Dosage form:

• Dapagliflozin/metformin: 5 mg/850 mg film-coated tablet
• Dapagliflozin/metformin: 5 mg/1000 mg film-coated tablet

What is Glodaplus® (Dapagliflozin plus metformin) used for?

• It is used to lower blood sugar in people with type 2 diabetes.

Important notes before taking Glodaplus® (Dapagliflozin plus metformin):

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• To reduce the risk of medication toxicity, avoid taking dapagliflozin and metformin pills together when taking Glodaplas®.
• If you have type 1 diabetes. Do not use this drug to treat type 1 diabetes.
• If you have an acidic blood problem.
• If you have uncontrolled diabetes and severe hyperglycemia (a marked increase in blood sugar), and you develop symptoms such as nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis, or ketoacidosis, you should seek emergency medical attention from your doctor.
• Tell your doctor if you have a history of diabetic coma.
• If you have kidney disease or are on dialysis.
• If you have liver disease.
• Tell your doctor if you have a severe infection.
• If you have had a recent heart attack or stroke.
• If you are not able to eat or drink like normal, including before certain procedures or surgery.
• If you are having an exam or test with contrast or have had one within the past 48 hours, talk with your doctor.
• If you are taking or have recently taken drugs that suppress your immune system to treat kidney disease.
• If you are pregnant or may be pregnant. Do not take this drug if you are in the second or third trimester of pregnancy.
• If you are breast-feeding. Do not breast-feed while you take this drug.
• If you drink alcohol, consult your doctor.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Important notes while taking Glodaplus® (Dapagliflozin plus metformin):

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. This drug may need to be stopped before certain types of surgery as your doctor has told you. If this drug is stopped, your doctor will tell you when to start taking this drug again after your surgery or procedure.
• Talk with your doctor before you drink alcohol.
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Long-term treatment with metformin may lead to low vitamin B-12 levels. If you have ever had low vitamin B-12 levels, talk with your doctor.
• Too much acid in the blood or urine (ketoacidosis) has happened with this drug. This may need to be treated in the hospital and can be deadly. This can happen even when blood sugar is normal. Patients with some health problems, including diabetes or pancreas problems, have a higher risk of ketoacidosis. Check your ketones as you have been told by the doctor. Talk with the doctor.
• Severe urinary tract infections (UTIs) have happened with this drug. Sometimes, this needed to be treated in a hospital.
• Kidney problems have happened. Sometimes, these may need to be treated in the hospital or with dialysis.
• If you cannot drink liquids by mouth or if you have upset stomach, throwing up, or diarrhea that does not go away; you need to avoid getting dehydrated. Contact your doctor to find out what to do. Dehydration may lead to low blood pressure or to new or worse kidney problems.
• It is common to have stomach problems like upset stomach, throwing up, or diarrhea when you start taking this drug. If you have stomach problems later during treatment, call your doctor right away. This may be a sign of an acid health problem in the blood (lactic acidosis).
• If you are on a low-salt or salt-free diet, talk with your doctor.
• A rare but very bad infection has happened with drugs like this one. This infection may be deadly. Get medical help right away if your genitals or the area between your genitals and rectum becomes tender, red, or swollen, and you have a fever or do not feel well.
• If you are 65 or older, use this drug with care. You could have more side effects.
• There is a chance of pregnancy in people of childbearing age who have not been ovulating. If you want to avoid pregnancy, use birth control while taking this drug.
• This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.

Glodaplus® (Dapagliflozin plus metformin) side effects:

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Vaginal yeast infection. Report itching or discharge.
• Yeast infection of the penis. Report pain, swelling, rash, or discharge.
• Severe stomach pain.
• Blood test results may change, including changes in cholesterol and lipid levels, an increase in red blood cell count, and a decrease in creatinine clearance.
• Low blood sugar can happen. The chance may be raised when this drug is used with other drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do for low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea, upset stomach, or throwing up.
• Nose or throat irritation.

What do I do if I miss a dose?

Regular-release tablets:

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children.