Package leaflet: information for the patient

Ozempic 0.5 mg solution for injection in pre-filled pen

semaglutide

This medication is subject to additional monitoring, which will speed up the detection of new information
about its safety. You can help by reporting any adverse effects you may have. The final part of section 4
includes information on how to report these side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information
for you.
– Please keep this leaflet as you may need to read it again.
– If you have any questions, ask your doctor, pharmacist or nurse.
– This medicine has been prescribed only for you and should not be given to other people.
even if they have the same symptoms as you, since it can harm them.
– If you experience side effects, talk to your doctor, pharmacist or nurse, even if
These are side effects that are not listed in this leaflet. See section 4.

Leaflet content

1. What Ozempic is and what it is used for

2. What you need to know before you start using Ozempic
3. How to use Ozempic
4. Possible adverse effects
5. Conservation of Ozempic
6. Package contents and additional information

1. What Ozempic is and what it is used for

Ozempic contains the active substance semaglutide. It helps your body lower blood sugar only when blood
sugar is too high and can help prevent heart disease.

Ozempic is used:
• as the only antidiabetic medication: if your blood sugar level is not controlled properly
adequately with diet and exercise alone, and cannot use metformin (another diabetes medicine) or
• with other diabetes medications: when these are not enough to control your
blood sugar levels. These other medications may include oral antidiabetics (such as metformin,
thiazolidinediones, and sulfonylureas) or insulin.

It is important that you continue with the diet and exercise plan prescribed by your doctor, pharmacist, or nurse
.

2. What you need to know before you start using Ozempic

Do not use Ozempic:

• if you are allergic to semaglutide or any of the other ingredients of this medicine
(included in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using this medicine.

This medicine is not an insulin and should not be used if:

• suffers from type 1 diabetes, a disease in which the body does not produce any insulin;
• develops diabetic ketoacidosis, a complication of diabetes that is characterized by high

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 blood sugar level, difficulty breathing, confusion, excessive thirst, sweet-smelling breath, or a sweet or
metallic taste in the mouth.

Ozempic is not an insulin and therefore should not be used as an insulin substitute.

Effects on the digestive system

During treatment with this medication, you may have nausea, vomiting, or even diarrhea. These side effects
can cause dehydration (fluid loss). It is important to drink plenty of fluids to avoid dehydration. This is
especially important if you have kidney problems. If you have any questions, consult your doctor.

Severe, continuous stomach pain that may be due to acute pancreatitis

If you have severe and continuous pain in the stomach area, see a doctor immediately, as it could be a
symptom of acute pancreatitis (inflammation of the pancreas).

Hypoglycemia
Combining a sulfonylurea or insulin with this medication may increase the risk of experiencing low blood
sugar (hypoglycemia). See section 4 for warning symptoms of low blood sugar. Your doctor may ask you to
test your blood sugar levels. This will help your doctor decide if the dose of sulfonylurea or insulin needs to be
changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medication may cause your vision to worsen for
which you may need treatment. Tell your doctor if you have diabetic eye disease or experience eye problems
during treatment with this medication .

Children and adolescents

This medication is not recommended for children and adolescents under 18 years of age as safety and
effectiveness have not yet been established in these age groups.

Other medications and Ozempic

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines,
including herbal medicines or other medicines obtained without a prescription.

In particular, tell your doctor, pharmacist or nurse if you are using medicines that contain any of the following
ingredients:
• Warfarin or other similar oral medications to reduce blood clotting
(oral anticoagulants). Frequent blood tests may be necessary to determine your blood's ability to clot.
• If you are using insulin, your doctor will tell you how to reduce your insulin dose and
will recommend monitoring your blood sugar levels more frequently to avoid hyperglycemia (high
blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot
break down glucose because it cannot there is enough insulin).

Pregnancy and lactation

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.

This medication should not be used during pregnancy because it is unknown if it could affect the fetus.
Therefore, it is recommended to use contraception while using this medication. If you want to become
pregnant, you should stop using this medicine at least two months in advance. If you become pregnant while
using this medication, consult your doctor immediately as your treatment will need to be changed.

Do not use this medication during breast-feeding as it is unknown if it passes into breast milk.

Driving and using machines

If you use this medication in combination with a sulfonylurea or insulin, you may experience low blood sugar
(hypoglycemia), which may reduce your ability to concentrate. Avoid driving or using machines if you
experience any symptoms of low blood sugar. See Section 2, “Warnings and Precautions,” for information

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about the increased risk of low blood sugar and Section 4 for warning symptoms of low blood sugar. Consult
your doctor for more information.

sodium content
This medication contains less than 1 mmol sodium (23 mg) per dose; that is, essentially “sodium-free.”

