PHENTERMINE GH phentermine 30 mg sustained release capsule blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

phentermine, Quantity: 30 mg

Tilgængelig fra:

Lupin Australia Pty Limited

Lægemiddelform:

Capsule, modified release

Sammensætning:

Excipient Ingredients: magnesium stearate; sodium polystyrene sulfonate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide; brilliant blue FCF; erythrosine; Gelatin; iron oxide black

Indgivelsesvej:

Oral

Enheder i pakken:

300 capsules, 30 capsules

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Phentermine GH 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 GH 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.

Produkt oversigt:

Visual Identification: Size 3 hard gelatin capsule with purple cap and grey opaque body, imprinted with PT on cap and 30 on body in white ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

2020-05-04

Indlægsseddel

CONSUMER MEDICINE INFORMATION
PHENTERMINE GH
(PHENTERMINE HYDROCHLORIDE) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PHENTERMINE GH. 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 GH please ask
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risk of you taking
PHENTERMINE GH 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.
WHAT PHENTERMINE GH
IS USED FOR
The name of your medicine is
PHENTERMINE GH.
PHENTERMINE GH capsules
contain the active ingredient,
phentermine. Phentermine is
combined with a resin which
slowly releases the phentermine
so the effect of PHENTERMINE
GH lasts all day.
PHENTERMINE GH is used to
reduce body weight in obese or
overweight patients. Your doctor
will assess whether
PHENTERMINE GH is suitable
for
you. PHENTERMINE GH
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 GH should be
used as a part of an overall
weight management plan which
should include a medically
controlled diet and exercise
program.
PHENTERMINE GH is available
only with a doctor's prescription.
Your doctor may prescribe
PHENTERMINE GH for another
purpose. If you are not sure why
you are taking this medicine ask
your doctor.
BEFORE YOU TAKE
PHENTERMINE GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PHENTERMINE
GH 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 symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelli

Produktets egenskaber

Australian PI – Phentermine GH v2 Page 1 of 8
(phentermine hydrochloride) capsules
AUSTRALIAN PRODUCT INFORMATION – PHENTERMINE GH
(PHENTERMINE HYDROCHLORIDE) SUSTAINED RELEASE CAPSULES
1
NAME OF THE MEDICINE
Phentermine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Phentermine GH capsule contains phentermine as an ion-exchange
resin complex equivalent to 15,
30 or 40 mg phentermine depending on strength. The ion-exchange resin
is quite stable, highly insoluble
and without pharmacological effect until it reacts with cations
(hydrogen, potassium, sodium, etc.)
present in the gastrointestinal fluids. Phentermine is then released
from the resin complex at a rate
dependent on the total concentration of these cations. Since this
concentration is fairly constant
throughout the entire gastrointestinal tract, continuous and
controlled ionic release occurs over a 10 to
14 hour period.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Sustained release capsules.
Phentermine GH 15 mg: Size ‘3’ hard gelatin capsule with white
opaque cap and grey opaque body,
imprinted with “PT” on cap and “15” on body in black ink and
containing brown to light brown coloured
spherical beads.
Phentermine GH 30 mg: Size ‘3’ hard gelatin capsule with purple
cap and grey opaque body, imprinted
with “PT” on cap and “30” on body in white ink and containing
brown to light brown coloured spherical
beads.
Phentermine GH 40 mg: Size ‘2’ hard gelatin capsule with pink
opaque cap and grey opaque body
imprinted with “PT” on cap and “40” on body in black ink and
containing brown to light brown coloured
spherical beads.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Phentermine GH 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 m