Ozempic

Italy
Brand name Ozempic
Form solution for injection
Active substance / Dosage
SEMAGLUTIDE
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
A10BJ06
Registration number 046128
Manufacturer NOVO NORDISK A/S
Ozempic solution for injection

Table of Contents

Package leaflet: Information for the patient

Ozempic 0.25 mg solution for injection in pre-filled pen

semaglutide
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

  1. What Ozempic is and what it is used for
  2. What you need to know before you use Ozempic
  3. How to use Ozempic
  4. Possible side effects
  5. How to store Ozempic
  6. Contents of the pack and other information

1. What Ozempic is and what it is used for

Ozempic contains the active substance semaglutide, which helps the body reduce blood sugar levels only when they are too high, and can help prevent heart disease in patients with type 2 diabetes mellitus. It also helps slow the decline in kidney function in patients with type 2 diabetes through a mechanism beyond blood glucose reduction.
Ozempic is used to treat adults (aged 18 years and older) with type 2 diabetes mellitus when diet and exercise alone are not sufficient:

  • on its own – when metformin (another diabetes medicine) cannot be used, or
  • in combination with other diabetes medicines, when these are not sufficient to control blood sugar levels. These medicines may be given orally or by injection, such as insulin.

It is important that you continue to follow the diet and exercise programme recommended by your doctor, pharmacist, or nurse.

2. What you should know before using Ozempic

Do not use Ozempic

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using this medicine.
This medicine is not insulin and you must not use it if:

  • you have type 1 diabetes, a condition in which your body does not produce insulin
  • you develop diabetic ketoacidosis, a complication of diabetes involving high blood sugar levels, breathing difficulties, confusion, excessive thirst, sweet-smelling breath, or a sweet or metallic taste in the mouth.

Ozempic is not insulin and therefore must not be used as a substitute for insulin.
If you are undergoing surgery under anaesthesia, inform your doctor that you are taking Ozempic.

Stomach and intestinal problems and dehydration
During treatment with this medicine, you may experience nausea, vomiting, or diarrhoea. These side effects may cause dehydration (loss of fluids). It is important that you drink plenty of fluids to prevent dehydration. This is particularly important if you have kidney problems. Contact your doctor if you have concerns or questions.

Severe and persistent stomach pain which may be due to acute pancreatitis
If you have severe and persistent pain in the stomach area, seek immediate medical attention as this may be a sign of acute pancreatitis (inflammation of the pancreas). See section 4 for signs indicating inflammation of the pancreas.

Low blood sugar levels (hypoglycaemia)
Combining a sulphonylurea or insulin with this medicine may increase the risk of low blood sugar levels (hypoglycaemia). See section 4 for warning signs of low blood sugar levels. Your doctor may ask you to monitor your blood sugar levels. This will help your doctor decide whether the dose of sulphonylurea or insulin needs to be adjusted to reduce the risk of low blood sugar levels.

Diabetic retinopathy (a diabetes complication affecting the eyes)
If you have had diabetic retinopathy and are using insulin, this medicine may lead to worsening eyesight, which may require treatment. Inform your doctor if you have diabetic retinopathy or if you experience eye problems during treatment with this medicine.
The use of Ozempic 2 mg is not recommended in cases of potentially unstable diabetic retinopathy.

Sudden changes in vision
If you notice sudden vision loss or rapid worsening of vision during treatment with this medicine, contact your doctor immediately for advice. This could be caused by a very rare side effect called non-arteritic anterior ischemic optic neuropathy (NAION) (see section 4: Serious side effects). Your doctor may recommend an eye examination and may need to discontinue treatment with this medicine.

Patients with delayed gastric emptying (gastroparesis)
If you suffer from slow (delayed) gastric emptying (called gastroparesis), using Ozempic may cause severe or serious gastrointestinal adverse events. Consult your doctor before using Ozempic.

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age, as efficacy and safety have not yet been established in this age group.

Other medicines and Ozempic
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other medicines purchased without a prescription.
In particular, inform your doctor, pharmacist, or nurse if you are taking medicines containing:

  • Warfarin or similar oral medicines taken to reduce blood clotting (oral anticoagulants). Frequent blood tests are needed to determine your blood clotting speed.
  • If you are using insulin, your doctor will advise you on how to reduce your insulin dose and recommend more frequent blood glucose monitoring to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a diabetes complication that occurs when the body cannot break down glucose due to insufficient insulin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
This medicine must not be used during pregnancy because it is not known whether it could harm the unborn child. Therefore, you are advised to use a contraceptive method while using this medicine. If you plan to become pregnant, talk to your doctor about changing your therapy, as you must stop using this medicine at least 2 months before conception. If you become pregnant while using this medicine, contact your doctor immediately, as your treatment will need to be changed.
Do not use this medicine if you are breastfeeding, as it is not known whether Ozempic passes into breast milk.

Driving and using machines
It is unlikely that Ozempic will affect your ability to drive or operate machinery. However, if you use this medicine in combination with a sulphonylurea or insulin, low blood sugar levels (hypoglycaemia) may occur, which could impair your ability to concentrate. Do not drive or operate machinery if you experience signs of low blood sugar levels. See section 2, “Warnings and precautions”, for information on the increased risk of low blood sugar levels and section 4 for warning signs of low blood sugar levels. Consult your doctor for further information.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to use Ozempic

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor, pharmacist, or nurse.

How much medicine 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 the dose to 1 mg once a week if your blood sugar level is not adequately controlled with a 0.5 mg once-weekly dose.
  • Your doctor may increase the dose to 2 mg once a week if your blood sugar level is not adequately controlled with a 1 mg once-weekly dose.

Do not change the dose unless your doctor tells you to do so.

How Ozempic is administered

Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or into a muscle.

  • The best places to give the injection are the front of the thighs, the abdomen (tummy), or the upper arm.
  • Before you use the pen for the first time, your doctor or nurse will show you how to do it. Detailed instructions for use are provided on the reverse of this leaflet.

When to use Ozempic

  • You must use this medicine once a week, preferably on the same day each week.
  • You can inject it at any time of day, regardless of meals.

To help you remember to inject this medicine only once a week, it is recommended that you write the chosen day of the week (e.g. Wednesday) on the carton and record the date on the carton each time you inject Ozempic.

If necessary, you may change the day of the weekly injection of this medicine, provided at least 3 days have passed since the last dose. Once you have chosen a new administration day, continue with weekly administration on that day.

If you use more Ozempic than you should

If you use more Ozempic than you should, inform 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:

  • 5 days or fewer have passed since you were supposed to use Ozempic, inject it as soon as you remember. Then inject the next dose on your usual scheduled day.
  • more than 5 days have passed since you were supposed to use Ozempic, skip the missed dose. Then inject the next dose on your usual scheduled day. Do not use a double dose to make up for the forgotten dose.

If you stop using Ozempic

Do not stop treatment with this medicine without first talking to your doctor. If you stop treatment, your blood sugar levels may rise.

If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Common (affects up to 1 in 10 people)

  • Complications of retinopathy – you should speak with your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (affects up to 1 in 100 people)

  • Inflammation of the pancreas (acute pancreatitis) which may cause severe stomach and back pain that does not go away. You must consult a doctor immediately if you experience these symptoms.

Rare (affects up to 1 in 1,000 people)

  • Severe allergic reactions (anaphylactic reactions, angioedema). You must seek immediate medical assistance and inform your doctor immediately if you experience symptoms such as breathing difficulties, swelling of the face, lips, tongue and/or throat with difficulty swallowing, and rapid heartbeat.

Very rare (affects up to 1 in 10,000 people)

  • A medical condition affecting the eye called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause loss of vision in one eye without any pain. You must contact your doctor immediately if you notice sudden loss or gradual worsening of vision (see section 2: "Sudden changes in vision").

Not known (frequency cannot be estimated from the available data)

  • Intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.

Other side effects
Very common (affects more than 1 in 10 people)

  • Nausea – usually resolves over time
  • Diarrhoea – usually resolves over time
  • Low blood sugar levels (hypoglycaemia) when this medicine is used with other diabetes medicines containing sulphonylurea or insulin

Warning signs of low blood sugar levels may occur suddenly. They may include: cold sweat, cold and pale skin, headache, rapid heartbeat, nausea or feeling very hungry, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating or tremor.
Your doctor will tell you how to treat low blood sugar levels and what to do if you notice these warning signs.
Low blood sugar levels are more likely to occur if you are also taking a sulphonylurea or insulin. Before you start using this medicine, your doctor may reduce the dose of these medicines.

  • Difficulty digesting
  • Inflammation of the stomach (gastritis). Signs include stomach pain, nausea and vomiting
  • Reflux or heartburn, also known as gastroesophageal reflux disease (GERD)
  • Stomach pain
  • Stomach bloating
  • Constipation
  • Belching
  • Gallstones
  • Dizziness
  • Tiredness
  • Weight loss
  • Decreased appetite
  • Intestinal gas (flatulence)
  • Increased levels of pancreatic enzymes (such as lipase and amylase)
  • Headache

Uncommon (affects up to 1 in 100 people)

  • Change in taste of food or drinks
  • Rapid pulse
  • Injection site reactions, such as bruising, pain, irritation, itching, and skin rash
  • Allergic reactions such as rash, itching or hives
  • Delayed emptying of the stomach

Not known (frequency cannot be estimated from the available data)

  • Skin sensitivity changes

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ozempic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and on the box after 'Exp.'. The expiry date refers to the last day of that month.
Before first use:
Store in a refrigerator (2 °C–8 °C). Do not freeze. Keep away from the cooling elements.
Keep the cap on the pen to protect the medicine from light.
After first use:

  • The pen may be stored for up to 6 weeks at a temperature below 30 °C or in the refrigerator (2 °C–8 °C), away from the cooling elements. 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 the medicine from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ozempic contains

  • The active substance is semaglutide. One mL of injectable solution contains 1.34 mg of semaglutide. A pre-filled pen contains 2 mg of semaglutide in 1.5 mL of solution. Each dose contains 0.25 mg of semaglutide in 0.19 mL.
  • The other components are: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2, "Sodium content".

