Active ingredient
- tacrolimus monohydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 are: EU/1/09/523/002, EU/1/09/523/001.
Modigraf 0.2mg & 1mg granules for oral suspension
Package leaflet: Information for the user
Modigraf 0.2 mg, granules for oral suspension
Modigraf 1 mg, granules for oral suspension
Tacrolimus
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
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
1. What Modigraf is and what it is used for
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.
2. What you need to know before you take Modigraf
Do not take Modigraf
Warnings and precautions
Talk to your doctor or pharmacist before taking Modigraf
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.
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.
Other medicines and Modigraf
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).
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. In particular, you should tell your doctor if you are taking or have recently taken medicines like:
Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), amphotericin B (used to treat bacterial infections) or antivirals (used to treat viral infections e.g. aciclovir). These may worsen kidney or nervous system problems when taken together with Modigraf.
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), 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.
Modigraf with food and drink
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.
Pregnancy and breast-feeding
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.
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 Modigraf. These effects are more frequent if you also drink alcohol.
Modigraf contains lactose and sodium
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’.
3. How to take Modigraf
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
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 take more Modigraf than you should
If you have accidentally taken too much Modigraf, contact your doctor or nearest hospital emergency department immediately.
If you forget to take Modigraf
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.
If you stop taking Modigraf
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Modigraf reduces your body’s defence 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.
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.
Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) 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.
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):
Not known (frequency cannot be estimated from the available data):
Children and adolescents
Children and adolescents may experience the same side effects as adults.
Reporting of side effects
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 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.
5. How to store Modigraf
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.
6. Contents of the pack and other information
What Modigraf contains
What Modigraf looks like and contents of the pack
Modigraf granules for oral suspension are white granules supplied in sachets.
Packs containing 50 sachets are available.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in: Sept 2019
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
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