3. How to use Ozempic

Exactly follow the instructions for administering this medication given by your doctor. If in doubt, consult
your doctor, pharmacist or nurse again.

How much to use

• The starting dose is 0.25 mg once a week for four weeks.
• After four weeks, your doctor will increase the dose to 0.5 mg once a week.
• Your doctor may increase your dose to 1 mg once a week if your blood sugar level
Blood is not adequately controlled with a dose of 0.5 mg once a week.
Do not change your dose unless your doctor tells you to.

How to administer Ozempic

Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject into a vein or muscle.
• The best areas for injection are the front of your thigh, the front of your waist
(abdomen) or upper arm.
• Before you use the pen for the first time, your doctor or nurse will show you how to use it.
On the other side of this leaflet you will find detailed instructions on its use.

When to use Ozempic

• You should use this medicine once a week, on the same day of the week if possible.
• The injection can be given at any time of the day, regardless of meals.

To help you remember to inject this medication only once a week, it is a good idea to write down the day of
the week you choose (for example, Wednesday) on the box, as well as the date of each injection.

If necessary, you can change the day of the weekly injection of this medication, as long as at least 3 days have
passed since the last injection. Once the new administration day has been selected, you should continue with
the weekly dosing schedule.

If you use more Ozempic than you should

If you use more Ozempic than you should, consult your doctor immediately. You may experience side effects
such as nausea.

If you forget to use Ozempic

If you forget to inject a dose and:
• It has been 5 days or less since you should have used Ozempic, use it as soon as you
agree. Then take your next dose as usual on the scheduled day;
• It has been more than 5 days since you should have used Ozempic, skip the missed dose.
Then take your next dose as usual on the scheduled day.
Do not use a double dose to make up for a missed dose.

If you stop taking Ozempic

Do not stop taking this medicine without talking to your doctor. If you stop taking it, your blood sugar levels
may increase.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

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4. Possible adverse effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious adverse effects

Common: may affect up to 1 in 10 people

• complications of diabetic eye disease (retinopathy); if you experience problems
eye problems, such as changes in vision during treatment with this medicine, you should tell your
doctor.

Uncommon: may affect up to 1 in 100 people

• Inflamed pancreas (acute pancreatitis) which can cause severe pain that does not go away
in the stomach and back. If you experience such symptoms, see your doctor immediately.

Rare: may affect up to 1 in 1,000 people

• severe allergic reactions (anaphylactic reactions). You should seek medical help and inform
Call your doctor immediately if you experience symptoms such as breathing problems, swelling of the
face and throat, and palpitations.

Other adverse effects

Very common: may affect more than 1 in 10 people

• nausea; This effect usually disappears over time.
• diarrhea; This effect usually disappears over time.

Common: may affect up to 1 in 10 people

• vomiting
• low blood sugar (hypoglycemia), when this medicine is used with another
antidiabetic medication

The warning symptoms of low blood sugar can appear suddenly. Some of these symptoms are: cold sweat,
cold, pale skin, headache, palpitations, nausea or excessive appetite, vision changes, drowsiness or feeling
weak, nervousness, anxiety or confusion, difficulty concentrating, and tremors.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning symptoms.

This low blood sugar is more likely to happen if you also use a sulfonylurea or insulin. Your doctor may
reduce the dose of these medications before you start using this medication.

• indigestion
• inflamed stomach (gastritis); symptoms include stomach pain, nausea or vomiting
• reflux or heartburn; Also called “gastroesophageal reflux disease.”
(GERD)”
• stomachache
• stomach swelling
• constipation
• burps
• stones in the gallbladder
• dizziness
• fatigue
• weightloss
• decreased appetite
• gas (flatulence)
• increased pancreatic enzymes (such as lipase and amylase).

Uncommon: may affect up to 1 in 100 people

• changes in the taste of foods and drinks

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• rapid pulse
• injection site reactions such as bruising, pain, irritation, itching and rash.

Reporting of adverse effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System
for Medicines for Human Use : www.notificaRAM.es . By reporting side effects you can help provide more
information about the safety of this medicine.

5. Conservation of Ozempic

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen label and carton after EXP. The
expiration date is the last day of the month indicated.

Before opening:
Store in the refrigerator (between 2°C and 8°C). Do not freeze. Keep away from walls or cooling component of
refrigerator. Protect from light.

During use:
• You can keep the pen for 6 weeks if stored below 30°C or in the refrigerator
(between 2°C and 8°C), away from the walls or cooling component of the refrigerator. Do not freeze
Ozempic and do not use it if it has been frozen.
• When not in use, keep the pen with the cap on to protect it from light.