Description of the appearance of Ozempic and contents of the pack
Ozempic is supplied as a clear, colourless or almost colourless injectable solution in a pre-filled pen. Each pre-filled pen contains 1.5 mL of solution and delivers 4 doses of 0.25 mg.
Ozempic 0.25 mg solution for injection is available in the following pack:
1 pen and 4 NovoFine Plus disposable needles.
Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Instructions for use

Ozempic 0.25 mg solution for injection in pre-filled pen

semaglutide

Instructions for use of Ozempic 0.25 mg injectable solution in a pre-filled pen
Read these instructions carefully before using your pre-filled Ozempic pen. Speak with your doctor, nurse, or pharmacist about how to correctly inject Ozempic. Use the medicine in the pen only as prescribed. Start by checking the pen to ensure it contains Ozempic 0.25 mg, then review the illustrations below to become familiar with the different parts of the pen and the needle. If you are blind or have severe vision problems and cannot read the dose counter, do not use this pen without assistance. Ask someone with good eyesight who knows how to use the Ozempic pre-filled pen to help you. The pen is a pre-filled, dose-selectable pen containing 2 mg of semaglutide. You can select doses of 0.25 mg. An unused pen contains four doses of 0.25 mg. After injecting four doses, some solution will remain in the pen. The pen must still be discarded. Use the table inside the box lid to keep track of how many injections you have administered and when you administered them. The pen is designed to be used with 30G, 31G, and 32G single-use needles up to 8 mm in length. NovoFine Plus needles are included in the package.Pre-filled Ozempic pen and needle (example) Pen cap Outer needle cap Inner needle cap Needle Protective seal Pen window Pen label Dose counter Dose indicator Dose selector Injection button Flow check symbol
Important InformationPay close attention to these notes, as they are important for the safe use of the pen.
Exploded diagram of an Ozempic pen showing the various components separated, such as cap, pen body, dose selector, and blue square base
  • 1. Preparing the pen with a new needle
  • Check the name and colored label on the pen to ensure it contains Ozempic 0.25 mg. This is especially important if you use more than one type of injectable medicine. Using the wrong medicine can harm your health. • Remove the cap from the pen.

A
Two hands hold a cylindrical blue and white medical device, with a dark arrow indicating a sliding movement to the right

  • Check that the solution in the pen is clear and colorless. Look through the pen window. If the solution appears cloudy or discolored, do not use the pen.
B
A hand holds a cylindrical blue and white medical device horizontally against a light blue background

  • Take a new needle. Check the protective seal and the outer needle cap for any damage that could affect sterility. If you notice any damage, use a new needle. • Remove the protective seal.
C
Two hands hold and rotate a cylindrical medical device, with a blue arrow indicating a counterclockwise rotational movement

Ensure the needle is properly attached• Push the needle straight onto the pen. • Rotate it until it is firmly secured.D
A hand rotates the top part of a pen-shaped medical device following the direction indicated by a curved arrow pointing downward

The needle is covered by two caps. You must remove both. If you forget to remove both caps, you will not be able to inject the solution. • Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.E
A hand holds a cap while the

  • Remove the inner needle cap and discard it. If you try to replace it, you may accidentally prick yourself with the needle. A drop of solution may appear at the tip of the needle. This is normal, but you should still perform a flow check if this is the first time using a new pen. See step 2, “Flow check with each new pen.” Do not attach a new needle to the pen until you are ready to administer the injection.
F
A hand moves a medical device to the right to engage it with another cylindrical component, indicated by a blue directional arrow

Always use a new needle for each injection. This prevents needle blockages, contamination, infections, and inaccurate dosing.
Never use a bent or damaged needle.




  • 2. Flow check with each new pen


Two hands hold a blue injection pen with a numerical indicator set to 0, and a curved arrow indicates rotation of the device

  • If the pen has already been used, go to step 3, “Selecting the dose.” Perform the flow check only before the first injection with a new pen. • Rotate the dose selector to the flow check symbol () immediately after “0”. Ensure the flow check symbol is aligned with the dose indicator.
A Flow check symbol selected


  • Hold the pen with the needle pointing upward. Press and hold the injection button until the dose counter resets to “0”. The “0” must align with the dose indicator. A drop of solution should appear at the needle tip.
B
A hand holds a blue and white injection pen with an arrow pointing toward the
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2, “Flow check with each new pen,” up to six times. If still no drop appears, change the needle and repeat step 2 once more. Discard the pen and use a new one if no solution drop appears.
Always ensure a drop appears at the needle tip before using a new pen for the first time. The presence of a drop confirms proper solution flow. If no drop appears, no medicine will be injected, even if the dose counter moves. This may indicate a blocked or damaged needle. If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and therefore may not achieve the intended effect of Ozempic.
  • 3. Selecting the dose

Two hands hold a blue injection pen with a curved arrow indicating rotation of the dosage dial set to 0.25 mg
  • Rotate the dose selector to select 0.25 mg. Turn it until the dose counter displays 0.25 mg.
A 0.25 mg selected
Only the dose counter and dose indicator show that 0.25 mg has been selected. You can select only 0.25 mg per dose. The dose selector makes a distinct click when rotated forward, backward, or beyond 0.25 mg. Do not count the clicks of the pen.
Before injecting this medicine, always use the dose counter and dose indicator to confirm that 0.25 mg has been selected. Do not count the clicks of the pen. Only 0.25 mg doses should be selected using the dose selector. 0.25 mg must align precisely with the dose indicator to ensure a correct dose is delivered.
  • 4. Injecting the dose

A hand holds an injection pen ready to be pressed downward onto a curved surface indicated by a blue arrow
  • Insert the needle into the skin as shown to you by your doctor or nurse. • Make sure you can see the dose counter. Do not cover it with your fingers, as this may interrupt the injection.
A
A hand presses a downward-pointing injection pen onto a surface, with a blue arrow indicating the downward movement

  • Press and hold the injection button. Watch as the dose counter returns to “0”. The “0” must align with the dose indicator. You may hear or feel a click. • Continue holding the injection button while the needle remains in the skin.
B




  • Count slowly to 6 while holding the injection button pressed. • If the needle is withdrawn before this, you may notice solution leaking from the needle tip. In this case, the full dose will not be delivered.
C 1-2-3-4-5-6 Count slowly
A hand holds an injection pen vertically, ready for
  • Remove the needle from the skin. You may then release the injection button. If bleeding occurs at the injection site, apply light pressure.
D
Illustration of an injection pen with a blue arrow pointing toward the

After injection, you may see a drop of solution at the needle tip. This is normal and does not affect the dose administered.
Always watch the dose counter to know how many mg you are injecting. Hold the injection button pressed until the dose counter returns to “0”. Identifying a blocked or damaged needle – If the dose counter does not show “0” after continuously pressing the injection button, you may have used a blocked or damaged needle. – In this case, no medicine will have been delivered, even if the dose counter moved from the originally set dose. Managing a blocked needle Replace the needle as described in step 5, “After the injection,” and repeat all steps starting from step 1, “Preparing the pen with a new needle.” Ensure you select the full required dose. Never touch the dose counter during injection, as this may interrupt the injection.
  • 5. After the injection
Always discard the needle after each injection to ensure comfortable injections and prevent needle blockages. If the needle is blocked, no medicine will be injected. • Insert the needle tip into the outer needle cap placed on a flat surface, without touching the needle or cap.A
  • Once the needle is covered, press the outer cap fully and carefully. • Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist, or local authorities.
B
A blue arrow indicates the motion of inserting a white protective cap onto the tip of a medical injection pen

  • Replace the pen cap on the pen after each use to protect the solution from light.
C
A hand pushes the top part of a cylindrical medical device downward with the thumb onto a flat surface

When the pen is empty, discard it without the needle attached, as instructed by your doctor, nurse, pharmacist, or local authorities.
Two hands hold a blue and white cylindrical medical device, with a black arrow indicating an insertion or leftward sliding movement

Never attempt to reinsert the inner needle cap after removing it. You may injure yourself with the needle. Always remove the needle from the pen immediately after each injection. This prevents needle blockages, contamination, infections, leakage of solution, and inaccurate dosing.
Additional important information




  • Always keep the pen and needles out of sight and reach of others, especially children. • Never share the pen or needles with other people. • Anyone assisting the patient must be very careful when handling used needles to prevent cross-infection and needle-stick injuries.

Pen maintenance
Handle the pen with care. Careless or incorrect use may result in inaccurate dosing. In such a case,
the desired effect of the medicine may not be achieved.

  • Do not leave the pen in a car or in other places where it could become too hot or too cold.
  • Do not inject Ozempic if it has been frozen. If injected, the desired effect of the medicine may not be achieved.
  • Do not inject Ozempic if it has been exposed to direct sunlight. If injected, the desired effect of the medicine may not be achieved.
  • Do not expose the pen to dust, dirt, or liquids.
  • Do not wash, immerse in liquid, or lubricate the pen. It may be cleaned with a mild detergent and a damp cloth.
  • Do not drop the pen or allow it to hit hard surfaces. If the pen is dropped or if you suspect a problem, attach a new needle and check the solution flow before injection.
  • Do not attempt to refill the pen.
  • Do not attempt to repair or disassemble the pen.

Patient information leaflet

Ozempic 0.5 mg solution for injection in pre-filled pen

semaglutide
Read this entire leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

  1. What Ozempic is and what it is used for
  2. What you need to know before using Ozempic
  3. How to use Ozempic
  4. Possible side effects
  5. How to store Ozempic
  6. Contents of the pack and other information

1. What Ozempic is and what it is used for

Ozempic contains the active substance semaglutide, which helps the body reduce blood sugar levels only when they are too high, and may help prevent heart disease in patients with type 2 diabetes mellitus. It also helps slow the decline in kidney function in patients with type 2 diabetes mellitus through a mechanism beyond blood glucose reduction.

Ozempic is used to treat adults (aged 18 years and older) with type 2 diabetes mellitus when diet and exercise alone are not sufficient:

  • on its own – when metformin (another diabetes medicine) cannot be used, or
  • in combination with other diabetes medicines, when these are not sufficient to control blood sugar levels. These medicines may be administered orally or by injection, such as insulin.

