Find similar products:
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 00166/0206.
Prograf 0.5mg, 1mg, 5mg Hard Capsules (UK)
Prograf 0.5 mg hard capsules
Prograf 1 mg hard capsules
Prograf 5 mg hard capsules
Tacrolimus
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
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.
Talk to your doctor or pharmacist before taking Prograf
Precaution for handling:
Direct contact with any part of your body like your skin or eyes, or breathing in of injection solutions, powder or granules contained in tacrolimus products should be avoided during preparation. If such contact occurs, wash the skin and eyes.
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.
If you need to attend a doctor other than your transplant specialist, tell the doctor that you are taking tacrolimus. Your doctor may need to consult your transplant specialist if you should use another medicine that could increase or decrease your tacrolimus blood level.
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.
Some patients have experienced increases in tacrolimus blood levels while taking other medicines. This could lead to serious side effects, such as kidney problems, nervous system problems, and heart rhythm disturbances (see section 4).
An effect on the Prograf blood levels may occur very soon after starting the use of another medicine, therefore frequent continued monitoring of your Prograf blood level may be needed within the first few days of starting another medicine and frequently while treatment with the other medicine continues. Some other medicines may cause tacrolimus blood levels to decrease, which could increase the risk of rejecting the transplanted organ. In particular, you should tell your doctor if you are taking or have recently taken medicines with active substances like:
Tell your doctor if you are receiving treatment for hepatitis C. The drug treatment for hepatitis C may change your liver function and may affect blood levels of tacrolimus. Tacrolimus blood levels may fall or may increase depending on the medicines prescribed for hepatitis C. Your doctor may need to closely monitor tacrolimus blood levels and make necessary adjustments of Prograf dose after you start treatment for hepatitis C.
Tell your doctor if you are taking or need to take ibuprofen, amphotericin B, antibiotics (cotrimoxazole, vancomycin, or so-called aminoglycoside antibiotics such as gentamicin), or antivirals (e.g. acyclovir, ganciclovir, cidofovir, or foscarnet). These may worsen kidney or nervous system problems when taken together with Prograf.
Tell your doctor if you are taking sirolimus or everolimus. When tacrolimus is taken together with sirolimus or everolimus, the risk of developing thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and haemolytic uraemic syndrome may increase (see section 4).
Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim or cotrimoxazole that may increase levels of potassium in your blood, certain pain killers (so-called NSAIDs, e.g. ibuprofen), anticoagulants, or oral medication for diabetic treatment, while you receive Prograf.
If you need to have any vaccinations, please inform your doctor beforehand.
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.
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. One study assessed pregnancy outcomes in women treated with tacrolimus and those treated with other immunosuppressants. While there was insufficient evidence in this study to draw conclusions, higher rates of miscarriage were reported among liver and kidney transplant patients treated with tacrolimus, as well as higher rates among kidney transplant patients of persistent hypertension associated with protein loss in the urine that develops during pregnancy or the postpartum period (a condition called pre-eclampsia). No increased risk of major birth defects associated with Prograf use was found.
Prograf is excreted into breast milk. Therefore you should not breast-feed whilst receiving Prograf.
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. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
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.
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 have accidentally taken too much Prograf see your doctor or contact your nearest hospital emergency department immediately.
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.
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.
Like all medicines, Prograf can cause side effects, although not everybody gets them.
Prograf reduces your body’s own defense 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.
Some infections could be serious or fatal and may include infections caused by bacteria, viruses, fungi, parasites, or other infections.
Tell your doctor immediately if you get signs of an infection including:
Severe side effects may occur, including the ones listed below.
Serious common side effects (may affect up to 1 in 10 people):
Serious uncommon side effects (may affect up to 1 in 100 people):
Serious rare side effects (may affect up to 1 in 1,000 people):
Serious very rare side effects (may affect up to 1 in 10,000 people):
Serious side effects - frequency not known (frequency cannot be estimated from the available data):
The side effects listed below may also occur after receiving Prograf and could be serious:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Very rare side effects (may affect up to 1 in 10,000 people):
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 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.
Prograf 0.5 mg hard capsules
Prograf 1 mg hard capsules
Prograf 5 mg hard capsules
Prograf 0.5 mg hard capsules
Opaque light yellow capsules imprinted in red with "0.5 mg" and "[f] 607", containing white powder.
Prograf 0.5 mg hard capsules are supplied as blister strips or perforated unit-dose blister strips containing 10 capsules within a protective foil wrapper, including a desiccant protecting the capsules from moisture. The desiccant should not be swallowed. Packs of 20, 30, 50, 60 and 100 hard capsules are available in blister strips and packs of 20×1, 30×1, 50×1, 60×1 and 100×1 hard capsules are available in unit-dose blister strips.
Prograf 1 mg hard capsules
Opaque white capsules imprinted in red with "1 mg" and "[f] 617", containing white powder.
Prograf 1 mg hard capsules are supplied as blister strips or perforated unit-dose blister strips containing 10 capsules within a protective foil wrapper, including a desiccant protecting the capsules from moisture. The desiccant should not be swallowed. Packs of 20, 30, 50, 60, 90 and 100 hard capsules are available in blister strips and packs of 20×1, 30×1, 50×1, 60×1, 90×1 and 100×1 hard capsules are available in unit-dose blister strips.
Prograf 5 mg hard capsules
Opaque greyish red capsules imprinted in white with "5 mg" and "[f] 657", containing white powder.
Prograf 5 mg hard capsules are supplied as blister strips or perforated unit-dose blister strips containing 10 capsules within a protective foil wrapper, including a desiccant protecting the capsules from moisture. The desiccant should not be swallowed. Packs of 30, 50, 60 and 100 hard capsules are available in blister strips and packs of 30×1, 50×1, 60×1 and 100×1 hard capsules are available in unit-dose blister strips.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Prograf:
Austria, Cyprus, Czech Republic, Denmark, Germany, Greece, Spain, Finland, France, Hungary, Iceland, Ireland, Italy, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden.
Prograft:
Belgium, Luxembourg, The Netherlands.
This leaflet was last revised in 09/2024