Ozempic 1mg Cmi v3.0
Ozempic 1mg Cmi v3.0
Ozempic 1mg Cmi v3.0
▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details.
Ozempic® 1
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. [Include if applicable]
Ozempic®
Active ingredient(s): semaglutide
Ozempic® 2
It is not known if Ozempic® passes into breast milk. Do not If you do not understand the instructions, ask your
use Ozempic® if you are breast-feeding. doctor, diabetes education nurse or pharmacist for help.
Type 1 diabetes/ketoacidosis Your doctor or diabetes education nurse will tell you how
much of this medicine you need to use.
• Ozempic® should not be used if you have type 1
• When you first start using Ozempic®, the starting dose
diabetes or diabetic ketoacidosis (a complication of
is 0.25 mg once a week for four weeks.
diabetes that happens when the body is not able to
• After four weeks you should increase your dose to 0.5
break don glucose because there is not enough
mg once a week. Talk to your doctor before
insulin). Ozempic® is not an insulin.
increasing your dose.
Acute pancreatitis • Your doctor may increase your dose to 1 mg if your
blood sugar is not controlled well enough with a dose
• If you experience symptoms of acute pancreatitis, like of 0.5 mg once a week.
persistent, severe abdominal pain, you should consult • Follow the instructions provided and use Ozempic®
your doctor. until your doctor tells you to stop. Do not change your
Dehydration dose unless your doctor has told you to. Any change
in dose should be made cautiously and only under
• Drink plenty of fluids to avoid dehydration if you medical supervision.
experience vomiting or diarrhoea when beginning • Do not stop using Ozempic® unless your doctor tells
treatment with Ozempic® you to. If you stop using it, your blood sugar levels
• Dehydration can lead to kidney problems, particularly may increase.
in patients who have pre-existing kidney disease
• If you notice your urine changes appearance or you When to take / use Ozempic®
produce urine less frequently, see your doctor. • 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
3. What if I am taking other medicines?
day – regardless of meals.
Tell your doctor, pharmacist or diabetes education nurse if • To help you remember to inject Ozempic® once a
you are taking any other medicines, including any week only, it is recommended to note the chosen
medicines, vitamins or supplements that you buy without weekday (e.g. Wednesday) on the carton. You can also
a prescription from your pharmacy, supermarket, write the date on the carton every time you have
naturopath or health food shop. injected Ozempic®.
In particular, tell your doctor if you are using a • If necessary, you can change the day of your weekly
sulfonylurea (such as glimepiride or glibenclamide), and/or injection of Ozempic® as long as it has been at least 3
insulin. days since your last injection of Ozempic®.
This is because using Ozempic® at the same time may How to use Ozempic®
cause your blood sugar level to become too low
(hypoglycaemia or a “hypo”). • Inject Ozempic® under the skin (subcutaneous
• When you first start using these medicines together, injection) as shown to you by your doctor or diabetes
your doctor may tell you to lower the dose of the education nurse. Never inject Ozempic® into a vein or
sulfonylurea or insulin. muscle.
• Ozempic® may be injected into the front of your waist
• If you are also taking a sulfonylurea and/or insulin
(abdomen), the front of your thigh, or your upper arm.
together with Ozempic®, your doctor may ask you to
• Before you use the pen for the first time, your doctor
test your blood sugar levels to begin with. This will
or diabetes education nurse will show you how to use
help your doctor to decide if the dose of the
it.
sulfonylurea and/or insulin needs to be changed.
Check with your doctor, pharmacist, or diabetes Checking your Ozempic® pen:
education nurse if you are not sure about what Ozempic® should be clear and colourless, or almost
medicines, vitamins or supplements you are taking and if colourless.
these affect Ozempic®. 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.
4. How do I use Ozempic®? Read the instructions printed later in this leaflet carefully
How much to take / use in order to prepare and handle your Ozempic® pen
correctly.