It is important that you continue the diet and exercise programme recommended by your doctor, pharmacist, or nurse.

2. What you need to know before using Ozempic

Do not use Ozempic

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using this medicine.
This medicine is not insulin and you should not use it if:

  • you have type 1 diabetes, a condition in which your body does not produce insulin
  • you develop diabetic ketoacidosis, a complication of diabetes involving high blood sugar levels, difficulty breathing, confusion, excessive thirst, sweet-smelling breath, or a sweet or metallic taste in the mouth.

Ozempic is not insulin and therefore should not be used as an insulin substitute.
If you are undergoing surgery with anaesthesia, inform your doctor that you are taking
Ozempic.
Stomach and intestinal problems and dehydration
During treatment with this medicine, you may experience nausea, vomiting, or diarrhoea. These
side effects may cause dehydration (loss of fluids). It is important that you drink plenty of fluids to
prevent dehydration. This is especially important if you have kidney problems. Contact your
doctor if you have any concerns or questions.
Severe and persistent stomach pain that may be due to acute pancreatitis
If you have severe and persistent pain in the stomach area, seek immediate medical attention as this
may be a sign of acute pancreatitis (inflammation of the pancreas). See section 4 for signs indicating
pancreatic inflammation.
Low blood sugar levels (hypoglycaemia)
Taking a sulphonylurea or insulin together with this medicine may increase the risk of low
blood sugar levels (hypoglycaemia). See section 4 for warning signs of low blood sugar levels. Your doctor may ask you to monitor your blood sugar levels. This will help your doctor decide whether the dose of sulphonylurea or insulin should be adjusted to reduce the risk of low blood sugar levels.
Diabetic retinopathy (a diabetes complication affecting the eyes)
If you have had diabetic retinopathy and are using insulin, this medicine may lead to worsening of vision, which may require treatment. Inform your doctor if you have diabetic retinopathy or if you develop eye problems during treatment with this medicine.
Use of Ozempic 2 mg is not recommended in cases of potentially unstable diabetic retinopathy.
Sudden changes in vision
If you notice sudden loss of vision or rapid worsening of vision during treatment with this
medicine, contact your doctor immediately for advice. This could be caused by a very rare side effect called non-arteritic anterior ischemic optic neuropathy (NAION) (see section 4: Serious side effects). Your doctor may recommend an eye examination and may need to discontinue treatment with this medicine.
Patients with delayed gastric emptying (gastroparesis)
If you suffer from slow (delayed) gastric emptying (called gastroparesis), using Ozempic may cause severe or serious gastrointestinal adverse events. Consult your doctor before using Ozempic.
Children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age as its efficacy and safety have not yet been established in this age group.
Other medicines and Ozempic
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other over-the-counter medicines.
In particular, inform your doctor, pharmacist, or nurse if you are taking medicines containing:

  • Warfarin or similar medicines taken by mouth to reduce blood clotting (oral anticoagulants). Frequent blood tests are needed to determine your blood clotting rate.
  • If you are using insulin, your doctor will advise you on how to reduce your insulin dose and recommend more frequent blood glucose monitoring to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a diabetes complication that occurs when the body cannot break down glucose due to insufficient insulin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
This medicine should not be used during pregnancy because it is not known whether it could harm the unborn child. Therefore, you are advised to use contraception while using this medicine. If you plan to become pregnant, talk to your doctor about changing your therapy, as you must stop using this medicine at least 2 months before conception. If you become pregnant while using this medicine, contact your doctor immediately, as your treatment will need to be changed.
Do not use this medicine if you are breastfeeding because it is not known whether Ozempic passes into breast milk.
Driving and using machines
It is unlikely that Ozempic will affect your ability to drive or operate machinery. However, if you use this
medicine in combination with a sulphonylurea or insulin, low blood sugar levels (hypoglycaemia) may occur, which could impair your concentration. Do not drive or operate machinery if you experience symptoms of low blood sugar. See section 2, “Warnings and precautions”, for information on increased risk of low blood sugar levels and section 4 for warning signs of low blood sugar levels. Consult your doctor for further information.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to use Ozempic

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor, pharmacist or nurse.

How much medicine to use

  • The starting dose is 0.25 mg once weekly for four weeks.
  • After four weeks, your doctor will increase the dose to 0.5 mg once weekly.
  • Your doctor may increase the dose to 1 mg once weekly if your blood sugar level is not adequately controlled with the 0.5 mg once-weekly dose.
  • Your doctor may increase the dose to 2 mg once weekly if your blood sugar level is not adequately controlled with the 1 mg once-weekly dose.

Do not change the dose unless your doctor tells you to do so.

How Ozempic is administered

Ozempic is administered by subcutaneous injection (an injection under the skin). Do not inject it into a vein or muscle.

  • The best sites for injection are the front of the thighs, the abdomen (tummy), or the upper arm.
  • Before you use the pen for the first time, your doctor or nurse will show you how to do it. Detailed instructions for use are provided on the back of this leaflet.

When to use Ozempic

  • You must use this medicine once a week, preferably on the same day each week.
  • You can inject it at any time of day, regardless of meals.

To help you remember to inject this medicine only once a week, it is recommended that you write the chosen day of the week (e.g. Wednesday) on the carton, and each time you inject Ozempic, write the date on the carton as well.

If necessary, you may change the day of the weekly injection of this medicine, provided at least 3 days have passed since the last injection. Once you have chosen a new day, continue with weekly administration on that day.

If you use more Ozempic than you should

If you use more Ozempic than you should, inform 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:

  • 5 days or fewer have passed since you were supposed to use Ozempic, inject it as soon as you remember. Then inject the next dose on your regularly scheduled day.
  • more than 5 days have passed since you were supposed to use Ozempic, skip the missed dose. Then inject the next dose on your regularly scheduled day. Do not use a double dose to make up for the forgotten dose.

If you stop using Ozempic

Do not stop treatment with this medicine without first talking to your doctor. If you stop treatment, your blood sugar levels may increase.

If you have any questions about how to use this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Serious side effects

Common (affects up to 1 in 10 people)

  • Retinopathy complications – you should speak to your doctor if you experience eye problems such as changes in vision during treatment with this medicine.

Uncommon (affects up to 1 in 100 people)

  • Inflammation of the pancreas (acute pancreatitis) which could cause severe stomach and back pain that does not go away. You must consult a doctor immediately if you experience these symptoms.

Rare (affects up to 1 in 1,000 people)

  • Serious allergic reactions (anaphylactic reactions, angioedema). You must seek immediate medical assistance and inform your doctor immediately if you experience symptoms such as breathing difficulties, swelling of the face, lips, tongue and/or throat with difficulty swallowing, and rapid heartbeat.

Very rare (affects up to 1 in 10,000 people)

  • A medical condition affecting the eye called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause painless vision loss in one eye. You must contact your doctor immediately if you notice sudden loss or gradual worsening of vision (see section 2: "Sudden changes in vision").

Not known (frequency cannot be estimated from the available data)

  • Intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.

Other side effects

Very common (affects more than 1 in 10 people)

  • Nausea – usually goes away with time
  • Diarrhoea – usually goes away with time
  • Low blood sugar levels (hypoglycaemia) when this medicine is used with other diabetes medicines containing sulphonylurea or insulin

Common (affects up to 1 in 10 people)

  • Vomiting
  • Low blood sugar levels (hypoglycaemia) when this medicine is used with another oral diabetes medicine other than sulphonylurea or with insulin

Warning signs of low blood sugar levels may occur suddenly. They may include: cold sweating, cold and pale skin, headache, rapid heartbeat, nausea or feeling very hungry, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating or trembling.
Your doctor will tell you how to treat low blood sugar levels and what to do if you notice these warning signs.
Low blood sugar levels are more likely if you are also taking a sulphonylurea or insulin. Before you start using this medicine, your doctor may reduce the dose of these medicines.

  • Difficulty digesting
  • Inflammation of the stomach (gastritis). Signs include stomach pain, nausea and vomiting
  • Reflux or heartburn, also known as gastroesophageal reflux disease (GERD)
  • Stomach pain
  • Stomach bloating
  • Constipation
  • Belching
  • Gallstones
  • Dizziness
  • Tiredness
  • Weight loss
  • Decreased appetite
  • Intestinal gas (flatulence)
  • Increased levels of pancreatic enzymes (such as lipase and amylase)
  • Headache

Uncommon (affects up to 1 in 100 people)

  • Change in taste of food or drinks
  • Rapid pulse
  • Reactions at the injection site, such as bruising, pain, irritation, itching and skin rash
  • Allergic reactions such as rash, itching or hives
  • Delayed stomach emptying

Not known (frequency cannot be estimated from the available data)

  • Skin sensitivity changes

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ozempic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and on the carton after 'Exp.'. The expiry date refers to the last day of that month.

Before first use:
Store in a refrigerator (2 °C–8 °C). Do not freeze. Keep away from the cooling elements.
Keep the cap on the pen to protect the medicine from light.

After first use:
Ozempic 0.5 mg 4-dose pen

  • The pen may be stored for 6 weeks at a temperature below 30 °C or in the refrigerator (2 °C–8 °C), away from the cooling elements. Do not freeze Ozempic and do not use it if it has been frozen.

Ozempic 0.5 mg 8-dose pen

  • The pen may be stored for 8 weeks at a temperature below 30 °C or in the refrigerator (2 °C–8 °C), away from the cooling elements. Do not freeze Ozempic and do not use it if it has been frozen.
  • When not in use, store the pen with the cap on to protect the medicine from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Ozempic contains

  • The active substance is semaglutide.
  • Ozempic 4-dose pens
    • 1.5 mL: One mL of injectable solution contains 1.34 mg of semaglutide. A pre-filled pen contains 2 mg of semaglutide in 1.5 mL of solution. Each dose contains 0.5 mg of semaglutide in 0.37 mL.
    • 3 mL: One mL of injectable solution contains 0.68 mg of semaglutide. A pre-filled pen contains 2 mg of semaglutide in 3 mL of solution. Each dose contains 0.5 mg of semaglutide in 0.74 mL.
  • Ozempic 8-dose pen
    • 3 mL: One mL of injectable solution contains 1.34 mg of semaglutide. A pre-filled pen contains 4 mg of semaglutide in 3 mL of solution. Each dose contains 0.5 mg of semaglutide in 0.37 mL.
  • The other components are: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2, “Sodium content”.

