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PROGRAG 1MG CAPSULES

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Prograf® 1 mg Capsules
(tacrolimus)
Your medicine is known by the above name, but will be referred to as Prograf throughout
this leaflet. Other strengths 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
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
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-arrhytmic drugs (amiodarone) used to control arrhymia (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.
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 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.

CNM/PIL/0027/09/14

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 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 Prograf out of the sight and reach of children.
Take the hard capsules immediately following removal from the blister.
Do not use Prograf after the last day of the month shown in the expiry date on the carton and blister.
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.
If your capsules show signs of deterioration or discolouration, you should seek the advice of your
pharmacist who will tell you what to do.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer require or medicines that have expired. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Prograf contains
Prograf 1 mg hard capsules
Each capsule contains 1 mg tacrolimus (as tacrolimus monohydrate) as the active ingredient.
-

The other ingredients are:
Capsule content: Hypromellose, croscarmellose sodium, lactose monohydrate, magnesium
stearate.
Capsule shell: Titanium dioxide (E 171), gelatine.
Printing ink of capsule shell: Shellac, lecithin (soya), hydroxypropyl cellulose, simeticone,
red iron oxide (E 172).

Who manufactured your medicine
Manufactured by: Astellas Ireland Co., Ltd, Killorglin, County Kerry, Ireland.
Product Licence Holder: C&N Medical Limited, Unit G2, RD Park, Stephenson Close, Hoddesdon,
EN11 0BW, United Kingdom. Procured from within the EU.
Repackaged by:
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
PL 40775/0027
Prograf® 1mg Capsules
Leaflet date: 26th September 2014
Prograf® is a registered trademark of Astellas Pharma Inc.

POM

CNM/PIL/0027/09/14

What Prograf looks like and contents of the pack
Prograf 1 mg hard capsules are opaque white hard gelatin capsules imprinted in red with “1 mg”
and “[f] 617”, containing white powder.
Prograf 1 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. Supplied in packs of 30 or 60 hard capsules.

Expand Transcript

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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