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 KOMBIGLYZE XR?
KOMBIGLYZE XR contains two active ingredients, saxagliptin and metformin hydrochloride
KOMBIGLYZE XR is used to lower blood sugar levels in patients with type 2 diabetes
mellitus along with diet and exercise.
For more information, see Section
1. Why am I taking KOMBIGLYZE XR? in the full CMI.
2. What should I know before I take KOMBIGLYZE XR?
Do not use if you have ever had an allergic reaction to saxagliptin 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 drink alcohol.
3. What if I am taking other medicines?
Some medicines may interfere with KOMBIGLYZE XR and affect how it works.
4. How do I take KOMBIGLYZE XR?
Your doctor will tell you how many KOMBIGLYZE XR tablets to take and how often you
should take them.
KOMBIGLYZE 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 KOMBIGLYZE 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 need to have any medical tests while taking KOMBIGLYZE
XR.
Remind any doctor, dentist or pharmacist you visit for any new medicine that you are
taking KOMBIGLYZE XR.
If you become pregnant while taking KOMBIGLYZE 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 KOMBIGLYZE
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 KOMBIGLYZE 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.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s): saxagliptin/metformin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking KOMBIGLYZE 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 KOMBIGLYZE
XR.
Where to find information in this leaflet:
1. Why am I taking KOMBIGLYZE XR?
KOMBIGLYZE XR contains two active ingredients, saxagliptin and metformin hydrochloride
(modified release). Saxagliptin is a member of a class of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4 inhibitors), and metformin belongs to a class of medicines
called biguanides. Saxagliptin and metformin work together to lower blood sugar levels
in patients with type 2 diabetes mellitus.
KOMBIGLYZE XR is used to lower blood sugar levels in patients with type 2 diabetes
mellitus along with diet and exercise. KOMBIGLYZE XR may also be used in combination
with other medicines including insulin, a sulfonylurea (such as gliclazide) or a SGLT2
inhibitor (such as dapagliflozin) along with diet and exercise to treat type 2 diabetes.
Type 2 diabetes mellitus
Type 2 diabetes mellitus is a condition in which your body does not make enough insulin
and the insulin that your body produces does not work as well as it should. Your body
can also make too much sugar. When this happens, sugar (glucose) builds up in the
blood and can lead to serious medical problems.
The main goal of treating diabetes is to lower your blood sugar to a normal level.
Lowering and controlling blood sugar may help prevent or delay complications of diabetes,
such as heart disease, kidney disease, blindness and amputation.
2. What should I know before I take KOMBIGLYZE XR?
Warnings
Do not take KOMBIGLYZE XR if you:
are allergic to saxagliptin or metformin hydrochloride, or any of the ingredients
listed at the end of this leaflet.
any other medicine in the same class as saxagliptin (ie a DPP-4 inhibitor).
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
have type 1 diabetes mellitus that is well controlled by insulin alone
have type 2 diabetes that is already well controlled by diet alone
diabetic ketoacidosis (a symptom of uncontrolled diabetes, in which substances called
ketone bodies build up in the blood - you may notice this as an unusual fruity odour
on your breath, difficulty breathing, confusion and frequent urination)
severe liver disease
excessive alcohol intake, binge drinking, alcohol dependence
drink excessive alcohol, binge drinking, alcohol dependence
kidney failure or severe kidney disease
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 vomit
Do not take KOMBIGLYZE XR if you need to have major surgery or an examination such
as an X-ray or a scan requiring an injection of iodinated contrast (dye).
You must stop taking KOMBIGLYZE XR for a certain period of time before and after the
examination or the surgery. Your doctor will decide whether you need any other treatment
for this time. It is important that you follow your doctor's instructions precisely.
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 or liver problems
heart failure
drink alcohol. Alcohol can affect the control of your diabetes. Drinking excessive
amounts of alcohol while you are being treated with KOMBIGLYZE XR may also lead to
serious side effects. Your doctor may suggest you stop drinking or reduce the amount
of alcohol you drink.
