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: PLGB 00166/0418.
Modigraf 0.2mg & 1mg granules for oral suspension (Great Britain)
Modigraf 0.2 mg, granules for oral suspension
Modigraf 1 mg, granules for oral suspension
1. What Modigraf is and what it is used for
2. What you need to know before you take Modigraf
3. How to take Modigraf
4. Possible side effects
5. How to store Modigraf
6. Contents of the pack and other information
Modigraf contains the active substance tacrolimus. It is an immunosuppressant. Following your organ transplant (e.g., liver, kidney, heart), your body’s immune system will try to reject the new organ. Modigraf is used to control your body’s immune response enabling your body to accept the transplanted organ.
You may also be given Modigraf 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.
Modigraf is used in adults and children.
Talk to your doctor or pharmacist before taking Modigraf
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 Modigraf that you need to receive. If in doubt please consult your doctor prior to taking any herbal products or remedies.
Your doctor may need to adjust your dose of Modigraf.
You should keep in regular contact with your doctor. From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Modigraf.
You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Modigraf. This is because immunosuppressants like Modigraf could increase the risk of skin cancer. In case of sun exposure, wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
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.
It is not recommended that Modigraf is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
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.
Modigraf blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Modigraf, which may require interruption, an increase or a decrease in Modigraf 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 Modigraf blood levels may occur very soon after starting the use of another medicine, therefore frequent continued monitoring of your Modigraf 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 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 Modigraf dose after you start treatment for hepatitis C.
Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), amphotericin B (used to treat fungal infections) or antivirals (used to treat viral infections e.g., acyclovir, ganciclovir, cidofovir, foscarnet). These may worsen kidney or nervous system problems when taken together with Modigraf.
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 certain diuretics used for heart failure, hypertension and kidney disease, (e.g., amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim or cotrimoxazole that may increase levels of potassium in your blood, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes, while you take Modigraf.
If you need to have any vaccinations, please tell your doctor before.
You should generally take Modigraf 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 Modigraf, since it can affect its levels in the blood.
If you take Modigraf during pregnancy, it may pass into your baby through the placenta. It could potentially influence the health of the baby or adversely influence the course of the pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Modigraf passes into breast milk. Therefore, you should not breast-feed whilst using Modigraf.
Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Modigraf. These effects are more frequent if you also drink alcohol.
Modigraf contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Modigraf should be prescribed by doctors trained to treat transplant patients and experienced in the use of medicines that control the body’s immune system (immunosuppressants).
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 physical appearance has changed from the normal white granules, or if dose 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. When treating rejection, these same doses may be used.
Your dose depends on your general condition and on which other immunosuppressive medicines you are taking.
Children and adolescents will receive doses of Modigraf calculated in the same way as adults. In general children need higher doses per kg of body weight to achieve the same effective levels in the blood as adults.
Following the initiation of your treatment with Modigraf, frequent blood tests will be taken by your doctor to define the correct dose and to adjust the dose from time to time. Your doctor will usually reduce your Modigraf dose once your condition has stabilised. Your doctor will tell you exactly how many sachets to take.
You will need to take Modigraf every day as long as you need immunosuppression to prevent rejection of your transplanted organ. You should keep in regular contact with your doctor.
Modigraf is taken orally twice daily, usually in the morning and evening. Take Modigraf on an empty stomach or 2 to 3 hours after a meal. Wait at least 1 hour until the next meal.
How to prepare the Modigraf sachets for use?
Your doctor will advise you on the number of sachets that you need to open and the volume of water that is required to make a suspension. For accurate measuring the volume of water you can use a syringe or graduated cylinder.
Pour the prescribed volume of water (at room temperature) into a glass or cup, up to a maximum of 50 ml. Place the cup with water on a stable surface. Do not use cups or spoons that are made of PVC (polyvinylchloride) to take Modigraf because the active substance in Modigraf may stick to PVC.
Carefully open the prescribed number of sachets, e.g., with a pair of scissors at the point indicated with an arrow. Hold the opened sachet between thumb and index finger above the cup with the open side of the sachet facing downwards. Gently tap on the closed end of the sachet and pour the contents of each sachet into the glass or cup containing the water. Do not use any utensils or liquids to empty the sachet. If you follow these instructions, you will get the right amount of granules from the sachet. It is normal that some granules stay behind; the sachet was designed that way.
Stir, or swirl gently until the granules have been suspended completely. The suspension can be drawn up with a syringe or swallowed directly by the patient. The liquid has a sweet taste. Rinse the glass or cup once with the same amount of water and drink this, too. The liquid should be drunk immediately after preparation.
If you have accidentally taken too much Modigraf, contact your doctor or 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 Modigraf, wait until it is time for the next dose, and then continue as before.
Stopping your treatment with Modigraf 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 medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Modigraf reduces your body’s defense mechanism (immune system), which will not be as good at fighting infections. Therefore, you may be more prone to infections while you are taking Modigraf.
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 effects may occur, including allergic and anaphylactic reactions (a very serious type of allergic reaction with fainting and difficulty breathing, which needs immediate medical attention). Benign and malignant tumours have been reported following Modigraf treatment.
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 Modigraf 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):
Children and adolescents may experience the same side effects as adults.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions.
After preparation, the suspension should be taken immediately.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Modigraf granules for oral suspension are white granules supplied in sachets.
Packs containing 50 sachets are available.
This leaflet was last revised in: December 2022