Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking XIGDUO XR?
XIGDUO XR contains two active ingredients, dapagliflozin and metformin hydrochloride.
XIGDUO XR is used to lower blood sugar in people with type 2 diabetes mellitus. It
can also reduce hospitalisation for heart failure in patients with type 2 diabetes.
2. What should I know before I take XIGDUO XR?
Do not use if you have ever had an allergic reaction to dapagliflozin or metformin
hydrochloride, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How do I take XIGDUO XR?
Your Doctor will tell you how many XIGDUO XR tablets to take and how often you should
take them.
XIGDUO XR should be taken with or immediately after food in the evening. Swallow tablet
whole with a full glass of water.
5. What should I know while taking XIGDUO XR?
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Things you should do
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Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia (low blood sugar) and hyperglycaemia (high blood sugar) and know
how to treat them.
Talk to your doctor if you are about to have surgery (including dental surgery), an
X-ray or scan requiring an injection of iodinated contrast (dye) to discuss when to
stop and start taking it again.
Remind any doctor, dentist or pharmacist you visit that you are taking XIGDUO XR.
If you become pregnant while taking XIGDUO XR, tell your doctor immediately.
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Things you should not do
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Do not stop taking your medicine or change the dosage without checking with your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how XIGDUO
XR affects you
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your XIGDUO XR tablets in the blister until it is time to take them.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
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6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, some can
be minor and temporary. However, some side effects may be serious and could require
urgent medical attention or hospitalisation. See Section
6. Are there any side effects? in the full CMI and, if you need to, ask your doctor if you have any further questions
about side effects. Tell your doctor if you experience any side effects, including
those not listed in this leaflet.
Active ingredient(s): dapagliflozin/metformin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking XIGDUO XR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking XIGDUO XR.
Where to find information in this leaflet:
1. Why am I taking XIGDUO XR?
XIGDUO XR contains two active ingredients dapagliflozin and metformin hydrochloride. Dapagliflozin is a member of a class of medicines you take by mouth called SGLT-2
(Sodium Glucose Cotransporter-2) inhibitors and metformin belongs to a class of medicines
called biguanides.
XIGDUO XR is used with diet, exercise and sometimes other medicines such as insulin,
a sulfonylurea, or a dipeptidyl peptidase (DPP-4) inhibitor, or a glucagon like peptide
1 (GLP-1) receptor agonist such as exenatide to control the levels of blood sugar
(glucose) in patients with type 2 diabetes mellitus. It can also reduce hospitalisation
for heart failure in patients with type 2 diabetes.
Type 2 diabetes mellitus
Type 2 diabetes mellitus (also called non-insulin-dependent diabetes mellitus, or
NIDDM) is the condition of having high levels of blood sugar (hyperglycaemia). This
is usually because your body does not make enough insulin and /or the insulin that
your body produces does not work as well as it should. Left uncontrolled, the build-up
of high levels of sugar in your blood can lead to serious medical problems.
The main goal of treating type 2 diabetes is to control your blood sugar to a normal
level. Lowering and controlling blood sugar may help prevent or delay complications
of diabetes, which include kidney disease, blindness and amputation.
2. What should I know before I take XIGDUO XR?
Warnings
Do not take XIGDUO XR if you:
are allergic to dapagliflozin or metformin hydrochloride, or any of the ingredients
listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin or
you may feel faint
Always check the ingredients to make sure you can take this medicine.
have type 1 diabetes mellitus that is well controlled by insulin alone
have type 2 diabetes that is already well controlled by diet alone
have any type of metabolic acidosis such as lactic acidosis or diabetic ketoacidosis.
Symptoms of lactic acidosis may include feeling weak and tired, unusual muscle pain,
trouble breathing, stomach pain with nausea and vomiting or diarrhoea, feeling cold
specially in arms or legs, felling dizzy or light-headed, having slow or irregular
heart beat or your medical condition suddenly changes. Diabetic ketoacidosis is a
symptom of uncontrolled diabetes, in which substances called ketone bodies build up
in the blood. You may notice this as rapid weight loss, feeling sick or being sick,
stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness
or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth,
or a different odour to your urine or sweat).
have had a diabetic pre-coma
have problems with your liver
drink excessive alcohol, binge drinking, alcohol dependence
have poorly functioning kidneys, severe kidney disease or kidney failure
have dehydration, severe blood loss, shock
have a severe infection
have certain heart or blood vessel problems, including a recent heart attack or severe
heart failure (when the heart fails to pump blood effectively)
have severe breathing difficulties
have blood clots in the lungs (symptoms include coughing, shortness of breath, chest
pain and a fast heart rate)
have gangrene
have inflammation of the pancreas (pancreatitis), symptoms include severe upper stomach
pain, often with nausea and vomiting.