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 this medicine if you are pregnant or plan to become pregnant.
The safety of KOMBIGLYZE XR in pregnant women has not been established. Insulin is
more suitable for controlling blood glucose during pregnancy. Your doctor will replace
KOMBIGLYZE XR with insulin while you are pregnant.
Do not take KOMBIGLYZE XR if you are breastfeeding.
KOMBIGLYZE XR is not recommended while you are breastfeeding. Your doctor will discuss
the options available to you.
Children
KOMBIGLYZE XR is not recommended for use in children.
There is not enough information on its effects in children.
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.
KOMBIGLYZE XR may affect how well other medicines work and some medicines can affect
how well KOMBIGLYZE 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
If you have not told your doctor about any of these things, tell them before you take
any KOMBIGLYZE XR.
4. How do I take KOMBIGLYZE XR?
How to take KOMBIGLYZE 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 KOMBIGLYZE XR tablet whole with a full glass of water.
KOMBIGLYZE XR tablets must not be chewed or crushed.
How much to take
Your Doctor will tell you how many KOMBIGLYZE 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.
When to take KOMBIGLYZE XR
KOMBIGLYZE XR should be taken with or immediately after food in the evening. This will reduce the chance of a stomach upset.
KOMBIGLYZE 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 KOMBIGLYZE XR to last over weekends and holidays.
KOMBIGLYZE XR helps control your condition, but does not cure it. Therefore, you
must take KOMBIGLYZE XR every day.
If you forget to use KOMBIGLYZE XR
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much KOMBIGLYZE XR
Immediately telephone your doctor or the Poisons Information Centre (13 11 26) for
advice, or go to Accident and Emergency at your nearest hospital if you think that
you or anyone else may have taken too much KOMBIGLYZE XR. Do this even if there are
no signs of discomfort or poisoning.
You may need urgent medical attention.
5. What should I know while taking KOMBIGLYZE XR?
Things you should do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking KOMBIGLYZE XR.
If you are about to be started on any new medicines, tell your doctor, dentist or
pharmacist that you are taking KOMBIGLYZE 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.
Attend your doctor or diabetes centre for regular check-ups about your diabetes.
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 KOMBIGLYZE XR with
insulin.
If you need to have any medical tests while you are taking KOMBIGLYZE XR, tell your
doctor.
KOMBIGLYZE XR may affect the results of some tests.
Visit your doctor regularly for check ups.
Your doctor may want to perform blood tests to check your kidneys, liver, heart and
vitamin B12 level while you are taking KOMBIGLYZE XR.
Metformin may reduce Vitamin B12 levels. Periodic monitoring may be necessary in patients
at risk for Vitamin B12 deficiency.
Hypoglycaemia
KOMBIGLYZE XR does not normally cause hypoglycaemia, although you may experience it
if you take certain other medicines.
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 KOMBIGLYZE XR than prescribed
taking certain other medicines
too little exercise
eating more carbohydrates than normal.
Things you should not do
Do not take KOMBIGLYZE XR to treat any other complaints unless your doctor tells you
to.
Do not give this medicine to anyone else, even if their symptoms seem similar or they
have the same condition as you.
Do not skip meals while taking KOMBIGLYZE XR.
Do not stop taking your medicine or change the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how KOMBIGLYZE
XR affects you.
KOMBIGLYZE 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. Do
not drive a car if you have signs of low blood sugar.
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 KOMBIGLYZE 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 KOMBIGLYZE XR tablets in the blister until it is time to take them. If you take KOMBIGLYZE 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.
Do not store it or any other medicine in the bathroom or near a sink. Do not leave
it in the car or on a window sill.