Your doctor, diabetes education nurse or pharmacist will
have given you advice on how to use your medicine. If you forget to use Ozempic®
Carefully follow all the directions. You should use Ozempic® once a week on the same day
They may differ from the information contained in this each week if possible.
leaflet. If you forget a dose and:
Ozempic® 3
• it is 5 days or less since you should have used Hypoglycaemia
Ozempic®, use it as soon as you remember. Then inject
your next dose as usual on your scheduled day. Tell your doctor if you often have hypos (low blood sugar
levels). When Ozempic® is used with a sulfonylurea (such
• it is more than 5 days since you should have used as glimepiride or glibenclamide) or with insulin, hypos can
Ozempic®, skip the missed dose. Then inject your next occur. The dose of your sulfonylurea or insulin may need
dose as usual on your scheduled day. to be reduced while you take Ozempic®.
Do not take an extra dose or increase the dose to make If you experience any of the symptoms of a hypo,
up for a missed dose. immediately eat some sugary food or have a sugary drink,
If you use too much Ozempic® e.g. lollies, biscuits or fruit juice.
If you use more Ozempic® than you should, you may get Driving or using machines
side effects such a feeling sick (nausea) or being sick
(vomiting), or diarrhoea. Be careful before you drive or use any machines or tools
until you know how Ozempic®affects you.
If you think that you have used too much Ozempic®, you
may need urgent medical attention. Low blood sugar (hypoglycaemia) may affect your ability to
concentrate. Avoid driving or using machines if you get any
You should immediately: signs of low blood sugar, including dizziness. Talk to your
• phone the Poisons Information Centre doctor for further information.
(by calling 13 11 26), or
Drinking alcohol
• contact your doctor, or
• go to the Emergency Department at your nearest Tell your doctor if you drink alcohol.
hospital. Alcohol may mask the symptoms of hypoglycaemia or
You should do this even if there are no signs of make it worse.
discomfort or poisoning. Looking after your medicine
5. What should I know while using Storage
Before opening:
Ozempic®? Keep your unopened Ozempic® pens in a refrigerator (2°C
Things you should do to 8°C). Keep away from the cooling element. Do not
freeze.
Make sure all your friends, relatives, workmates or carers During use:
know that you have diabetes. While you are using your Ozempic® pen you can keep it for
Tell your doctor, diabetes education nurse or pharmacist if 6 weeks either at room temperature (not above 30˚C), or
you are travelling. in a refrigerator (2˚C to 8˚C), away from the cooling
element. Do not freeze.
Ask them for a letter explaining why you are taking
injecting devices with you. Each country you visit will need The medicine in Ozempic® must not be frozen or exposed
to see this letter, so you should take several copies. to heat or direct sunlight.
You may not be able to get Ozempic® in the country you When you are not using the pen, keep the pen cap on in
are visiting. order to protect from light.
Your doctor, diabetes education nurse or pharmacist can Never use Ozempic® if the solution is not clear and
provide you with some helpful information. colourless, or almost colourless.
Remind any doctor, dentist or pharmacist you visit that Follow the instructions in the carton on how to take care
you are using Ozempic®. of your medicine properly.
Things you should not do Store it in a cool dry place away from moisture, heat or
sunlight; for example, do not store it:
• Do not stop using your medicine unless your doctor
• in the bathroom or near a sink, or
tells you to. If you stop using it, your blood sugar
• in the car or on window sills.
levels may increase.
• Do not use this medicine if you think it has been Keep it where young children cannot reach it.
frozen or exposed to excessive heat. It will not work as
well. When to discard your medicine
• Do not use this medicine to treat any other complaints
Discard the Ozempic® pen you are using after 6 weeks
unless your doctor tells you to.
even if there is still some medicine left in it.
• Do not give your medicine to anyone else, even if they
have the same condition as you. Dispose of used needles safely into a yellow plastic sharps
• Do not share your pen or needles with anyone else. container.
Ozempic® 4
Getting rid of any unwanted medicine • feeling nervous or anxious,
shaking (tremor), fast heart beat
If you no longer need to use this medicine or it is out of
• feeling confused, difficulty
date, take it to any pharmacy for safe disposal.
concentrating.
