Advagraf 5mg modified-release capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tacrolimus monohydrate

Available from:

Astellas Pharma Ltd

ATC code:

L04AD02

INN (International Name):

Tacrolimus monohydrate

Dosage:

5mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020200; GTIN: 5013346003814

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADVAGRAF
® 0.5 MG PROLONGED-RELEASE HARD CAPSULES
ADVAGRAF
® 1 MG PROLONGED-RELEASE HARD CAPSULES
ADVAGRAF
® 3 MG PROLONGED-RELEASE HARD CAPSULES
ADVAGRAF
® 5 MG PROLONGED-RELEASE 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 and 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 Advagraf
®
is and what it is used for
2.
What you need to know before you take Advagraf
®
3.
How to take Advagraf
®
4.
Possible side effects
5.
How to store Advagraf
®
6.
Contents of the pack and other information
1.
WHAT ADVAGRAF
® IS AND WHAT IT IS USED FOR
Advagraf
®
contains the active substance tacrolimus. It is an immunosuppressant.
Following your
organ transplant (liver, kidney), your body’s immune system will try
to reject the new organ. Advagraf
®
is used to control your body’s immune response, enabling your body
to accept the transplanted organ.
You may also be given Advagraf
®
for an ongoing rejection of your transplanted liver, kidney, heart or
other organ when any previous treatment you were taking was unable to
control this immune response
after your transplantation.
Advagraf
®
is used in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADVAGRAF
®
DO NOT TAKE ADVAGRAF
®
-
if you are allergic (hypersensitive) to tacrolimus or any of the other
ingredients of Advagraf
®
(see section 6).
-
if you are allergic to sirolimus or to any macrolide-antibiotic (e.g.
erythromycin, clarithromycin,
josamycin).
WARNINGS AND PRECAUTIONS
Prograf
®
and Advagraf
®
both contain the activ

Summary of Product characteristics

OBJECT 1
ADVAGRAF 0.5MG PROLONGED-RELEASE HARD CAPSULES
Summary of Product Characteristics Updated 07-Aug-2015 | Astellas
Pharma Ltd
1. Name of the medicinal product
Advagraf 0.5 mg prolonged-release hard capsules
Advagraf 1 mg prolonged-release hard capsules
Advagraf 3 mg prolonged-release hard capsules
Advagraf 5 mg prolonged-release hard capsules
2. Qualitative and quantitative composition
ADVAGRAF 0.5 MG PROLONGED-RELEASE HARD CAPSULES
Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as
monohydrate).
Excipients with known effect:
Each capsule contains 51.09 mg lactose.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of total printing
ink composition).
ADVAGRAF 1 MG PROLONGED-RELEASE HARD CAPSULES
Each prolonged-release hard capsule contains 1 mg tacrolimus (as
monohydrate).
Excipients with known effect:
Each capsule contains 102.17 mg lactose.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of total printing
ink composition).
ADVAGRAF 3 MG PROLONGED-RELEASE HARD CAPSULES
Each prolonged-release hard capsule contains 3 mg tacrolimus (as
monohydrate).
Excipients with known effect:
Each capsule contains 306.52 mg lactose.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of total printing
ink composition).
ADVAGRAF 5 MG PROLONGED-RELEASE HARD CAPSULES
Each prolonged-release hard capsule contains 5 mg tacrolimus (as
monohydrate).
Excipients with known effect:
Each capsule contains 510.9 mg lactose.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of total printing
ink composition).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
ADVAGRAF 0.5 MG PROLONGED-RELEASE HARD CAPSULES
Prolonged-release hard capsule.
Gelatin capsules imprinted in red with “0.5 mg“ on the light yellow
capsule cap and “
647“
on the orange capsule body, containing white powder.
ADVAGRAF 1 MG PROLONGED-RELEASE HARD CAPSULES
Prolonged-release h