Prograf 5mg capsules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Tacrolimus

Tillgänglig från:

Pharmaram Ltd

ATC-kod:

L04AD02

INN (International namn):

Tacrolimus

Dos:

5mg

Läkemedelsform:

Oral capsule

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Caution - AMP level prescribing advised

Produktsammanfattning:

BNF: 08020200; GTIN: 05060666560374

Bipacksedel

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 or pharmacist before taking Progr

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
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
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.
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, 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