Saxagliptin/Metformin hydrochloride 2.5 mg/1,000 mg film-coated tablets What Saxagliptin/Metformin hydrochloride is used for: This medicine is used to treat a type of diabetes called ‘type 2 diabetes Saxagliptin and metformin work together to control your blood sugar. They increase the levels of insulin after a meal. They also lower the amount of sugar made by your body. Along with diet and exercise, this helps lower your blood sugar. This medicine can be used alone or together with other antidiabetic medicines, including insulin. Do not take Saxagliptin/Metformin hydrochloride: If you are allergic to saxagliptin, metformin or any of the other ingredients of this medicine If you have had a serious allergic (hypersensitive) reaction to any other similar medications that you take to control your blood sugar. If you have these symptoms, stop taking this medicine and call your doctor or nurse right away. If you have ever had a diabetic coma If you have uncontrolled diabetes If you have severely reduced kidney function or problems with your liver If you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing which could be a sign of heart problems If you have a severe infection or are dehydrated If you are breastfeeding If you drink a large amount of alcohol Warnings & Precautions: It may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). Talk to your doctor or pharmacist before taking this medicine: If you have type 1 diabetes If you have or have had a disease of the pancreas; If you are taking insulin or an antidiabetic medicine known as ‘sulphonylurea’ If you have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood If you have a problem or take a medicine that can lower your body’s defense against infections If you have ever had heart failure or you have other risk factors for developing heart failure such as problems with your kidneys Possible Side Effects: Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using the product if you develop hives or itching of the face or body. Other medicines and Saxagliptin/Metformin hydrochloride: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage. It is especially important to mention the following: cimetidine ketoconazole bronchodilators (beta-2 agonists) which are used to treat asthma diltiazem which is used for high blood pressure rifampicin corticosteroids carbamazepine medicines which increase urine production (diuretics) medicines used to treat pain and inflammation certain medicines for the treatment of high blood pressure How to use Saxagliptin/Metformin hydrochloride: Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If your doctor prescribes this medicine together with a sulphonylurea or insulin, remember to take this other medicine as directed by your doctor to achieve the best results for your health. How much to take The amount of this medicine that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of saxagliptin and metformin. Your doctor will tell you exactly the dose of this medicine to take. The recommended dosing is one tablet twice a day. If you have reduced kidney function, your doctor may prescribe a lower dose. Take this medicine by mouth. Take with a meal to lower your chance of getting an upset stomach. How to store Saxagliptin/Metformin hydrochloride: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month. Store below 25°C. Do not use this medicine if the package is damaged or shows signs of tampering.