IMPORTANT: PLEASE READ

• have diabetic ketoacidosis (DKA, a complication of

diabetes) or a history of DKA.
• have a history of too much acid in the blood (lactic
acidosis).
PART III: • have or ever had kidney or liver problems.
CONSUMER INFORMATION • consume large amounts of alcohol all the time or short-
term ‘binge’.
•
XIGDUO® •
have heart failure or other severe heart problems.
are stressed, have a serious infection, have recently had a
dapagliflozin and metformin hydrochloride tablets trauma, are about to have surgery or are recovering from
(as dapagliflozin propanediol monohydrate and surgery.
metformin hydrochloride) • are dehydrated (have lost a lot of water from your body).
• are allergic (hypersensitive) to dapagliflozin, metformin
Read this carefully before you start taking XIGDUO and hydrochloride or any of the ingredients listed below.
each time you get a refill. This leaflet is a summary and • are pregnant or planning to become pregnant; it is not
will not tell you everything about this drug. Talk to your known if XIGDUO will harm your unborn baby. Talk to
healthcare professional about your medical condition and your doctor about the best way to control your blood sugar
treatment and ask if there is any new information about while you are pregnant.
XIGDUO. • are breast-feeding or plan to breast-feed; it is not known if
XIGDUO will pass into your breast milk. Talk to your
ABOUT THIS MEDICATION doctor if you would like to breast feed.
• will have certain x-ray tests with injectable dyes or
What the medication is used for: contrast agents. Talk to your physician or pharmacist
XIGDUO is used along with diet and exercise in adults with about when to stop XIGDUO and when to start again.
type 2 diabetes to help control their blood sugar levels.
XIGDUO can be used: What the medicinal ingredients are:
XIGDUO contains dapagliflozin (as dapagliflozin propanediol
• in patients taking dapagliflozin (FORXIGA®) and monohydrate) and metformin hydrochloride.
metformin as separate tablets, or
• in patients taking dapagliflozin (FORXIGA®), What the nonmedicinal ingredients are:
metformin and a sulfonylurea as separate tablets, or cellulose microcrystalline, hydroxypropylcellulose, magnesium
• in patients taking dapagliflozin (FORXIGA®), stearate (extragranular) and sodium starch glycolate. In addition,
metformin and sitagliptin as separate tablets, or the film coating contains the following inactive ingredients:
polyvinyl alcohol, macrogol/polyethylene glycol, talc, titanium
• in patients taking dapagliflozin (FORXIGA®),
dioxide, yellow iron oxide and/or red iron oxide.
metformin and insulin.
What dosage forms it comes in:
What it does:
XIGDUO is supplied as tablets containing
XIGDUO contains dapagliflozin and metformin
dapagliflozin/metformin hydrochloride 5 mg/850 mg or 5
hydrochloride.
mg/1000 mg.
Dapagliflozin removes excess sugar from the body through
WARNINGS AND PRECAUTIONS
the urine.

Metformin helps your body respond better to the insulin it Serious Warnings and Precautions
makes naturally. It helps to lower the amount of sugar made
by the liver and lower the amount of sugar moved from the • XIGDUO contains metformin and it can rarely cause a
gut into the blood. serious condition that can cause death called lactic
acidosis. Alcohol may increase the risk of lactic acidosis.
When it should not be used: Do not drink a lot of alcohol while taking XIGDUO (see
Do not take XIGDUO if you: Lactic Acidosis section below).
• Diabetic ketoacidosis (DKA) is a serious and life-
• have unstable and/or insulin-dependent (Type I) threatening condition that requires urgent
diabetes mellitus. hospitalization. DKA has been reported in patients with
• have increased ketones in the blood or urine type 2 diabetes mellitus (T2DM) with normal or high
(metabolic acidosis) or have had ketoacidosis with or blood sugar levels, who are treated with dapagliflozin
without coma. and other sodium-glucose co-transporter 2 (SGLT2)
inhibitors. Some cases of DKA have led to death.
Page 1 of 5
 IMPORTANT: PLEASE READ

• Seek medical attention right away and stop taking • have a problem with your adrenal glands (found on top of
XIGDUO immediately if you have any of the following your kidneys) or pituitary gland (found in your brain).
symptoms (even if your blood sugar levels are normal): • will be having surgery.
difficulty breathing, nausea, vomiting, stomach pain, • have had a heart attack, severe infection, or stroke.
loss of appetite, confusion, feeling very thirsty, feeling • feel very weak and tired.
unusually tired, a sweet smell to the breath, a sweet or • are 80 years of age or older and have not had your kidney
metallic taste in the mouth, or a different odour to urine function tested.
or sweat. • have low B12 levels.
• Do not use XIGDUO if you have: • have had an allergic reaction to SGLT2 inhibitors (used to
• DKA or a history of DKA treat Type 2 diabetes).
• type 1 diabetes • often get urinary tract infections.

