TACNI

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TACROLIMUS

Available from:

Teva Pharma B.V.

ATC code:

L04AD02

INN (International Name):

TACROLIMUS

Dosage:

5 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

tacrolimus

Authorization status:

Not Marketed

Authorization date:

2011-08-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TACNI 0.5 MG HARD CAPSULES
TACNI 1 MG HARD CAPSULES
TACNI 5 MG HARD CAPSULES
Tacrolimus
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tacni is and what it is used for
2.
What you need to know before you take Tacni
3.
How to take Tacni
4.
Possible side effects
5.
How to store Tacni
6.
Contents of the pack and other information
1.
WHAT TACNI IS AND WHAT IT IS USED FOR
Tacni is an immunosuppressant. Following your organ transplant (e.g.
liver, kidney, heart), your body‟s
immune system will try to reject the new organ.
Tacni is used to control your body‟s immune response enabling your
body to accept the transplanted organ.
Tacni is often used in combination with other medicines that also
suppress the immune system.
You may also be given Tacni for an ongoing rejection of your
transplanted liver, kidney, heart or other organ
when any previous treatment you were taking was unable to control this
immune response after your
transplantation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TACNI
DO NOT TAKE TACNI

If you are allergic to tacrolimus or any of the other ingredients of
this medicine (listed in section 6)

If you are allergic to sirolimus or to any macrolide antibiotic (e.g.
erythromycin, clarithromycin,
josamycin).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Tacni
-
if you are taking any medicines mentioned below under „Other
medicines and Tacni‟.
-
if you have or have had liver problems
-
if you have diarrhoea for mor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tacni 5 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tacni 5 mg hard capsule contains 5 mg tacrolimus
Excipient with known effect:
Each Tacni 5 mg hard capsule contains 104.6 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
Red cap and red body hard shell capsules with white powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in liver, kidney or heart
allograft recipients.
Treatment of allograft rejection resistant to treatment with other
immunosuppressive medicinal products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tacni therapy requires careful monitoring by adequately qualified and
equipped personnel.
The 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 recommended initial dosages presented below are intended to act
solely as a guideline. Tacrolimus dosing should
primarily be based on clinical assessments of rejection and
tolerability in each patient individually aided by blood level
monitoring (see belo