PROGRAF-XL tacrolimus 5 mg prolonged-release capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tacrolimus, Quantity: 5 mg

Available from:

Astellas Pharma Australia Pty Ltd

INN (International Name):

Tacrolimus

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: lactose monohydrate; titanium dioxide; hypromellose; sodium lauryl sulfate; iron oxide red; magnesium stearate; iron oxide yellow; ethylcellulose; Gelatin; hyprolose; butan-1-ol; purified water; industrial methylated spirit; simethicone; lecithin; ethanol; Shellac; strong ammonia solution; sulfuric acid

Administration route:

Oral

Units in package:

30, 50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PROGRAF-XL is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Product summary:

Visual Identification: Oblong, greyish red & orange capsule imprinted with '5mg' & '*687'; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2010-03-31

Patient Information leaflet

PROGRAF
®
_CAPSULES, XL PROLONGED-RELEASE CAPSULES, CONCENTRATED INJECTION_
_Tacrolimus_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROGRAF
Capsules, PROGRAF XL Prolonged-
Release Capsules and PROGRAF
Concentrated Injection. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking PROGRAF or
PROGRAF XL against the benefits
this medicine is expected to have for
you.
If you have any concerns about using
PROGRAF or PROGRAF XL ask
your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT PROGRAF /
PROGRAF XL IS USED
FOR
You have been given a new
transplanted liver, kidney, lung or
heart from another person because
your own was no longer healthy.
Your body recognises that this new
organ is different from your other
organs and will try to reject it by
attacking it in the same way that it
would attack germs that enter your
body. This could make you become
ill again. PROGRAF or PROGRAF
XL stops this attack; it is very
important to take PROGRAF or
PROGRAF XL given to you by your
doctor regularly so that your new
liver, kidney, lung or heart will not
be attacked or rejected.
If you have been taking other
medicines for this purpose, but are
still feeling unwell, your doctor may
change your treatment and begin
giving you PROGRAF or PROGRAF
XL.
PROGRAF or PROGRAF XL
contains the active ingredient
tacrolimus, which is an
immunosuppressive agent.
Your doctor may have prescribed
PROGRAF or PROGRAF XL for
another reason.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
BEFORE YOU USE
PROGRAF OR
PROGRAF XL
_WHEN YOU MUST NOT USE IT_
Do not use PROGRAF or
PROGRAF XL if you have an
allergy to:
•
any medicine containing
tacrolimus or other macrolides
(these are antibiotics of the
erythromycin family - trade
names are Eryc, EES, Klacid,
Zi

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION PROGRAF
® (TACROLIMUS) CAPSULES AND CONCENTRATED INJECTION
PROGRAF
® XL (TACROLIMUS) PROLONGED-RELEASE CAPSULES
1
NAME OF THE MEDICINE
Tacrolimus
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROGRAF CAPSULES
Each 0.5 mg capsule contains 0.5 mg tacrolimus
Each 1 mg capsule contains 1 mg tacrolimus
Each 5 mg capsule contains 5 mg tacrolimus
Contains: lactose
The printing ink used to mark the capsule contains trace amounts of
soya lecithin
For the full list of excipients, see Section 6.1 List of excipients.
PROGRAF XL PROLONGED-RELEASE CAPSULES
Each 0.5 mg prolonged-release capsule contains 0.5 mg tacrolimus
Each 1 mg prolonged-release capsule contains 1 mg tacrolimus
Each 3 mg prolonged-release capsule contains 3 mg tacrolimus
Each 5 mg prolonged-release capsule contains 5 mg tacrolimus
Contains: lactose
The printing ink used to mark the capsule contains trace amounts of
soya lecithin
For the full list of excipients, see Section 6.1 List of excipients.
PROGRAF CONCENTRATED INJECTION
Each mL of Concentrated Injection contains 5 mg tacrolimus.
Contains: ethanol
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PROGRAF CAPSULES
Capsule
Supplied as:
PROGRAF capsules 0.5 mg: light yellow hard gelatine capsules with
‘0.5 mg’ and ‘[f]607’ printed in red.
PROGRAF capsules 1 mg: white, hard gelatine capsules with '1 mg' and
'[f]617' printed in red.
2
PROGRAF capsules 5 mg: greyish-red, hard gelatine capsules with '5 mg'
and '[f]657' printed in white.
PROGRAF XL PROLONGED-RELEASE CAPSULES
Prolonged release capsule
Supplied as:
PROGRAF XL 0.5 mg prolonged-release capsules: oblong capsules with a
light yellow cap imprinted
with “0.5 mg” and an orange body imprinted with “
647”.
PROGRAF XL 1 mg prolonged-release capsules: oblong capsules with a
white cap imprinted with
“1 mg” and an orange body imprinted with “
677”.
PROGRAF XL 3 mg prolonged-release capsules: oblong capsules with an
orange cap imprinted with
“3 mg” and an oran