Prograf 5mg hard capsules

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

TACROLIMUS

Disponible desde:

Astellas Pharma Europe B.V.

Código ATC:

L04AD02

Designación común internacional (DCI):

TACROLIMUS

formulario farmacéutico:

HARD CAPSULE

Composición:

TACROLIMUS 5 milligram(s)

tipo de receta:

POM

Área terapéutica:

IMMUNOSUPPRESSANTS

Estado de Autorización:

Authorised

Fecha de autorización:

2013-04-05

Información para el usuario

Page 1 of 10
PACKAGE LEAFLET
Page 2 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROGRAF 0.5 MG HARD CAPSULES
PROGRAF 1 MG HARD CAPSULES
PROGRAF 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 Prograf is and what it is used for
2.
What you need to know before you take Prograf
3.
How to take Prograf
4.
Possible side effects
5.
How to store Prograf
6.
Contents of the pack and other information
1.
WHAT PROGRAF IS AND WHAT IT IS USED FOR
Prograf belongs to a group of medicines called immunosuppressants.
Following your organ
transplant (e.g. liver, kidney, heart), your body’s immune system
will try to reject the new organ.
Prograf is used to control your body’s immune response enabling your
body to accept the
transplanted organ.
Prograf is often used in combination with other medicines that also
suppress the immune system.
You may also be given Prograf for an ongoing rejection of your
transplanted liver, kidney, heart or
other organ or if 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 PROGRAF
DO NOT TAKE PROGRAF
-
If you are allergic (hypersensitive) to tacrolimus or any of the other
ingredients of Prograf
(listed in section 6).
-
If you are allergic (hypersensitive) to any antibiotic belonging to
the subgroup of macrolide
antibiotics (e.g. erythromycin, clarithromycin, josamycin).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist before taking Prograf
-

Ficha técnica

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Prograf 0.5 mg hard capsules
Prograf 1 mg hard capsules
Prograf 5 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prograf 0.5 mg hard capsules
Each capsule contains 0.5 mg of tacrolimus (as monohydrate).
Excipient with known effect: 62.85 mg of lactose monohydrate
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of total
printing ink composition).
Prograf 1 mg hard capsules
Each capsule contains 1 mg of tacrolimus (as monohydrate).
Excipient with known effect: 61.35 mg of lactose monohydrate
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of total
printing ink composition).
Prograf 5 mg hard capsules
Each capsule contains 5 mg of tacrolimus (as monohydrate).
Excipient with known effect: 123.60 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prograf 0.5 mg hard capsules
Capsule, hard
Opaque light yellow hard gelatin capsules imprinted in red with "0.5
mg" and "[f] 607", containing
white powder.
Prograf 1 mg hard capsules
Capsule, hard
Opaque white hard gelatin capsules imprinted in red with "1 mg" and
"[f] 617", containing white
powder.
Prograf 5 mg hard capsules
Capsule, hard
Opaque greyish red hard gelatin capsules imprinted in white with "5
mg" and "[f] 657", containing
white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in liver, kidney or heart
allograft recipients.
Page 3 of 19
Treatment of allograft rejection resistant to treatment with other
immunosuppressive medicinal
products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prograf 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 transplant
patients.
Inadvertent, unin