מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
pioglitazone hydrochloride, Quantity: 16.535 mg
Sandoz Pty Ltd
Pioglitazone hydrochloride
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; carmellose calcium; magnesium stearate; hyprolose
Oral
28
(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, in combination with insulin; as triple therapy to improve glycaemic control: in combination with metformin and sulfonylurea.
Visual Identification: white, round tablet, with imprint "PGT 15" on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2011-02-18
PIOGLITAZONE SANDOZ ® 1 PIOGLITAZONE SANDOZ ® _pioglitazone hydrochloride tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pioglitazone Sandoz. 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 risk of you taking this medicine against the benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT PIOGLITAZONE SANDOZ IS USED FOR Pioglitazone Sandoz helps 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 controlled by diet, certain oral medications and occasionally insulin. This medicine is used: • to improve the action of the body's naturally produced insulin. • in the management of type 2 diabetes not controlled by diet. • alone (when diet and exercise is not enough to treat your diabetes) or together with other anti- diabetic medicines. It contains the active ingredients Pioglitazone hydrochloride. Pioglitazone hydrochloride belongs to a group of medicines called glitazones. It works by decreasing insulin resistance. 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 not addictive. This medicine is available only with a doctor's prescription. The use of Pioglitazone Sandoz has not been studied in children. BEFORE YOU TAKE PIOGLITAZONE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • Pioglitazone hydrochloride, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description. • any other similar medicines (Rosiglitazone maleate). Some of the symptoms of an allergic reaction may include: • shortness of breath • קרא את המסמך השלם
190108-pioglitazone-sandoz-pi Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION PIOGLITAZONE SANDOZ ® (PIOGLITAZONE HYDROCHLORIDE) TABLETS 1. NAME OF THE MEDICINE Pioglitazone hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Pioglitazone Sandoz 15 mg tablets contains 16.535 mg pioglitazone hydrochloride equivalent to 15 mg pioglitazone. Each Pioglitazone Sandoz 30 mg tablets contains 33.07 mg pioglitazone hydrochloride equivalent to 30 mg pioglitazone. Each Pioglitazone Sandoz 45 mg tablets contains 49.605 mg pioglitazone hydrochloride equivalent to 45 mg pioglitazone. _Excipient(s) with known effect:_ lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablets Pioglitazone Sandoz 15 mg tablets are white, round tablet, with imprint “PGT 15” on one side. Pioglitazone Sandoz 30 mg tablets are white, round tablet, with imprint “PGT 30” on one side and with score line on both sides. Pioglitazone Sandoz 45 mg tablets are white, round tablet, with imprint “PGT 45” on one side. _Not all strengths may be marketed. _ 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Pioglitazone Sandoz is indicated for the 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 - in combination with insulin • As triple therapy to improve glycaemic control: - in combination with metformin and sulfonylurea. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE Pioglitazone Sandoz should be taken once daily with or without food. 190108-pioglitazone-sandoz-pi Page 2 of 22 After initiation of Pioglitazone Sandoz or with dose increase, patients should be carefully monitored for adverse events related to fluid retention (see Section 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 קרא את המסמך השלם