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PROGRAF 0.5MG HARD CAPSULES

Active substance(s): TACROLIMUS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PROGRAF® 0.5mg hard capsules
(tacrolimus)
Your medicine is available as the above name but will be
referred to as Prograf throughout this leaflet.
This product is available in multiple strengths and all strengths will
be referred to throughout this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
 If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Prograf is and what it is used for
2. What you need to know before you take Prograf
3. How to take Prograf
4. Possible side effects
5. How to store Prograf
6. Contents of the pack and other information
1.

What Prograf is and what it is used for

Prograf belongs to a group of medicines called immunosuppressants.
Following your organ transplant (e.g. liver, kidney, heart), your body’s
immune system will try to reject the new organ.
Prograf is used to control your body’s immune response enabling your
body to accept the transplanted organ.
Prograf is often used in combination with other medicines that also
suppress the immune system.
You may also be given Prograf for an ongoing rejection of your
transplanted liver, kidney, heart or other organ or if any previous
treatment you were taking was unable to control this immune response
after your transplantation.
2.

What you need to know before you take Prograf

Do not take Prograf
 If you are allergic (hypersensitive) to tacrolimus or any of the other
ingredients of Prograf (listed in section 6).
 If you are allergic (hypersensitive) to any antibiotic belonging to the
subgroup of macrolide antibiotics (e.g. erythromycin, clarithromycin,
josamycin).
Warnings and precautions
Talk to your doctor or pharmacist before taking Prograf
 You will need to take Prograf every day as long as you need
immunosuppression to prevent rejection of your transplanted organ.
You should keep in regular contact with your doctor.
 Whilst you are taking Prograf your doctor may want to carry out a
number of tests (including blood, urine, heart function, visual and
neurological tests) from time to time. This is quite normal and will
help your doctor to decide on the most appropriate dose of Prograf
for you.
 Please avoid taking any herbal remedies, e.g. St. John’s wort
(Hypericum perforatum) or any other herbal products as this may
affect the effectiveness and the dose of Prograf that you need to
receive. If in doubt please consult your doctor prior to taking any
herbal products or remedies.
 If you have liver problems or have had a disease which may have
affected your liver, please tell your doctor as this may affect the
dose of Prograf that you receive.
 If you feel strong abdominal pain accompanied or not with other
symptoms, such as chills, fever, nausea or vomiting.
 If you have diarrhoea for more than one day, please tell your doctor,
because it might be necessary to adapt the dose of Prograf that you
receive.
 If you have an alteration of the electrical activity of your heart called
“QT prolongation”.
 Limit your exposure to sunlight and UV light whilst taking Prograf by
wearing appropriate protective clothing and using a sunscreen with
a high sun protection factor. This is because of the potential risk of
malignant skin changes with immunosuppressive therapy.
 If you need to have any vaccinations, please inform your doctor
beforehand. Your doctor will advise you on the best course of
action.
 Patients treated with Prograf have been reported to have an
increased risk of developing lymphoproliferative disorders (see section 4). Ask your doctor for specific advice on these disorders.
Other medicines and Prograf
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained without a
prescription and herbal remedies.

 magnesium-aluminium-hydroxide (antacid), used to treat heartburn
 hormone treatments with ethinylestradiol (e.g. the oral contraceptive
pill) or danazol

 medicines for high blood pressure or heart problems such as
nifedipine, nicardipine, diltiazem and verapamil

 anti-arrhythmic medicines (amiodarone) used to control arrhythmia
(uneven beating of the heart)

 medicines known as “statins” used to treat elevated cholesterol and





triglycerides
the anti-epileptic medicines phenytoin or phenobarbital
the corticosteroids prednisolone and methylprednisolone
the anti-depressant nefazodone
herbal preparations containing St. John's Wort (Hypericum
perforatum) or extracts of Schisandra sphenanthera.