Do not use this medicine if you notice that the solution is not clear and colorless or almost colorless.

Medications should not be disposed of down drains or in the trash. Ask your pharmacist how to dispose of
containers and medicines you no longer need. This way you will help to protect the environment.

6. Package contents and additional information

Composition of Ozempic

• The active ingredient is semaglutide. One ml of injectable solution contains 1.34 mg of

semaglutide. One prefilled pen contains 2 mg of semaglutide in 1.5 ml of solution. Each dose
contains 0.5 mg of semaglutide in 0.37 ml.
• The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for
injectable preparations, sodium hydroxide/hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the packaging

Ozempic is a clear, colorless or almost colorless solution for injection in a pre-filled pen. Each pen contains
1.5 ml of solution, being able to administer 4 doses of 0.5 mg.

Ozempic 0.5 mg solution for injection is available in the following pack sizes :
1 NovoFine Plus disposable pen and 4 needles.
3 disposable pens and 12 NovoFine Plus needles.

Only certain pack sizes may be marketed.

Marketing authorization holder and responsible for manufacturing

Novo Nordisk A/S
New Allé
DK-2880 Bagsværd

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Denmark

Date of last revision of this leaflet: 03/2020

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency
http://www.ema.europa.eu .

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Instructions for use of Ozempic 0.5 mg solution for injection in pre-filled pen

Please read these instructions carefully before using your

Ozempic pre-filled pen.
Do not use the pen without receiving proper training from your
doctor or nurse. Ozempic pre-filled pen and
Start by checking the pen to make sure it contains Ozempic 0.5 needle (example)
mg , and then look at the images below to familiarize yourself with
the different parts of the pen and needle.
If you are blind or have low vision and cannot read the dose
Cap
counter on the pen, do not use this pen without assistance. Seek Cap
help from a person who can see well and is trained in using the exterior of
Ozempic pre-filled pen. feather I'm the needle
Your pen is a pre-filled metering pen. It contains 2 mg of
semaglutide and you can only select 0.5 mg doses. The pen is n Cap
designed to be used with NovoFine and NovoTwist disposable rj
needles up to 8 mm in length. inside of the
The packaging includes NovoFine Plus needles. needle
Needles are medical products. gq Aoiiia
Needle

A.K.
and-- Tongue
Window of paper
of the
L.L. feather

N
pen label
•
TO
Dose counter
Dose marker
Symbol
Selector
dose (Vm >
of
check-
Button bation of
flow
1. Preparing the pen with a new needle
• Check the name and label color of your TO
pen to make sure it contains Ozempic. This is especially
important if you use more than one type of injectable
medication. Using the wrong medication could cause
serious damage to your health. BOXWOOD
• Remove the pen cap.

• Check that the pen solution is

transparent and colorless. Look through the pen window.
If the solution looks cloudy or colored, do not use the pen.

©=
c
• Take a new needle.
Check the paper tab and outer needle cap for damage that
could affect sterility. If you see any damage use a new
needle.
• Remove the paper tab.

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• Place the needle straight into the pen. Screw it up d
make it tight.

• Remove the outer needle cap and store it

for later. You will need it after the injection to safely
remove the needle from the pen.

V0
F
• Remove the inner needle cap and discard it. Yeah
try to put it back, you could accidentally stick yourself with
the needle. Yes,\

A drop of solution may appear at the tip of the needle. This is

normal, but you should still check the flow if it is a new pen and
you are using it for the first time. See step 2 “Flow Check”.
Do not put a new needle in the pen until you are ready to give
yourself an injection.
TO Always use a new needle for each injection.
This reduces the risk of needle sticking, contamination, infection and inaccurate dosing.

Never use a bent or damaged needle.

2. Flow Check
• Check flow before first injection with
every new pen. If the pen is already in use, go to step 3,
“Dose selection.” TO
• Turn the dose selector until the dose counter
Uo 1 —Of —6
dose the flow check symbol ( ) appears.
Selected flow check symbol

• Hold the pen with the needle pointing up. b

l
Press and hold the button until the dose counter returns to 1 1 p
0. The 0 should be aligned with the dose marker.
A drop of solution should appear at the tip of the needle.

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l

needle and repeat step 2 “Flow Check” one more time. tD

A small drop may remain on the tip of the needle, but it will not be injected.
If no drops appear, repeat step 2 “Flow Check” a maximum of 6 times. If no drop is still visible, change the

If, despite everything, no drop appears, throw away the pen and use a new one.
TO Always make sure a drop appears at the tip of the needle before using a pen
new for the first time. This ensures that the solution flows.

