PROGRAF-XL

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					PROGRAF-XL®
Prolonged-Release Capsules
Tacrolimus
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
                                                                                    your treatment.
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
                                                                                    blood levels.
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




PROGRAF®                                                                                                                   1
   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
                                                                                    protective clothing.
  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
                                                                                 Side Effects
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
PROGRAF-XL.                              handy.
                                                                                   appetite, diarrhoea, stomach
                                                                                   cramps
How to take it:
                                                                                 • tremor (shaking)
• PROGRAF-XL capsules should
                                         While you are taking                    • headache
  be taken at least 1 hour before a
  meal.
                                         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
                                                                                   weakness
  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
                                           PROGRAF-XL
                                                                                 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.
                                                                                 • fever
                                           This increases your risk of skin



PROGRAF®                                                                                                                2
• 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
  the body
• 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.
                                                                                    December 2011
• yellowing of the skin and/or eyes
  (jaundice) often accompanied by
                                          Product Description
  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)
                                            30 capsules).
• buzzing or ringing in the ears,
                                          • PROGRAF XL 1mg prolonged-
  difficulty hearing
                                            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
                                            60 capsules).
                                          • 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
wrapper.
                                          Ingredients

Keep PROGRAF-XL Capsules in the           PROGRAF-XL prolonged-release
blisters until it is time to take them.   capsules contain hypromellose,
                                          ethylcellulose, lactose and




PROGRAF®                                                                                                                 3

				
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posted:1/11/2012
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