Tell your doctor if you are taking or need to take ibuprofen, amphotericin
B, or antivirals (e.g. aciclovir).
These may worsen kidney or nervous system problems when taken
together with Prograf.
Your doctor also needs to know if you are taking potassium
supplements or potassium-sparing diuretics (e.g., amiloride,
triamterene, or spironolactone), certain pain killers (so-called NSAIDs,
e.g. ibuprofen), anticoagulants, or oral medication for diabetic treatment,
while you take Prograf.
If you need to have any vaccinations, please inform your doctor
beforehand.
Prograf with food and drink
You should generally take Prograf on an empty stomach or at least 1
hour before or 2 to 3 hours after a meal. Grapefruit and grapefruit juice
should be avoided while taking Prograf.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Prograf is excreted into breast milk. Therefore you should not
breast-feed whilst receiving Prograf.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy or sleepy, or
have problems seeing clearly after taking Prograf. These effects are
more frequently observed if Prograf is taken in conjunction with alcohol
use.
Prograf contains lactose and lecithin (soya)
Prograf contains lactose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking
this medicinal product.
The printing ink used on Prograf capsules 0.5 mg and 1 mg contains
soya lecithin. If you are allergic to peanut or soya, talk to your doctor to
determine whether you should use this medicine.
3.

How to take Prograf

Always take Prograf exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Make sure that you receive the same tacrolimus medicine every time
you collect your prescription, unless your transplant specialist has
agreed to change to a different tacrolimus medicine.
This medicine should be taken twice a day. If the appearance of this
medicine is not the same as usual, or if dosage instructions have
changed, speak to your doctor or pharmacist as soon as possible to
make sure that you have the right medicine.
The starting dose to prevent the rejection of your transplanted organ will
be determined by your doctor calculated according to your body weight.
Initial doses just after transplantation will generally be in the range of
0.075 – 0.30 mg per kg body weight per day
depending on the transplanted organ.
Your dose depends on your general condition and on which other
immunosuppressive medication you are taking. Regular blood tests by
your doctor will be required to define the correct dose and to adjust the
dose from time to time. Your doctor will usually reduce your Prograf
dose once your condition has stabilised. Your doctor will tell you exactly
how many capsules to take and how often.
Prograf is taken orally twice daily, usually in the morning and evening.
You should generally take Prograf on an empty stomach or at least 1
hour before or 2 to 3 hours after the meal. The capsules should be
swallowed whole with a glass of water. Take the capsules immediately
following removal from the blister. Avoid grapefruit and grapefruit juice
while taking Prograf. Do not swallow the desiccant contained in the foil
wrapper.
If you take more Prograf than you should
If you have accidentally taken too much Prograf see your doctor or
contact your nearest hospital emergency department immediately.

Prograf must not be taken with ciclosporin.
Prograf blood levels can be affected by other medicines you take, and
blood levels of other medicines can be affected by taking Prograf which
may require interruption, an increase or a decrease in Prograf dose. In
particular, you should tell your doctor if you are taking or have
recently taken medicines with active substances like:
 antifungal medicines and antibiotics (particularly so-called macrolide
antibiotics) used to treat infections e.g. ketoconazole, fluconazole,
itraconazole, voriconazole, clotrimazole, erythromycin,
clarithromycin, josamycin, and rifampicin
 HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), used to
treat HIV infection
 HCV protease inhibitors (e.g. telaprevir, boceprevir), used to treat
hepatitis C infection
 medicines for stomach ulcer and acid reflux (e.g. omeprazole,
lansoprazole or cimetidine)
 antiemetics, used to treat nausea and vomiting (e.g.
metoclopramide)

If you forget to take Prograf
Do not take a double dose to make up for forgotten individual doses.
If you have forgotten to take your Prograf capsules, wait until it is time
for the next dose, and then continue as before.
If you stop taking Prograf
Stopping your treatment with Prograf may increase the risk of rejection
of your transplanted organ.
Do not stop your treatment unless your doctor tells you to do so.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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