Do not use this medicine after the expiry date. The expiry Other effects
date refers to the last day of that month. • gallstones
• inflamed gall bladder
• dehydration.
6. Are there any side effects? When initiating treatment with
All medicines can have side effects. If you do experience Ozempic®, you may in some cases
any side effects, most of them are minor and temporary. experience dehydration as a result of
However, some side effects may need medical attention. vomiting, nausea or diarrhoea. It is
important to avoid dehydration by
See the information below and, if you need to, ask your
drinking plenty of fluids.
doctor or pharmacist if you have any further questions
about side effects.
The most common side effects when using Ozempic® are Serious side effects
diarrhoea and nausea. These side effects are usually mild
and normally decrease with continued use. Serious side effects What to do
Call your doctor
Less serious side effects Acute pancreatitis:
straight away,
• Inflamed pancreas (acute or go straight
Less serious side effects What to do pancreatitis) which could cause to the
General effects severe pain in the stomach and Emergency
Speak to your back which does not go away. .
• decreased appetite Department at
doctor if you
• headache your nearest
have any of Allergic reaction:
• vomiting (being sick) hospital if you
these less
• indigestion (dyspepsia) • skin rashes over a large part of the notice any of
serious side
• burping, wind (flatulence) or body these serious
effects and
constipation • shortness of breath, wheezing side effects.
they worry you.
• heartburn • swelling of the face, lips or tongue
• painful or swollen stomach • fast pulse
(abdomen) • sweating.
• blocked or runny nose, sneezing,
cough and/or sore throat (upper
respiratory tract infection) Tell your doctor or pharmacist if you notice anything else
• injection site reactions (such as that may be making you feel unwell.
bruising, pain, irritation, itching Other side effects not listed here may occur in some
and rash) people.
• fast heart beat
• feeling tired Reporting side effects
• feeling dizzy After you have received medical advice for any side effects
• changes to your vision or eyesight you experience, you can report side effects to the
• unpleasant, abnormal or altered Therapeutic Goods Administration online at
taste sensation www.tga.gov.au/reporting-problems. By reporting side
• increase in pancreas blood test effects, you can help provide more information on the
results safety of this medicine.
Hypoglycaemia Always make sure you speak to your doctor or
• low blood sugar (a hypo). pharmacist before you decide to stop taking any of your
Hypos are more likely to occur if you medicines.
are also taking a sulfonylurea (such If you are
as glimepiride or glibenclamide) or already taking a
insulin. A hypo may come on sulfonylurea or 7. Product details
suddenly. The warning signs of a insulin, your
hypo can include: This medicine is only available with a doctor's prescription.
doctor may
• cold sweat, cool pale skin reduce the dose
• headache of these
• feeling sick medicines
• feeling very hungry before you start
• changes in vision using Ozempic®.
• feeling sleepy, feeling weak
Ozempic® 5
What Ozempic® contains
Active ingredient semaglutide
(main ingredient)
Other ingredients • dibasic sodium phosphate
(inactive ingredients) dihydrate
• propylene glycol
• phenol
• hydrochloric acid
• sodium hydroxide
• water for injections.
Potential allergens phenol
Ozempic® 6
Ozempic®
semaglutide 1 mg/dose solution for injection pre-filled pen
Paper tab
NovoFine® Plus needles are included in the pack.
Pen window
Pen label
Dose counter
Dose pointer
Dose selector
Flow
Dose button check
symbol
Important information
Pay special attention to these notes, as they are important for safe use of the pen.
Ozempic® 7
1. Prepare your pen with a new needle
Check the name and coloured label of your pen to make sure that it contains
Ozempic® 1 mg/dose. This is especially important if you take more than one type of
injectable medicine. Using the wrong medicine could be harmful to your health.
A. Pull off the pen cap. A
B. Check that the solution in your pen is clear and colourless. Look through the B
pen window. If the solution looks cloudy or coloured, do not use the pen.