Description of the appearance of Ozempic and contents of the pack
Ozempic is supplied as a clear, colourless or almost colourless injectable solution in a pre-filled pen.

  • 1.5 mL: Each pre-filled pen contains 1.5 mL of solution and delivers 4 doses of 0.5 mg.
  • 3 mL: Each pre-filled pen contains 3 mL of solution and delivers 4 doses of 0.5 mg.
  • 3 mL: Each pre-filled pen contains 3 mL of solution and delivers 8 doses of 0.5 mg.
    Ozempic 0.5 mg solution for injection is available in the following pack sizes:
    1 pen and 4 NovoFine Plus disposable needles.
    1 pen and 8 NovoFine Plus disposable needles.
    3 pens and 12 NovoFine Plus disposable needles.
    Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.

Instructions for use

Ozempic 0.5 mg solution for injection in a pre-filled pen delivering 4 doses

semaglutide

Instructions for use of Ozempic 0.5 mg injectable solution in a pre-filled pen
Read these instructions carefully before using your pre-filled Ozempic pen. Speak with your doctor, nurse, or pharmacist about how to correctly inject Ozempic. Start by checking the pen to ensure it contains Ozempic 0.5 mg, then review the illustrations below to become familiar with the different parts of the pen and the needle. If you are blind or have severe vision problems and cannot read the dose counter, do not use this pen without assistance. Ask for help from someone with good eyesight who knows how to use the Ozempic pre-filled pen. The pen is a pre-filled pen with an adjustable dose. It contains 2 mg of semaglutide. You can select doses of 0.5 mg. An unused pen contains four doses of 0.5 mg. Use the table inside the box lid to keep track of how many injections you have administered and when you administered them. The pen is designed to be used with 30G, 31G, and 32G disposable needles up to 8 mm in length. NovoFine Plus needles are included in the package. Note: The pen may differ in size from the pen shown in the image. These instructions apply to all Ozempic 0.5 mg pens.Pre-filled Ozempic pen and needle (example) Pen cap Outer needle cap Inner needle cap Needle Protective seal Pen window Pen label Dose counter Dose indicator Dose selector Injection button Flow check symbol
Important informationPay special attention to these notes, as they are important for the safe use of the pen.
Exploded diagram of an Ozempic pen showing its separated components including the pen body, cap, and
  • 1. Preparing the pen with a new needle
  • Check the name and colored label on the pen to ensure it contains Ozempic 0.5 mg. This is particularly important if you use more than one type of injectable medicine. Using the wrong medicine may harm your health. • Remove the pen cap.

A
Two hands hold a cylindrical medical device and separate it by pulling outward

  • Check that the solution in the pen is clear and colorless. Look through the pen window. If the solution appears cloudy or colored, do not use the pen.
B
A hand holds a blue and white cylindrical medical device horizontally against a light blue background

  • Take a new needle. Check the protective seal and the outer needle cap for any damage that might affect sterility. If you notice any damage, use a new needle. • Remove the protective seal.
C
Two hands grasp and rotate a cylindrical medical device, with a blue arrow indicating a counterclockwise rotation

Ensure you attach the needle correctly• Push the needle straight onto the pen. • Rotate it until it is securely fastened.D
A hand rotates the upper part of a pen-shaped medical device downward, following the direction of a curved arrow

The needle is covered by two caps. You must remove both. If you forget to remove both caps, you will not be able to inject the solution. • Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.E
A hand holds a cap while the

  • Remove the inner needle cap and discard it. If you try to replace it, you may accidentally prick yourself with the needle. A drop of solution may appear at the tip of the needle. This is normal, but you must still perform a flow check if using a new pen for the first time. See step 2 “Flow check with each new pen.” Do not attach a new needle to the pen until you are ready to administer the injection.
F
A hand moves a medical device to the right to connect it with another cylindrical component, indicated by a directional arrow

Always use a new needle for each injection. This prevents needle blockages, contamination, infections, and inaccurate dosing.
Never use a bent or damaged needle.




  • 2. Flow check with each new pen


Two hands hold a blue injection pen with a numerical indicator set to 0, and a curved arrow indicates rotation of the device

  • If the pen has already been used, go to step 3 “Dose selection.” Perform the flow check only before the first injection with a new pen. • Rotate the dose selector to the flow check symbol () immediately after “0”. Ensure the flow check symbol is aligned with the indicator.
A Flow check symbol selected


  • Hold the pen with the needle pointing upward. Press and hold the injection button until the dose counter resets to “0”. The “0” must align with the dose indicator. A drop of solution should appear at the tip of the needle.
B
A hand holds a blue and white injection pen with an arrow pointing toward the
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 “Flow check with each new pen” up to 6 times. If still no drop appears, change the needle and repeat step 2 “Flow check with each new pen” once more. Discard the pen and use a new one if no drop of solution appears.
Always ensure a drop appears at the tip of the needle before using a new pen for the first time. The presence of a drop ensures proper solution flow. If no drop appears, no medicine will be injected, even if the dose counter moves. This may indicate a blocked or damaged needle. If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and therefore may not achieve the desired effect of Ozempic.
  • 3. Dose selection
  • Rotate the dose selector to select 0.5 mg. Rotate until the dose counter displays 0.5 mg.
0.5 mg selected A
Two hands hold a blue injection pen with a curved arrow indicating rotation of the dosage dial set to 0.5 mg
Only the dose counter and dose indicator show that 0.5 mg has been selected. You can only select 0.5 mg per dose. When the pen contains less than 0.5 mg, the dose counter will stop before 0.5 is displayed. The dose selector makes a different click sound when rotated forward, backward, or beyond 0.5 mg. Do not count the clicks of the pen.
Before injecting this medicine, always use the dose counter and dose indicator to verify that 0.5 mg has been selected. Do not count the clicks of the pen. Only doses of 0.5 mg should be selected using the dose selector. 0.5 mg must align precisely with the dose indicator to ensure a correct dose is delivered.
Amount of solution remaining
  • To accurately determine how much solution remains, use the dose counter: Rotate the dose selector until the dose counter stops. If it shows 0.5, at least 0.5 mg remains in the pen. If the dose counter stops before reaching 0.5, there is not enough solution left for a full 0.5 mg dose.
A Dose counter stopped: 0.5 mg remaining
Two hands hold a blue injection pen with the indicator at 0 and a curved arrow indicating rotation of the device toward the
If there is not enough solution left in the pen for a complete dose, do not use the pen. Use a new Ozempic pen.
  • 4. Injecting the dose

A hand holds an injection pen ready for

  • Insert the needle into the skin as shown to you by your doctor or nurse. • Ensure you can see the dose counter. Do not cover it with your fingers, as this may block the injection.
A
  • Press and hold the injection button. Watch as the dose counter returns to “0”. The “0” must align with the dose indicator. You may hear or feel a click. • Continue holding the injection button while the needle is inserted in the skin.
B
A hand presses a downward-pointing injection pen onto a surface, with a blue arrow indicating the direction of movement
  • Count slowly to 6 while holding the injection button pressed. • If the needle is withdrawn before this, you may notice a flow of solution leaking from the needle tip. In this case, the full dose will not be delivered.
C 1-2-3-4-5-6 Count slowly
A hand holds a pen-shaped medical device vertically above a flat surface, with an empty speech bubble beside it





  • Remove the needle from the skin. You may then release the injection button. If bleeding occurs at the injection site, apply light pressure.
D
Illustration of a pen-shaped medical device with a blue arrow pointing toward the

After injection, you may see a drop of solution at the needle tip. This is normal and does not affect the administered dose.
Always watch the dose counter to know how many mg you are injecting. Hold the injection button pressed until the dose counter returns to “0”. How to identify a blocked or damaged needle – If “0” does not appear on the dose counter after continuously pressing the injection button, you may have used a blocked or damaged needle. – In this case, no medicine will have been administered, even if the dose counter moved from the originally set dose. How to handle a blocked needle Replace the needle as described in step 5 “After injection” and repeat all steps starting from step 1 “Preparing the pen with a new needle.” Ensure you select the full required dose. Never touch the dose counter during injection, as this may stop the injection.
  • 5. After injection
Always discard the needle after each injection to ensure comfortable injections and prevent needle blockages. If the needle is blocked, no medicine will be injected. • Place the needle tip into the outer needle cap placed on a flat surface, without touching the needle or cap.A
  • Once the needle is covered, press the outer cap fully and carefully. • Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist, or local authorities.
B
A blue arrow indicates the motion of inserting a white protective cap onto the tip of a medical injection pen

  • Replace the pen cap on the pen after each use to protect the solution from light.
C
A hand pushes the top part of a cylindrical medical device downward with the thumb onto a flat surface

When the pen is empty, dispose of it without the needle attached, as instructed by your doctor, nurse, pharmacist, or local authorities.
Two hands hold a blue and white cylindrical medical device, with a dark arrow indicating an insertion movement between the two parts

Never attempt to replace the inner needle cap after removing it. You may injure yourself with the needle. Always remove the needle from the pen immediately after each injection.


This prevents needle blockages, contamination, infections, leakage of solution, and inaccurate dosing.

Other important information

  • Always keep the pen and needles out of sight and reach of others, especially children.
  • Never share the pen and needles with other people.
  • Anyone assisting the patient must be very careful when handling used needles to prevent cross-infections and needle-stick injuries.

Pen maintenance
Handle the pen with care. Improper or careless use may result in inaccurate delivery. In such cases, the desired effect of the medicine may not be achieved.

