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Metformin Hydrochloride + Vildagliptin is a combination of two medicines that control high blood sugar levels in people with type 2 diabetes mellitus. This helps prevent serious complications of diabetes such as kidney damage and blindness and may reduce your chance of having a heart attack or stroke. Metformin Hydrochloride + Vildagliptin can be prescribed alone or together with other diabetes medications. All diabetes medicines work best when used along with a healthy diet and regular exercise. The dose you are given will depend on your condition, blood sugar levels and what other medicines you are taking. Taking it with meals helps to reduce the chances of developing an upset stomach. You should take it regularly, at the same time each day, to get the most benefit and you should not stop unless your doctor recommends it. It is controlling your blood sugar levels and helping to prevent serious complications in the future. It is important to stay on the diet and exercise program recommended by your doctor while taking this medicine. Your lifestyle plays a big part in controlling diabetes. The most common side effects of taking this medicine include diarrhea, nausea, vomiting, upset stomach, headache, and sore throat. Low blood sugar level (hypoglycemia) is a possible side effect if you are also taking other diabetes medicines like insulin or sulphonylurea, so you need to know how to recognize and deal with it. This medicine is not suitable for everyone. Before taking it, you should let your doctor know if you have ever had kidney, liver or heart disease, problems with your pancreas, or if you drink a lot of alcohol. Pregnant or breastfeeding women should also consult their doctor before taking this medicine. Some other medicines can affect this one so tell your doctor about all the medicines you are taking to make sure you are safe. You should try to avoid drinking alcohol as it lowers blood glucose. Your doctor will check your kidney function and blood sugar levels before and during treatment. Metformin Hydrochloride + Vildagliptin is a combination of two antidiabetic medicines: Metformin and Vildagliptin. Metformin is an anti-diabetic medication (biguanide). It works by lowering glucose production in the liver, delaying glucose absorption from intestines and increasing the body's sensitivity to insulin. Vildagliptin is a DPP-4 inhibitor which works by increasing the release of insulin from the pancreas and decreasing the hormones that raise blood sugar levels. This reduces both fasting and postmeal sugar levels. Together, they provide better control of blood sugar.

• Type 2 diabetes mellitus

Metformin: Biguanide; acts by decreasing endogenous hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization; improves glucose tolerance and lowers both basal and postprandial plasma glucose . Vildagliptin is a dipeptidylpeptidase-4 (DPP-4) inhibitor that improves glycaemic control by preventing DPP-4 from inactivating the incretin hormones glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide, thus prolonging incretin activity in response to ingestion of nutrients. This increases insulin sensitivity, decreases glucagon secretion and improves ?-cell function.

Adult Dose: Oral Type 2 DM Adults: Based on the patient's current dose of Metformin, Combination of Vildagliptin & Metformin may be initiated at either 50 mg/500 mg or 50 mg/850 mg twice daily, 1 tab in the morning and the other in the evening. The recommended maximum daily dose is 100 mg Vildagliptin plus 2000 mg Metformin HCl. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to Combination of Vildagliptin & Metformin containing the same doses of each component. Hepatic impairment: This combination is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >3 X the upper limit of normal. Child Dose: Not recommended in patients <18 years of age Renal Dose: Renal impairment: This combination should not be used in patients with renal failure or renal dysfunction, e.g. serum creatinine levels > 1.5 mg/dL (>135 micro mol/L) in males and > 1.4 mg/dL (>110 micro mol/L) in females.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Metformin Hydrochloride + Vildagliptin is to be taken with food.

Common: • Nausea • Vomiting • Diarrhea • Stomach pain • Loss of appetite • Dizziness • Headache • Trembling • Metallic taste • Hypoglycemia (low blood glucose level)

[CAUTION] Your ability to drive may be affected if your blood sugar is too low or too high. Do not drive if these symptoms occur. Take it with food to lower your chance of having an upset stomach. Chances of weight gain and low blood sugar are lesser as compared to other diabetes medicines. Inform your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic. Tell your doctor immediately if you experience any deep or rapid breathing, persistent nausea, vomiting, and stomach pain as Metformin Hydrochloride + Vildagliptin may cause a rare but serious condition called lactic acidosis, which is an excess of lactic acid in the blood. Your doctor may check your kidney and liver function before starting treatment and regularly thereafter. Inform your doctor if you develop symptoms such as abdominal pain, fatigue, loss of appetite, darkened urine or yellowing of the eyes or skin (jaundice).

This combination is contraindicated in patients with known hypersensitivity to Vildagliptin or Metformin Hydrochloride or to any of the excipients. It is contraindicated in patients with renal disease or renal dysfunction, acute myocardial infarction, and septicaemia. It is also contraindicated in patients with congestive heart failure patients and in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

Additive effect w/ sulfonylureas. Thiazide diuretics, corticosteroids, phenothiazines, OC, sympathomimetics, niacin, Ca channel blockers and isoniazid may exacerbate loss of glycaemic control. ACE inhibitors may reduce fasting blood glucose concentrations. May increase serum level w/ cimetidine. Potentially Fatal: Concurrent use w/ iodinated contrast agents may increase the risk of metformin-induced lactic acidosis.

[UNSAFE] It is unsafe to consume alcohol with Metformin Hydrochloride + Vildagliptin.

[CONSULT YOUR DOCTOR] Metformin Hydrochloride + Vildagliptin may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[CONSULT YOUR DOCTOR] Information regarding the use of Metformin Hydrochloride + Vildagliptin during breastfeeding is not available. Please consult your doctor.

[CAUTION] Metformin Hydrochloride + Vildagliptin should be used with caution in patients with kidney disease. Dose adjustment of Metformin Hydrochloride + Vildagliptin may be needed. Please consult your doctor. [CAUTION] Metformin Hydrochloride + Vildagliptin should be used with caution in patients with liver disease. Dose adjustment of Metformin Hydrochloride + Vildagliptin may be needed. Please consult your doctor. Regular monitoring of liver function tests is recommended if you are taking this medicine. Use of this medicine is preferably not advised in patients with liver disease.

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