C. Take a new needle and tear off the paper tab. If the paper tab is broken, do not C
use the needle, as sterility is not guaranteed.
D. Push the needle straight onto the pen. Turn until it is on tight. D
E. Pull off the outer needle cap and keep it for later. You will need it after the E
injection, to safely remove the needle from the pen.
F. Pull off the inner needle cap and throw it away. If you try to put it back on, you F
may accidentally stick yourself with the needle.
A drop of solution may appear at the needle tip. This is normal, but you must still
check the flow, if you use a new pen for the first time.
Do not attach a new needle to your pen until you are ready to take your injection.
Flow check
symbol
selected
Ozempic® 8
B. Hold the pen with the needle pointing up. Press and hold the dose button until B
the dose counter returns to 0. The 0 must line up with the dose pointer.
A drop of solution should appear at the needle tip.
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 ‘Check the flow’ up to 6 times. If there is still no drop, change the needle and
repeat step 2 ‘Check the flow’ once more.
If a drop still does not appear, dispose of the pen and use a new one.
Always make sure that a drop appears at the needle tip before you use a
new pen for the first time. This makes sure that the solution flows.
If no drop appears, you will not inject any medicine even though the dose
counter may move. This may indicate a blocked or damaged needle.
If you do not check the flow before your first injection with each new pen,
you may not get the prescribed dose and the intended effect of Ozempic®.
1 mg
selected
Only the dose counter and dose pointer will show that 1 mg has been selected.
You can only select 1 mg per dose. When your pen contains less than 1 mg, the dose counter stops before 1 is
shown.
The dose selector clicks differently when turned forwards, backwards or past 1 mg. Do not count the pen clicks.
Always use the dose counter and dose pointer to see that 1 mg has been selected before injecting this
medicine.
Do not count the pen clicks.
Only doses 1 mg must be selected with the dose selector. 1 mg must line up precisely with the dose pointer to
ensure that you get a correct dose.
How much solution is left
A. To see how much solution is left, use the dose counter: Turn the dose selector A
until the dose counter stops.
If it shows 1, at least 1 mg is left in your pen.
If the dose counter stops before 1 mg, there is not enough solution left for a full
dose of 1 mg.
Dose counter
stopped:
1 mg left
If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic® pen.
Ozempic® 9
4. Inject your dose
A. Insert the needle into your skin as your doctor or nurse has shown you. A
Make sure you can see the dose counter.
Do not cover it with your fingers. This could interrupt the injection.
B. Press and hold down the dose button until the dose counter shows 0. The 0 B
must line up with the dose pointer. You may then hear or feel a click.
C. Keep the needle in your skin after the dose counter has returned to 0 and count C Count slowly:
slowly to 6.
1-2-3-4-5-6
If the needle is removed earlier, you may see a stream of solution coming from the
needle tip. If so, the full dose will not be delivered.
D. Remove the needle from your skin. If blood appears at the injection site, press D
lightly. Do not rub the area.
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose.
Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose
counter shows 0.
How to identify a blocked or damaged needle
– If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a
blocked or damaged needle.
– In this case, you have not received any medicine – even though the dose counter has moved from the
original dose that you have set.
How to handle a blocked needle
Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare
your pen with a new needle’. Make sure that you select the full dose you need.
Never touch the dose counter when you inject. This can interrupt the injection.
Ozempic® 10
B. Once the needle is covered, carefully push the outer needle cap completely on. B
Unscrew the needle and dispose of it carefully.
C. Put the pen cap on your pen after each use to protect the solution from light. C
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles. If
the needle is blocked, you will not inject any medicine.
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse or pharmacist.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always remove the needle from your pen immediately after each injection.
This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Further important information
Always keep your pen and needles out of the sight and reach of others, especially children.
Never share your pen or your needles with other people.
Caregivers must be very careful when handling used needles to prevent needle injury and cross-infection.
Ozempic® 11