ALENAMI phentermine (as hydrochloride) 40 mg sustained release capsule blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

phentermine hydrochloride, Quantity: 49.79 mg (Equivalent: phentermine, Qty 40 mg)

Dostępny od:

Aspen Pharmacare Australia Pty Ltd

Forma farmaceutyczna:

Capsule, modified release

Skład:

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

Droga podania:

Oral

Sztuk w opakowaniu:

30

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

ALENAMI 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 ALENAMI 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: 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.; 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

Status autoryzacji:

Registered

Data autoryzacji:

2021-02-25

Ulotka dla pacjenta

ASPEN ADRENALINE Injection - CMI
Page 1 of 4
ALENAMI
TM
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALENAMI. 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 ALENAMI
please ask your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risk of
you taking ALENAMI 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 ALENAMI CAPSULES IS
USED FOR
The name of your medicine is
ALENAMI. ALENAMI capsules contain
the active ingredient, phentermine.
Phentermine is combined with a resin
which slowly
releases the phentermine so the effect
of ALENAMI lasts all day.
ALENAMI is used to reduce body
weight in obese or overweight
patients. Your doctor will assess
whether ALENAMI is suitable for you.
ALENAMI 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.
ALENAMI should be used as a part of
an overall weight management plan
which should include a medically
controlled diet and exercise program.
ALENAMI is available only with a
doctor's prescription.
Your doctor may prescribe ALENAMI
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 ALENAMI 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 or hives on

Charakterystyka produktu

1
AUSTRALIAN PRODUCT INFORMATION – ALENAMI ( PHENTERMINE )
1
NAME OF THE MEDICINE
Phentermine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ALENAMI capsule contains phentermine as an ion-exchange resin
complex equivalent
to 15, 30 or 40 mg phentermine depending on strength.
‘For the full list of excipients, see Section 6.1 List of
excipients’.
ALENAMI capsules are gluten-free_. _
3
PHARMACEUTICAL FORM
ALENAMI phentermine capsules are modified release capsules and are
supplied in 3
strengths as described below:
ALENAMI phentermine 15mg capsule blister pack are hard gelatin
capsules (pale green
opaque cap/grey opaque body, marked 15 in black ink)
ALENAMI phentermine 30mg capsule blister pack are hard gelatin
capsules (reddish/brown
opaque cap/grey opaque body, marked 30 in black ink)
ALENAMI phentermine 40mg capsule blister pack are hard gelatin
capsules (orange opaque
cap/grey opaque body, marked 40 in black ink)
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
ALENAMI 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 ALENAMI
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 presc