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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using Ozempic®?
Ozempic
® contains the active ingredient semaglutide. Ozempic
® is used to lower blood sugar (glucose) in adults with type 2 diabetes mellitus.
For more information, see Section
1. Why am I using Ozempic®? in the full CMI.
2. What should I know before I use Ozempic®?
Do not use if you have ever had an allergic reaction to semaglutide 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 Ozempic®? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Ozempic®?
Ozempic® is an injection that is used once a week.
When you first start using Ozempic®, the starting dose is 0.25 mg once a week for four weeks, after four weeks you should
increase your dose to 0.5 mg once a week. Your doctor may increase your dose to 1
mg.
Inject Ozempic® under the skin as shown to you by your doctor or diabetes education nurse.
5. What should I know while using Ozempic®?
|
Things you should do
|
Remind any doctor, dentist, pharmacist or diabetes education nurse you visit that
you are using Ozempic®.
If you experience any of the symptoms of a hypo, immediately eat some sugary food
or have a sugary drink, e.g. lollies, biscuits or fruit juice.
|
|
Things you should not do
|
Do not stop using this medicine suddenly. If you stop using it, your blood sugar levels
may increase.
Do not use this medicine if you think it has been frozen or exposed to excessive heat.
|
|
Driving or using machines
|
Low blood sugar (hypoglycaemia) may affect your ability to concentrate. Avoid driving
or using machines if you get any signs of low blood sugar, including dizziness.
|
|
Drinking alcohol
|
Alcohol may mask the symptoms of hypoglycaemia or make it worse.
|
|
Looking after your medicine
|
Before opening: store in a refrigerator (2°C to 8°C). Keep away from the cooling element.
Do not freeze.
During use: you can keep it for 6 weeks either at room temperature (not above 30°C), or in a refrigerator (2°C to 8°C), away from the cooling element. Do not freeze.
|
6. Are there any side effects?
The most common side effects when using Ozempic
® are diarrhoea and nausea. Inflamed pancreas (acute pancreatitis) which could cause
severe pain in the stomach and back which does not go away and allergic reaction (skin
rashes over a large part of the body, shortness of breath, wheezing, swelling of the
face, lips or tongue, fast pulse, sweating) are very serious side effects for which
you may need urgent medical attention.
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.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information.
You can help by reporting any side effects you may get. You can report side effects
to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
semaglutide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Ozempic®. 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 Ozempic
®
.
Where to find information in this leaflet:
1. Why am I using Ozempic®?
Ozempic
®
contains the active ingredient semaglutide. Ozempic® belongs to a group of medicines called 'GLP-1 receptor agonists' which help control
how the pancreas works.
Ozempic® is an injection that is used once a week.
Ozempic
®
is used to lower blood sugar (glucose) in adults with type 2 diabetes mellitus.
Diabetes mellitus is a condition where your pancreas does not produce enough insulin
to control the level of sugar in your blood or, your body is not able to use the insulin
it makes properly.
Ozempic® helps your body to produce more insulin when your blood sugar level is high.
Ozempic® is used on its own if your blood sugar is not properly controlled by diet and exercise
alone. Ozempic® is also able to be used with other medicines for diabetes when they are not enough
to control your blood sugar levels. These medicines may include oral antidiabetics
(such as metformin, thiazolidinedione medicines (TZD’s), sulfonylurea medicines, SGLT2
inhibitor medicines such as Jardiance®) or insulin.
It is important that you keep following any diet and lifestyle advice from your doctor,
diabetes education nurse or pharmacist while using Ozempic®.
Ozempic® has not been studied in children and should not be used in children or adolescents
under 18 years.
Ozempic® is not addictive.
2. What should I know before I use Ozempic®?
Warnings
Do not use Ozempic
®
if:
you are allergic to semaglutide, or any of the ingredients listed at the end of this
leaflet
Some of the symptoms of an allergic reaction may include:
redness, swelling, rash and itching at the injection site
rash, itching or hives on the skin
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body.
it is after the expiry date printed on the pack or if the packaging is torn or shows
signs of tampering
it has expired or is damaged, return it to your pharmacist for disposal. The expiry
date refers to the last day of that month.
