国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
pioglitazone hydrochloride, Quantity: 49.9 mg (Equivalent: pioglitazone, Qty 45 mg)
Arrotex Pharmaceuticals Pty Ltd
Pioglitazone hydrochloride
Tablet
Excipient Ingredients: hyprolose; lactose monohydrate; carmellose calcium; magnesium stearate
Oral
98, 28, 7, 50
(S4) Prescription Only Medicine
Treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise: as monotherapy; as dual therapy to improve glycaemic control: in combination with metformin or sulfonylurea or in combination with insulin; as triple therapy to improve glycaemic control: in combination with metformin and sulfonylurea.
Visual Identification: white to off-white, round, flat, bevelled edge, uncoated tablets embossed "45" on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2010-11-11
APO- APOTEX- CHEMMART TERRY WHITE CHEMISTS PIOGLITAZONE 1 APOTEX- PIOGLITAZONE _Pioglitazone hydrochloride _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about pioglitazone. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will 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 THIS MEDICINE IS USED FOR Pioglitazone is used to treat type 2 diabetes not controlled by diet and exercise. It helps to improve the action of insulin produced by your body. Pioglitazone belongs to a group of medicines called glitazones. Glitazones decrease insulin resistance and help to control the level of glucose in your blood when you have type 2 diabetes. This is the 'adult onset' type of diabetes and is usually controlled by diet, certain oral medications and occasionally insulin. Pioglitazone can be used alone (when diet and exercise is not enough to treat your diabetes) or together with other anti-diabetic medicines. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine in children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • pioglitazone • any of the ingredients listed at the end of this leaflet 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 • 阅读完整的文件
1 AUSTRALIAN PRODUCT INFORMATION – APOTEX- PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Pioglitazone hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone (as hydrochloride) as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 15 MG TABLETS White to off-white, round, biconvex, uncoated tablet embossed “15” on one side and plain on the other side. 30 MG TABLETS White to off-white, round, flat, bevelled edged, uncoated tablets embossed “30” on one side and plain on the other side. 45 MG TABLETS White to off-white, round, flat, bevelled edged, uncoated tablet embossed “45” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise: as monotherapy as dual therapy to improve glycaemic control o in combination with metformin or sulfonylurea o in combination with insulin as triple therapy to improve glycaemic control o in combination with metformin and sulfonylurea 2 4.2 DOSE AND METHOD OF ADMINISTRATION Pioglitazone should be taken once daily with or without food. After initiation of pioglitazone or with dose increase, patients should be carefully monitored for adverse events related to fluid retention (see 4.4-Special warnings and precautions for use). FEMALE PATIENTS Oedema has been reported more often in women. Dosage should start at 15 mg and be increased cautiously, paying attention to the development of oedema. MONOTHERAPY The recommended dose of pioglitazone is 15 mg or 30 mg once daily, increasing after four weeks, if greater therapeutic effect is needed, to 45 mg once daily. DUAL THERAPY The recommended dose of pioglitazone is 30 mg once daily in combination with sulfonylureas, insulin or metformin. It may be possible to achieve metabolic control at a reduced dose of the 阅读完整的文件