Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 850 mg; sitagliptin hydrochloride monohydrate, Quantity: 56.69 mg (Equivalent: sitagliptin, Qty mg)
Sandoz Pty Ltd
Tablet, film coated
Excipient Ingredients: hypromellose; sodium lauryl sulfate; croscarmellose sodium; povidone; sodium stearylfumarate; hyprolose; titanium dioxide; iron oxide red; triethyl citrate; purified talc; microcrystalline cellulose; iron oxide yellow
Oral
56
(S4) Prescription Only Medicine
Sitagliptin/Metformin Sandoz is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.
Visual Identification: A light orange, oval, film coated tablet debossed with "SM2" on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2021-09-13
SITAGLIPTIN/METFORMIN SANDOZ ® 1 SITAGLIPTIN/ METFORMIN SANDOZ ® _sitagliptin hydrochloride monohydrate/metformin hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sitagliptin/Metformin 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 risks of you taking Sitagliptin/Metformin Sandoz 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 need to read it again. WHAT SITAGLIPTIN/METFORMIN SANDOZ IS USED FOR Sitagliptin/Metformin Sandoz helps to lower blood sugar levels in patients with type 2 diabetes mellitus along with diet and exercise. Sitagliptin/Metformin Sandoz can be used alone, or in combination with ertugliflozin, insulin, or sulfonylurea medicines such as glimepiride, gliclazide and glibenclamide. TYPE 2 DIABETES MELLITUS Type 2 diabetes mellitus is a condition in which your body does not make enough insulin and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood resulting in high blood sugar (hyperglycaemia). This can lead to serious medical problems. The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, such as heart disease, kidney disease, blindness and foot amputation. High blood sugar can be lowered by diet and exercise and by certain medicines. _HOW SITAGLIPTIN/METFORMIN _ _SANDOZ WORKS _ Sitagliptin/Metformin Sandoz contains two active ingredients, sitagliptin (as hydrochloride monohydrate) and metformin hydrochloride. Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and Прочитать полный документ
210913-sitagliptin/metformin sandoz-pi Page 1 of 42 AUSTRALIAN PRODUCT INFORMATION SITAGLIPTIN/METFORMIN SANDOZ ® 50/500 SITAGLIPTIN/METFORMIN SANDOZ ® 50/850 SITAGLIPTIN/METFORMIN SANDOZ ® 50/1000 (SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE/METFORMIN HYDROCHLORIDE) FILM COATED TABLET 1. NAME OF THE MEDICINE Sitagliptin hydrochloride monohydrate/metformin hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sitagliptin/Metformin Sandoz is available for oral administration as film-coated tablets containing sitagliptin hydrochloride monohydrate and metformin hydrochloride equivalent to: 50 mg sitagliptin as free base and 500 mg metformin hydrochloride (Sitagliptin/Metformin 50/500), 850 mg metformin hydrochloride (Sitagliptin/Metformin 50/850) or 1000 mg metformin hydrochloride (Sitagliptin/Metformin 50/1000). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Sitagliptin/Metformin Sandoz 50/500 - A pink, film coated tablet with "SM 1" on one side and plain on the other. Sitagliptin/Metformin Sandoz 50/850 - A light orange, film coated tablet with "SM 2" on one side and plain on the other. Sitagliptin/Metformin Sandoz 50/1000 - A light red, film coated tablet with "SM 3" on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Sitagliptin/Metformin Sandoz (sitagliptin hydrochloride monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. [see Section 5.1 Pharmacodynamic properties, Clinical trials and 4.2 Dose and method of administration]. 4.2. D OSE AND METHOD OF ADMINISTRATION Life-threatening lactic acidosis can occur due to accumulation of metformin. Risk factors include renal impairment, old age and the use of high doses of metformin above 2000 mg per day. 210913-sitagliptin/metformin sandoz-pi Page 2 of 42 _Sitagliptin/Metformin _ _Sandoz _ _50/500, _ _Sitagliptin/Met Прочитать полный документ