  • Do not leave the pen in a car or in other places where it could become too hot or too cold.
  • Do not inject Ozempic if it has been frozen. If injected, the desired effect of the medicine may not be achieved.
  • Do not inject Ozempic if it has been exposed to direct sunlight. If injected, the desired effect of the medicine may not be achieved.
  • Do not expose the pen to dust, dirt, or liquids.
  • Do not wash, immerse in liquid, or lubricate the pen. It may be cleaned with a mild detergent and a damp cloth.
  • Do not drop the pen or allow it to hit hard surfaces. If the pen is dropped or if you suspect a problem, attach a new needle and check the solution flow before injection.
  • Do not attempt to refill the pen.
  • Do not attempt to repair or disassemble the pen.

Instructions for use

Ozempic 0.5 mg solution for injection in a pre-filled pen delivering 8 doses

semaglutide

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

Read these instructions carefully before using your

Exploded diagram of an Ozempic pen showing its separated components including the pen body, the

Ozempic pre-filled pen
Ozempic pre-filled pen. Speak with your doctor, nurse, or
and needle (example)
pharmacist about how to correctly inject Ozempic.
Start by checking the pen to make sure it contains
Ozempic 0.5 mg, then look at the illustrations below to
learn about the different parts of the pen and the needle.
If you are blind or have severe vision problems and cannot
read the dose counter, do not use this pen without help.
Ask for help from someone with good eyesight who knows how to use the Ozempic pre-filled pen.
The pen is a pre-filled pen with selectable dose.
It contains 4 mg of semaglutide. You can only select doses of
0.5 mg. An unused pen contains eight doses of 0.5 mg.
After injecting the prescribed doses, some solution will remain
in the pen. The pen must be discarded.
Use the table inside the box lid to keep track of how many injections you have administered and when you administered them.
The pen is designed to be used with 30G, 31G, and 32G disposable needles up to 8 mm in length.
NovoFine Plus needles are included in the package.

Important information
Pay special attention to these notes, as they are important for the safe use of the pen.

1. Preparing the pen with a new needle

  • Check the name and the coloured label on the pen to
    ensure it contains Ozempic 0.5 mg. This is
    particularly important if you use more than one type of
    injectable medicine. Using the wrong medicine can harm your health.

  • Remove the cap from the pen.

  • Check that the solution in the pen is clear and

Two hands hold a blue and white cylindrical medical device, with a dark arrow indicating a rightward sliding movement

colourless. Look through the window of the pen. If the
solution appears cloudy or coloured, do not use the pen.

  • Take a new needle.

Check the protective seal and the outer needle cap for any damage that could affect
sterility. If you notice any damage, use a new needle.

  • Remove the protective seal. Make sure the needle is properly attached
Two illustrations show hands gripping a blue and white medical device for preparation or
  • Push the needle straight onto the pen.
  • Rotate it until it is securely fastened.

The needle is covered by two caps. You must remove both
caps. If you forget to remove both caps, you will not be able to inject the solution.

  • Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.
  • Remove the inner needle cap and discard it. If you try
Two illustrations show a hand rotating and then removing a protective cap from a syringe-shaped medical device

to reinsert it, you may accidentally prick yourself with the needle.
A drop of solution may appear at the tip of the needle. This is
normal, but you should still perform a flow check when using a
new pen for the first time. See section 2, “Flow check with every new pen”.
Do not attach a new needle to the pen until you are ready to administer the injection.

Always use a new needle for each injection.
This prevents needle blockages, contamination, infections, and inaccurate dosing.

Never use a bent or damaged needle.

2. Flow check with each new pen

  • If the pen has already been used, go to
Two hands hold a blue injection pen with a numerical indicator and a curved arrow indicating rotation of the device

point 3 "Dose selection". Perform the flow check only
before the first injection with a new pen.

  • Rotate the dose selector to the flow check symbol ( ) immediately after “0”. Make sure the
    flow check symbol is aligned with
    the indicator .
  • Hold the pen with the needle pointing upwards. Press and hold the injection button until the dose counter returns to 0. The 0 must align with the dose indicator. A drop of solution should appear at the tip of the needle.
B
A small drop may remain at the tip of the needle, but it will not be injected. If no drop appears, repeat step 2 "Flow check with each new pen" up to 6 times. If still no drop appears, replace the needle and repeat step 2 "Flow check with each new pen" once again. Discard the pen and use a new one if no drop of solution appears.
A hand holds a blue and gray medical injection pen with an arrow pointing toward the
Always make sure that a drop appears at the tip of the needle before using a new pen for the first time. The presence of a drop ensures proper solution flow. If no drop appears, no medicine will be injected, even though the dose counter may move. This situation may indicate a blocked or damaged needle. If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and therefore may not achieve the desired effect of Ozempic.
  • 3. Dose selection

  • Rotate the dose selector to select 0.5 mg. Turn until the dose counter displays 0.5 mg.
0.5 mg selected A
Only the dose counter and dose indicator show that 0.5 mg has been selected. You can select only 0.5 mg per dose. When the pen contains less than 0.5 mg, the dose counter will stop before reaching 0.5. The dose selector will produce a different click when turned forward, backward, or beyond 0.5 mg. Do not count the clicks of the pen.
Two hands hold a blue injection pen with an arrow indicating rotation of the dosage dial set to 0.5 mg
Before injecting this medicine, always use the dose counter and dose indicator to confirm that 0.5 mg has been selected. Do not count the clicks of the pen. Only doses of 0.5 mg should be selected using the dose selector. Ensure that 0.5 mg aligns precisely with the dose indicator to ensure a correct dose is delivered.
Amount of solution remaining
  • To see how much solution remains, use the dose counter: Rotate the dose selector until the dose counter stops. If it shows 0.5, at least 0.5 mg remains in the pen. If the dose counter stops before reaching 0.5 mg, there is not enough solution left for a full 0.5 mg dose.
A Dose counter blocked: 0.5 mg remaining
If there is not enough solution left in the pen for a complete dose, do not use the pen. Use a new Ozempic pen.
Two hands hold a blue injection pen with the indicator at 0 and a curved arrow indicating rotation of the device
  • 4. Injecting the dose

  • Insert the needle into the skin as shown to you by your doctor
Two illustrations show a hand holding an injection pen and pressing it downward, with an arrow indicating the downward movement

or nurse.

  • Make sure you can see the dose counter. Do not cover it with your fingers, as this may cause the injection to stop.
  • Press and hold the injection button. Watch

for the dose counter to return to “0”.
The “0” must align with the dose indicator. You may
hear or feel a click.

  • Continue holding the injection button down while the needle remains inserted in the skin.
  • Count slowly to 6 while keeping the injection button
Drawing of a hand holding an injection pen above the skin, with a blue arrow pointing toward the

pressed.

  • If the needle is removed earlier, you may notice a flow of solution leaking from the needle tip. In this case, the full dose will not have been delivered.
  • Remove the needle from the skin. You may then

release the injection button.
If bleeding occurs at the injection site, apply gentle pressure.
After the injection, you may see a drop of solution at the needle tip. This is normal and
does not affect the administered dose.

Always watch the dose counter to know how many mg you are injecting. Hold the
injection button down until the dose counter returns to “0”.
How to identify a blocked or damaged needle

  • If a “0” does not appear on the dose counter after continuously pressing the injection button, you may have used a blocked or damaged needle.
  • In this case, no medication will have been delivered, even if the dose counter has moved from the originally set dose.

How to handle a blocked needle
Replace the needle as described in section 5 “After the injection” and repeat all steps starting from
section 1 “Preparing the pen with a new needle”. Make sure to select the full required dose.
Never touch the dose counter during injection, as this may cause the injection to stop.

5. After injection

Always dispose of the needle after each injection to ensure

A blue arrow indicates the motion of an injection pen being inserted into a white needle cap against a blue background

comfortable injections and prevent needle blockages.
If the needle is blocked, no medicine will be injected.

  • Place the tip of the needle into the outer needle cap placed on a flat surface, without touching the needle or the cap.
  • When the needle is covered, press down completely on the
Two illustrations show hands applying or removing a protective cap from a cylindrical medical device using lateral movements

outer needle cap carefully.

  • Unscrew the needle and dispose of it properly and with caution as instructed by your doctor, nurse, pharmacist, or local authorities.
  • Replace the pen cap on the pen after each use to protect the solution from light.
    When the pen is empty, dispose of it without the needle attached, as instructed by your doctor, nurse, pharmacist, or local authorities.

Never try to reattach the inner needle cap after removing it. You could injure yourself with the needle.
Always remove the needle from the pen immediately after each injection.
This helps prevent needle blockages, contamination, infections, leakage of solution, and inaccurate dosing.

Other important information

  • Always keep the pen and needles out of sight and reach of others, especially children.
  • Never share the pen or needles with other people.
  • Anyone assisting the patient must be extremely careful when handling used needles to prevent cross-infections and needle-stick injuries.

Pen maintenance
Handle the pen with care. Improper or careless use may result in inaccurate delivery. In such cases, the medicine may not have the intended effect.

  • Do not leave the pen in a car or in other places where it could become too hot or too cold.
  • Do not inject Ozempic if it has been frozen. If injected, the medicine may not have the intended effect.
  • Do not inject Ozempic if it has been exposed to direct sunlight. If injected, the medicine may not have the intended effect.
  • Do not expose the pen to dust, dirt, or liquids.
  • Do not wash, immerse in liquid, or lubricate the pen. It may be cleaned with a mild detergent and a damp cloth.
  • Do not drop the pen or let it hit hard surfaces. If the pen is dropped or if you suspect a problem, attach a new needle and check the solution flow before injection.
  • Do not attempt to refill the pen.
  • Do not attempt to repair or disassemble the pen.

Patient information leaflet

Ozempic 1 mg solution for injection in a pre-filled pen

semaglutide
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

  1. What Ozempic is and what it is used for
  2. What you need to know before using Ozempic
  3. How to use Ozempic
  4. Possible side effects
  5. How to store Ozempic
  6. Contents of the pack and other information

1. What Ozempic is and what it is used for

Ozempic contains the active substance semaglutide, which helps the body reduce blood sugar levels only when they are too high, and can help prevent heart disease in patients with type 2 diabetes mellitus. It also helps slow the decline in kidney function in patients with type 2 diabetes mellitus through a mechanism beyond blood glucose reduction.
Ozempic is used to treat adults (aged 18 years and older) with type 2 diabetes mellitus when diet and exercise alone are not sufficient:

  • on its own – when metformin (another diabetes medicine) cannot be used, or
  • in combination with other diabetes medicines, when these are not sufficient to control blood sugar levels. These medicines may be administered orally or by injection, such as insulin.

