ALCEPT 250 mycophenolate mofetil 250 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mycophenolate mofetil, Quantity: 250 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Mycophenolate mofetil

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; pregelatinised maize starch; povidone; titanium dioxide; indigo carmine; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

One carton contains 100 capsules (10 strips of 10 capsules)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Alcept 250 is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Alcept 250 is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

Product summary:

Visual Identification: Capsule with Blue cap, Brown body imprinted 266 on body in black; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2011-11-21

Patient Information leaflet

Page 1 of 5
ALCEPT 250 CMI (V-06)
ALCEPT 250
(MYCOPHENOLATE MOFETIL CAPSULES 250 MG)
_contains the active ingredient mycophenolate mofetil _
_ _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
ALCEPT 250. 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
ALCEPT 250 against the benefits
expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
ALCEPT
250
IS
USED FOR
ALCEPT 250 contains the active
ingredient mycophenolate
mofetil.
ALCEPT 250 belongs to a group
of medicines called
immunosuppressants.
Immunosuppressants are used to
prevent rejection of transplanted
organs
and
work
by
stopping
your
immune
system
from
reacting to the transplanted organ.
There are many different types of
medicines
used
to
prevent
rejection of a transplanted organ.
ALCEPT
250
may
be
used
together
with
other
medicines
known
as
cyclosporine
and
corticosteroids.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ALCEPT
250
HAS
BEEN
PRESCRIBED
FOR
YOU.
Your doctor may have prescribed
ALCEPT 250 for another reason.
ALCEPT 250 is not addictive.
This medicine is only available
with a doctor’s prescription.
BEFORE YOU TAKE OR ARE
GIVEN ALCEPT 250
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE ALCEPT 250 IF:
1.
YOU HAVE AN ALLERGY TO:

ALCEPT 250 or any of the
ingredients listed at the end
of the leaflet.
Some
of
the
symptoms
of
an
allergic reaction may include:

shortness of breath

wheezing or difficulty
breathing

swelling of the face, lips,
tongue or other parts of the
body

rash, itching, hives on the
skin.
2.
YOU ARE PREGNANT

ALCEPT 250 is harmful to an
unborn baby when taken by a
pregnant woman.

There
have
been
cases
of
miscarriage
and
severe
birth
defects reported when patients
have
taken
ALCE

Summary of Product characteristics

ALCEPT 250 PI (V-06) Page
1
of
33
AUSTRALIAN PRODUCT INFORMATION
ALCEPT 250 (MYCOPHENOLATE MOFETIL) CAPSULES
1. NAME OF THE MEDICINE
Mycophenolate Mofetil
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ALCEPT 250 MG CAPSULES:
Each capsules contains 250 mg mycophenolate mofetil
For the full list of excipients, see section 6.1 - list of excipients
.
3. PHARMACEUTICAL FORM
Capsules, hard.
ALCEPT 250 MG CAPSULES:
The capsules are oblong, size “1” blue colored cap, brown colored
body hard gelatin capsule
imprinted with “266” on body with black ink.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ALCEPT 250 mg capsule is indicated for the prophylaxis of solid organ
rejection in adults receiving
allogeneic organ transplants.
ALCEPT 250 mg capsule is indicated for the prophylaxis of organ
rejection in paediatric patients (2
to 18 years) receiving allogeneic renal transplants.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The initial dose of mycophenolate mofetil should be given as soon as
clinically feasible following
transplantation. Intravenous administration is recommended in those
patients unable to take oral
medication. However, oral administration should be initiated as soon
as possible.
ADULTS
_RENAL TRANSPLANTATION _
The recommended dose in renal transplant patients is 1 g administered
orally or intravenously twice
daily (2 g daily dose).
ALCEPT 250 PI (V-06) Page
2
of
33
_CARDIAC TRANSPLANTATION _
The recommended dose in cardiac transplant patients is 1.5 g
administered orally or intravenously
twice daily (3 g daily dose).
_HEPATIC TRANSPLANTATION _
The recommended dose in hepatic transplant patients is 1 g
administered intravenously twice daily
(2 g daily dose) followed by 1.5 g administered orally twice daily (3
g daily dose)
_OTHER TRANSPLANTS _
The
recommended
dose
in
other
transplants
is
2
to
3g
per
day
depending
on
the
level
of
immunosuppression required.
_PAEDIATRICS (2 TO 18 YEARS) _
The recommended dose for renal transplant patients is 600 mg/m
2
of mycophenolate mofetil (MMF)
administered orall