PROGRAF 0.5MG HARD CAPSULES

Active substance: 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.

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. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1.
What Prograf is and what it is used for
2.
Before you take Prograf
3.
How to take Prograf
4.
Possible side effects
5.
How to store Prograf
6.
Further 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.

Before you take Prograf

Do not take Prograf
- If you are allergic (hypersensitive) to tacrolimus or any of the
other ingredients of Prograf.
- If you are allergic (hypersensitive) to any antibiotic belonging to
the subgroup of macrolide antibiotics (e.g. erythromycin,
clarithromycin, josamycin).
Take special care with 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 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.
- 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription and herbal remedies.

-

the anti-epileptic medicines phenytoin or phenobarbital
the corticosteroids prednisolone and methylprednisolone
the anti-depressant nefazodone
St. John’s Wort (hypericum perforatum)

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.
Taking 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 plan to become pregnant or think that you may be pregnant,
ask your doctor or pharmacist for advice before taking any
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.
Important information about some of the ingredients of
Prograf
- 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.
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.
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.

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 an increase or 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
- omeprazole or lansoprazole, used for treating stomach ulcers
- 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
- medicines known as “statins” used to treat elevated cholesterol
and triglycerides

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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