Talk to your doctor about when to stop taking XIGDUO XR and when to start taking it
again if you:
are going to have an X-ray or scan where you will be injected with an iodinated contrast
(dye)
are planning to have surgery (including where the use of insulin is essential).
XIGDUO XR contains dapagliflozin and metformin. If you have more than one medicine
containing dapagliflozin or metformin in your possession, you may accidentally take
too much (overdose). Accidentally taking too much metformin can cause a very serious
side effect called lactic acidosis.
ACCIDENTAL METFORMIN OVERDOSING IS A SIGNIFICANT SAFETY RISK.
Ask your doctor or pharmacist if you are unsure if you have any other medicines containing
metformin.
Metformin is sold under many different brand names in Australia. Your doctor or pharmacist
will know which other medicines also contain metformin.
Check with your doctor if you:
have any allergies to any other medicines, foods, dyes or preservatives.
Have or have had any other medical conditions:
kidney, liver or pancreas problems
heart failure
frequently get genital or urinary tract infections (infections of the bladder, kidney,
or tubes that carry urine)
an illness that will make you dehydrated such as diarrhoea or a severe infection.
drink alcohol
take any medicines for any other condition
are lactose intolerant. XIGDUO XR tablets contain lactose.
Your doctor will do some tests for kidney function at the start of treatment and regularly
while you are on treatment.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take XIGDUO XR if you are pregnant or plan to become pregnant.
Tell your doctor if you are pregnant or intend to become pregnant.
The safety of XIGDUO XR in pregnant women has not been established. Insulin is more
suitable for controlling blood glucose during pregnancy. Your doctor will replace
XIGDUO XR with insulin while you are pregnant.
Do not take XIGDUO XR if you are breastfeeding.
Tell your doctor if you are breastfeeding or plan to breastfeed.
XIGDUO XR is not recommended while you are breastfeeding. Your doctor will discuss
the options available to you.
Children
XIGDUO XR is not recommended for use in children.
It has not been studies in children younger than 18 years old.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Discard any other medicines containing dapagliflozin or metformin that your doctor
might have prescribed to you in the past and that you may still have in your possession.
XIGDUO XR contains dapagliflozin and metformin. If you have more than one medicine
containing dapagliflozin or metformin in your possession, you may accidentally take
too much (overdose).
XIGDUO XR may affect how well other medicines work and some medicines can affect how
well XIGDUO XR works. These include:
other medicines used to treat diabetes
medicines that contain alcohol, such as cough and cold syrups
tetracosactrin, a medicine used in people with multiple sclerosis, and in young children
to treat some types of seizures (fits)
danazol, a medicine used to treat endometriosis
some medicines used to treat high blood pressure and some heart conditions, including
beta-blockers, calcium channel blockers and ACE inhibitors
medicines used to prevent blood clots, such as warfarin
diuretics, also called fluid tablets
chlorpromazine, a medicine used to treat schizophrenia and other mental illnesses
NSAIDs (non-steroidal anti-inflammatory drugs), medicines used to relieve pain, swelling
and other symptoms of inflammation, such as aspirin, diclofenac, ibuprofen, meloxicam,
naproxen or piroxicam
cimetidine, a medicine used to treat reflux and ulcers
corticosteroids such as prednisone or cortisone
some medicines used to treat asthma such as salbutamol or terbutaline
lithium, a medicine to treat and prevent mental illness, including mania or depression
in a condition called bipolar disorder
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect XIGDUO XR.
4. How do I take XIGDUO XR?
How to take XIGDUO XR
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.
Swallow your XIGDUO XR tablet whole with a full glass of water.
XIGDUO XR tablets must not be chewed or crushed.
How much to take
Your Doctor will tell you how many XIGDUO XR tablets to take and how often you should
take them.
The dose varies from person to person. Your doctor will decide the right dose for
you.
Your doctor may prescribe XIGDUO XR along with certain other medicines that lower
blood sugar.
When to take XIGDUO XR
XIGDUO XR should be taken with or immediately after food in the evening. This will reduce the chance of a stomach upset.
XIGDUO XR should be taken at approximately the same time each day. Taking your tablets at the same time each day will have the best effect. It will also
help you remember when to take the tablets.
How long to take
Continue taking your medicine for as long as your doctor tells you. Make sure you keep enough XIGDUO XR to last over weekends and holidays.
XIGDUO XR helps control your condition, but does not cure it. Therefore, you must
take XIGDUO XR every day.
If you forget to use XIGDUO XR
XIGDUO XR should be taken regularly at the same time each day. If you miss your dose
at the usual time take it as soon as you remember, and then go back to taking your
medicine as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much XIGDUO XR
If you think that you have used too much XIGDUO XR, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking XIGDUO XR?
