METERMINE phentermine 40mg capsule blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

phentermine, Quantity: 40 mg

זמין מ:

iNova Pharmaceuticals (Australia) Pty Ltd

INN (שם בינלאומי):

Phentermine

טופס פרצבטיות:

Capsule, hard

הרכב:

Excipient Ingredients: titanium dioxide; lactose monohydrate; iron oxide black; magnesium stearate; sunset yellow FCF; liquid paraffin; sodium polystyrene sulfonate; erythrosine; Gelatin; silicon dioxide; sodium lauryl sulfate

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

300, 7, 3, 30

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

METERMINE 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 METERMINE 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.

leaflet_short:

Visual Identification: Opaque orange cap with opaque-light grey body with markings METERMINE 40 on cap and body.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

2004-07-01

עלון מידע

METERMINE
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING METERMINE?
Metermine contains the active ingredient phentermine. Metermine is
used to reduce body weight in obese or overweight patients.
For more information, see Section 1. Why am I using Metermine? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METERMINE?
Do not use if you have ever had an allergic reaction to phentermine or
any of the ingredients listed at the end of the CMI.
There are a number of circumstances in which a person should not use
this medicine or may need to use caution. It is important to
understand if these apply to you before taking Metermine (see the full
CMI for more details).
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Metermine? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Metermine and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE METERMINE?
•
Carefully follow all directions given by your doctor or other
healthcare professionals and never change the dose yourself.
•
The usual dose of Metermine is one capsule a day.
•
Swallow the capsule whole with plenty of water. Do not chew or open
the capsules.
More instructions can be found in Section 4. How do I use Metermine?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METERMINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
Metermine.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking Metermine.
•
Stop taking and contact your doctor immediately if you become pregnant
while taking Metermine.
•
Tell your doctor

מאפייני מוצר

1
AUSTRALIAN PRODUCT INFORMATION – METERMINE
(PHENTERMINE) CAPSULE
1
NAME OF THE MEDICINE
Phentermine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Metermine 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.
Each Metermine capsule also contains, as inactive ingredients, lactose
monohydrate, liquid
paraffin, magnesium stearate, gelatin capsules hard PI (1947),
titanium dioxide, iron oxide black
(CI 77499) and sodium polystyrene sulfonate. In addition, Metermine 15
also contains brilliant
blue FCF (CI 42090), iron oxide yellow (CI 77492); Metermine 30 also
contains iron oxide red (CI
77491); Metermine 40 also contains erythrosine (CI 45430) and sunset
yellow FCF (CI 15985).
Metermine capsules are gluten-free.
Excipient with known effect:
Each modified-release capsule contains sugars as lactose monohydrate.
3
PHARMACEUTICAL FORM
Modified-release capsule.
15mg capsule – grey and green, marked Metermine 15 on cap and body
30mg capsule – grey and reddish brown, marked Metermine 30 on cap
and body
40mg capsule – grey and orange, marked Metermine 40 on cap and body
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Metermine 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 Metermi