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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tacrolimus 1.0mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1 mg of tacrolimus
Excipients: 48.68 mg of lactose monohydrate
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Capsule hard
White / White hard gelatin capsules, size "5" imprinted with “TCR” on cap & “1” on body containing white to off
white granular powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.
Treatment of allograft rejection of resistant to treatment with other immunosuppressive medicinal products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel. This medicinal
product should only be prescribed and changes in immunosuppressive therapy, initiated by physicians experienced in
immunosuppressive therapy and the management of transplanted patients.
Inadvertent, unintentional or unsupervised switching of immediate or prolonged-release formulations of tacrolimus is
unsafe. This can lead to graft rejection or increased incidence of side effects, including under or over
immunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus. Patients should be
maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in
formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4
and 4.8). Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose
adjustments made to ensure that systemic exposure to tacrolimus is maintained.
GENERAL CONSIDERATIONS
The recommend
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