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XIGDUO XR contains 2 prescription medicines called dapagliflozin (FARXIGA) and metformin HCl (GLUCOPHAGE). XIGDUO XR is used in adults with type 2 diabetes mellitus: To improve blood sugar (glucose) control along with diet and exercise Who have known cardiovascular disease or multiple cardiovascular risk factors and dapagliflozin is needed to reduce the risk of hospitalization for heart failure Who have heart failure (when the heart is weak and cannot pump enough blood to the rest of your body) and dapagliflozin is needed to reduce the risk of cardiovascular death and hospitalization for heart failure. To reduce the risk of further worsening of your kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease. How to use Do not change your dose of XIGDUO XR without talking to your healthcare provider. Take XIGDUO XR by mouth 1 time each day with meals to lower your chance of an upset stomach. Talk to your healthcare provider about the best time of day for you. Swallow XIGDUO XR whole. Do not crush, cut, or chew XIGDUO XR. You may sometimes pass a soft mass in your stools (bowel movement) that looks like XIGDUO XR tablets. When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider’s instructions. Warnings and precautions Do not take XIGDUO XR if: Have moderate to severe kidney problems or are on dialysis. Are allergic to dapagliflozin, metformin HCl, or any of the ingredients in XIGDUO XR. (See section 6) Symptoms of a serious allergic reaction to XIGDUO XR may include: - skin rash - raised red patches on your skin (hives) - swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing If you have any of these symptoms, stop taking XIGDUO XR and contact your healthcare provider or go to the nearest hospital emergency room right away. Have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine) Take special care with XIGDUO XR: Check with your doctor or pharmacist before taking XIGDUO XR if you: Have type 1 diabetes or have had diabetic ketoacidosis Have kidney problems Have liver problems Have heart problems, including congestive heart failure Drink alcohol very often or drink a lot of alcohol in short-term (‘‘binge’’ drinking). Are pregnant or plan to become pregnant. XIGDUO XR may harm your unborn baby. If you are pregnant or plan to become pregnant, talk to your healthcare provider about the best way to control your blood sugar. Are breastfeeding or plan to breastfeed. It is not known if XIGDUO XR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking XIGDUO XR. Side Effects The most common side effects of XIGDUO XR include: Vaginal yeast infections and yeast infections of the penis Stuffy or runny nose and sore throat Urinary tract infections Diarrhoea Headache Other serious side effects include: Lactic Acidosis. Metformin HCl, 1 of the medicines in XIGDUO XR, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital Stop taking XIGDUO XR and call your healthcare provider right away if you have any of the following symptoms which could be signs of lactic acidosis: You feel very weak or tired You have unusual (not normal) muscle pain You have trouble breathing You have unusual sleepiness or sleep longer than usual You have stomach pains, nausea, or vomiting You feel dizzy or lightheaded You have a slow or irregular heartbeat Storage Information Store XIGDUO XR below 30°C. Drug Interactions XIGDUO XR may affect the way other medicines work and other medicines may affect the way XIGDUO XR works. Especially tell your healthcare provider if you take: Water pills (diuretics) Rifampin (used to treat or prevent tuberculosis) Phenytoin (used to control seizures) Digoxin (used to treat heart problems) Ingredients Active ingredients: dapagliflozin and metformin hydrochloride
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