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 your doctor tells you to stop taking KOMBIGLYZE XR or the tablets have passed their
expiry date, ask your pharmacist what to do with any that are left over.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking KOMBIGLYZE XR.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
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:
vomiting or diarrhoea
stomach pain or discomfort
Nervous system-related:
loss of appetite
loss of taste
headache
Others:
signs of an infection in the breathing passages including runny nose, sore throat
and cough
soreness in the back of the nose and throat and discomfort when swallowing
difficulty breathing or tightness in the chest
signs of urinary tract infection such as an urge to urinate frequently and in small
amounts, and painful burning when passing urine
feeling depressed or anxious
signs of anaemia such as tiredness, headaches, being short of breath when exercising,
dizziness and looking pale
increased blood pressure
back pain.
joint 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:
severe allergic reaction (may include 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:
signs of hypoglycaemia (low blood sugar) that persist despite administering sugar
as described under 'While you are taking Kombiglyze XR' in this leaflet . Signs of
hypoglycaemia may include weakness, trembling or shaking, sweating, light-headedness,
headache, dizziness, 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.
Heart problems:
signs and symptoms of heart failure. Signs of heart failure may include, increasing
shortness of breath, rapid increase in weight and swelling of the feet.
severe upper stomach pain, often with nausea and vomiting
signs and symptoms of heart failure. Signs of heart failure may include, increasing
shortness of breath, rapid increase in weight and swelling of the feet.
develop blisters or the breakdown of your skin (erosion). These symptoms could be
a sign of a skin reaction called bullous pemphigoid that can require treatment in
a hospital. Your doctor may tell you to stop taking KOMBIGLYZE XR.
Lactic Acidosis
IN RARE CASES, METFORMIN, ONE OF THE MEDICINES IN KOMBIGLYZE 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 KOMBIGLYZE XR IF YOU GET ANY OF THE FOLLOWING SYMPTOMS OF LACTIC ACIDOSIS
AND SEE YOUR DOCTOR IMMEDIATELY:
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. Do not be alarmed by this list of possible side effects. You may not
experience any of them.
Other side effects not listed here may occur in some people.
Occasionally, KOMBIGLYZE XR may be associated with changes in your 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 KOMBIGLYZE XR contains
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Active ingredient
(main ingredient)
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saxagliptin 5 mg and metformin hydrochloride 500 mg
saxagliptin 5 mg and metformin hydrochloride 1000 mg
saxagliptin 2.5 mg and metformin hydrochloride 1000 mg
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Other ingredients
(inactive ingredients)
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carmellose sodium
magnesium stearate
hypromellose
microcrystalline cellulose
macrogol 3350
titanium dioxide
purified talc
iron oxide red CI77491 (5 mg/500 mg and 5 mg/1000 mg tablets)
iron oxide yellow CI77492 (5 mg/500 mg and 2.5 mg/1000 mg tablets)
Opacode Blue (printing ink).
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Potential allergens
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N/A
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Do not take this medicine if you are allergic to any of these ingredients.
KOMBIGLYZE XR tablets do not contain lactose, gluten or sucrose.
What KOMBIGLYZE XR looks like
KOMBIGLYZE XR 5mg/500mg, light brown to brown, biconvex, capsule shaped, film-coated
tablets, with "5/500" printed on one side and "4221" printed on the other side, in
blue ink. Available in blister packs of 7 and 28 tablets (AUST R 202209).
KOMBIGLYZE XR 5mg/1000mg, pink, biconvex, capsule shaped, film-coated tablets, with
"5/1000" printed on one side and "4223" printed on the other side in blue ink. Available
in blister packs of 7 and 28 tablets (AUST R 202208).
KOMBIGLYZE XR 2.5mg/1000mg, pale yellow to light yellow, biconvex, capsule shaped,
film-coated tablets with "2.5/1000" printed on one side and ‘"4222" printed on the
other side. Available in blister packs of 14 and 56 tablets. (AUST R 202207).
Who distributes KOMBIGLYZE 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.
® KOMBIGLYZE XR is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca, 2023
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