Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN
ASTRAZENECA (ISRAEL) LTD
A10BA02
FILM COATED TABLETS - EXTENDED RELEASE
SAXAGLIPTIN 2.5 MG; METFORMIN HYDROCHLORIDE 1000 MG
PER OS
Required
ASTRA ZENECA PHARMACEUTICALS LP, USA
METFORMIN
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.
2019-03-31
PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) –1986 This medicine is dispensed with a doctor's prescription only KOMBIGLYZE® XR 5 MG/1000 MG EXTENDED-RELEASE TABLETS COMPOSITION: Each tablet contains: 5 mg saxagliptin 1000 mg metformin hydrochloride KOMBIGLYZE® XR 2.5 MG/1000 MG EXTENDED-RELEASE TABLETS COMPOSITION: Each tablet contains: 2.5 mg saxagliptin 1000 mg metformin hydrochloride For inactive ingredients please see section 6 – “Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. Keep this leaflet; you may need it again. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. THIS MEDICINE IS NOT INTENDED FOR CHILDREN AND ADOLESCENTS UNDER THE AGE OF 18 YEARS. VERY IMPORTANT INFORMATION TO KNOW BEFORE USING KOMBIGLYZE XR: LACTIC ACIDOSIS AND PANCREATITIS – please see section 2 below, “Special warnings regarding use of this medicine”. 1. WHAT IS THE MEDICINE INTENDED FOR? Kombiglyze XR is intended to balance blood sugar levels in adult patients (from 18 years and above) with type 2 diabetes in combination with diet and exercise. 2. BEFORE USING THE MEDICINE X DO NOT USE THE MEDICINE IF: • you have type 1 diabetes • you have severe decreased renal function (your doctor will define your renal disfunction level) • you have kidney function problems • you are sensitive to the active ingredients: metformin hydrochloride or saxagliptin or to any of the other ingredients of Kombiglyze XR (see section 6 “Further Information”). Signs of a severe allergic reaction (hypersensitivity) to Kombiglyze XR can include: • swelling of the face, lips, throat and other areas on the skin • difficulty breathing or swallowing • raised red marks on the skin (hives) • skin rash, itching, flakin Belgenin tamamını okuyun
THE CONTENT OF THIS LEAFLET WAS APPROVED BY THE MINISTRY OF HEALTH IN JULY 2015 AND UPDATED ACCORDING TO THE GUIDELINES OF THE MINISTRY OF HEALTH IN AUG 2019 KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HCL EXTENDED-RELEASE) TABLETS 2.5MG/1000MG KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HCL EXTENDED-RELEASE) TABLETS 5MG/1000MG 1. 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 (14)_ .] 1.1 LIMITATIONS OF USE KOMBIGLYZE XR should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. KOMBIGLYZE XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using KOMBIGLYZE XR. [See _Warnings and Precautions (5.2)_ . 2. DOSAGE AND ADMINISTRATION 2.1. ADULTS WITH NORMAL RENAL FUNCTION (GLOMERULAR FILTRATION RATE [EGFR] ≥ 90 ML/MIN) 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/1000 mg • KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets 2.5 mg/1000 mg WARNING: LACTIC ACIDOSIS • POST-MARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE RESULTED IN DEATH, HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. THE ONSET OF METFORMIN- ASSOCIATED LACTIC ACIDOSIS IS OFTEN SUBTLE, ACCOMPANIED ONLY BY NONSPECIFIC SYMPTOMS SUCH AS MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL PAIN. METFORMIN-ASSOCIATED LACTIC ACIDOSIS WAS CHARACTERIZED BY Belgenin tamamını okuyun