XIGDUO XR contains 2 prescription medicines called dapagliflozin (FARXIGA) and metformin
HCl (GLUCOPHAGE). XIGDUO XR is used in adults with type 2 diabetes mellitus:
o to improve blood sugar (glucose) control along with diet and exercise
o who have known cardiovascular disease or multiple cardiovascular risk factors and
dapagliflozin is needed to reduce the risk of hospitalization for heart failure
o 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.
o 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.
 XIGDUO XR is not for people with type 1 diabetes. XIGDUO XR may increase the risk of diabetic
ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes.
 XIGDUO XR is only for use in adults with type 2 diabetes mellitus, because it contains the
prescription medicine metformin HCl.
 XIGDUO XR is not for use for treatment of chronic kidney disease in people with certain genetic
forms of polycystic kidney disease, or who are taking or have recently received
immunosuppressive therapy to treat kidney disease. If you have these conditions, XIGDUO XR is
not expected to work for treatment of chronic kidney disease.
It is not known if XIGDUO XR is safe and effective in children younger than 18 years of age.

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.

•        have a history of urinary tract infections or problems urinating

•        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

•        Are going to get an injection of dye or contrast agents for an x-ray procedure. XIGDUO XR will need to be stopped for a short time. Talk to your healthcare provider about when you should stop XIGDUO XR and when you should start XIGDUO XR again. See “What is the most important information I should know about XIGDUO XR?

•        Are going to have surgery and will not be able to eat or drink much. XIGDUO XR will need to be stopped for a short time. Talk to your healthcare provider about when you should stop XIGDUO

XR and when you should start XIGDUO XR again. See “What is the most important information

I should know about XIGDUO XR?”

Using other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines.

This includes medicines that you buy without a prescription.

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)

Ask your healthcare provider for a list of these medicines if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of them and show it to you healthcare provider and pharmacist when you get a new medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should stop taking this medicine if you become pregnant, since it is not recommended during the second and third trimesters (the last six months) of pregnancy. Talk to your doctor about the best way to control your blood sugar while you are pregnant.

Talk to your doctor if you would like to or are breast-feeding before taking this medicine. You should not use this medicine if you are breast-feeding. It is not known if this medicine passes into human breast milk.

Taking XIGDUO XR with food and drink Take your tablet with food.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. Taking it with other medicines that lower the amount of sugar in your blood, such as insulin or a “sulphonylurea” medicine, can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as weakness, dizziness, increased sweating, fast heartbeat, change in vision or difficulties concentrating, and may affect your ability to drive and use machines. Do not drive or use any tools or machines, if you start to feel these symptoms.

Take XIGDUO XR exactly as your healthcare provider tells you to take it. You should check with your doctor or pharmacist if you are not sure.

•        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.

•        Stay on your prescribed diet and exercise program while taking XIGDUO XR.

•        XIGDUO XR will cause your urine to test positive for glucose.

•        Your healthcare provider may do certain blood tests before you start XIGDUO 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 (hypoglycaemia). Talk to your healthcare provider if low blood sugar is a problem for you.

If you take XIGDUO XR more than you should, call your healthcare provider or go to the nearest hospital emergency room right away.

If you forget to take XIGDUO 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. Do not take 2 tablets of XIGDUO XR at the same time unless your healthcare provider tells you to do so.

What should I avoid while taking XIGDUO XR?

•        Avoid drinking alcohol very often, or drinking a lot of alcohol in a short period of time (“binge” drinking). It can increase your chances of getting serious side effects.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

You have a higher chance of getting lactic acidosis with XIGDUO XR if you:

-      have kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye.  People whose kidneys are not working properly should not take XIGDUO XR.

-      have liver problems

-      have congestive heart failure that requires treatment with medicines

-      drink alcohol very often or drink a lot of alcohol in short-term “binge” drinking

-      get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhoea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.  

-      have surgery

-      have a heart attack, severe infection, or stroke

-      are 80 years of age or older and have not had your kidneys tested

•        dehydration. XIGDUO XR can cause some people to have dehydration (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). 

You may be at a higher risk of dehydration if you:

-      have low blood pressure

-      take medicines to lower your blood pressure, including water pills (diuretics)

-      are 65 years of age or older

-      are on a low salt diet

-      have kidney problems

•        low blood sugar (hypoglycaemia). If you take XIGDUO XR 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 XIGDUO XR. Signs and symptoms of low blood sugar may include: 

•        headache

•        weakness

•        confusion

•        shaking or feeling jittery

•        drowsiness

•        dizziness

•        irritability

•        sweating

•        hunger

•        fast heartbeat

•        kidney problems

•        low vitamin B₁₂ (vitamin B₁₂ deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B₁₂ in your blood, especially if you have had low vitamin B₁₂ levels before. Your healthcare provider may do blood tests to check your vitamin B₁₂ levels.

•        vaginal yeast infection. Women who take XIGDUO XR may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:

-      vaginal odour

-      white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)

-      vaginal itching

•        yeast infection of the penis (balanitis). Men who take XIGDUO XR may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:

-      redness, itching, or swelling of the penis

-      rash of the penis

-      foul smelling discharge from the penis

-      pain in the skin around the penis

•        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 XIGDUO XR. 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your health care provider or pharmacist. 

-      Keep XIGDUO XR and all medicines out of the reach and sight of children.

-      Store XIGDUO XR below 30°C. 

-      Do not use this medicine after the expiry date, which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.

-      Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.