Lactic Acidosis XIGDUO is not recommended for use in patients under 18 years
Stop taking XIGDUO and tell your doctor if you get the of age.
following symptoms of lactic acidosis:
• You feel very weak and tired. XIGDUO will cause your urine to test positive for sugar
• You have unusual (not normal) muscle pain. (glucose).
• You have trouble breathing or fast breathing.
• You have stomach pain with nausea and vomiting, or XIGDUO may cause changes in the amount of cholesterol or fats
diarrhea. in your blood.
• You feel cold, especially in your arms and legs.
• You feel dizzy or lightheaded. XIGDUO increases the chance of getting a yeast infection of the
• You feel unusual fatigue and drowsiness. penis or vagina. This is more likely in people who have had yeast
• You have a slow or irregular heart beat. infections in the past.
• Your medical condition suddenly changes.
XIGDUO may cause abnormal kidney function. Your doctor will
• You develop or experience a worsening of heart
do blood tests to monitor how well your kidneys are working
problems and particularly heart failure.
while you are taking XIGDUO.
BEFORE you use XIGDUO talk to your doctor or pharmacist
XIGDUO may cause necrotizing fasciitis of the perineum (area
if you:
between and around the anus and genitals). This is a rare but
serious and potentially life-threatening infection that can affect
• have type 1 diabetes (your body does not produce any
both men and women. It is also known as Fournier’s gangrene
insulin). XIGDUO should not be used in patients with
and requires urgent treatment. If you experience tenderness,
type 1 diabetes.
redness or swelling of the genitals or the area from the genitals to
• have an increased chance of developing DKA, the rectum, especially if you also have a fever or are feeling very
including if you: weak, tired, or uncomfortable, seek medical attention
o are dehydrated or suffer from excessive immediately. These may be signs of Fournier’s gangrene.
vomiting, diarrhea, or sweating;
o are on a very low carbohydrate diet; Driving and using machines: XIGDUO may cause dizziness or
o drink a lot of alcohol; lightheadedness. Do not drive or use machines until you know
o have/have had problems with your pancreas, how the medicine affects you.
including pancreatitis or surgery on your
pancreas;
INTERACTIONS WITH THIS MEDICATION
o are hospitalized for major surgery, serious
infection or serious medical illnesses;
Talk to your healthcare professional about all the medicines you
o have a history of diabetic ketoacidosis (DKA).
take, including any drugs, vitamins, minerals, natural
• are older than 65 years of age. supplements or alternative medicines.
• have heart problems or low blood pressure.
• are taking medicines for high blood pressure or taking Some drugs may interact with XIGDUO. Tell your doctor if you
a water pill (used to remove excess water from the are taking:
body). • Medicines for diabetes; low blood sugar (hypoglycemia)
• are taking medicines to lower blood sugar such as may occur if you already take another medication to treat
glyburide, gliclazide or glimepiride (sulfonylureas) or diabetes.
insulin. Taking XIGDUO with any of these • Nifedipine (used to treat high blood pressure and chest
medications can increase the risk of having low blood pain).
sugar (hypoglycemia).

Page 2 of 5
 IMPORTANT: PLEASE READ

• Cationic drugs (e.g. amiloride, digoxin, morphine,

procainamide, quinidine, quinine, ranitidine, Side effects may include:
triamterene, trimethoprim and vancomycin). • sore throat
• Certain “blood thinners” (phenprocoumon or other • the flu
Vitamin K anticoagulants). • constipation
• Diuretics (water pills), especially loop diuretics, that • diarrhea
may increase the risk of lactic acidosis (e.g. • nausea
furosemide). • back pain
• Other drugs that tend to produce high blood sugar • pain in the arms, legs, hands or feet
(hyperglycemia) and may lead to a loss of blood sugar • headache
control. Some examples of drugs that can increase the • rash
blood sugar include:
• Thiazide and other diuretics (water pills) If any of these affects you severely, tell your doctor or
• Corticosteroids (used to treat joint pain and pharmacist.
swelling)
• Phenothiazines (used to treat schizophrenia) XIGDUO can cause abnormal blood test results. Your doctor will
• Thyroid products decide when to perform blood tests. They may check how well
• Estrogens or estrogens plus progestogen your kidneys are working, blood fat levels (cholesterol) and the
• Oral contraceptives (birth control pills) amount of red blood cells in your blood (hematocrit).
• Phenytoin (used to treat epilepsy)
• Nicotinic Acid Diabetic Ketoacidosis (DKA) is a serious medical condition
• Sympathomimetics (used for heart problems) normally seen at high blood sugar levels; however it has also been
• Calcium channel blocking drugs (used for high seen at near normal blood sugar levels. Get medical help right
blood pressure) away if you have any of the symptoms under DKA in the table
• Isoniazid (used to treat tuberculosis) below, even if your blood sugar levels are normal.
• Beta-2-agonists (used to treat breathing
problems) SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
• ACE inhibitor drugs (may lower blood glucose).
Frequency / Symptom / Effect Talk with
PROPER USE OF THIS MEDICATION your doctor Get
or pharmacist immediate
Follow the directions given to you by your doctor. Your Only In medical
if all help
doctor will tell you how many XIGDUO tablets to take and
severe cases
how often you need to take them. Urinary tract X
infection: pain,
USUAL ADULT DOSE: difficulty or
The recommended adult dose is one tablet (5 mg/850 mg or increased need to
5 mg/1000 mg), twice daily, taken with a meal. urinate
Yeast infection X
Common

