국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
ASTRAZENECA SDN. BHD.
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
28tablet Tablets; 7tablet Tablets
AstraZeneca Pharmaceuticals LP
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ KOMBIGLYZE ® XR TABLET SAXAGLIPTIN / METFORMIN HYDROCHLORIDE (5/1000 MG) 1 WHAT IS IN THIS LEAFLET 1. What KOMBIGLYZE XR is used for 2. How KOMBIGLYZE XR works 3. Before you use KOMBIGLYZE XR 4. How to use KOMBIGLYZE XR 5. While you are using it 6. Side effects 7. Storage and disposal of KOMBIGLYZE XR 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT IS KOMBIGLYZE XR USED FOR • KOMBIGLYZE XR is a prescription medicine that contains saxagliptin and metformin hydrochloride. • KOMBIGLYZE XR is used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes. _What is type 2 diabetes? _ Type 2 diabetes 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. This can lead to serious medical problems. The main goal of treating diabetes is to lower your blood sugar so that it is as close to normal as possible. High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary. HOW KOMBIGLYZE XR WORKS • Saxagliptin lowers blood sugar by helping the body increase the level of insulin after meals. • Metformin helps in improving insulin sensitivity by increasing glucose uptake and utilization in the body. BEFORE YOU USE KOMBIGLYZE XR - _When you must not use it _ _ _ DO NOT TAKE KOMBIGLYZE XR IF YOU: • have kidney problems. • are allergic to metformin hydrochloride, saxagliptin, or any of the ingredients in KOMBIGLYZE XR. See the end of this Patient Information Leaflet for a complete list of ingredients in KOMBIGLYZE XR. Symptoms of a serious allergic reaction to KOMBIGLYZE XR may include: - swelling of your face, lips, throat, and other areas on your skin - raised, red areas on your skin (hives) - difficulty with swallowing or breathing - skin rash, itching, flaking, 전체 문서 읽기
1 KOMBIGLYZE ® XR saxagliptin and metformin HCl extended-release tablets INDICATIONS AND USAGE KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate [see _Clinical Studies_ ]. _ _ LIMITATION OF USE KOMBIGLYZE XR is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. DOSAGE AND ADMINISTRATION _ _ RECOMMENDED DOSAGE The dosage of KOMBIGLYZE XR should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability. KOMBIGLYZE XR should generally be administered once daily with the evening meal, with gradual dose titration to reduce the gastrointestinal side effects associated with metformin. The following dosage form is available: • KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets 5 mg/1000 mg In patients treated with metformin, the dosage of KOMBIGLYZE XR should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose. Following a switch from metformin immediate-release to metformin extended-release, glycemic control should be closely monitored and dosage adjustments made accordingly. Patients who need 2.5 mg saxagliptin who are either metformin naive or who require a dose of metformin higher than 1000 mg should use the individual components. The maximum daily recommended dosage is 5 mg for saxagliptin and 2000 mg for metformin extended-release. No studies have been performed specifically examining the safety and efficacy of KOMBIGLYZE XR in patients previously treated with other antihyperglycemic medications and switched to KOMBIGLYZE XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur. Inform patients that KOMBIGLYZE XR tablets must be swallowed whole and never crushed, cut, or chewed. Occasionally, the inactive ingredients of KOMBIGLYZE XR will be e 전체 문서 읽기