Always check the ingredients to make sure you can use this medicine.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Check with your doctor if you:
have any other medical conditions including a history of diabetic retinopathy or pancreatitis.
are also taking a sulfonylurea (such as glimepiride or glibenclamide) or insulin.
Your doctor may tell you to test your blood sugar levels. This will help your doctor
to decide if the dose of the sulfonylurea or insulin needs to be changed to avoid
you getting hypoglycaemia (low blood sugar).
take any medicines for any other condition.
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
Check with your doctor if you are pregnant, think you are pregnant, or intend to become
pregnant.
Ozempic® should not be used during pregnancy and for at least two months before a planned
pregnancy because Ozempic® may harm your unborn child. If you could become pregnant while using Ozempic®, it is recommended to use contraception.
Do not use Ozempic® if you are breast-feeding. It is not known if Ozempic® passes into breast milk.
Type 1 diabetes/ketoacidosis
Ozempic® should not be used if you have type 1 diabetes or diabetic ketoacidosis (a complication
of diabetes that happens when the body is not able to break down glucose because there
is not enough insulin). Ozempic® is not an insulin.
Acute pancreatitis
If you experience symptoms of acute pancreatitis, like persistent, severe abdominal
pain, you should consult your doctor.
Dehydration
Drink plenty of fluids to avoid dehydration if you experience vomiting or diarrhoea
when beginning treatment with Ozempic®
Dehydration can lead to kidney problems, particularly in patients who have pre-existing
kidney disease
If you notice your urine changes appearance or you produce urine less frequently,
see your doctor.
3. What if I am taking other medicines?
Tell your doctor, pharmacist or diabetes education nurse if you are taking, have recently
taken, or might take, any other medicines, including any medicines, vitamins or supplements
that you buy without a prescription from your pharmacy, supermarket, naturopath or
health food shop.
In particular, tell your doctor, pharmacist or nurse if you are using medicines containing
any of the following:
a sulfonylurea (such as glimepiride or glibenclamide)
insulin.
Combining these medicines with Ozempic® might increase the risk of getting low blood sugar (hypoglycaemia or a “hypo”). Please
see section 6 for the warning signs of low blood sugar. Your doctor may tell you to
test your blood sugar levels. This will help your doctor decide if the dose of the
sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.
Check with your doctor, pharmacist, or diabetes education nurse if you are not sure
about what medicines, vitamins or supplements you are taking and if these affect Ozempic
®
.
4. How do I use Ozempic®?
How much to use
Your doctor, diabetes education nurse or pharmacist will have given you advice on
how to use your medicine.
Carefully follow all the directions.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor, diabetes education nurse
or pharmacist for help.
Your doctor or diabetes education nurse will tell you how much of this medicine you
need to use.
When you first start using Ozempic®, the starting dose is 0.25 mg once a week for four weeks.
After four weeks you should increase your dose to 0.5 mg once a week. Talk to your doctor before increasing your dose.
Your doctor may increase your dose to 1 mg if your blood sugar is not controlled well
enough with a dose of 0.5 mg once a week.
Follow the instructions provided and use Ozempic® until your doctor tells you to stop. Do not change your dose unless your doctor has told you to. Any change in dose should be made cautiously and only under medical supervision.
Do not stop using Ozempic® unless your doctor tells you to. If you stop using it, your blood sugar levels may
increase.
When to use Ozempic®
You should use Ozempic® once a week on the same day each week if possible.
You can give yourself the injection at any time of the day - regardless of meals.
To help you remember to inject Ozempic® once a week only, it is recommended to note the chosen weekday (e.g. Wednesday) on
the carton. You can also write the date on the carton every time you have injected
Ozempic®.
If necessary, you can change the day of your weekly injection of Ozempic® as long as it has been at least 3 days since your last injection of Ozempic®.
How to use Ozempic®
Inject Ozempic® under the skin (subcutaneous injection) as shown to you by your doctor or diabetes
education nurse. Never inject Ozempic® into a vein or muscle.
Ozempic® may be injected into the front of your waist (abdomen), the front of your thigh,
or your upper arm.
