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PROGRAF 1MG HARD CAPSULES

Active substance(s): TACROLIMUS

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Prograf® 1mg Hard Capsules
(tacrolimus)
Patient Information Leaflet
This medicine is available using the above name and will be referred to
as Prograf throughout this leaflet. Please note this leaflet may refer to
other strengths of the medicine, Prograf 0.5mg hard capsules and
Prograf 5mg hard capsules.
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
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.



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.
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 and lecithin (soya)
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
soya lecithin. 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 – 0.30 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 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

medicines for stomach ulcer and acid reflux (e.g. omeprazole,
lansoprazole or cimetidine)

antiemetics, used to treat nausea and vomiting (e.g.
metoclopramide)

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.

Product: Prograf 1mg Hard Capsules PLPI: 10380/1658 Dimensions: 210mm x 400mm Colours: Black Item Code: PRO2009S/L Proof:1

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 (jaudince) 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





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.
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 and blister after EXP. 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.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Prograf contains
Each capsule contains 1 mg of the active ingredient tacrolimus.
Other ingredients include:
Hypromellose, croscarmellose sodium, lactose monohydrate and
magnesium stearate. The capsules shells are made of titanium dioxide
(E171), gelatin and red printing ink (shellac), lecithin (soya),
hydroxypropyl cellulose, simethicone, red iron oxide (E172)).
What Prograf looks like and contents of the pack
Prograf white, opaque capsules are marked on one side in red with
‘1mg’ and ‘[f] 617’. The capsules are supplied in blister strips enclosed
in an aluminium wrapper with a sachet containing silica gel (a
desiccant) to keep the medicine dry. Do not swallow the desiccant. The
aluminium wrapper is contained in a cardboard carton, available in
pack sizes of 30 or 60 capsules.
Manufacturer:
Astellas Ireland Co. Ltd., Killorglin, Co. Kerry, Ireland and procured
from within the EU by the Product Licence Holder Swinghope Ltd,
Commerce Way, Edenbridge TN8 6ED and repackaged by Kent
Pharmaceuticals Ltd, Repton Road, Measham, DE12 7DT, UK.

POM

Prograf 1mg Hard Capsules PL No: 10380/1658

Leaflet revision and issue date: 29/12/2017
Prograf® is a 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.

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
Product: Prograf 1mg Hard Capsules PLPI: 10380/1658 Dimensions: 210mm x 400mm Colours: Black Item Code: PRO2009S/L Proof:1

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