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 If no drop appears, no medication will be injected, even if the dose counter moves.
This may indicate that the needle is clogged or damaged.
If you do not check the flow before the first injection with each new pen, you may not receive the
prescribed dose or achieve the intended effect of Ozempic.
3. Dose selection
• TO
Turn the dose selector until 0.5 mg is selected. Continue
UAi M stR
turning until the dose counter stops and shows 0.5 mg.

05- 0.5mg
selected

Only the dose counter and dose marker will show that 0.5 mg has been selected.
The dose selector makes a different click when turned forward, backward or beyond 0.5 mg. Don't count the
pen clicks.
TO Before injecting this medication, always use the dose counter and dose marker to see that you
have selected 0.5 mg.
Don't count the pen clicks.
The 0.5 mg dose on the dose counter must be exactly aligned with the dose marker to ensure you
receive the correct dose.
How much solution is left
• To find out how much solution is left, use the dose TO

counter: turn the dose selector until the dose counter stops. A0 - ~
If it shows 0.5, there is at least 0.5 mg left in the pen.
If the dose counter stops before 0.5 mg, there is not
enough solution left for a full 0.5 mg dose. Accountant of
05 Stopped dose:
remain

If there is not enough solution left in the pen for a full dose, do not use it. Instead, use a new Ozempic
pen.
4. Dose injection
• Insert the needle under the skin as your doctor or nurse TO

has taught you.

• Check that you can see the dose counter. Do not cover it
with your fingers. This could interrupt the injection.

• Press and hold the button until the dose counter shows b
0. The 0 should be aligned with the dose marker. At this
point you may hear or notice a click.
0- '-J —U---------------

• Hold the needle under the skin after the dose counter has C Count slowly:

returned to 0 and slowly count to 6. This ensures that the 1-2-3-4-5-6

full dose is administered.
If you remove the needle early, you may see solution
• coming out of the tip of the needle. In this case, the full
dose will not have been administered. ——------------------------—

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• Remove the needle from the skin. If blood appears at the d
site
injection, press lightly. Do not rub the area. ■w
Yo

A drop of solution may appear on the tip of the needle after the injection. This is normal and does not affect
your dose.
TO Always watch the dose counter to know how many mg you are injecting. Press and hold the
push button until the dose counter indicates 0.

How to detect if the needle is clogged or damaged

– If 0 does not appear in the dose counter after continuously pressing the button, you may
who has used a clogged or damaged needle.
– In this case, you will not have received any medication, even if the dose counter
has moved from the original dose you set.

What to do if the needle is clogged

Change the needle as described in step 5 “After the injection” and repeat all steps from step 1
“Preparing the pen with a new needle”. Be sure to select the full dose you need.

Never touch the dose counter during injection. This may interrupt the injection.

5. After injection
• Insert the tip of the needle into its cap TO
outside, placed on a flat surface, without touching the <be
needle or the outside cap.

• When the needle is protected, carefully press b

the outer needle cap all the way down.
• Unscrew the needle and carefully discard it.
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according to local regulations. Ask your doctor, pharmacist
or nurse about disposal of sharps.
• Put the cap back on the pen after each use to c
Protect the solution from light.
—
406
DB
Always throw away the needle after each injection to ensure that injections are given correctly and to
prevent needles from getting stuck. If the needle is clogged, no medicine will be injected.
When the pen is empty, throw it away without the needle attached, following the instructions of your doctor,
nurse, pharmacist or local authorities.
TO Never try to put the inner cap back on the needle. You could get stuck with the needle.
TO Always remove the needle from the pen immediately after each injection.
This reduces the risk of needle sticking, contamination, infection, loss of solution and inaccurate
dosing.
TO Other important information
• Always keep the pen and needles out of the sight and reach of other people,
especially from children.
• Never share the pen or needles with others.

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0
• People caring for patients should be very careful when handling needles.
used to avoid accidental punctures and infections.
Maintaining your pen
Handle the pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens, you may
not get the intended effect of this medication.
• Do not inject Ozempic that has been frozen. If you do so, you may not achieve the effect
planned for this medication.
• Do not inject Ozempic if it has been exposed to direct sunlight. If you do, you may not
achieve the intended effect of this medication.
• Do not expose the pen to dust, dirt, or liquids.
• Do not wash, wet or lubricate the pen. If necessary, clean it with a cloth dampened with a
mild detergent.
• Be careful not to drop the pen or hit it against hard surfaces. If you drop your pen or
suspect you may have a problem, insert a new needle and check the flow before injecting.
• Do not try to refill the pen. Once empty, it should be discarded.
• Do not attempt to repair or disassemble the pen.

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