Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VILDAGLIPTIN; METFORMIN HYDROCHLORIDE
ALCON LABORATORIES (MALAYSIA) SDN. BHD.
VILDAGLIPTIN; METFORMIN HYDROCHLORIDE
30 Tablets; 60 Tablets
NOVARTIS PHARMA PRODUKTIONS GMBH
XILIARX ® MET Vidagliptin and Metformin fixed combination (50mg/500mg, 50mg/850mg, 50mg/1000mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET 1. WHAT XILIARX MET IS USED FOR 2. HOW XILIARX MET WORKS 3. BEFORE YOU USE XILIARX MET 4. HOW TO USE XILIARX MET 5. WHILE YOU ARE USING XILIARX MET 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF XILIARX MET 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT XILIARX MET IS USED FOR Xiliarx Met is available as tablets. Each Xiliarx Met tablet contains two active substances: vildagliptin and metformin hydrochloride. Both substances belong to a group of medicines called “oral antidiabetics”. Three dosage strengths are available (vildagliptin/metformin hydrochloride) 50 mg/500 mg, 50 mg/850 mg and 50 mg/1,000 mg. Xiliarx Met is a medicine used to treat type 2 diabetes. It helps to control the level of sugar in the blood. It is prescribed together with diet and exercise in patients who have already received treatment with vildagliptin and metformin hydrochloride together, or whose diabetes is not adequately controlled with metformin hydrochloride or vildagliptin alone, or as a first diabetes treatment in patients whose diabetes is not adequately controlled by diet and exercise alone. Xiliarx Met is also prescribed in combination with a sulfonylurea, together with diet and exercise in patients whose diabetes is not adequately controlled with metformin and a sulfonylurea. Xiliarx Met is also prescribed as an add- on to insulin, together with diet and exercise, to improve control of blood sugar (glycemic control) in patients when a stable dose of insulin and metformin alone do not provide adequate glycemic control. HOW XILIARX MET WORKS Xiliarx Met works by making the pancreas produce more insulin and less glucagon (effect of vildagliptin) and also by helping the body to make better use of the insulin it produces (effect of metformin hydrochloride). Xiliarx Met helps to control the blood sugar level. It is Soma hati kamili
Regulatory Affairs XILIARX ® MET_ _ (VILDAGLIPTIN AND METFORMIN FIXED COMBINATION) 50 mg/500 mg, 50 mg/850 mg, 50 mg/1,000 mg Tablets MALAYSIA PACKAGE INSERT (MAR 18) (with reference to EU SmPC – 22-May-2017) NEW INDICATION: INITIAL COMBINATION THERAPY WITH METFORMIN Author: AK Swain, J Evans, C. Hasenfratz GLC approval: 30-Oct-2013, amended 03 June 2014 Effective date: 28-Nov-2016 SLC Tracking Number: 2016-PSB/GLC-0844-s Document status: Final Number of pages: 21 Novartis Page 2 Malaysia Package Insert 28-Nov-2016 Xiliarx Met XILIARX MET COMPOSITION AND PHARMACEUTICAL FORM Vildagliptin: (S)-1-[2-(3-Hydroxy-adamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile Metformin hydrochloride: Imidodicarbinimidic, N,N-dimethyl-, monohydrochloride Three strengths are available. One tablet of Xiliarx Met contains: 50 mg vildagliptin and 500 mg metformin hydrochloride (corresponding to 390 mg metformin). Light yellow, ovaloid bevelled edge, film-coated tablet imprinted with "NVR" on one side and "LLO" on the other side. 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg metformin). Yellow, ovaloid bevelled edge, film-coated tablet imprinted with "NVR" on one side and "SEH" on the other side. 50 mg vildagliptin and 1,000 mg metformin hydrochloride (corresponding to 780 mg metformin). Dark yellow, ovaloid bevelled edge, film-coated tablet imprinted with "NVR" on one side and "FLO" on the other side. Certain dosage strengths may not be available in all countries. For a full list of excipients, see section EXCIPIENTS. INDICATIONS Xiliarx Met is indicated in the treatment of type 2 diabetes mellitus: Xiliarx Met is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. Xiliarx Met is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct t Soma hati kamili