRAF-XL stops this attack; it is
and year) printed on the pack. of these medicines.
very important to take PROGRAF-
XL given to you by your doctor Effects on driving and operating
regularly so that your new liver, Before you start to use it machinery
kidney, lung or heart will not be You must tell your doctor if • PROGRAF-XL may cause visual
attacked or rejected. or nervous disturbances. If
affected, do not drive or operate If you forget to take it cancer and other cancers while
machinery. taking PROGRAF-XL. Always
• If it is almost time for your next
Effects of food and alcohol protect yourself from the sun,
dose, skip the dose you missed
wear sunscreen, a hat and
• Food reduces the absorption of and take your next dose when you
PROGRAF-XL so the capsules are meant to.
should be taken at least 1 hour • Do not take a double dose to Things you must not do
before a meal. make up for the dose you missed.
• Do not take PROGRAF-XL to
If you have missed more than one treat any other complaint unless
dose, or are not sure what to do, your doctor says so.
check with your doctor or
Using PROGRAF-XL pharmacist. • Do not give this medicine to
anyone else, even if their
If you have trouble remembering symptoms seem similar to yours.
How much to take:
when to take your medicine, ask your
You can only get PROGRAF-XL pharmacist for some hints.
from your doctor. Your dose will be
calculated according to your weight, If you have taken too much
age, and medical condition. As your (overdose)
health and the function of your new
Immediately telephone your doctor All medicines can have side effects.
liver or kidney, lung or heart can be Sometimes they are serious, most of
or the Poisons Information Centre for
affected by how much medicine you the time they are not. You may need
advice, or go to Accident and
take, it is normal that your doctor
Emergency at your nearest hospital. medical treatment if you get some
collects samples of blood and urine at side effects. Do not be alarmed by
regular intervals. This is in order to Do this even if there are no signs of
this list of possible side effects. You
test whether your medicine requires discomfort or poisoning. You may
may not experience any of them.
adjustment. need urgent medical attention.
Ask your doctor or pharmacist to
PROGRAF-XL should be taken once Poisons Information Centre
answer any questions you may have.
a day in the morning. Take the telephone numbers:
Tell your doctor if you experience
capsule from the blister pack and • Australia: 13 11 26
swallow it whole with plenty of any of the following:
• New Zealand: 0800 POISON or
water. Do not use grapefruit juice, • tiredness, lack of energy
0800 764 766
grapefruit juice contains substances • stomach upset, including nausea
that interfere with the action of Keep these telephone numbers
(feeling sick), vomiting, loss of
appetite, diarrhoea, stomach
How to take it:
• tremor (shaking)
• PROGRAF-XL capsules should
While you are taking • headache
be taken at least 1 hour before a
PROGRAF-XL • feeling depressed (sad)
• You must never change the dose • sleeping difficulties
Things you must do
yourself even if you are feeling • blurred vision or sensitive to light
better. It is very important that • Always follow your doctor's
• muscle cramps, tenderness or
you keep taking this medicine so instructions carefully
that your body will not reject • Tell your doctor if you become
your new liver kidney, lung or Tell your doctor immediately if
pregnant while taking
heart. you notice any of the following as
you may need urgent medical care:
• If you accidentally take a larger • If you are about to start taking a
dose than recommended, tell your • signs of allergy such as rash,
new medicine, tell your doctor
doctor immediately. itching or hives on the skin;
and pharmacist that you are
swelling of the face, lips, tongue
• If you do not understand the taking PROGRAF-XL.
or other part of the body;
instructions provided with this • PROGRAF-XL suppresses your shortness of breath, wheezing or
medicine, ask your doctor or immune system by lowering your troubled breathing
pharmacist for help. body's immune defence system.
This increases your risk of skin
• diabetes / increased blood sugar Keep PROGRAF-XL Capsules in a magnesium stearate. The capsule
• swelling, numbness or tingling cool dry place where the temperature shells contain gelatin, titanium
(pins and needles) in your hands is below 25°C. dioxide, iron oxide yellow CI77492,
and feet Keep your medicines where children iron oxide red CI77491 and sodium
cannot reach them. A locked lauryl sulfate. The capsules also have
• constant "flu-like" symptoms
cupboard at least one-and-a-half a trace of printing ink, Opacode S-1-
such as chills, sore throat, aching 15083 red, which contains shellac,
joints, swollen glands, or any metres (1.5 m) above the ground is a
good place to store medicines. soya lecithin, simethicone and iron
other signs of infection
oxide red CI77491.
• unusual bleeding or bruising Do not store PROGRAF-XL, or any
other medicine, in the bathroom or Sponsor
• high blood pressure near a sink. Do not leave medicines
• palpitations, abnormal heart in the car or on window sills. Heat JANSSEN-CILAG Pty Ltd
rhythms, chest pain and dampness can destroy some 1-5 Khartoum Road
• new lumps or moles, or changes medicines.
Macquarie Park NSW 2113 Australia
to existing moles, anywhere on
Disposal Telephone: (02) 8875 3333
• swelling of the eyelids, hands or If your doctor tells you to stop taking
feet due to excess fluid PROGRAF-XL Capsules, or your NZ Office: Auckland New Zealand
• a change in the amount of urine medicine has passed its expiry date, Telephone: 0800 800 806
ask your pharmacist what to do with
passed or in the number of times
you urinate, pain on urinating, or any medicine which may be left over.
This leaflet was prepared in
other kidney problems.
• yellowing of the skin and/or eyes
(jaundice) often accompanied by
generally feeling unwell (for
example, tiredness, lack of
energy, loss of appetite, nausea What it looks like
and vomiting, pain in the • PROGRAF XL 0.5mg prolonged-
abdomen) release capsules (AUST R
• symptoms of anaemia, such as 158439) are oblong capsules with
shortness of breath, tiredness or a light yellow cap imprinted with
dizziness "0.5 mg" and an orange body
imprinted with "647" (Pack size
• seizures (fits)
• buzzing or ringing in the ears,
• PROGRAF XL 1mg prolonged-
release capsules (AUST R
Other side effects not listed above 158440) are oblong capsules with
may also occur in some people. Tell a white cap imprinted with "1
your doctor if you notice any other mg" and an orange body
effects. imprinted with "677" (Pack size
• PROGRAF XL 5mg prolonged-
release capsules (AUST R
After using 158444) are oblong capsules with
PROGRAF-XL a greyish red cap imprinted with
"5 mg" and an orange body
Storage imprinted with "687" (Pack size
Use all the capsules within 12 30 capsules).
months of opening the aluminium
Keep PROGRAF-XL Capsules in the PROGRAF-XL prolonged-release
blisters until it is time to take them. capsules contain hypromellose,
ethylcellulose, lactose and