Jardiance®
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.
Jardiance tablets contain the active ingredient empagliflozin. Jardiance is used to
lower blood sugar levels in people with type 2 diabetes mellitus. Jardiance can be
used to help lower the risk of dying from cardiovascular disease in patients with
type 2 diabetes mellitus and cardiovascular disease. Jardiance is also used with other
medicines to treat heart failure and to slow the progression of kidney disease in
patients with or without type 2 diabetes mellitus. For more information, see Section
1. Why am I using Jardiance? in the full CMI.
Do not use if you have ever had an allergic reaction to empagliflozin 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.
For more information, see Section 2. What should I know before I use Jardiance? in the full CMI.
Some medicines may interfere with Jardiance and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Your doctor will tell you how many tablets you need to take each day. The usual dose
for adults is one tablet a day. More instructions can be found in Section 4. How do I use Jardiance? in the full CMI.
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Things you should do
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Check your blood sugar levels regularly to tell if your diabetes is being controlled
properly
Be careful when doing activities that can lower your sugar levels, such as drinking
alcohol, not eating enough, or exercising suddenly or vigorously.
Remind any doctor, dentist or pharmacist you visit that you are using Jardiance.
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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 Jardiance
affects you.
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Drinking alcohol
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Drinking alcohol can increase the risk of your blood sugar levels becoming too low.
Talk to your doctor if you drink alcohol.
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Looking after your medicine
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Keep your tablets in the pack until it is time to take it.
Store it in a cool, dry place where the temperature stays below 30°C.
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For more information, see Section 5. What should I know while using Jardiance? in the full CMI.
Common side effects include: genital burning, redness, pain, discharge; passing more
urine than normal; thirst; itchiness; and constipation. Serious potential side effects
that may require medical attention include: low blood sugar (when used in combination
with other anti-diabetic medicines); dehydration; burning sensation when passing urine;
cloudy urine; straining or pain when passing urine; and pain in the pelvis or mid-back.
Side effects that require urgent medical attention include swelling of the penis;
Fournier's gangrene; allergic reactions; and ketoacidosis. 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.
Jardiance®
Active ingredient:
empagliflozin
Consumer Medicine Information (CMI)
This leaflet provides important information about using Jardiance. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Jardiance.
Where to find information in this leaflet:
Jardiance contains the active ingredient empagliflozin.
It belongs to a group of medicines called sodium-glucose co-transporter 2 (SGLT2)
inhibitors. It works by blocking a protein in the kidneys called SGLT2 and removes
blood sugar via the urine. As a result, the levels of sugar in your blood are reduced.
Jardiance also reduces the amount of salt reabsorbed by your kidneys, which helps
to reduce excess strain on the heart. Jardiance may also help to protect your kidneys
from further damage caused by high blood sugar levels and excess strain on the heart.
Jardiance is used to lower blood sugar levels in patients with type 2 diabetes mellitus
when diet and exercise is not enough to control your blood sugar levels. It may be
used either: alone as a single medicine, or in combination with other anti-diabetic
medicines such as: metformin, sulfonylurea medicines (such as glimepiride and glibenclamide),
pioglitazone, insulin, or dipeptidyl peptidase-4 inhibitor medicines (such as linagliptin
or sitagliptin).
If you have type 2 diabetes mellitus and cardiovascular disease, Jardiance can also
be used to reduce your risk of dying from your cardiovascular disease.
Jardiance is also used with other medicines to treat heart failure and to slow the
progression of kidney disease in patients with or without type 2 diabetes mellitus.
Your doctor may have prescribed this medicine for another reason. Ask your doctor
if you have any questions about why Jardiance has been prescribed for you.
Type 2 diabetes mellitus
Type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus) develops
when your body doesn’t make enough insulin or the insulin your body makes does not
work as well as it should. Insulin helps to control your blood sugar levels, and when
there is not enough insulin or it does not work well, the amount of sugar in your
blood can start to build up. Too much sugar in the blood can cause damage to the body’s
cells, and can lead to problems with your eyes, heart, kidneys, and circulation.
