Forxiga (Dapagliflozin Propanediol Monohydrate)

Serious Warnings and Precautions

Diabetic ketoacidosis (DKA), is a serious and life-threatening condition that requires urgent hospitalization. DKA has been reported in patients with type 2 diabetes mellitus (T2DM) with normal or high blood sugar levels who are treated with FORXIGA and other sodium-glucose co-transporter 2 (SGLT2) inhibitors. Some cases of DKA have led to death.

Seek medical attention right away and stop taking FORXIGA immediately if you have any of the following symptoms (even if your blood sugar levels are normal): difficulty breathing, nausea, vomiting, stomach pain, loss of appetite, confusion, feeling very thirsty, feeling unusually tired, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.

Do not use FORXIGA if you have:

• DKA or a history of DKA.
• type 1 diabetes.

BEFORE you use FORXIGA talk to your doctor or pharmacist if you:

• have type 1 diabetes (your body does not produce any insulin). FORXIGA should not be used in patients with type 1 diabetes.
• have an increased chance of developing DKA, including if you:
  • are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
  • are on a very low carbohydrate diet;
  • drink a lot of alcohol;
  • have/have had problems with your pancreas, including pancreatitis or surgery on your pancreas;
  • are hospitalized for major surgery, serious infection or serious medical illness;
  • have a history of diabetic ketoacidosis (DKA).
• are older than 65 years of age
• have or have had any kidney problems
• have or have had any cases of liver disease
• have heart disease or low blood pressure
• are taking a medicine for high blood pressure or taking a water pill (used to remove excess water from the body)
• are taking medicines to lower your blood sugar such as glyburide, gliclazide or glimepiride (sulfonylureas) or insulin. Taking FORXIGA with any of these medicines can increase the risk of having low blood sugar (hypoglycemia)
• have a history of bladder cancer
• have intolerance to some milk sugars. FORXIGA tablets contain lactose
• often get urinary tract infections

FORXIGA is not recommended for use in patients under 18 years of age.

FORXIGA will cause your urine to test positive for sugar (glucose).

FORXIGA may cause changes in the amount of cholesterol or fats in your blood.

FORXIGA increases the chance of getting a yeast infection of the penis or vagina. This is more likely in people who have had yeast infections in the past.

FORXIGA may cause abnormal kidney function. Your doctor will do blood tests to monitor how well your kidneys are working while you are taking FORXIGA.

Driving and using machines:

FORXIGA may cause dizziness or lightheadedness. Do not drive or use machines until you know how the medicine affects you.

These are not all the possible side effects you may feel when taking FORXIGA. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• sore throat
• influenza
• constipation
• diarrhea
• nausea
• back pain
• pain in the arms, legs, hands or feet
• headache

If any of these affects you severely, tell your doctor or pharmacist.

FORXIGA can cause abnormal blood test results. Your doctor will decide when to perform blood tests. They may check kidney function, blood fat levels (Low Density Lipoprotein cholesterol or LDL-C) and amount of red blood cells in your blood (hematocrit).

Diabetic Ketoacidosis (DKA) is a serious medical condition normally seen at high blood sugar levels; however, it has also been seen at near normal blood sugar levels. Get medical help right away if you have any of the symptoms in the table below under DKA, even if your blood sugar levels are normal.

Talk to your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Drugs that may interact with FORXIGA include

• medicines you take for diabetes, especially sulfonylurea medications or insulin. Low blood sugar (hypoglycemia) may occur if you already take another medication to treat diabetes. Discuss with doctor how much of each medicine to take.

Recommended adult starting dose: one 5 mg tablet a day. Your doctor may increase your dose to one 10mg tablet, if needed to further control your blood sugar level.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose of FORXIGA, take it as soon as you remember. If you do not remember until it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose.