Envarsus

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

tacrolimus

MAH:

Chiesi Farmaceutici S.p.A.

ATC_code:

L04AD02

INN:

tacrolimus

therapeutic_group:

Immunosuppressants

therapeutic_area:

Graft Rejection

therapeutic_indication:

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.

leaflet_short:

Revision: 12

authorization_status:

Authorised

authorization_date:

2014-07-18

PIL

41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENVARSUS 0.75 MG PROLONGED-RELEASE TABLETS
ENVARSUS 1 MG PROLONGED-RELEASE TABLETS
ENVARSUS 4 MG PROLONGED-RELEASE TABLETS
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 Envarsus is and what it is used for
2.
What you need to know before you take Envarsus
3.
How to take Envarsus
4.
Possible side effects
5.
How to store Envarsus
6.
Contents of the pack and other information
1.
WHAT ENVARSUS IS AND WHAT IT IS USED FOR
Envarsus contains the active substance tacrolimus. It is an
immunosuppressant. Following your kidney
or liver transplant, your body’s immune system will try to reject
the new organ.
Envarsus is used to control your body’s immune response, enabling
your body to accept the
transplanted organ.
You may also be given Envarsus 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.
Envarsus is used in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENVARSUS
DO NOT TAKE ENVARSUS
-
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
Envarsus contains the active substance tacrolimus presented in a
prolonged release formulation.
Envarsus is taken once daily and is
NOT
interchange

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Envarsus 0.75 mg prolonged-release tablets
Envarsus 1 mg prolonged-release tablets
Envarsus 4 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Envarsus 0.75 mg prolonged-release tablets
Each prolonged-release tablet contains 0.75 mg tacrolimus (as
monohydrate).
_Excipient with known effect _
Each tablet contains 41.7 mg lactose monohydrate.
Envarsus 1 mg prolonged-release tablets
Each prolonged-release tablet contains 1 mg tacrolimus (as
monohydrate).
_Excipient with known effect _
Each tablet contains 41.7 mg lactose monohydrate.
Envarsus 4 mg prolonged-release tablets
Each prolonged-release tablet contains 4 mg tacrolimus (as
monohydrate).
_ _
_Excipient with known effect _
Each tablet contains 104 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Envarsus 0.75 mg prolonged-release tablets
Oval, white to off-white uncoated tablet, debossed with “0.75” on
one side and “TCS” on the other
side.
Envarsus 1 mg prolonged-release tablets
Oval, white to off-white uncoated tablet, debossed with “1” on one
side and “TCS” on the other side.
Envarsus 4 mg prolonged-release tablets
Oval, white to off-white uncoated tablet, debossed with “4” on one
side and “TCS” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in adult kidney or liver allograft
recipients.
3
Treatment of allograft rejection resistant to treatment with other
immunosuppressive medicinal
products in adult patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Envarsus is a once-a-day oral formulation of tacrolimus. Tacrolimus
therapy requires careful
monitoring by adequately qualified and equipped personnel. This
medicinal product should only be
prescribed, and changes in immunosuppressive therapy be initiated, by
physicians experienced in
immunosuppressive therapy and the management of transplant patients.
I