Before you use the pen for the first time, your doctor or diabetes education nurse
will show you how to use it.
Follow the detailed instructions on how to inject Ozempic
®
in the instructions for use supplied with the product. These instructions are also available via the following hyperlinks:
Checking your Ozempic
®
pen:
Ozempic® should be clear and colourless, or almost colourless.
Do not use this medicine if it is thickened, coloured, or has solid bits in it.
Ozempic
®
should not be used if it has been frozen.
Read the instructions printed later in this leaflet carefully in order to prepare
and handle your Ozempic
®
pen correctly.
If you forget to use Ozempic®
You should use Ozempic® once a week on the same day each week if possible.
If you forget a dose and:
it is 5 days or less since you should have used Ozempic®, use it as soon as you remember. Then inject your next dose as usual on your scheduled
day.
it is more than 5 days since you should have used Ozempic®, skip the missed dose. Then inject your next dose as usual on your scheduled day.
Do not take an extra dose or increase the dose to make up for a missed dose.
If you use too much Ozempic®
If you use more Ozempic® than you should, you may get side effects such as feeling sick (nausea) or being
sick (vomiting), or diarrhoea.
If you think that you have used too much Ozempic®, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26 in Australia or 0800 764766 in New Zealand), or
contact your doctor, or
go to the Accident and 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 using Ozempic®?
Things you should do
Make sure all your friends, relatives, workmates or carers know that you have diabetes.
Tell your doctor, diabetes education nurse or pharmacist if you are travelling.
Ask them for a letter explaining why you are taking injecting devices with you. Each
country you visit will need to see this letter, so you should take several copies.
You may not be able to get Ozempic® in the country you are visiting.
Your doctor, diabetes education nurse or pharmacist can provide you with some helpful
information.
Remind any doctor, dentist or pharmacist you visit that you are using Ozempic®.
Things you should not do
Do not stop using your medicine unless your doctor tells you to. If you stop using
it, your blood sugar levels may increase.
Do not use this medicine if you think it has been frozen or exposed to excessive heat.
It will not work as well.
Do not use this medicine to treat any other complaints 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 share your pen or needles with anyone else.
Hypoglycaemia
Tell your doctor if you often have hypos (low blood sugar levels). When Ozempic® is used with a sulfonylurea (such as glimepiride or glibenclamide) or with insulin,
hypos can occur. The dose of your sulfonylurea or insulin may need to be reduced while
you take Ozempic®.
If you experience any of the symptoms of a hypo, immediately eat some sugary food
or have a sugary drink, e.g. lollies, biscuits or fruit juice.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Ozempic
®
affects you.
Low blood sugar (hypoglycaemia) may affect your ability to concentrate. Avoid driving
or using machines if you get any signs of low blood sugar, including dizziness. See
section 6 for the warning signs of low blood sugar. Talk to your doctor for further
information.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may mask the symptoms of hypoglycaemia or make it worse.
Looking after your medicine
Storage
Before opening:
Keep your unopened Ozempic® pens in a refrigerator (2°C to 8°C). Keep away from the cooling element. Do not freeze.
During use:
While you are using your Ozempic® pen you can keep it for 6 weeks either at room temperature (not above 30°C), or in a refrigerator (2°C to 8°C), away from the cooling element. Do not freeze.
The medicine in Ozempic® must not be frozen or exposed to heat or direct sunlight.
When you are not using the pen, keep the pen cap on in order to protect from light.
Never use Ozempic
®
if the solution is not clear and colourless, or almost colourless.
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 young children cannot reach it.
When to discard your medicine
Discard the Ozempic® pen you are using after 6 weeks even if there is still some medicine
left in it.
Dispose of used needles safely into a yellow plastic sharps container.
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. The expiry date refers to the last
day of that month.
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.
The most common side effects when using Ozempic® are diarrhoea and nausea. These side effects are usually mild and normally decrease
with continued use.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
General effects
decreased appetite
headache
vomiting (being sick)
indigestion (dyspepsia)
burping, wind (flatulence) or constipation
heartburn
painful or swollen stomach (abdomen)
weight loss
injection site reactions (such as bruising, pain, irritation, itching and rash)
a delay in the emptying of the stomach
fast heart beat
feeling tired
feeling dizzy
changes to your vision or eyesight
unpleasant, abnormal or altered taste sensation
increase in pancreas blood test results
Other effects
Tell your doctor if you experience:
gallstones
inflamed gall bladder
dehydration.