It is important that you continue the diet and exercise programme recommended by your doctor, pharmacist, or nurse.

2. What you need to know before using Ozempic

Do not use Ozempic

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using this medicine.
This medicine is not insulin and you must not use it if:

  • you have type 1 diabetes, a condition in which your body does not produce insulin
  • you develop diabetic ketoacidosis, a diabetes complication involving high blood sugar levels, breathing difficulties, confusion, excessive thirst, sweet-smelling breath, or a sweet or metallic taste in the mouth.

Ozempic is not insulin and therefore must not be used as a substitute for insulin.
If you are undergoing surgery under anaesthesia, inform your doctor that you are taking Ozempic.

Stomach and intestinal problems and dehydration
During treatment with this medicine, you may experience nausea, vomiting, or diarrhoea. These side effects may cause dehydration (loss of fluids). It is important that you drink plenty of fluids to prevent dehydration. This is particularly important if you have kidney problems. Contact your doctor if you have any concerns or questions.

Severe and persistent stomach pain which may be due to acute pancreatitis
If you have severe and persistent pain in the stomach area, contact a doctor immediately as this may be a sign of acute pancreatitis (inflammation of the pancreas). See section 4 for signs indicating inflammation of the pancreas.

Low blood sugar levels (hypoglycaemia)
Taking a sulphonylurea or insulin together with this medicine may increase the risk of low blood sugar levels (hypoglycaemia). See section 4 for warning signs of low blood sugar levels. Your doctor may ask you to check your blood sugar levels. This will help your doctor decide whether the dose of sulphonylurea or insulin needs to be changed to reduce the risk of low blood sugar levels.

Diabetic retinopathy (a diabetes complication affecting the eyes)
If you have had diabetic retinopathy and are using insulin, this medicine may lead to worsening of vision, which may require treatment. Inform your doctor if you have diabetic retinopathy or if you develop eye problems during treatment with this medicine.
Use of Ozempic 2 mg is not recommended in patients with potentially unstable diabetic retinopathy.

Sudden changes in vision
If you notice sudden loss of vision or rapid worsening of vision during treatment with this medicine, contact your doctor immediately for advice. This could be caused by a very rare side effect called non-arteritic anterior ischemic optic neuropathy (NAION) (see section 4: Serious side effects). Your doctor may recommend an eye examination and may need to discontinue treatment with this medicine.

Patients with delayed gastric emptying (gastroparesis)
If you suffer from slow (delayed) gastric emptying (called gastroparesis), using Ozempic may cause severe or serious gastrointestinal adverse events. Consult your doctor before using Ozempic.

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age, as its efficacy and safety have not yet been established in this age group.

Other medicines and Ozempic
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other medicines purchased without a prescription.
In particular, inform your doctor, pharmacist, or nurse if you are taking medicines containing:

  • Warfarin or similar oral medicines taken to reduce blood clotting (oral anticoagulants). Frequent blood tests are needed to determine your blood clotting speed.
  • If you are using insulin, your doctor will advise you on how to reduce the insulin dose and recommend more frequent blood glucose monitoring to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a diabetes complication that occurs when the body cannot break down glucose due to insufficient insulin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine.
This medicine must not be used during pregnancy because it is not known whether it could harm the unborn child. Therefore, you are advised to use a contraceptive method while using this medicine. If you plan to become pregnant, talk to your doctor about changing your therapy, as you must stop using this medicine at least 2 months before conception. If you become pregnant while using this medicine, contact your doctor immediately, as your treatment will need to be changed.
Do not use this medicine if you are breastfeeding because it is not known whether Ozempic passes into breast milk.

Driving and using machines
It is unlikely that Ozempic will affect your ability to drive or use machines. However, if you use this medicine in combination with a sulphonylurea or insulin, low blood sugar levels (hypoglycaemia) may occur, which could impair your concentration. Do not drive or operate machinery if you experience signs of low blood sugar levels. See section 2, "Warnings and precautions", for information on increased risk of low blood sugar levels and section 4 for warning signs of low blood sugar levels. Consult your doctor for further information.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to use Ozempic

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.

How much medicine to use

  • The starting dose is 0.25 mg once weekly for four weeks.
  • After four weeks, your doctor will increase the dose to 0.5 mg once weekly.
  • Your doctor may increase the dose to 1 mg once weekly if your blood sugar level is not adequately controlled with the 0.5 mg once-weekly dose.
  • Your doctor may increase the dose to 2 mg once weekly if your blood sugar level is not adequately controlled with the 1 mg once-weekly dose.

Do not change the dose unless your doctor tells you to do so.

How Ozempic is administered
Ozempic is administered by subcutaneous injection (injection under the skin). Do not inject it into a vein or muscle.

  • The best sites for injection are the front of the thighs, the abdomen (stomach), or the upper arm.
  • Before you use the pen for the first time, your doctor or nurse will show you how to do it. Detailed instructions for use are provided on the reverse of this leaflet.

When to use Ozempic

  • You must use this medicine once a week, preferably on the same day each week.
  • You may administer the injection at any time of day, regardless of meals.

To help you remember to inject this medicine only once a week, it is recommended that you write the chosen day of the week (e.g., Wednesday) on the carton and record the date on the carton each time you inject Ozempic.
If necessary, you may change the day of the weekly injection of this medicine, provided at least 3 days have passed since the last dose. Once you have chosen a new day for administration, continue taking the medicine once weekly on that day.

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

If you forget to use Ozempic
If you forget to inject a dose and:

  • 5 days or fewer have passed since you were supposed to use Ozempic, inject the missed dose as soon as you remember. Then take the next dose on your regularly scheduled day.
  • more than 5 days have passed since you were supposed to use Ozempic, skip the missed dose. Then take the next dose on your regularly scheduled day. Do not use a double dose to make up for the forgotten dose.

If you stop using Ozempic
Do not stop treatment with this medicine without first talking to your doctor. If you stop treatment, your blood sugar levels may rise.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Common ( affects up to 1 in 10 people)

  • Complications of the disease retinopathy – you should speak to your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (affects up to 1 in 100 people)

  • Inflammation of the pancreas (acute pancreatitis) which could cause severe stomach and back pain that does not go away. You must consult a doctor immediately if you experience these symptoms.

Rare (affects up to 1 in 1,000 people)

  • Severe allergic reactions (anaphylactic reactions, angioedema). You must seek immediate medical assistance and inform your doctor immediately if you experience symptoms such as breathing difficulties, swelling of the face, lips, tongue and/or throat with difficulty swallowing, and rapid heartbeat.

Very rare (affects up to 1 in 10,000 people)

  • A medical condition of the eye called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause vision loss in one eye without any pain. You must contact your doctor immediately if you notice sudden loss or gradual worsening of vision (see section 2: "Sudden changes in vision").

Not known (frequency cannot be estimated from the available data)

  • Intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.

Other side effects
Very common (affects more than 1 in 10 people)

  • Nausea – usually goes away with time
  • Diarrhoea – usually goes away with time
  • Low blood sugar levels (hypoglycaemia) when this medicine is used with other diabetes medicines containing sulphonylurea or insulin

Common (affects up to 1 in 10 people)

  • Vomiting
  • Low blood sugar levels (hypoglycaemia) when this medicine is used with another oral diabetes medicine other than sulphonylurea or with insulin

Warning signs of low blood sugar levels may occur suddenly. They may include: cold sweat, cold and pale skin, headache, rapid heartbeat, nausea or feeling very hungry, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating or trembling.
Your doctor will tell you how to treat low blood sugar levels and what to do if you notice these warning signs.
Low blood sugar levels are more likely to occur if you are also taking a sulphonylurea or insulin. Before you start using this medicine, your doctor may reduce the dose of these medicines.

  • Difficulty digesting
  • Inflammation of the stomach (gastritis). Signs include stomach pain, nausea and vomiting
  • Reflux or heartburn, also known as gastroesophageal reflux disease (GERD)
  • Stomach pain
  • Stomach bloating
  • Constipation
  • Belching
  • Gallstones
  • Dizziness
  • Tiredness
  • Weight loss
  • Decreased appetite
  • Intestinal gas (flatulence)
  • Increased pancreatic enzymes (such as lipase and amylase)
  • Headache

Uncommon (affects up to 1 in 100 people)

  • Change in taste of food or drinks
  • Rapid pulse
  • Reactions at the injection site, such as bruising, pain, irritation, itching and skin rash
  • Allergic reactions such as rash, itching or hives
  • Delayed stomach emptying

Not known (frequency cannot be estimated from the available data)

  • Skin sensitivity changes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ozempic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and on the box after 'Exp.'. The expiry date refers to the last day of that month.

Before first use:
Store in the refrigerator (2 °C–8 °C). Do not freeze. Keep away from refrigerating elements.
Keep the cap on the pen to protect the medicine from light.

After first use:
Ozempic 1 mg pen with 4 doses

  • The pen can be stored for 6 weeks at a temperature below 30 °C or in the refrigerator (2 °C–8 °C), away from refrigerating elements. Do not freeze Ozempic and do not use it if it has been frozen.

Ozempic 1 mg pen with 8 doses

  • The pen can be stored for 8 weeks at a temperature below 30 °C or in the refrigerator (2 °C–8 °C), away from refrigerating elements. 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 the medicine from light.

Do not use this medicine if the solution is not clear and colourless or almost colourless.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ozempic contains

  • The active substance is semaglutide.
  • Ozempic pen with 4 doses
    One mL of injectable solution contains 1.34 mg of semaglutide. A pre-filled pen contains 4 mg of semaglutide in 3 mL of solution. Each dose delivers 1 mg of semaglutide in 0.74 mL.
  • Ozempic pen with 8 doses
    One mL of injectable solution contains 2.68 mg of semaglutide. A pre-filled pen contains 8 mg of semaglutide in 3 mL of solution. Each dose delivers 1 mg of semaglutide in 0.37 mL.
  • The other components are: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2, “Sodium content”.

