Tacforius

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

tacrolimus monohydrate

Available from:

Teva B.V.

ATC code:

L04AD02

INN (International Name):

tacrolimus

Therapeutic group:

Immunosuppressants

Therapeutic area:

Liver Transplantation; Kidney Transplantation

Therapeutic indications:

Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.

Product summary:

Revision: 7

Authorization status:

Authorised

Authorization date:

2017-12-08

Patient Information leaflet

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TACFORIUS 0.5 MG PROLONGED-RELEASE HARD CAPSULES
TACFORIUS 1 MG PROLONGED-RELEASE HARD CAPSULES
TACFORIUS 3 MG PROLONGED-RELEASE HARD CAPSULES
TACFORIUS 5 MG PROLONGED-RELEASE 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 and 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 Tacforius is and what it is used for
2.
What you need to know before you take Tacforius
3.
How to take Tacforius
4.
Possible side effects
5.
How to store Tacforius
6.
Contents of the pack and other information
1.
WHAT TACFORIUS IS AND WHAT IT IS USED FOR
Tacforius contains the active substance tacrolimus. It is an
immunosuppressant. Following your organ
transplant (liver, kidney), your body’s immune system will try to
reject the new organ. Tacforius is
used to control your body’s immune response, enabling your body to
accept the transplanted organ.
You may also be given Tacforius 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.
Tacforius is used in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TACFORIUS
_ _
DO NOT TAKE TACFORIUS_ _
-
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
Tacrolimus immediate release capsules (e.g, Tacni) and

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tacforius 0.5 mg prolonged-release hard capsules
Tacforius 1 mg prolonged-release hard capsules
Tacforius 3 mg prolonged-release hard capsules
Tacforius 5 mg prolonged-release hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tacforius 0.5 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as
monohydrate).
_Excipient with known effect _
Each capsule contains 53.725 mg lactose.
Tacforius 1 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 1 mg tacrolimus (as
monohydrate).
_Excipient with known effect _
Each capsule contains 107.45 mg lactose.
Tacforius 3 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 3 mg tacrolimus (as
monohydrate).
_Excipient with known effect _
Each capsule contains 322.35 mg lactose.
Tacforius 5 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 5 mg tacrolimus (as
monohydrate).
_Excipients with known effect _
Each capsule contains 537.25 mg lactose and 0.0154 mg ponceau 4R.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release hard capsule (prolonged-release capsule)
Tacforius 0.5 mg prolonged-release hard capsules
Gelatin capsules imprinted with “TR” on the light yellow capsule
cap and “0.5 mg” on the light orange
capsule body.
Tacforius 1 mg prolonged-release hard capsules
Gelatin capsules imprinted with “TR” on the white capsule cap and
“1 mg” on the light orange capsule
body.
3
Tacforius 3 mg prolonged-release hard capsules
Gelatin capsules imprinted with “TR” on the light orange capsule
cap and “3 mg” on the light orange
capsule body.
Tacforius 5 mg prolonged-release hard capsules
Gelatin capsules imprinted with “TR” on the greyish red capsule
cap and “5 mg” on the light orange
capsule body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in adult kidney or