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Active substance: TACROLIMUS

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Prograf® 0.5 mg Hard capsules


The name of your product is Prograf® 0.5 mg Hard capsules but will be referred to as
Prograf® throughout the following:
Other strengths of this product are also available.
Patient Information 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



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
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.



Do not take Prograf®
- If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of
- 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.
Prograf® must not be taken with ciclosporin.

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
- 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
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
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.



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.
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.



Like all medicines, Prograf® can cause side effects, although not everybody gets them.
Prograf® reduces your body’s own defence mechanism to stop you rejecting your
transplanted organ. Consequently, your body will not be as good as usual at fighting
infections. So if you are taking Prograf® you may therefore catch more infections than
usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.
Severe effects have been reported, including allergic and anaphylactic reactions. Benign
and malignant tumours have been reported following Prograf® treatment as a result of
Possible side effects are listed according to the following categories:
Very common side effects are experienced in more than one in ten patients.
Common side effects are experienced in less than one in ten patients but in more than one
per one hundred patients.
Uncommon side effects are experienced in less than one in one hundred patients but more
than one per one thousand patients.
Rare side effects are experienced in less than one per one thousand patients but more
than one per ten thousand patients.
Very rare side effects are experienced in less than one per ten thousand patients.


Very common side effects:
- Increased blood sugar, diabetes mellitus, increased potassium in the blood
- Difficulty in sleeping
- Trembling, headache
- Increased blood pressure
- Diarrhoea, nausea
- Kidney problems
Common side effects:
- Reduction in blood cell counts (platelets, red or white blood cells), increase in white
blood cell counts, changes in red blood cell counts
- Reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid
overload, increased uric acid or lipids in the blood, decreased appetite, increased
acidity of the blood, other changes in the blood salts
- Anxiety symptoms, confusion and disorientation, depression, mood changes,
nightmare, hallucination, mental disorders
- Fits, disturbances in consciousness, tingling and numbness (sometimes painful) in
the hands and feet, dizziness, impaired writing ability, nervous system disorders
- Blurred vision, increased sensitivity to light, eye disorders
- Ringing sound in your ears
- Reduced blood flow in the heart vessels, faster heartbeat
- Bleeding, partial or complete blocking of blood vessels, reduced blood pressure
- Shortness in breath, changes in the lung tissue, collection of liquid around the lung,
inflammation of the pharynx, cough, flu-like symptoms
- Inflammations or ulcers causing abdominal pain or diarrhoea, bleeds in the stomach,
inflammations or ulcers in the mouth, collection of fluid in the belly, vomiting,
abdominal pains, indigestion, constipation, flatulence, bloating, loose stools,
stomach problems
- Changes in liver enzymes and function, yellowing of the skin due to liver problems,
liver tissue damage and inflammation of the liver
- Itching, rash, hair loss, acne, increased sweating
- Pain in joints, limbs or back, muscle cramps
- Insufficient function of the kidneys, reduced production of urine, impaired or painful
- General weakness, fever, collection of fluid in your body, pain and discomfort,
increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of
temperature disturbed
- Insufficient function of your transplanted organ



What Prograf® contains
Prograf® 0.5 mg hard capsules
• The active substance is tacrolimus. Each capsule contains 0.5 mg of tacrolimus as
tacrolimus monohydrate.
• The other ingredients are:
Capsule content: Hydroxypropyl cellulose, croscarmellose sodium, lactose
monohydrate, magnesium stearate.
Capsule shell: Titanium dioxide (E 171), yellow iron oxide (E 172), gelatine.
Printing ink of capsule shell: Shellac, lecithin (soya), hydroxypropyl cellulose,
simeticone, red iron oxide (E 172).
What Prograf® looks like and contents of the pack
Prograf® 0.5 mg hard capsules
Opaque light yellow capsules imprinted in red with “0.5 mg” and “[f] 607”, containing white
Prograf® 0.5 mg hard capsules are supplied as blister strips containing 10 capsules within
a protective foil wrapper, including a desiccant protecting the capsules from moisture. The
desiccant should not be swallowed.
Prograf® 0.5 mg hard capsules are available in blister packs of 30 capsules.
Manufacturer and Product Licence Holder
This medicine is manufactured by Astellas Ireland Co., Ltd, Killorglin, County Kerry,
Ireland. It is procured from within the EU by the Product Licence Holder: Swinghope
Limited, Brandon House, Marlowe Way, Croydon CR0 4XS and repackaged by Interport
Limited, Brandon House, Marlowe Way, Croydon CR0 4XS.

PL No: 10380/1407

Leaflet revision date: 11/03/2013
Prograf® is a registered trademark of Astellas Pharma Inc, Japan.

Uncommon side effects:
- Changes in blood clotting, reduction in all blood cell counts
- Dehydration, reduced protein or sugar in the blood, increased phosphate in the
- Coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language
abnormalities, memory problems
- Blurring of the vision due to abnormality in the lens of the eye
- Impaired hearing
- Irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder
of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal
ECG, heart rate and pulse abnormal
- Blood clot in a vein of a limb, shock
- Difficulties in breathing, respiratory tract disorders, asthma
- Obstruction of the gut, increased blood level of the enzyme amylase, reflux of
stomach content in your throat, delayed emptying of the stomach
- Dermatitis, burning sensation in the sunlight
- Joint disorders
- Inability to urinate, painful menstruation and abnormal menstrual bleeding
- Failure of some organs, influenza like illness, increased sensitivity to heat and cold,
feeling of pressure on your chest, jittery or abnormal feeling, increase of the enzyme
lactate dehydrogenase in your blood, weight loss
Rare side effects:
- Small bleeds in your skin due to blood clots
- Increased muscle stiffness
- Blindness
- Deafness
- Collection of fluid around the heart
- Acute breathlessness
- Cyst formation in your pancreas
- Problems with blood flow in the liver
- Serious illness with blistering of skin, mouth, eyes and genitals, increased hairiness
- Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
Very rare side effects:
- Muscular weakness
- Echocardiogram abnormal
- Liver failure, narrowing of the bile vessel
- Painful urination with blood in the urine
- Increase of fat tissue
Cases of pure red cell aplasia (a very severe reduction in red blood cell counts),
agranulocytosis (a severely lowered number of white blood cells) and haemolytic anaemia
(decreased number of red blood cells due to abnormal breakdown) have been reported.
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.



Keep out of the sight and reach of children.
Take the hard capsules immediately following removal from the blister.
Do not use Prograf® after the expiry date which is stated on the pack. The expiry date
refers to the last day of that month. Use all the capsules within 1 year of opening the
aluminium wrapping.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.


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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.