מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
phentermine, Quantity: 30 mg
iNova Pharmaceuticals (Australia) Pty Ltd
Capsule, modified release
Excipient Ingredients: lactose monohydrate; magnesium stearate; sodium polystyrene sulfonate; liquid paraffin; iron oxide red; iron oxide black; titanium dioxide; Gelatin; silicon dioxide; sodium lauryl sulfate
Oral
30, 300, 7, 3
(S4) Prescription Only Medicine
Duromine 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 Duromine 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 3 locking capsule, opaque reddish brown cap with opaque light grey body with markings DUROMINE 30/DUROMINE 30.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2000-11-17
DUROMINE ® D u r o m i n e ® 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 DUROMINE? Duromine contains the active ingredient phentermine. Duromine is used to reduce body weight in obese or overweight patients. For more information, see Section 1. Why am I using Duromine? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DUROMINE? 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 Duromine (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 Duromine? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Duromine 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 DUROMINE? • Carefully follow all directions given by your doctor or other healthcare professionals and never change the dose yourself. • The usual dose of Duromine 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 Duromine? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DUROMINE? THINGS YOU SHOULD DO • Remind any doctor, dentist, or pharmacist you visit that you are using Duromine. • If you are going to have surgery, tell the surgeon or anaesthetist that you are taking Duromine. • Stop taking and contact your doctor immediately if you become pregnant while taking Duromine. • Tell your doctor immediately if you קרא את המסמך השלם
1 AUSTRALIAN PRODUCT INFORMATION – DUROMINE (PHENTERMINE) CAPSULE 1 NAME OF THE MEDICINE Phentermine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Duromine 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 Duromine 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, Duromine 15 also contains brilliant blue FCF (CI 42090), iron oxide yellow (CI 77492); Duromine 30 also contains iron oxide red (CI 77491); Duromine 40 also contains erythrosine (CI 45430) and sunset yellow FCF (CI 15985). Duromine 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 Duromine 15 on cap and body 30mg capsule – grey and reddish brown, marked Duromine 30 on cap and body 40mg capsule – grey and orange, marked Duromine 40 on cap and body 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Duromine 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 Duromine can be in קרא את המסמך השלם