PROGRAF 1 MG CAPSULES

Active substance: TACROLIMUS

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Prograf® 1 mg Capsules

2240
11.06.14[7]

(tacrolimus)
PATIENT INFORMATION LEAFLET
Your medicine is available using the above name but will be referred to as
Prograf throughout this leaflet.
Other strengths are available. This leaflet also contains information
regarding other strengths of Prograf.
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.
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.

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
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.

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).

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

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 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.

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.

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.
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
- 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
- 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
- anti-arrhythmic drugs (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
- 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.

0.075 – 0.30 mg per kg body weight per day
depending on the transplanted organ.

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.
4. POSSIBLE SIDE EFFECTS
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 immunosuppression.
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 (may affect more than 1 in 10 people):
- 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 (may affect up to 1 in 10 people):
- 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 urination
- 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
Uncommon side effects (may affect up to 1 in 100 people):
- Changes in blood clotting, reduction in all blood cell counts
- Dehydration, reduced protein or sugar in the blood, increased phosphate
in the blood
- 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 (may affect up to 1 in 1,000 people):
- 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 (may affect up to 1 in 10,000 people):
- 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE PROGRAF
- 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 carton.
The expiry date refers to the last day of that month. Use all the capsules
within 1 year after opening the aluminium wrapping.
- Store in the original package. Protect from moisture
- If your capsules become discoloured or show any other signs of
deterioration, consult a pharmacist who will advise you what to do.
- If your doctor tells you to stop taking this medicine, return any unused
capsules to your doctor for safe disposal. Only keep the capsules if your
doctor tells you to.
6. FURTHER INFORMATION
What Prograf contains
- Each Prograf 1 mg capsule contains 1 mg of the active ingredient
tacrolimus.
- The other ingredients are: hypromellose, croscarmellose sodium, lactose
monohydrate, magnesium stearate
Capsule shell contains - titanium dioxide E171, gelatin.
Printing ink contains - shellac, lecithin soya, hyprolose, simeticone, red iron
oxide (E 172).
What Prograf looks like and contents of the pack
Prograf 1 mg capsules are small, opaque white, hard gelatin capsules
imprinted in red ink with “1mg” twice on the cap and “[f]617” twice on the
body. These are available in blister strips in a sealed aluminium pouch
packed in a cardboard carton of 30 capsules. The pouch also contains a
desiccant. Do not swallow.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Prograf is manufactured by Astellas Ireland Co. Ltd, Killorglin, County
Kerry, Ireland and procured from within the EU and repackaged by product
licence holder: P.I.E. Pharma Ltd., 207 Kenton road, Harrow, Middlesex
HA3 0HD.
POM

PL 15361/2240

Leaflet revision and issue date (Ref.) 11.06.14[7]
Prograf is a trademark of Astellas Pharma Inc. Japan

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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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