Description of the appearance of Ozempic and pack contents
Ozempic is supplied as a clear, colourless or almost colourless injectable solution in a pre-filled pen.
Each pre-filled pen contains 3 mL of solution and delivers 4 doses of 1 mg.
Each pre-filled pen contains 3 mL of solution and delivers 8 doses of 1 mg.
Ozempic 1 mg solution for injection is available in the following pack sizes:
1 pen and 4 NovoFine Plus disposable needles.
1 pen and 8 NovoFine Plus disposable needles.
3 pens and 12 NovoFine Plus disposable needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Instructions for use

Ozempic 1 mg solution for injection in a pre-filled pen delivering 4 doses

semaglutide

Instructions for use of Ozempic 1 mg injection solution in a prefilled pen
Read these instructions carefully before using your prefilled Ozempic pen. Talk to your doctor, nurse, or pharmacist about how to correctly inject Ozempic. Do not use the pen without receiving adequate training from your doctor or nurse. Begin by checking the pen to ensure it contains Ozempic 1 mg, then review the illustrations below to become familiar with the different parts of the pen and the needle. If you are blind or have severe vision problems and cannot read the dose counter, do not use this pen without assistance. Ask for help from someone with good eyesight who knows how to use the Ozempic prefilled pen. The pen is a prefilled pen with selectable dose. It contains 4 mg of semaglutide. You can select doses of 1 mg. An unused pen contains four doses of 1 mg. Use the table inside the box lid to keep track of how many injections you have administered and when you administered them. The pen is designed to be used with 30G, 31G, and 32G disposable needles up to 8 mm in length. NovoFine Plus needles are included in the package.Ozempic prefilled pen and needle (example) Pen cap Outer needle cap Inner needle cap Needle Protective seal Dose window Pen label Dose counter Dose indicator Dose selector Injection button Flow check symbol
Exploded diagram of the components of an Ozempic pen, labeled with pen body, cap, needle, and application devices
Important informationPay close attention to these notes, as they are important for the safe use of the pen.
  • 1. Preparing the pen with a new needle

  • Check the name and colored label on the pen to make sure it contains Ozempic 1 mg. This is particularly important if you use more than one type of injectable medicine. Using the wrong medicine may harm your health. • Remove the cap from the pen.
A
Two hands hold a blue and white cylindrical medical device, with a dark arrow indicating a rightward sliding movement

  • Check that the solution in the pen is clear and
Two illustrations show a hand holding an injection pen and two hands rotating a cap to remove or attach it

colourless. Look through the window of the pen. If the
solution appears cloudy or coloured, do not use the pen.

  • Take a new needle.

Check the protective seal and the outer needle cap for any signs of damage that could affect
sterility. If you notice any damage,
use a new needle.

  • Remove the protective seal. Make sure you attach the needle correctly
Two illustrations show a hand rotating and then removing the protective cap from a medical syringe for drug administration
  • Push the needle straight onto the pen.
  • Turn it until it is securely fixed.

The needle is covered by two caps. You must remove
both. If you forget to remove both caps,
you will not be able to inject the solution.

  • Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.
  • Remove the inner needle cap and discard it. If you try
A hand moves an injection pen to the right to attach it to

to replace it, you may accidentally prick yourself with the needle.
A drop of solution may appear at the tip of the needle. This is
normal, but you should still check the flow if you are using a
new pen for the first time. See step 2, "Flow check with each new pen".
Do not attach a new needle to the pen until you are ready to
administer the injection.

Always use a new needle for each injection.
This prevents needle blockages, contamination, infections, and inaccurate dosing.

Never use a bent or damaged needle.

2. Flow check with each new pen

  • If the pen has already been used, go to
Two hands hold a blue injection pen with a numerical indicator set to 0, and a curved arrow indicates rotation of the device

point 3 "Dose selection". Perform the flow check only
before the first injection with a new pen.

  • Rotate the dose selector to the flow check symbol ( ) immediately after “0”. Make sure that the
    flow check symbol is aligned with the indicator .
  • Hold the pen with the needle pointing upwards. Press and keep pressing the injection button until the dose counter resets to 0. The 0 must align with the dose indicator. A drop of solution should appear at the tip of the needle.
B
A small drop may remain at the needle tip, but it will not be injected. If no drop appears, repeat step 2 "Flow check with each new pen" up to 6 times. If still no drop appears, replace the needle and repeat step 2 "Flow check with each new pen" once again. Discard the pen and use a new one if no drop of solution appears.
A hand holds a blue and gray injection pen with an arrow pointing toward the
Always make sure that a drop appears at the needle tip the first time you use a new pen. The presence of a drop ensures proper solution flow. If no drop appears, no medication will be injected, even if the dose counter moves. This situation may indicate a blocked or damaged needle. If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and therefore will not achieve the intended effect of Ozempic.
  • 3. Selecting the dose

  • Turn the dose selector to select 1 mg. Rotate until the dose counter displays 1 mg.
1 mg selected A
Only the dose counter and dose indicator show that 1 mg has been selected. You can select only 1 mg per dose. When less than 1 mg remains in the pen, the dose counter will stop before reaching 1 mg. The dose selector will produce a different click when turned forward, backward, or beyond 1 mg. Do not count the clicks of the pen.
Two hands hold a blue injection pen with an arrow indicating rotation of the dosage dial toward 0, and a detail showing '1mg'
Before injecting this medicine, always use the dose counter and dose indicator to confirm that 1 mg has been selected. Do not count the clicks of the pen. Only 1 mg doses should be selected using the dose selector. The 1 mg mark must align precisely with the dose indicator to ensure a correct dose is delivered.
How much solution remains
  • To see exactly how much solution remains, use the dose counter: Turn the dose selector until the dose counter stops. If it shows 1, at least 1 mg remains in the pen. If the dose counter stops before reaching 1, there is not enough solution left for a full 1 mg dose.
A Dose counter stopped: 1 mg remaining
If there is not enough solution left in the pen for a complete dose, do not use the pen. Use a new Ozempic pen.
Two hands hold a blue medical device with a display showing 0, and a curved arrow indicates rotation of the device
  • 4. Injecting the dose



  • Insert the needle into the skin as shown to you by your doctor
Two illustrations show a hand holding an injection pen and pressing it downward, with an arrow indicating the downward movement L

or nurse.

  • Make sure you can see the dose counter. Do not cover it with your fingers, otherwise the injection may stop.
  • Press and keep pressing the injection button.

Watch as the dose counter returns to “0”.
The “0” must align with the dose indicator. You may
hear or feel a click.

  • Continue to keep the injection button pressed while the needle remains inserted in the skin.
  • Count slowly to 6 while keeping the injection button
Medical illustration showing a hand holding an injection pen above the skin, with a blue arrow pointing toward the

pressed.

  • If the needle is withdrawn too early, you may notice a flow of solution leaking from the needle tip. In this case, the full dose will not have been delivered.
  • Remove the needle from the skin. You may then
    release the injection button.
    If bleeding occurs at the injection site, apply light pressure.
    After the injection, you may see a drop of solution at the needle tip. This is normal and
    does not affect the administered dose.

Always watch the dose counter to know how many mg you are injecting. Keep pressing the
injection button until the dose counter returns to “0”.
How to identify a blocked or damaged needle

  • If a “0” does not appear on the dose counter after continuously pressing the injection button, you may have used a blocked or damaged needle.
  • In this case, no medication will have been delivered, even if the dose counter has moved from the originally set dose.

How to handle a blocked needle
Replace the needle as described in section 5 “After the injection” and repeat all steps starting from
section 1 “Preparing the pen with a new needle”. Make sure to select the full required dose.
Never touch the dose counter during injection, otherwise the injection may stop.

5. After injection

Always dispose of the needle after each injection to ensure
comfortable injections and prevent needle blockages.
If the needle is blocked, no medicine will be injected.

  • Place the needle tip into the outer needle cap placed on a flat surface, without touching the needle or the cap.
  • When the needle is covered, press the outer needle cap
    completely and carefully.
Two illustrations show hands applying or removing a protective cap from a cylindrical medical device with directional arrows
  • Unscrew the needle and dispose of it properly as instructed by your doctor, nurse, pharmacist, or local authorities.
  • Replace the pen cap on the pen after each use to protect the solution from light.
    Always dispose of the needle after each injection to ensure comfortable injections and prevent needle blockages.
    If the needle is blocked, no medicine will be injected.
    When the pen is empty, dispose of it without the needle attached, as instructed by your doctor, nurse, pharmacist, or local authorities.

Never attempt to re-sheathe the inner needle cap after removing it. You may injure yourself with the needle.
Always remove the needle from the pen immediately after each injection.
This helps prevent needle blockages, contamination, infections, leakage of solution, and inaccurate dosing.

Other important information

  • Always keep the pen and needles out of sight and reach of others, especially children.
  • Never share the pen or needles with other people.
  • Anyone assisting the patient must be very careful when handling used needles to prevent cross-infections and needle-stick injuries.

Pen maintenance
Handle the pen with care. Improper or careless use may result in inaccurate delivery. In such cases, the medicine may not have the intended effect.

  • Do not leave the pen in a car or in other places where it could become too hot or too cold.
  • Do not inject Ozempic if it has been frozen. If injected, the medicine may not have the intended effect.
  • Do not inject Ozempic if it has been exposed to direct sunlight. If injected, the medicine may not have the intended effect.
  • Do not expose the pen to dust, dirt, or liquids.
  • Do not wash, immerse in liquid, or lubricate the pen. It may be cleaned with a mild detergent and a damp cloth.
  • Do not drop the pen or allow it to hit hard surfaces. If the pen is dropped or if you suspect a problem, attach a new needle and check the solution flow before injection.
  • Do not attempt to refill the pen.
  • Do not attempt to repair or disassemble the pen.

