PHENTODUR phentermine (as hydrochloride) 30 mg modified release capsule blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

phentermine hydrochloride, Quantity: 37.332 mg

Dostępny od:

Arrotex Pharmaceuticals Pty Ltd

Forma farmaceutyczna:

Capsule, modified release

Skład:

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

Droga podania:

Oral

Sztuk w opakowaniu:

30 capsules, 7 capsules

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

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.

Podsumowanie produktu:

Visual Identification: Cap reddish brown and body light grey coloured, "PHE30" marked on cap, size "3" hard gelatin capsule.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Registered

Data autoryzacji:

2021-08-11

Ulotka dla pacjenta

PHENTODUR
_Phentermine (fen-ter-mean)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PHENTODUR. 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 PHENTODUR please ask your
doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risk of
you taking PHENTODUR 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
PHENTODUR. PHENTODUR capsules
contain the active ingredient,
phentermine. Phentermine is combined
with a resin which slowly releases the
phentermine so the effect of
PHENTODUR lasts all day.
WHAT PHENTODUR IS USED
FOR
PHENTODUR is used to reduce body
weight in obese or overweight
patients. Your doctor will assess
whether PHENTODUR is suitable for
you. PHENTODUR 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.
PHENTODUR should be used as a part of
an overall weight management plan
which should include a medically
controlled diet and exercise program.
PHENTODUR is available only with a
doctor's prescription.
Your doctor may prescribe PHENTODUR
for another purpose. If you are not sure
why you are taking this medicine ask
your doctor.
BEFORE YOU TAKE
PHENTODUR
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PHENTODUR 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
•
swelling of the face, lips, tongue, or
other parts of the body
•
rash, itching

Charakterystyka produktu

Australian Product Information - PHENTODUR (phentermine (as
hydrochloride)) capsules
1
NAME OF THE MEDICINE
Phentermine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PHENTODUR capsule contains phentermine as an ion-exchange resin
complex equivalent to 15,
30 or 40 mg phentermine depending on strength.
Excipients of known effect: lactose monohydrate and sulphites (from
gelatin capsules).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Modified release capsules
15mg: grey and green coloured, marked with ‘PHE15’
30mg: grey and reddish brown, marked with ‘PHE30’
40mg: grey and orange, marked with ‘PHE40’
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.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 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
D
OSE AND METHOD OF ADMINISTRATION
Adults and adolescents over 12 years:
One capsule daily at breakfast, swallowed whole. Evening dosing should
be avoided, as this agent
may induce insomnia. It is recommended that treatmen