Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
phentermine hydrochloride, Quantity: 37.332 mg
Arrotex Pharmaceuticals Pty Ltd
Capsule, modified release
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
Oral
30 capsules, 7 capsules
(S4) Prescription Only Medicine
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.
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
Registered
2021-08-11
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 Läs hela dokumentet
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 Läs hela dokumentet