Prograf 1mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Tacrolimus

Tilgjengelig fra:

Astellas Pharma Ltd

ATC-kode:

L04AD02

INN (International Name):

Tacrolimus

Dosering :

1mg

Legemiddelform:

Oral capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Caution - AMP level prescribing advised

Produkt oppsummering:

BNF: 08020200; GTIN: 5390332111112 5390332111129

Informasjon til brukeren

PROGRAF
® 1 MG CAPSULES
(tacrolimus)
PATIENT INFORMATION LEAFLET
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.
This medication is available using the above name but will be referred
to as
Prograf throughout this leaflet. Also available in other strengths.
This leaflet
also contains information regarding other strengths of Prograf.
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,

Preparatomtale

OBJECT 1
PROGRAF 0.5MG HARD CAPSULES
Summary of Product Characteristics Updated 02-Oct-2015 | Astellas
Pharma Ltd
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.
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
o