PHENTERMINE JUNO ER phentermine (as hydrochloride) 30 mg extended release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phentermine hydrochloride, Quantity: 37.275 mg

Available from:

Juno PC Holdings Pty Limited

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: cetostearyl alcohol; sorbitol; maltodextrin; stearic acid; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide

Administration route:

Oral

Units in package:

30, 90

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Phentermine is an anorectic agent indicated in the management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction based, for example, on exercise, diet (caloric/kilojoule restriction) and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m2 or greater.,The treatment with Phentermine can be initiated in overweight patients with a lower BMI (25 to 29.9 kg/m2), which increases the risk of morbidity from a number of disorders. Secondary organic causes of obesity should be excluded by diagnosis before prescribing this agent.

Product summary:

Visual Identification: Phentermine ER 30 mg tablets are red film coated capsule shaped tablets; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-01-09

Patient Information leaflet

Phentermine Juno
1
PHENTERMINE JUNO ER
_Phentermine (fen-ter-mean) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Phentermine
J u n o
ER.
It
does
not contain
all
the
available information.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist.
If
you
need
any
more
information
about
Phentermine
Juno
please
ask
your doctor or pharmacist.
All
medicines
have
risks
and benefits.
Your
doctor
has weighed
the
risk
of
you
taking
Phentermine
Juno
against
the
benefits
it
can
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 want to read it again.
YOUR MEDICINE
The name of your medicine is
Phentermine
Juno.
Phentermine
Juno
tablets
contain
the
active
ingredient,
phentermine.
The
release mechanism of the drug in
this
tablet
is
controlled
by
hydrophobic
and
hydrophilic
release
modifiers.
The
tablet
consists of a hydrophobic wax
matrix
which
contains
a
hydrophilic release modifier and
the drug substance.
WHAT
PHENTERMINE
JUNO IS USED FOR
Phentermine
Juno
is
used
to
reduce body weight in obese or
overweight patients. Your doctor
will assess whether Phentermine
Juno
is
suitable
for
you.
Phentermine
Juno
works
by
directly affecting the area of the
brain that controls your appetite
making you feel less hungry.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Phentermine Juno should be used
as a part of an overall weight
management plan which should
include
a
medically
controlled
diet and exercise program.
Phentermine
Juno
is
available
only with a doctor's prescription.
Your
doctor
may
prescribe
Phentermine
Juno
for
another
purpose. If you are not sure why
you are taking this medicine ask
your doctor.
BEFORE
YOU
TAKE
PHENTERMINE JUNO
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PHENTERMINE JUNO
IF YOU HAVE AN ALLERGY TO:
•
any
medicine
containing
phentermine
•
any of the ingredients listed
at the end of this leaflet
•
any ot

Summary of Product characteristics

Phentermine Juno ER tablets
Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
PHENTERMINE JUNO ER _(PHENTERMINE) _
_ _
1 NAME OF THE MEDICINE
Phentermine (as hydrochloride)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phentermine Juno ER are oral film coated extended release tablets,
containing the active
ingredient Phentermine HCl with three different strengths 15, 30 and
40 mg as Phentermine
base.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Phentermine Juno ER 15 mg are green film coated capsule shaped
tablets.
Phentermine Juno ER 30 mg are red film coated capsule shaped tablets.
Phentermine Juno ER 40 mg are orange film coated capsule shaped
tablets.
The release mechanism is controlled by hydrophobic and hydrophilic
release modifiers. The
tablet consists of a hydrophobic wax matrix which contains a
hydrophilic release modifier and
the drug substance.
When the drug product is taken, the GI tract fluids begin to dissolve
the hydrophilic
components. The dissolution process allows the gradual release of
phentermine over time.
Drug release is not dependent on pH.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Phentermine is an anorectic agent indicated in the management of
obesity as a short-term
adjunct in a medically monitored comprehensive regimen of weight
reduction based, for
example, on exercise, diet (caloric/kilojoule restriction) and
behaviour modification in obese
patients with a body mass index (BMI) of 30 kg/m
2
or greater. The treatment with Phentermine
Juno ER can be initiated in overweight patients with a lower BMI (25
to 29.9 kg/m
2
), which
increases the risk of morbidity from a number of disorders. Secondary
organic causes of
obesity should be excluded by diagnosis before prescribing this agent.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS OVER 12 YEARS
One tablet daily at breakfast, swallowed whole. Evening dosing should
be avoided, as this
Phentermine Juno ER tablets
Australian Product Information
Page | 2
age