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The active substances of Galvus Met, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”. Galvus Met is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus. Galvus Met is used when diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulphonylureas). Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should. It can also develop if the body produces too much glucagon. Both insulin and glucagon are made in the pancreas. Insulin helps to lower the level of sugar in the blood, especially after meals. Glucagon triggers the liver to make sugar, causing the blood sugar level to rise. How to use The recommended dose is one film-coated tablet of either 50 mg/850 mg or 50 mg/1000 mg taken twice a day If you have reduced kidney function, your doctor may prescribe a lower dose. Also if you are taking an anti-diabetic medicine known as a sulphonylurea your doctor may prescribe a lower dose. Your doctor may prescribe this medicine alone or with certain other medicines that lower the level of sugar in your blood. When and how to take Galvus Met: Swallow the tablets whole with a glass of water, Take one tablet in the morning and the other in the evening with or just after food. Taking the tablet just after food will lower the risk of an upset stomach. Warnings and precautions Talk to your doctor before taking vildagliptin/metformin if you think you are allergic to any of these ingredients. If you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies build up in the blood, which can lead to diabetic coma. Symptoms include stomach pain, rapid, deep breathing, drowsiness, or breath with an unusual, fruity odor. If you have recently had a heart attack or have heart failure, serious circulation problems or breathing problems, which may be signs of heart problems. If you have severely impaired kidney function. If you have a serious infection or are severely dehydrated (lost too much water from your body). If you are having a contrast X-ray (a special type of X-ray that includes an injectable dye). Side Effects Common (may affect up to 1 in 10 people): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, trembling that cannot be controlled, constipation, nausea (feeling sick), vomiting, diarrhoea, flatulence, heartburn, pain in and around the stomach (abdominal pain). Storage Information Do not store above 30°C. Store in the original package (blister) in order to protect from moisture. Drug Interactions Glucocorticoids generally used to treat inflammation Beta-2 agonists generally used to treat respiratory disorders Other medicines used to treat diabetes Medicines which increase urine production (diuretics) Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) Certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists) Certain medicines affecting the thyroid Certain medicines affecting the nervous system Certain medicines used to treat angina (e.g. ranolazine) Ingredients The active substances are vildagliptin and metformin hydrochloride. Specifications Galvus Met 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
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