When initiating treatment with Ozempic®, you may in some cases experience dehydration
as a result of vomiting, nausea or diarrhoea. It is important to avoid dehydration
by drinking plenty of fluids.
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
|
Hypoglycaemia
low blood sugar (a hypo).
Hypos are more likely to occur if you are also taking a sulfonylurea (such as glimepiride
or glibenclamide) or insulin. A hypo may come on suddenly. The warning signs of a
hypo can include:
cold sweat, cool pale skin
headache
feeling sick
feeling very hungry
changes in vision
feeling sleepy, feeling weak
feeling nervous or anxious, shaking (tremor), fast heart beat
feeling confused, difficulty concentrating.
|
If you are already taking a sulfonylurea or insulin, your doctor may reduce the dose
of these medicines before you start using Ozempic
®
.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Acute pancreatitis:
Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach
and back which does not go away.
Allergic reactions (anaphylactic reactions, angioedema):
skin rashes over a large part of the body
shortness of breath, wheezing
swelling of the face, lips, tongue and/or throat with difficulty swallowing
fast pulse
sweating.
Acute kidney injury:
passing water less often
swelling in legs, ankles, or feet
feeling sleepy
feeling short of breath
feeling very tired
feeling confused
feeling sick (nausea).
If you have any signs of sudden kidney failure, talk to a doctor straight away.
|
Call your doctor straight away, or go straight to the Accident and Emergency Department
at your nearest hospital if you notice any of these serious side effects.
|
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.
Reporting side effects in Australia
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 Ozempic
®
contains
|
Active ingredient
(main ingredient)
|
semaglutide
|
|
Other ingredients
(inactive ingredients)
|
dibasic sodium phosphate dihydrate
propylene glycol
phenol
hydrochloric acid
sodium hydroxide
water for injections.
|
|
Potential allergens
|
phenol
|
Do not take this medicine if you are allergic to any of these ingredients.
What Ozempic® looks like
Ozempic® is supplied as a clear, colourless, or almost colourless solution for injection in
a pre-filled pen. One mL solution for injection contains 1.34 mg semaglutide.
Ozempic 0.25 mg, 0.5 mg solution for injection (AUST R 308324)
Each pen contains 1.5 mL of solution, delivering doses of 0.25 mg or 0.5 mg.
One pre-filled pen contains 2 mg semaglutide.
Ozempic® 0.25 mg, 0.5 mg/dose is available in a pack containing 1 pen and 6 disposable NovoFine® Plus needles.
Ozempic 1 mg solution for injection (AUST R 315107)
Each pen contains 3 mL of solution delivering only doses of 1 mg.
One pre-filled pen contains 4 mg semaglutide.
Ozempic® 1 mg/dose is available in a pack containing 1 pen and 4 disposable NovoFine® Plus needles.
Who distributes Ozempic®
Ozempic® is supplied in Australia by:
Novo Nordisk Pharmaceuticals Pty. Ltd.
Level 10
118 Mount Street
North Sydney NSW 2060
Ozempic® is supplied in New Zealand by:
Novo Nordisk Pharmaceuticals Ltd.
PO Box 51-268
Pakuranga
Auckland
New Zealand.
Ozempic® and NovoFine® are registered trademarks of Novo Nordisk A/S. Jardiance® is a registered trademark of Boehringer Ingelheim International GmbH.
© 2023
Novo Nordisk A/S
Further information
For further information call Novo Nordisk Customer Care on 1800 668 626 (Australia)
or 0800 733 737 (New Zealand).
You can also get more information about diabetes from Diabetes Australia:
freecall helpline 1300 136 588
Diabetes New Zealand:
Freecall helpline 0800 342 238
Always check the following websites to ensure you are reading the most recent version
of the Ozempic® Consumer Medicine Information:
This leaflet was prepared October 2023.