Heart Failure
In heart failure, the heart does not work as well as it should. This means the heart
is unable to pump enough blood to meet the body's needs. The most common symptoms
of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
Kidney disease
Some conditions such as diabetes and high blood pressure can lead to kidney problems.
These problems develop slowly over several years. Good control of your blood sugar
and blood pressure are important in keeping your kidneys healthy, but may not always
prevent kidney damage from occurring.
Do not use Jardiance if:
you are allergic to empagliflozin, or any of the ingredients listed at the end of
this leaflet
Tell your doctor if you:
take any medicines for any other condition
have allergies to any other medicines, foods, preservatives, or dyes.
have or have had any of the following medical conditions:
- type 1 diabetes mellitus, a condition where your body does not produce insulin
- ketoacidosis, a condition where acids called “ketones” build up to a dangerous level
in the blood, which can lead to severe complications including pre coma in patients
with type 2 diabetes mellitus.
- kidney problems
- galactosaemia, a rare hereditary condition of galactose intolerance
- frequent genital or urinary tract infections (infections of the bladder, kidney,
or tubes that carry urine)
- illnesses that can cause dehydration (e.g. diarrhoea or a severe infection)
- increased urine loss which may affect the fluid balance in your body and increase
your risk of dehydration.
- if you have heart problems, a history of low blood pressure or are 75 years of age
or older, your risk of dehydration might be increased.
are over 85 years of age.
You should not start taking Jardiance for Type 2 diabetes mellitus if you are over
85 years of age.
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 Jardiance if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking Jardiance.
It is not known if the active ingredient in Jardiance passes into human breast milk
and there is a possibility that your baby may be affected.
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.
Jardiance can increase the effects of diuretic medicines (water pills) which are used
to treat blood pressure and fluid retention. Taking these medicines together can increase
your risk of low blood pressure and dehydration.
Jardiance may lower the amount of lithium in your blood (medicine used to treat and
prevent mood disorders). Your doctor will need to do more frequent monitoring to check
on the amount of lithium in your blood.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Jardiance.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet
How much to take
Type 2 diabetes mellitus
The recommended dose is one 10 mg tablet once a day.
Your doctor may increase your dose to one 25 mg tablet once a day if your blood sugar
levels remain high after starting treatment on 10 mg.
Your doctor will prescribe Jardiance alone or in combination with another anti-diabetic
medicine if that medicine alone is not sufficient to control you blood sugar level.
Heart Failure
The recommended dose is one 10 mg tablet once a day.
Kidney Disease
The recommended dose is one 10 mg tablet once a day.
Continue taking your medicine for as long as your doctor tells you.
When to take Jardiance
Take Jardiance at the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take Jardiance before or after food.
If you forget to take Jardiance
If you miss your dose at the usual time, and
it is almost time for your next dose (less than 12 hours), 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. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you use too much Jardiance
If you think that you have taken too much Jardiance, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using Jardiance, especially
if you are about to start any new medicine or if you are going to have surgery.
Tell your doctor immediately if you become pregnant while taking Jardiance.
If you are about to have any blood or urine tests, tell your doctor that you are taking
this medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Follow your doctor's and/or dietician's advice on diet, drinking alcohol and exercise.
Check your blood sugar levels regularly. This is the best way to tell if your diabetes
is being controlled properly. Your doctor or diabetes educator will show you how and
when to do this.
Check your feet regularly and see your doctor if you notice any problems. Follow any
other advice regarding foot care given by your doctor.
Talk to your doctor if you are about to have surgery. The doctor will provide instructions
on when to stop and restart Jardiance. Surgery can increase the risk of a very serious side effect of Jardiance called ketoacidosis.
See additional information under Section 6. Are there any side effects?
Things you should not do
Do not take Jardiance to treat any other conditions unless your doctor tells you to.
