Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
ASTRAZENECA SDN. BHD.
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
28tablet Tablets; 7tablet Tablets; 56tablet Tablets
AstraZeneca Pharmaceuticals LP
KOMBIGLYZE ® XR TABLET SAXAGLIPTIN / METFORMIN HYDROCHLORIDE (2.5/1000 MG, 5/500 MG & 5/1000 MG) _CONSUMER MEDICATION _ _INFORMATION LEAFLET _ _(RIMUP)_ 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 Lire le document complet
1 KOMBIGLYZE ® XR saxagliptin and metformin HCl extended -release tablets INDICATIONS AND USAG E 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 saxagl iptin and metformin is appropriate [s ee Clinical Studies ]. Limitation of Use KOMBIGLYZE XR is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. DOSAGE AND ADMINISTR ATION 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 forms are available: • KOMBIGLYZE XR (saxagliptin and metformin HCl extended -release) tablets 5 mg/500 mg • KOMBIGLYZE XR (saxagliptin and metformin HCl extended -releas e) tablets 5 mg/1000 mg • KOMBIGLYZE XR (saxagliptin and metformin HCl extended -release) tablets 2.5 mg/1000 mg The recommended starting dose of KOMBIGLYZE XR in patients who need 5 mg of saxagliptin and who are not currently treated with metformin is 5 mg saxagliptin/500 mg metformin extended -release once daily with gradual dose escalation to reduce the gastrointestinal side effects due to metformin. In patients treated with metformin, the dosage of KOMBIGLYZE XR should provide metformin at the dose alread y 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 in combination with metformin extended -release may be treated with KOMBIGLYZE XR 2.5 mg/1000 mg. 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 indivi dual components. Lire le document complet