Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
phentermine, Quantity: 40 mg
Lupin Australia Pty Limited
Capsule, modified release
Excipient Ingredients: magnesium stearate; sodium polystyrene sulfonate; titanium dioxide; purified water; erythrosine; Gelatin; iron oxide black; patent blue V; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; potassium hydroxide; ethanol absolute
Oral
300 capsules, 30 capsules
(S4) Prescription Only Medicine
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.
Visual Identification: 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.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-05-04
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 সম্পূর্ণ নথি পড়ুন
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 সম্পূর্ণ নথি পড়ুন