Do not give your medicine to anyone else even if they have the same condition as you.
Do not stop taking this medicine or change the dosage without checking with your doctor.
Things to be careful of
Be careful when doing any of the following things, which may increase the risk of
your blood sugar becoming too low:
- Drinking alcohol
- Not eating enough
- Doing unexpected or vigorous exercise
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Jardiance
affects you.
When Jardiance is taken with other anti-diabetic medicines, such as sulfonylurea or
insulin, it can increase the risk of your blood sugar levels becoming too low. Low
blood sugar can cause dizziness, lightheadedness, tiredness, drowsiness, and slow
your reaction time, which can affect your ability to drive or operate machinery.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may increase the risk of your blood sugar levels becoming too low.
Looking after your medicine
Keep your tablets in the pack until it is time to take them. If you take the tablets
out of the pack they may not keep well.
Keep your Jardiance 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.
Keep it where children cannot reach it.
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.
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.
Do not be alarmed by the following list of side effects. You may not experience any
of them.
Less serious side effects
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Less serious side effects
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What to do
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Symptoms of a genital yeast infection
genital burning, redness, pain or discharge
Other less serious side effects
passing more urine than normal
itching
thirst
constipation
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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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Symptoms of low blood sugar
sweating
weakness
hunger
dizziness
trembling
headache
confusion
flushing or paleness
numbness
fast, pounding heartbeat
Low blood sugar may occur in patients who already take another medication to treat
diabetes, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin
medicine may need to be reduced while taking Jardiance.
Symptoms of dehydration
dry or sticky mouth
unusual thirst
light-headedness or dizziness upon standing
fainting or loss of consciousness
urinating less often than normal or not at all
There is an increased risk of dehydration (loss of needed fluids from your body; volume
depletion) in patients who have diarrhoea or fever, are unable to eat or drink, aged
75 years or older or taking medicines to lower blood pressure.
Symptoms of a urinary tract infection
burning sensation when passing urine
urine that appears cloudy
pain in the pelvis or mid-back
straining or pain when passing urine
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Speak to your doctor as soon as possible if you have any of these serious side effects.
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Very serious side effects
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Very serious side effects
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What to do
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Genital
Swelling of the penis that makes it difficult to pull back the skin around the tip
of the penis (uncircumcised men)
Symptoms of Fournier's gangrene
pain, tenderness, itching, or swelling in the genital or back passage area
fever
generally feeling unwell
Symptoms of an allergic reaction
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
severe and sudden onset of itchy or raised skin rash, hives, or nettle rash
Symptoms of ketoacidosis
rapid weight loss
feeling sick or being sick
stomach pain
excessive thirst
fast and deep breathing
confusion
unusual sleepiness or tiredness
sweet smell to your breath
sweet or metallic taste in your mouth
different odour to your urine or sweat
In rare cases, empagliflozin, the active substance in Jardiance, can cause a serious
side effect called ketoacidosis. This has happened to patients with and without diabetes
mellitus who were taking Jardiance.
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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 very 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.
Some of these side effects 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.
This medicine is only available with a doctor's prescription.
What Jardiance contains
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Active ingredient
(main ingredient)
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empagliflozin (10 mg or 25 mg)
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
hyprolose
croscarmellose sodium
colloidal anhydrous silica
magnesium stearate.
Tablet coating:
hypromellose
titanium dioxide
purified talc
macrogol 400
iron oxide yellow.
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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.
What Jardiance looks like
Jardiance is available in two strengths:
Jardiance 10 mg tablets (AUST R 208829) are pale yellow, round, biconvex and bevel-edged,
marked with the BI company logo on one side and 'S10' on the other side.
Jardiance 25 mg tablets (AUST R 208827) are pale yellow, oval and biconvex, marked
with the BI company logo on one side and 'S25' on the other side.
Jardiance tablets are available in PVC/Aluminium blister packs of 10 (sample) or 30
tablets.
