Very common side effects:

Common side effects:

Uncommon side effects:

Rare side effects:

Very rare side effects:

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?
Keep out of the reach and sight of children.

Do not use Advagraf after the expiry date which is stated on the carton after “Exp”. The expiry date refers to the last day of that month. Use all the prolonged-release hard capsules within 1 year of opening the aluminium wrapping.

Store in the original package in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors
What is it?
Advagraf is a medicine containing the active substance tacrolimus. It is available as prolonged-released capsules containing tacrolimus (0.5 mg: yellow and orange; 1 mg: white and orange; 5 mg: greyish-red and orange). ‘Prolonged-release’ means that tacrolimus is released slowly from the capsule over a few hours.

What is it used for?
Advagraf is used in adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ). Advagraf can also be used to treat organ rejection in adult patients when other immunosuppressive medicines are not effective. The medicine can only be obtained with a prescription.

How is it used?
Treatment with Advagraf should only be prescribed by doctors who have experience in the management of transplant patients.
Advagraf is for long-term use. Doses are calculated based on the patient’s weight. Doctors should monitor the levels of tacrolimus in the blood to check that they stay within predefined ranges. In the prevention of rejection, the dose of Advagraf to use depends on the type of transplant the patient has received. In kidney transplant, the starting dose is 0.20 to 0.30 mg per kilogram body weight. In liver transplant, the starting dose is 0.10 to 0.20 mg/kg.
When treating rejection, these same doses may be used in kidney and liver transplants. Starting doses are 0.10 to 0.30 mg/kg in other types of transplant (heart, lung, pancreas or intestine). Advagraf is given once a day, in the morning, at least one hour before or two to three hours after food.

How does it work?
Tacrolimus, the active substance in Advagraf, is an immunosuppressive agent. This means that it reduces the activity of the immune system (the body’s natural defences). Tacrolimus acts on some special cells in the immune system called T-cells that are primarily responsible for attacking the transplanted organ (organ rejection).
Tacrolimus has been used since the mid-1990’s. In the European Union (EU), it has been available as capsules under the name Prograf or Prograft (depending on the country). Advagraf is very similar to Prograf/Prograft, but the way the medicine is made has been changed so that the active substance is released more slowly from the capsule than it is in Prograf/Prograft. This allows Advagraf to be given once a day, whereas Prograf/Prograft is given twice a day. This can hel