Prograf 0.5mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TACROLIMUS

Available from:

Astellas Pharmaceuticals A.E.B.E 6-8 Agisilaou Str., 151 23 Marousi, Athens,, Greece

ATC code:

L04AD02

INN (International Name):

TACROLIMUS

Pharmaceutical form:

HARD CAPSULE

Composition:

TACROLIMUS

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Authorization status:

Authorised

Authorization date:

2013-04-05

Patient Information leaflet

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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
-
You will need to take Prograf

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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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.
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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