CLOBEMIX moclobemide 300 mg film-coated tablet blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

moclobemide, Quantity: 300 mg

Доступно од:

Arrotex Pharmaceuticals Pty Ltd

INN (Међународно име):

Moclobemide

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: pregelatinised maize starch; lactose monohydrate; sodium starch glycollate; povidone; magnesium stearate; hypromellose; microcrystalline cellulose; PEG-8 stearate; titanium dioxide; propylene glycol; purified water

Пут администрације:

Oral

Јединице у пакету:

60 tablets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Treatment of major depression.

Резиме производа:

Visual Identification: White to yellowish-white, oblong, biconvex, film-coated tablet, scored on one side. Dimensions: 17mm x 8.2mm; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Licence status A

Датум одобрења:

2012-04-19

Информативни летак

Clobemix
tablets – Consumer Medicine Information
Doc ID: 77.AN.M.2.0
Page 1
CLOBEMIX tablets
Moclobemide
Consumer Medicine Information
What is in this leaflet
This
leaflet
answers
some
common
questions
about
Clobemix tablets.
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
Clobemix
tablets
against
the
benefits
they
expect it will have 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 Clobemix is used for
The name of your medicine is
Clobemix tablets.
Clobemix tablets belongs to a
group
of
medicines
called
antidepressants.
It
contains
the
active
ingredient
called
moclobemide.
Clobemix tablets is available
in two strengths: 150 mg and
300 mg tablets.
Antidepressants are used to
treat depression and work on
the
central
nervous
system.
They are thought to work by
their
action
on
brain
chemicals
called
amines,
which
are
involved
in
controlling mood.
There
are
many
different
types
of
medicines
used
to
treat
depression.
Clobemix
tablets belongs to a group of
medicines
called
reversible
inhibitors
of
monoamine
oxidase A (RIMA).
Your
doctor,
however,
may
have
prescribed
Clobemix
tablets for another purpose.
Ask your doctor if you have
any
questions
about
why
Clobemix
tablets
has
been
prescribed for you.
This
medicine
is
available
only
with
a
doctor's
prescription.
Before You Take Clobemix
Do not take Clobemix tablets
if:

You
have
ever
had
an
allergic
reaction
to
Clobemix tablets or any of
the
ingredients
listed
at
the end of this leaflet

You
are
suffering
from
severe confusion
 Do not take CLOBEMIX
if you are taking:
•
clomipramine
•
selegiline
•
bupropion
•
triptans (a family of
medicines commonly
used to treat migraines
e.g. zolmitriptan)
•
pethidine
•
tramadol
•
dextromethorphan
(often found in cough
and cold medicines)
•

Карактеристике производа

Clobemix PI
P a g e | 1
AUSTRALIAN PI
CLOBEMIX (MOCLOBEMIDE) FILM COATED TABLETS
1
NAME OF THE MEDICINE
Moclobemide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CLOBEMIX tablets contain 150 mg or 300 mg moclobemide.
Excipients with known effect: Contains sugars as lactose.
Moclobemide is a white crystalline powder. It contains no crystal
water and is not hygroscopic. It is soluble
in water at 0.4 g / 100 mL. The pKa is approximately 6.2.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CLOBEMIX 150 mg tablets are yellow, round, biconvex, film coated
tablet, scored on one side with a
diameter of 10 mm.
CLOBEMIX
300
mg
tablets
are
a
white
to
yellowish-white,
oblong,
biconvex,
film
coated tablet,
scored on one side with the following dimensions 17 mm x 8.2 mm.
4
CLINICAL PARTICULARS
T
HERAPEUTIC INDICATIONS
CLOBEMIX is indicated in the treatment of major depression.
D
OSE AND METHOD OF ADMINISTRATION
Adults:
CLOBEMIX therapy should be initiated in two divided daily doses. The
recommended initial daily dose
is 300 mg or 450 mg. The recommended dose range is 300 - 600 mg/day.
CLOBEMIX should be taken after
meals.
Dosage in the elderly:
No dosage adjustments are necessary in elderly patients.
Dosage in patients with impaired renal function:
Single dose pharmacokinetic data suggest that no dosage adjustment may
be required in patients with
reduced renal function. However multiple dose studies with moclobemide
have not been performed in
patients
with
renal dysfunction;
therefore,
CLOBEMIX
should
be
use
with caution in this patient
population. In normal volunteers, the absolute bioavailability almost
doubles following multiple dosing as
compared to a single dose.
Clobemix PI
P a g e | 2
Dosage in patients with impaired hepatic function:
In patients with severely impaired hepatic metabolism, the daily dose
of CLOBEMIX should be reduced
to half or one third of the dose to reach the usual plasma level.
C
ONTRAINDICATIONS
•
Known hypersensitivity to the drug.
•
Acute confusional sta