Product Description:

• 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

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.
• If you take more Divinusmet XR than you should
• If you take too much Divinusmet XR, call your healthcare provider or go to the nearest hospital emergency room right away.
• If you forget to take Divinusmet XR
• If you miss a dose of Divinusmet XR, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time.

Caution & Warnings:

Possible 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).

• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with dapagliflozin, one of the medicines in dapagliflozin/metformin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with dapagliflozin/metformin even if your blood sugar is less than 250 mg/dL. Stop taking dapagliflozin/metformin and call your doctor right away if you get any of the following symptoms:

1. Nausea
2. Tiredness
3. Vomiting
4. Trouble breathing
5. Stomach area (abdominal) pain

• Kidney problems. Sudden kidney injury has happened to people taking dapagliflozin/metformin.

• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin, one of the medicines in dapagliflozin/metformin. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.

• Low blood sugar (hypoglycemia). If you take dapagliflozin/metformin with another medicine that can cause low blood sugar, such as sulfonylureas or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take dapagliflozin/metformin. Signs and symptoms of low blood sugar may include:

1. Headache
2. Weakness
3. Confusion
4. Irritability
5. Shaking or feeling jittery
6. Sweating
7. Drowsiness
8. Hunger

Ingredients:

• Divinusmet® XR 5 mg/1000 mg and 10 mg/1000 mg Extendedrelease Tablets
• Dapagliflozin and Metformin hydrochloride.