<p><strong>Product Description:</strong></p> <ul> <li>The active substances in Vildagliptin/Metformin, vildagliptin and metformin, belong to a group of medicines called "oral antidiabetics".</li> <li>Vildagliptin/Metformin is used to treat adult patients with type 2 diabetes.</li> <li>This form of diabetes is also known as non-insulin dependent diabetes mellitus.</li> <li>Vildagliptin/Metformin is used when the diabetes cannot be controlled with diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulphonylurea).</li> <li>Type 2 diabetes develops if the body does not produce enough insulin, or if the insulin produced by the body does not work as well as it should.</li> <li>Diabetes can also develop if the body makes too much glucagon .</li> <li>Both insulin and glucagon are made in the pancreas.</li> <li>Insulin helps to reduce blood sugar levels, especially after meals.</li> <li>Glucagon induces the production of sugar in the liver, and causes blood sugar levels to rise.</li> </ul> <p>How Vildagliptin/Metformin works:</p> <ul> <li>Both active substances, vildagliptin and metformin, help regulate blood sugar levels.</li> <li>The active substance vildagliptin works so that the pancreas produces more insulin and less glucagon .</li> <li>The active substance metformin works so that the body can better utilize insulin.</li> <li>This medicine has been shown to reduce blood sugar, which can help prevent complications of your diabetes.</li> </ul> <p><strong>How To Use:</strong></p> <ul> <li>How much Vildagliptin/Metformin a person should take depends on his/her condition.</li> <li>The doctor will tell you exactly how many tablets to take of Vildagliptin/Metformin.</li> <li>Always use this medicine exactly as your doctor has told you. Contact a doctor or pharmacist if you are unsure.</li> </ul> <p>The recommended dose is:</p> <ul> <li>One film-coated tablet of either 50 mg/850 mg or 50 mg/1000 mg twice daily.</li> <li>If you have reduced kidney function, the doctor may prescribe a lower dose.</li> <li>The doctor may also prescribe a lower dose if you are taking a medicine for diabetes called a sulfonylurea.</li> <li>The doctor may prescribe this medicine alone or together with certain other medicines that lower your blood sugar.</li> </ul> <p>When and how to take Vildagliptin/Metformin:</p> <ul> <li>Swallow the tablets whole with a glass of water</li> <li>Take one tablet in the morning and the other in the evening, with or immediately after food.</li> <li>By taking the tablet immediately after a meal, the risk of an upset stomach will be reduced.</li> <li>Continue to follow the dietary recommendations you have received from your doctor.</li> <li>If you follow a diabetic weight control diet, it is particularly important that you continue this while taking Vildagliptin/Metformin.</li> </ul> <p>If you take too much Vildagliptin/Metformin:</p> <ul> <li>Contact a doctor or pharmacist immediately if you take too many tablets of Vildagliptin/Metformin or someone else has taken your tablets.</li> <li>Medical supervision may be necessary.</li> <li>If you have to see a doctor or hospital, you must take the package and this package insert with you.</li> </ul> <p>If you have forgotten to take Vildagliptin/Metformin:</p> <ul> <li>If you forget to take a tablet, take it with your next meal unless you are going to take one anyway.</li> <li>You should not take a double dose (two tablets) to replace a forgotten tablet.</li> </ul> <p>If you stop treatment with Vildagliptin/Metformin:</p> <ul> <li>Continue to take this medicine as long as your doctor prescribes it so that it can control your blood sugar.</li> <li>You must not stop treatment with Vildagliptin/Metformin unless your doctor tells you to.</li> <li>If you have questions about how long you should use this medicine, contact your doctor.</li> <li>Ask your doctor, pharmacist or nurse if you have any questions about the use of this medicine.</li> </ul> <p><strong>Warnings And precautions:</strong></p> <p>Do not use Vildagliptin/Metformin:</p> <ul> <li>If you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine.</li> <li>Talk to your doctor before taking Vildagliptin/Metformin if you think you may be allergic to any of these substances.</li> <li>If you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea , vomiting, diarrhoea , rapid weight loss, lactic acidosis (see "risk of lactic acidosis" below) or ketoacidosis.</li> <li>Ketoacidosis is a condition where substances called ketone bodies accumulate in the blood, and this can lead to diabetic pre-coma.</li> <li>Symptoms include stomach pain, rapid and deep breathing, sleepiness or the breath taking on an unusual and fruity smell.</li> <li>If you have recently had a heart attack or you have heart failure, severe problems with blood circulation or breathing problems, which may be signs of heart problems.</li> <li>If you have severely impaired kidney function.</li> <li>If you have a serious infection or are severely dehydrated (have lost a lot of water from the body).</li> <li>If you are going to have a contrast x-ray (a special type of x-ray that involves an injectable dye).</li> <li>If you have liver problems.</li> <li>If you drink excessive amounts of alcohol (either every day or occasionally).</li> <li>If you are breastfeeding.</li> </ul> <p>Risk of lactic acidosis:</p> <ul> <li>Vildagliptin/Metformin can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly.</li> <li>The risk of developing lactic acidosis is also elevated with uncontrolled diabetes, severe infections , prolonged fasting or alcohol intake, dehydration, liver problems and any medical condition where part of the body has reduced oxygen supply (such as acute severe heart disease).</li> <li>Talk to your doctor for further information if any of the above applies to you.</li> <li>Interrupt treatment with Vildagliptin/Metformin for a short period if you have a condition that may be associated with dehydration (have lost a lot of body fluid), such as severe vomiting, diarrhea , fever , exposure to heat or if you drink less fluid than normal.</li> <li>Talk to your doctor for further information.</li> <li>Stop treatment with Vildagliptin/Metformin and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis , as this condition can lead to coma.</li> </ul> <p>Symptoms of lactic acidosis include:</p> <ul> <li>Stomach pain (abdominal pain).</li> <li>Muscle cramps.</li> <li>A general feeling of malaise with severe fatigue.</li> <li>Breathing difficulties.</li> <li>Reduced body temperature and pulse.</li> </ul> <p><strong>Ingredients:</strong></p> <ul> <li>The active Ingredients are vildagliptin and metformin hydrochloride.</li> </ul> <p>Its available with two different concentrations and different manufacturers:</p> <ul> <li>Each Vildagliptin/Metformin 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (equivalent to 660 mg metformin).</li> <li>Each Vildagliptin/Metformin 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (equivalent to 780 mg metformin).</li> </ul>