1. What this product 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 use this product
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, 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.
Tell your doctor immediately if during treatment you suffer from:
• Problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
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.
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 monohydrate, sodium and lecithin (soya)
Prograf contains lactose monohydrate. Each hard capsule of Prograf 1 mg and 5 mg Hard Capsules contains 61.35 mg or 123.60 mg lactose monohydrate; respectively. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Prograf contains sodium. Each hard capsule of Prograf 1 mg and 5 mg Hard Capsules contains 0.091 mg or 0.453 mg sodium; respectively. This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.
The printing ink used on Prograf 1 mg Hard Capsules contains soya lecithin. Each hard capsule contains 0.0007 mg 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 use this product.
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 bottle. Avoid grapefruit and grapefruit juice while taking Prograf.
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 diarrhea, 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), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown accompanied with tiredness) and febrile neutropenia (a decrease in the type of white blood cells which fight infection, accompanied by fever) have been reported. It is not known exactly how often these side effects occur. 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.
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.
Not known (frequency cannot be estimated from the available data):
• Abnormality of the optic nerve (optic neuropathy).
5. How to store this product
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.