SUPREMINE ER phentermine (as hydrochloride) 40 mg extended release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phentermine hydrochloride, Quantity: 49.7 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; sunset yellow FCF aluminium lake; purified talc; polyvinyl alcohol; macrogol 3350; brilliant scarlet 4R aluminium lake

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 40 mg tablets are orange 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:

2021-10-20

Patient Information leaflet

Supremine
1
SUPREMINE
_ _
_Phentermine (fen-ter-mean) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Supremine. 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
Supremine please ask your doctor
or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risk of you taking
Supremine 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
Supremine.
Supremine
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. Drug release
is not dependent on pH or ionic
strength.
WHAT
SUPREMINE
IS
USED FOR
Supremine is used to reduce body
weight
in obese or overweight
patients. Your doctor will assess
whether Supremine is suitable for
you. Supremine 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.
Supremine should be used as a
part
of
an
overall
weight
management plan which should
include
a
medically
controlled
diet and exercise program.
Supremine is available only with
a doctor's prescription.
Your
doctor
may
prescribe
Supremine for another purpose. If
you are not sure why you are
taking
this
medicine
ask
your
doctor.
BEFORE
YOU
TAKE
SUPREMINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SUPREMINE IF YOU
HAVE AN ALLERGY TO:
•
any
medicine
containing
phentermine
•
any of the ingredients listed
at the end of this leaflet
•
any other similar medicines
used to reduce weight
Some
of
the
sympto

Summary of Product characteristics

Suprenza ER tablets
Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
SUPREMINE _(PHENTERMINE) _
_ _
1 NAME OF THE MEDICINE
Phentermine (as hydrochloride)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Supremine 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
Supremine 15 mg are green film coated capsule shaped tablets.
Supremine 30 mg are red film coated capsule shaped tablets.
Supremine 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 or ionic strength.
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 Supremine
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
agent may induce insomnia. It is recommended that treatment should be
initiated under the
Suprenza ER tablets
Australian