PHENTERMINE SANDOZ phentermine (as hydrochloride) 30 mg sustained release capsule blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

phentermine hydrochloride, Quantity: 37.34 mg (Equivalent: phentermine, Qty 30 mg)

থেকে পাওয়া:

Aspen Pharmacare Australia Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Capsule, modified release

রচনা:

Excipient Ingredients: lactose monohydrate; sodium polystyrene sulfonate; magnesium stearate; liquid paraffin; titanium dioxide; purified water; iron oxide red; Gelatin; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol; Shellac; sulfuric acid

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

30

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

PHENTERMINE SANDOZ 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 SANDOZ 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.

পণ্য সারাংশ:

Visual Identification: HGC size 3 gelatine capsule with opaque red and grey body and cap, both inscribed 30 in black ink. Containing a mixture of white powder and brilliant brown spherical beads; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2022-03-11

তথ্য লিফলেট

ASPEN ADRENALINE Injection - CMI
Page 1 of 4
PHENTERMINE SANDOZ
®
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PHENTERMINE
SANDOZ. 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
SANDOZ please ask your doctor or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risk of
you taking PHENTERMINE SANDOZ
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
SANDOZ CAPSULES IS USED
FOR
The name of your medicine is
PHENTERMINE SANDOZ.
PHENTERMINE SANDOZ capsules
contain the active ingredient,
phentermine. Phentermine is
combined with a resin which slowly
releases the phentermine so the effect
of PHENTERMINE SANDOZ lasts all
day.
PHENTERMINE SANDOZ is used to
reduce body weight in obese or
overweight patients. Your doctor will
assess whether PHENTERMINE
SANDOZ is suitable for you.
PHENTERMINE SANDOZ 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 SANDOZ should be
used as a part of an overall weight
management plan which should
include a medically controlled diet and
exercise program.
PHENTERMINE SANDOZ is available
only with a doctor's prescription.
Your doctor may prescribe
PHENTERMINE SANDOZ for another
purpose. If you are not sure why you
are taking this medicine ask your
doctor.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PHENTERMINE SANDOZ 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 in

পণ্য বৈশিষ্ট্য

1
AUSTRALIAN PRODUCT INFORMATION
– PHENTERMINE SANDOZ ( PHENTERMINE )
1
NAME OF THE MEDICINE
Phentermine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PHENTERMINE SANDOZ modified release capsule contains phentermine
hydrochloride
as an ion-exchange resin complex equivalent to 15, 30 or 40 mg
phentermine depending on
strength.
Excipient with known effect: lactose.
For the full list of excipients, see Section 6.1 List of excipients.
PHENTERMINE SANDOZ modified release capsules are gluten-free_. _
3
PHARMACEUTICAL FORM
PHENTERMINE SANDOZ phentermine capsules are modified release capsules
and are
supplied in 3 strengths as described below:
PHENTERMINE SANDOZ 15 mg are HGC size 3 gelatine capsule with opaque
emerald and grey
body and cap, both inscribed 15 in black ink. Containing a mixture of
white powder and
brilliant brown spherical beads.
PHENTERMINE SANDOZ 30 mg are HGC size 3 gelatine capsule with opaque
red and grey body
and cap, both inscribed 30 in black ink. Containing a mixture of white
powder and brilliant
brown spherical beads.
PHENTERMINE SANDOZ 40 mg are HGC size 3 gelatine capsule with opaque
orange and grey
body and cap, both inscribed 40 in black ink. Containing a mixture of
white powder and
brilliant brown spherical beads.
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.
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PHENTERMINE SANDOZ 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)