Things you should do
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are taking XIGDUO XR.
Talk to your doctor if you are having surgery (including dental surgery) or an X-ray
or scan where you will be injected with a iodinated contrast (dye) to discuss when
to stop taking XIGDUO XR and when to start taking it again.
If you become pregnant while taking XIGDUO XR, tell your doctor immediately.
If you need to have any medical tests while you are taking XIGDUO XR, tell your doctor.
XIGDUO XR may affect the results of some tests.
Keep all of you doctor's appointments so that your progress can be checked.
Like for all patients with diabetes it is important to check your feet regularly and
adhere to any other advice regarding foot care given by your doctor.
Your doctor may want to perform blood tests to check your kidneys, liver, heart, vitamin
B12 level and levels of cholesterol and fats in your blood while you are taking XIGDUO
XR.
Metformin may reduce Vitamin B12 levels. Periodic monitoring may be necessary in patients
at risk for Vitamin B12 deficiency.
Tell your doctor if you:
become ill
become dehydrated
are injured
have a fever
have a serious infection
are having surgery (including dental surgery).
Your blood glucose may become difficult to control at these times. You may also be
more at risk of developing a serious condition called lactic acidosis or diabetic
ketoacidosis. At these times, your doctor may temporarily replace XIGDUO XR with insulin.
Remind any doctor, dentist or pharmacist you visit that you are using XIGDUO XR.
Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia and hyperglycaemia and know how to treat them.
Hypoglycaemia
XIGDUO XR does not normally cause hypoglycaemia, although you may experience it if
you take certain other medicines, such as insulin or a sulfonylurea.
Hypoglycaemia can occur suddenly. Initial signs may include:
weakness, trembling or shaking
sweating
light-headedness, dizziness, headache or lack of concentration
irritability, tearfulness or crying
hunger
numbness around the lips and tongue.
If not treated promptly, these may progress to:
loss of co-ordination
slurred speech
confusion
fits or loss of consciousness.
If you experience any of the symptoms of hypoglycaemia, you need to raise your blood
glucose immediately.
You can do this by doing one of the following:
eating 5 to 7 jelly beans
eating 3 teaspoons of sugar or honey
drinking half a can of non-diet soft drink
taking 2 to 3 concentrated glucose tablets.
Unless you are within 10 to 15 minutes of your next meal or snack, follow up with
extra carbohydrates such as plain biscuits, fruit or milk.
Taking this extra carbohydrate will prevent a second drop in your blood glucose level.
Hyperglycaemia
If you notice the return of any of the signs of hyperglycaemia, contact your doctor
immediately.
Your doctor may need to consider additional or other treatments for your diabetes.
The risk of hyperglycaemia is increased in the following situations:
uncontrolled diabetes
illness, infection or stress
taking less XIGDUO XR than prescribed
taking certain other medicines
too little exercise
eating more carbohydrates than normal.
Things you should not do
Do not stop taking your medicine or change the dosage without checking with your doctor.
Do not take XIGDUO XR to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if their symptoms seem similar or they
have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how XIGDUO
XR affects you.
Although rare, XIGDUO XR may cause dizziness in some people. Low blood sugar levels
may also slow your reaction time and affect your ability to drive or operate machinery.
Make sure you know how you react to XIGDUO XR before you drive a car, operate machinery
or do anything else that could be dangerous if you are dizzy or lightheaded.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol can affect the control of your diabetes. Drinking excessive amounts of alcohol
while you are being treated with XIGDUO XR may also lead to serious side effects.
Your doctor may suggest you stop drinking or reduce the amount of alcohol you drink.
Looking after your medicine
Keep your XIGDUO XR tablets in the blister until it is time to take them. If you take XIGDUO XR out of the blister, it will not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Gut-related:
nausea, vomiting or diarrhoea
stomach pain or discomfort
Nervous system-related:
loss of appetite
loss of taste
headache
Others:
back pain
rash
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Allergic reaction:
Shortness of breath, wheezing or severe difficulty in breathing; shock, swelling of
the face, lips, tongue or other parts of the body; skin rash, itching or hives on
the skin, hayfever, or you may feel faint.
Hypoglycaemia:
low blood sugar that persist despite administering sugar as described in Section 5.What should I know while taking XIGDUO XR? in this leaflet. Signs of low blood sugar may include weakness, trembling or shaking,
sweating, light-headedness, headache, dizziness, rapid heart beat, lack of concentration,
tearfulness or crying, irritability, hunger and numbness around the lips and fingers.
Do not drive a car if you have signs of low blood sugar.
Serious kidney problems:
If you have kidney problems, you should take XIGDUO XR only if your doctor tells you
to.
