Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VILDAGLIPTIN
ACCORD HEALTHCARE SDN.BHD.
VILDAGLIPTIN
56 Tablets
INTAS PHARMACEUTICALS LIMITED
VILDACORD Vildagliptin (50mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Vildacord is used for 2. How Vildacord works 3. Before you use Vildacord 4. How to use Vildacord 5. While you are using it 6. Side effects 7. Storage and Disposal of Vildacord 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT VILDACORD IS USED FOR Each Vildacord tablet contains 50 mg of the active substance vildagliptin. Vildacord is a medicine used to treat patients with type 2 diabetes whose condition cannot be controlled by diet and exercise alone. It helps to control the level of sugar in the blood. Such medicines are known as oral antidiabetics. Type 2 diabetes develops if the body does not produce enough insulin or if the insulin that your body makes does not work as well as it should. It can also develop if the body produces too much glucagon. Insulin is a substance that helps to lower the level of sugar in your blood, especially after meals. Glucagon is a substance that triggers the production of sugar by the liver, causing the blood sugar level to rise. The pancreas makes both of these substances. HOW VILDACORD WORKS Vildacord works by making the pancreas produce more insulin and less glucagon. Vildacord helps to control the blood sugar level. Your doctor will prescribe Vildacord either alone or in combination with other antidiabetics depending on your condition. It is important that you continue to follow the diet and/or exercise recommended to you while you are on treatment with Vildacord. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU USE VILDACORD_ _ Follow all instructions given to you by your doctor or pharmacist carefully, even if they differ from the information contained in this leaflet. - _When you must not use it_ - If you are allergic (hypersensitive) to vildagliptin or any of the other ingredients of Vildacord. _PREGNANT WOMEN _ Tell your doctor if you are p Lire le document complet
PACKAGE INSERT VILDACORD (VILDAGLIPTIN TABLETS 50 MG) COMPOSITION AND PHARMACEUTICAL FORM Each uncoated tablets contains Vildagliptin 50 mg For a full list of excipients, see section EXCIPIENTS. VILDACORD: White to off-white, round, flat, beveled edge uncoated tablets, debossed with “GF1” and plain on other side. INDICATIONS Vildacord is indicated in the treatment of type 2 diabetes mellitus: _As monotherapy _ _As combination therapy, _ • Initial combination with metformin when diabetes is not adequately controlled by diet and exercise alone. • In combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control. DOSAGE AND ADMINISTRATION ADULTS When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a sulphonylurea, or in combination with insulin (with or without metformin), the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening. When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily. When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia. When used as initial combination therapy with metformin, the recommended dose of Vildagliptin is 50 mg once or twice daily. Doses higher than 100 mg are not recommended. If a dose of Vildacord is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established. Vildacord can be administered with or without a meal. PATIENTS WITH RENAL IMPAIRMENT No dose adjustment is required in pa Lire le document complet