OVERDOSE: of vagina:
severe itching,
In case of drug overdose, contact a health care practitioner, burning,
hospital emergency department or regional Poison Control soreness,
Centre immediately, even if there are no symptoms. irritation, and a
whitish or
whitish-gray
MISSED DOSE:
cottage cheese-
If you miss a dose of XIGDUO, wait for the next dose at the like discharge
usual time. Do not take a double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT

THEM

These are not all the possible side effects you may feel when
taking XIGDUO. If you experience any side effects not listed
here, contact your healthcare professional. Please also see
Warnings and Precautions.

Page 3 of 5
 IMPORTANT: PLEASE READ

SERIOUS SIDE EFFECTS, HOW OFTEN THEY SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM HAPPEN AND WHAT TO DO ABOUT THEM
Frequency / Symptom / Effect Talk with Frequency / Symptom / Effect Talk with
your doctor Get your doctor Get
or pharmacist immediate or pharmacist immediate
Only In medical Only In medical
if all help if all help
severe cases severe cases
Yeast infection X Lactic acidosis: X
of penis: Symptoms
red, swollen, include
itchy head of • feeling very
penis; thick, weak, tired
lumpy discharge or
under foreskin; uncomfort-
unpleasant odour; able
difficulty • unusual
retracting muscle pain
foreskin; pain • trouble
passing urine or breathing
during sex • unusual or
Volume X unexpected
depletion (loss stomach
of needed fluids discomfort
Uncommon

from the body; • feeling cold

dehydration): • feeling
dry or sticky dizzy or
mouth, headache, lightheaded
dizziness or • unusual
urinating less fatigue and
often than normal drowsiness
Low blood X • suddenly
pressure: develop a
dizziness, slow or
fainting,
Rare

irregular
lightheadedness; heartbeat
may occur when
Diabetic X
you go from
ketoacidosis
Uncommon

lying to sitting to
(DKA):
standing up
difficulty
Low blood X breathing,
sugar nausea, vomiting,
(hypoglycemia): stomach pain,
shaking, loss of appetite,
sweating, rapid confusion,
heartbeat, change feeling very
in vision, hunger, thirsty, feeling
headache and unusual
change in mood tiredness, a sweet
smell to the
breath, a sweet or
metallic taste in
the mouth or a
different odour to
urine or sweat.
Kidney X
problems: any
change in the
amount,
frequency or
colour (pale or
dark) of urine

Page 4 of 5
 IMPORTANT: PLEASE READ

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM This is not a complete list of side effects. For any unexpected
effects while taking XIGDUO, contact your doctor or
Frequency / Symptom / Effect Talk with
your doctor Get
pharmacist.
or pharmacist immediate
Only In medical Reporting Side Effects
if all help
severe cases You can report any suspected side effects associated with
Fournier’s X the use of health products to Health Canada by:
gangrene (a • Visiting the Web page on Adverse Reaction
serious infection Reporting (https://www.canada.ca/en/health-
affecting soft
canada/services/drugs-health-products/medeffect-
tissue around
the groin): pain canada/adverse-reaction-reporting.html) for
or tenderness, information on how to report online, by mail or by
fax; or
Rare

redness of the
skin, or swelling • Calling toll-free at 1-866-234-2345.
in the genital or
perineal area, NOTE: Contact your health professional if you need
with or without information about how to manage your side effects. The
fever or feeling
Canada Vigilance Program does not provide medical
very weak, tired,
or uncomfortable
advice.

Acute kidney X
infection: HOW TO STORE IT
painful,
urgent or Store at room temperature (15 to 30°C).
frequent
urination, lower Keep XIGDUO out of the reach and sight of children.
back (flank) pain,
fever or chills,
cloudy or foul MORE INFORMATION
smelling urine,
blood in your NOTE: This Consumer Information Leaflet provides you with the
urine most current information at the time of printing.
Severe infection X
that spreads The most current information, the Consumer Information Leaflet
from plus the full Product Monograph, prepared for health
urinary tract
professionals can be found at: http://www.astrazeneca.ca or by
throughout
body contacting the sponsor, AstraZeneca Canada Inc. at:
Very Rare

(sepsis): fever or Customer Inquiries 1-800-668-6000,

low body Renseignements 1-800-461-3787.
temperature,
chills, This leaflet was prepared by:
rapid breathing, AstraZeneca Canada Inc. Mississauga, Ontario L4Y 1M4
rapid
heartbeat, pain XIGDUO® and the AstraZeneca logo are registered trademarks
with
of AstraZeneca AB, used under license by AstraZeneca Canada
urination,
difficulty Inc.
urinating, ©AstraZeneca 2015 - 2020
frequent
urination Last revised: April 21, 2020
Inflammation of X
the pancreas
(pancreatitis):
severe stomach
pain that gets
worse when you
lie down, nausea,
vomiting

Page 5 of 5