Dehydration:
Volume depletion (loss of needed fluids from the body). If you are unable to keep
fluids down or if you have any of these symptoms of too much loss of body fluids (volume
depletion or dehydration) while taking XIGDUO XR: dry sticky mouth, severe thirst,
severe diarrhoea or vomiting, dizziness, or urinating less often than normal or not
at all.
Infections related:
Genital infections. If you experience painful urination, soreness and more severe
irritation or redness and swelling of your genitals, or an unpleasant odour or discharge
associated with your genitals.
Urinary tract infection. If you have symptoms, such as burning or pain when you pass
urine, more frequent or urgent need to urinate, fever, chills, or blood in the urine,
contact your doctor as soon as possible.
If you experience pain or tenderness, redness, swelling of the genitals or the area
from the genitals to the rectum, fever, and generally feeling unwell. These may be
symptoms of a rare but serious and potentially life-threating infection called Necrotising
fasciitis of the perineum (Fournier’s gangrene) and you will require prompt treatment.
Diabetic ketoacidosis:
In rare cases dapagliflozin one of the active ingredients in XIGDUO XR, may cause
a serious condition called diabetic ketoacidosis. Symptoms of diabetic ketoacidosis
may include feeling sick or being sick, difficulty breathing, severe thirst, feeling
weak and tired, confusion, a sweet smell to your breath, a sweet or metallic taste
in your mouth, a strange odour to your urine or sweat and frequent urination. The
risk of developing diabetic ketoacidosis may be increased with prolonged fasting,
excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or
a higher need of insulin due to major surgery or serious illness. Diabetes ketoacidosis
is a life-threatening condition.
Lactic Acidosis
IN RARE CASES, METFORMIN, ONE OF THE MEDICINES IN XIGDUO XR, CAN CAUSE A SERIOUS SIDE
EFFECT CALLED LACTIC ACIDOSIS.
LACTIC ACIDOSIS IS A MEDICAL EMERGENCY THAT CAN CAUSE DEATH AND MUST BE TREATED IN
THE HOSPITAL. LACTIC ACIDOSIS IS CAUSED BY A BUILD-UP OF LACTIC ACID IN YOUR BLOOD.
STOP TAKING XIGDUO XR IF YOU GET ANY OF THE FOLLOWING SYMPTOMS OF LACTIC ACIDOSIS
AND SEE YOUR DOCTOR IMMEDIATELY or go straight to the Emergency Department at your
nearest hospital:
You feel very weak and tired.
You have unusual (not normal) muscle pain.
You have trouble breathing.
You have stomach pain with nausea and vomiting, or diarrhoea.
You feel cold, especially in your arms and legs.
You feel dizzy or light-headed.
You have a slow or irregular heart beat
Your medical condition suddenly changes.
The risk of lactic acidosis is higher in the elderly, those whose diabetes is poorly
controlled, those with prolonged fasting, those with certain heart conditions, those
who drink alcohol and those with kidney or liver problems.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Occasionally, XIGDUO XR may be associated with changes in your cholesterol or fats
in your blood. These can only be found when your doctor does tests from time to time
to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What XIGDUO XR contains
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Active ingredient
(main ingredient)
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dapagliflozin 10 mg and metformin 500 mg
dapagliflozin 10 mg and metformin 1000 mg
dapagliflozin 5 mg and metformin 1000 mg
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
lactose
carmellose sodium
hypromellose
crospovidone
silicon dioxide
magnesium stearate
polyvinyl alcohol
titanium dioxide
macrogol 3350
purified talc
iron oxide yellow (10mg/1000mg tablets)
iron oxide red (10mg/500mg and 5mg/1000mg tablets)
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Potential allergens
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Lactose
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Do not take this medicine if you are allergic to any of these ingredients.
XIGDUO XR tablets do not contain gluten or sucrose.
What XIGDUO XR looks like
XIGDUO XR 10mg/500mg, pink, biconvex, capsule shaped, film-coated tablets with ‘1072’
and ‘10/500’ debossed on one side and plain on the other side. Available in blister
packs of 7 and 28 tablets. (AUST R 211294).
XIGDUO XR 10mg/1000mg, yellow to dark yellow, biconvex, oval shaped, film-coated tablets
with ‘1073’ and ‘10/1000’ debossed on one side and plain on the other side. Available
in blister packs of 7 and 28 tablets. (AUST R 211295).
XIGDUO XR 5mg/1000mg, pink to dark pink, biconvex, oval shaped, film-coated tablets
with ‘1071’ and ‘5/1000’ debossed on one side and plain on the other side. Available
in blister packs of 14 and 56 tablets. (AUST R 211296).
Who distributes XIGDUO XR
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in July 2023.
® XIGDUO XR is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca, 2023
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