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Divinusmet XR contains 2 prescription medicines called dapagliflozin and metformin HCl. Divinusmet XR is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes when treatment with either dapagliflozin or metformin has not controlled your blood sugar. Divinusmet XR is not for people with type 1 diabetes. Divinusmet XR is not for people with diabetic ketoacidosis (increased ketones in your blood or urine). It is not known if dapagliflozin/metformin is safe and effective in children younger than 18 years of age. How to use Take Divinusmet XR exactly as your healthcare provider tells you to take it. Do not change your dose of Divinusmet XR without talking to your healthcare provider. Take Divinusmet 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 Divinusmet XR whole. Do not crush, cut, or chew Divinusmet XR. You may sometimes pass a soft mass in your stools (bowel movement) that looks like Divinusmet 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. Stay on your prescribed diet and exercise program while taking Divinusmet XR. Your healthcare provider may do certain blood tests before you start Divinusmet XR and during your treatment. Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your A1C. Follow your healthcare provider’s instructions for treating low blood sugar (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you. Warnings and precautions Do not take Divinusmet XR if you Have moderate to severe kidney problems or are on dialysis Are allergic to dapagliflozin, metformin HCl, or any of the ingredients in Divinusmet XR. See the end of this package leaflet for a list of ingredients in Divinusmet XR. Symptoms of a serious allergic reaction to Divinusmet 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 Divinusmet 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). Warnings and Precautions Before you take Divinusmet XR, tell your healthcare provider if you: Have type 1 diabetes or have had diabetic ketoacidosis Have moderate to severe kidney problems Have liver problems Have a history of urinary tract infections or problems urinating Have heart problems, including congestive heart failure Are going to have surgery Are eating less due to illness, surgery or a change in your diet Have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas Drink alcohol very often, or drink a lot of alcohol in the short-term (“binge” drinking) Are going to get an injection of dye or contrast agents for an x-ray procedure. Divinusmet XR may need to be stopped for a short time. Have or have had bladder cancer Side Effects Dapagliflozin/metformin may cause serious side effects including: Dehydration. Dapagliflozin/metformin can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). The most common side effects of dapagliflozin/metformin include: Vaginal yeast infections and yeast infections of the penis Stuffy or runny nose and sore throat Diarrhea Nausea and vomiting Headache Storage Information Do not store above 30°C. Store in the original package. The shelf life after first opening is 1 month. Drug Interactions Divinusmet XR may affect the way other medicines work and other medicines may affect the way Divinusmet XR works. Especially tell your healthcare provider if you take: Water pills (diuretics) Rifampin (used to treat or prevent tuberculosis) Phenytoin or phenobarbital (used to control seizures) Ritonavir (used to treat HIV infections) Digoxin (used to treat heart problems) Ingredients The active substances are dapagliflozin and metformin hydrochloride.
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