Medication Guide App

PROGRAF 0.5MG CAPSULES

Active substance: TACROLIMUS MONOHYDRATE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Prograf 0.5mg Caps

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

06464/1393E

DATE OF PROOF

28/03/14

DATE:

PROOF HISTORY:
v.1 - waymade - 28/03/14

DATE:

Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

5. How to store Prograf
Keep out of the sight and reach of children.
Do not use Prograf after the expiry date which is stated on the carton and blister after {EXP}.
The expiry date refers to the last day of that month. Use all the capsules within 3 months of opening the
aluminium wrapping.
Prograf should be stored in the original package. After opening the aluminium wrapper do not store above
25°C. Keep the capsules in the blister pack.

6. Contents of the pack and other information
What prograf contains
Each capsule also contains the following: hypromellose, lactose, croscarmellose sodium and magnesium
stearate.
The capsule shells are made of gelatin with titanium dioxide (E171), yellow iron oxide (E172) for colouring.
The printing ink is composed of shellac, soya lecithin, hydroxypropyl cellulose, dimethyl polysiloxane, red iron
oxide (E172).
What Prograf looks like and contents of the pack
Your medicine is called Prograf 0.5mg capsules. Each yellow, hard gelatin capsule contains 0.5mg of the
active ingredient tacrolimus and is marked with ‘0.5mg’ on the cap and ‘[f]607 on the body in red ink.
Prograf 0.5mg capsules are available as blister packs of 30 and 60 capsules. Each blister strip contains 10
capsules. Three blister strips are enclosed in an aluminium wrapper with a sachet containing silica gel (a
desiccant) to keep the capsules dry. The desiccant should not be swallowed. The aluminium wrapper is
contained in a carton.
POM

PL No: 6464/1393

This product is manufactured by Astellas Ireland Co. Ltd., Killorglin, Co. Kerry, Ireland and procured from
within the EU and repackaged by the Product Licence Holder:
Waymade plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date: (Ref.) 28.03.2014
Prograf is a registered trademark of Astellas.

PROGRAF® 0.5 mg CAPSULES
(tacrolimus)
Patient Information Leaflet

The name of your medicine is Prograf 0.5mg Capsules but it will be referred to as Prograf throughout the rest
of this leaflet. Other strengths (1mg and 5mg) are also available.
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
Free Information Service
Dear Patient,
Your doctor has prescribed you Prograf to help treat your organ transplant.
To help ensure you have as much information as possible about your condition, Astellas Pharma Ltd has
produced a selection of booklets called the PA Transplantation Support Service. The information service
is free and has been produced with the help of transplant nurses and transplant coordinators.
If you would like more information about this information service, please talk to your transplant team.
This information is provided by Astellas Pharma Ltd, and is not associated with Waymade plc.

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 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.
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

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)
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Prograf 0.5mg Caps

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

06464/1393E

DATE OF PROOF

28/03/14

DATE:

PROOF HISTORY:
v.1 - waymade - 28/03/14

DATE:

Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 2

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

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.
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.

Pg 3

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.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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