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PROGRAF 0.5MG CAPSULES

Active substance(s): TACROLIMUS / TACROLIMUS MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PROGRAF® 0.5MG CAPSULES




(tacrolimus)

Your medicine is available using the name Prograf 0.5mg
Capsules but will be referred to as Prograf throughout 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.
2.
3.
4.
5.
6.

What Prograf is and what it is used for
What you need to know before you take Prograf
How to take Prograf
Possible side effects
How to store Prograf
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.
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 socalled 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)

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.

Page 1 of 2

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 monohydrate and lecithin
(soy)

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 lecithin (soy). 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 –
0.30mg 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 side effects may occur, including the ones listed
below. Tell your doctor immediately if you have or suspect
you may have any of the following serious side effects:

Opportunistic infections (bacterial, fungal, viral and
protozoal): prolonged diarrhoea, fever and sore throat.

Benign and malignant tumours have been reported
following treatment as a result of immunosuppression.

Thrombotic Thrombocytopenic Purpura (or TTP) a
condition characterised by fever and bruising under the
skin that may appear as red pinpoint dots, with or
without unexplained extreme tiredness, confusion,
yellowing of the skin or eyes (jaundice), with symptoms
of acute renal failure (low or no urine output).

Cases of pure red cell aplasia (a very severe reduction in
red blood cell counts) and haemolytic anaemia
(decreased number of red blood cells due to abnormal
breakdown accompanied with tiredness) have been
reported. You may have no symptoms or depending on
the severity of the condition, you may feel: fatigue,
apathy, abnormal paleness of the skin (pallor),
shortness of breath, dizziness, headache, chest pain and
coldness in hands and feet.

Cases of agranulocytosis (a severely lowered number of
white blood cells accompanied with ulcers in the mouth,
fever and infection(s)). You may have no symptoms or
you may feel sudden fever, rigors and sore throat.

Allergic and anaphylactic reactions with the following
symptoms: a sudden itchy rash (hives), swelling of
hands, feet, ankle, face, lips, mouth or throat (which
may cause difficulty in swallowing or breathing) and you
may feel you are going to faint.

Posterior Reversible Encephalopathy Syndrome (PRES):
headache, altered mental status, seizures, and visual
disturbances.

Torsades de Pointes: change in the heart frequency that
can be accompanied or not by symptoms, such as chest
pain (angina), faint, vertigo or nausea, palpitations
(feeling the heartbeat) and difficulty breathing.

Gastrointestinal perforation: strong abdominal pain
accompanied or not with other symptoms, such as chills,
fever, nausea or vomiting.

Stevens-Johnson syndrome: unexplained widespread
skin pain, facial swelling, serious illness with blistering of
skin, mouth, eyes and genitals, hives, tongue swelling,
red or purple skin rash that spreads, skin shedding.

Toxic epidermal necrolysis: erosion and blistering of skin
or mucous membranes, red swollen skin that can detach
in large parts of the body.

Haemolytic uraemic syndrome, a condition with the
following symptoms: low or no urine output (acute renal
failure), extreme tiredness, yellowing of the skin or eyes
(jaundice) and abnormal bruising or bleeding and signs
of infection.

Insufficient function of your transplanted organ
The side effects listed below may also occur after receiving
Prograf:

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):












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 spasms
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

5. How to store Prograf








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
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

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.

Page 2 of 2

This medicinal product does not require any special
temperature storage conditions.
Store in the original package in order to protect from
moisture.
Do not remove the capsules from the blister strip until
you are ready to take them.
Prograf capsules should all be used within 1 year of
opening the aluminium wrapping. Do not use Prograf
after the expiry date which is stated on the carton after
(EXP). The expiry date refers to the last day of the
month.
Keep out of the sight and reach of children.
If your capsules appear to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you.
If your doctor tells you to stop taking the capsules,
please take them back to the pharmacist for safe
disposal. Only keep the capsules if your doctor tells you
to.
Medicines must not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

6. Contents of the pack and other
information
What Prograf contains

Each hard capsule contains 0.5mg of tacrolimus
(as monohydrate).
Also contains: hypromellose, croscarmellose sodium,
lactose monohydrate, magnesium stearate, titanium dioxide
(E171), yellow iron oxide (E172), gelatin, shellac,
lecithin (soy), hydroxypropylcellulose, simethicone and
red iron oxide (E172).

What Prograf looks like and contents of the pack

Prograf are pale yellow, hard gelatin capsules marked with
‘0.5 mg’ in red on the cap, and the ‘Fujisawa logo’ and ‘607’
also in red on the body. The capsule blister strips are packed
in a sealed aluminium pouch also containing a desiccant. The
aluminium wrapper is contained in a carton.
Prograf are available in blister packs of 30 capsules.

Manufacturer

Your medicine is manufactured by: Astellas Ireland Co. Ltd.,
Killorglin, County Kerry, Ireland.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0234

POM

Leaflet revision and issue date (Ref): 21.06.16
Prograf® is a registered trademark of Astellas Pharma Inc.

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.

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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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