Prograf 5 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tacrolimus

Available from:

Astellas Pharma Co. Limited

ATC code:

L04AD; L04AD02

INN (International Name):

Tacrolimus

Dosage:

5 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Calcineurin inhibitors; tacrolimus

Authorization status:

Marketed

Authorization date:

1996-02-16

Patient Information leaflet

1
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 every day

Summary of Product characteristics

Health Products Regulatory Authority
15 May 2023
CRN00DKQF
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prograf 5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 in
formulation or regimen should only take place under
the close supervision of a transplant specialist (see sections 4.4 and
4.8). Following conversion to any alternative formulation,
therapeutic drug monitoring must be performed and dose adjustments
made to ensure that systemic exposure to tacrolimus is
maintained.
General considerations
The recommended initial dosages presented below are intended to act
solely as a guideline. Prograf dosing should primarily
be based on clinical assessments of rejecti