Land: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SAXAGLIPTIN HYDROCHLORIDE
ASTRAZENECA SDN. BHD.
SAXAGLIPTIN HYDROCHLORIDE
28Tablet Tablets
AstraZeneca Pharmaceuticals LP.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ONGLYZA ® TABLET SAXAGLIPTIN (5 MG) 1 WHAT IS IN THIS LEAFLET 1. What ONGLYZA is used for 2. How ONGLYZA works 3. Before you use ONGLYZA 4. How to use ONGLYZA 5. While you are using it 6. Side effects 7. Storage and disposal of ONGLYZA 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT IS ONGLYZA USED FOR ONGLYZA is a prescription medicine used with diet and exercise to 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 ONGLYZA WORKS • ONGLYZA lowers blood sugar by helping the body increase the level of insulin after meals. • ONGLYZA is unlikely to cause your blood sugar to be lowered to a dangerous level (hypoglycemia) because it does not work well when your blood sugar is low. However, hypoglycemia may still occur with ONGLYZA. Your risk for getting hypoglycemia is higher if you take ONGLYZA with some other diabetes medicines, such as a sulfonylurea or insulin. BEFORE YOU USE ONGLYZA - _When you must not use it _ _ _ DO NOT TAKE ONGLYZA IF YOU: • are allergic to any ingredients in ONGLYZA. See the end of this Patient Information Leaflet for a complete list of ingredients in ONGLYZA. Symptoms of a serious allergic reaction to ONGLYZA may include : - swelling of your face, lips, throat, and other areas on your skin - difficulty with swallowing or breathing - raised, red areas on your skin (hives) - skin rash, itching, flaking, or peeling If you have these symptoms, Lestu allt skjalið
ONGLYZA ® saxagliptin tablets INDICATIONS AND USAG E Monotherapy and Combination Therapy ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical St udies ]. Limitation of Use ONGLYZA is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these s ettings. DOSAGE AND ADMINISTR ATION Recommended Dosage The recommended dos ag e of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals. ONGLYZA tablets must not be split or cut. Dosage in Patients with Renal Impairment No dosage adjustment for ONGLYZA is recommended for patients with eGFR ≥45 mL/min/1.73 m2. The dos ag e of ONGLYZA is 2.5 mg once daily (regardless of meals) for patients with eGFR Lestu allt skjalið