Instructions for use

Ozempic 1 mg solution for injection in a pre-filled pen delivering 8 doses

semaglutide

Instructions for use of Ozempic 1 mg solution for injection in pre-filled pen

Read these instructions carefully before using your

Exploded diagram of an Ozempic pen showing its separated components including the pen body, cap, and

Ozempic pre-filled pen
Ozempic pre-filled pen. Speak with your doctor, nurse, or
and needle (example)
pharmacist about how to correctly inject Ozempic.
Start by checking the pen to make sure it contains
Ozempic 1 mg, then look at the illustrations below to
learn about the different parts of the pen and the needle.
If you are blind or have severe vision problems and cannot
read the dose counter, do not use this pen without help.
Ask for help from someone with good eyesight who knows how to use the Ozempic pre-filled pen.
The pen is a pre-filled pen with selectable dose.
It contains 8 mg of semaglutide. You can select only doses
of 1 mg. An unused pen contains eight doses of 1 mg.
After injecting the prescribed doses, some solution will
remain in the pen. The pen must be discarded.
Use the table inside the box lid to keep track of how many injections you have administered and when you administered them.
The pen is designed to be used with single-use 30G, 31G, and 32G needles up to 8 mm in length.
NovoFine Plus needles are included in the package.

Important information
Pay particular attention to these notes, as they are important for the safe use of the pen.

1. Preparing the pen with a new needle

  • Check the name and the coloured label on the pen to
    ensure it contains Ozempic 1 mg. This is
    particularly important if you use more than one type of
    injectable medicine. Using the wrong medicine
    can harm your health.

  • Remove the cap from the pen.

  • Check that the solution in the pen is clear and

Two hands hold a blue and white cylindrical medical device, with a black arrow indicating a rightward sliding movement

colourless. Look through the window of the pen. If the
solution appears cloudy or coloured, do not use the pen.

  • Take a new needle.

Check the protective seal and the outer needle cap for any damage that could affect
sterility. If you notice any damage,
use a new needle.

  • Remove the protective seal. Make sure you attach the needle correctly
Two illustrations show a hand rotating and then removing a protective cap from the tip of a medical syringe
  • Push the needle straight onto the pen.
  • Twist it until it is securely fixed.

The needle is covered by two caps. You must remove
both. If you forget to remove both caps,
you will not be able to inject the solution.

  • Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.
  • Remove the inner needle cap and discard it. If you try
A hand moves an injection pen to the right to attach a cap or device, indicated by a blue directional arrow

to reinsert it, you may accidentally prick yourself with the needle.
A drop of solution may appear at the tip of the needle. This
is normal, but you should still perform an injection flow check when using a
new pen for the first time. See section 2, "Flow check with every new pen".
Do not attach a new needle to the pen until you are ready to administer the injection.

Always use a new needle for each injection.
This prevents needle blockages, contamination, infections, and inaccurate dosing.

Never use a bent or damaged needle.

2. Flow check with each new pen

  • If the pen has already been used, go to
Two hands hold a blue injection pen with a numerical indicator and a curved arrow indicating rotation of the device

point 3 "Dose selection". Perform the flow check only
before the first injection with a new pen.

  • Rotate the dose selector to the flow check symbol ( ) immediately after "0". Make sure that the
    flow check symbol is aligned with the indicator .
  • Hold the pen with the needle pointing upwards. Press and hold the injection button until the dose counter returns to 0. The 0 must align with the dose indicator. A drop of solution should appear at the tip of the needle.
B
A small drop may remain at the needle tip, but it will not be injected. If no drop appears, repeat step 2 "Flow check with each new pen" up to six times. If still no drop appears, replace the needle and repeat step 2 "Flow check with each new pen" once more. Discard the pen and use a new one if no drop of solution appears.
A hand holds a blue and gray injection pen with an arrow pointing toward the
Always ensure that a drop appears at the tip of the needle the first time you use a new pen. The presence of a drop confirms that the solution is flowing. If no drop appears, no medicine will be injected, even if the dose counter moves. This situation may indicate a blocked or damaged needle. If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and therefore may not achieve the intended effect of Ozempic.
  • 3. Dose selection

  • Turn the dose selector to select 1 mg. Rotate until the dose counter displays 1 mg.
1 mg selected A
Only the dose counter and dose indicator show that 1 mg has been selected. You can only select 1 mg per dose. When less than 1 mg remains in the pen, the dose counter will stop before reaching 1. The dose selector makes a distinct click when turned forward, backward, or beyond 1 mg. Do not count the clicks of the pen.
Two hands hold a blue injection pen with an arrow indicating rotation of the dosage dial toward 0 and a detail showing '1 mg'
Before injecting this medicine, always use the dose counter and dose indicator to confirm that 1 mg has been selected. Do not count the clicks of the pen. Only 1 mg doses should be selected using the dose selector. The 1 mg mark must align precisely with the dose indicator to ensure a correct dose is delivered.
How much solution remains
  • To see how much solution remains, use the dose counter: Turn the dose selector until the dose counter stops. If it shows 1, at least 1 mg remains in the pen. If the dose counter stops before reaching 1 mg, there is not enough solution left for a full 1 mg dose.
A Dose counter stopped: 1 mg remaining
If there is not enough solution left in the pen for a complete dose, do not use the pen. Use a new Ozempic pen.
Two hands hold a blue medical device with a numerical indicator at zero and a curved arrow indicating rotational movement
  • 4. Injecting the dose



  • Insert the needle into the skin as shown to you by your doctor
Two illustrations show a hand holding an injection pen and pushing it downward, with a blue arrow indicating the movement L

or nurse.

  • Make sure you can see the dose counter. Do not cover it with your fingers, otherwise the injection may become blocked.
  • Press and keep pressing the injection button.

Watch as the dose counter returns to “0”.
The “0” must align with the dose indicator. You may
hear or feel a click.

  • Continue to keep the injection button pressed while the needle remains in the skin.
  • Count slowly to 6 while keeping the injection button
Medical illustration showing a hand holding an injection pen above the skin, with a blue arrow pointing toward the

pressed.

  • If the needle is withdrawn too early, you may notice a flow of solution leaking from the needle tip. In this case, the full dose will not have been delivered.
  • Remove the needle from the skin. You may then
    release the injection button.
    If bleeding occurs at the injection site, apply light pressure.
    After the injection, you may see a drop of solution at the needle tip. This is normal and
    does not affect the dose just administered.

Always watch the dose counter to know how many mg you are injecting. Keep pressing the
injection button until the dose counter returns to “0”.
How to identify a blocked or damaged needle

  • If a “0” does not appear on the dose counter after continuously pressing the injection button, you may have used a blocked or damaged needle.
  • In this case, no medication will have been delivered, even if the dose counter has moved from the originally set dose.

How to handle a blocked needle
Replace the needle as described in section 5 “After injection” and repeat all steps starting from
section 1 “Preparing the pen with a new needle”. Make sure to select the full required dose.
Never touch the dose counter during injection, otherwise the injection may become blocked.

5. After injection

Always dispose of the needle after each injection to ensure
comfortable injections and prevent needle blockages.
If the needle is blocked, no medicine will be injected.

  • Insert the needle tip into the outer needle cap placed on a flat surface, without touching the needle or the cap itself.
  • When the needle is covered, press down completely on the
Two illustrations show hands gripping and moving a cylindrical medical device with arrows indicating the direction of movement

outer needle cap carefully.

  • Unscrew the needle and dispose of it properly as instructed by your doctor, nurse, pharmacist, or local authorities.
  • Replace the pen cap on the pen after each use to protect the solution from light.
    When the pen is empty, dispose of it without the needle attached, as instructed by your doctor, nurse, pharmacist, or local authorities.

Never try to reinsert the inner needle cap after removing it. You could injure yourself with the needle.
Always remove the needle from the pen immediately after each injection.
This helps prevent needle blockages, contamination, infections, leakage of solution, and inaccurate dosing.

Other important information

  • Always keep the pen and needles out of sight and reach of others, especially children.
  • Never share the pen or needles with other people.
  • Anyone assisting the patient must be very careful when handling used needles to prevent cross-infections and needle-stick injuries.

Pen maintenance
Handle the pen with care. Improper or careless use may result in inaccurate delivery. In such cases, the medicine may not have the intended effect.

  • Do not leave the pen in a car or in other places where it could become too hot or too cold.
  • Do not inject Ozempic if it has been frozen. If injected, the medicine may not have the intended effect.
  • Do not inject Ozempic if it has been exposed to direct sunlight. If injected, the medicine may not have the intended effect.
  • Do not expose the pen to dust, dirt, or liquids.
  • Do not wash, immerse in liquid, or lubricate the pen. It may be cleaned with a mild detergent and a damp cloth.
  • Do not drop the pen or allow it to hit hard surfaces. If the pen is dropped or if you suspect a problem, attach a new needle and check the solution flow before injection.
  • Do not attempt to refill the pen.
  • Do not attempt to repair or disassemble the pen.

Patient information leaflet

Ozempic 2 mg solution for injection in a pre-filled pen

semaglutide
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

  1. What Ozempic is and what it is used for
  2. What you need to know before using Ozempic
  3. How to use Ozempic
  4. Possible side effects
  5. How to store Ozempic
  6. Contents of the pack and other information

1. What Ozempic is and what it is used for

Ozempic contains the active substance semaglutide which helps the body reduce blood sugar levels only when they are too high, and can help prevent heart disease in patients with type 2 diabetes mellitus. It also helps slow the decline in kidney function in patients with type 2 diabetes through a mechanism beyond blood glucose reduction.
Ozempic is used to treat adults (aged 18 years and older) with type 2 diabetes mellitus when diet and exercise alone are not sufficient:

  • on its own – when metformin (another diabetes medicine) cannot be used, or
  • in combination with other diabetes medicines, when these are not sufficient to control blood sugar levels. These medicines may be administered orally or by injection, such as insulin.

It is important that you continue the diet and exercise programme recommended by your doctor, pharmacist or nurse.

2. What you need to know before using Ozempic

Do not use Ozempic

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using this medicine.
This medicine is not insulin and you must not use it if:

  • you have type 1 diabetes, a condition in which your body does not produce insulin
  • you develop diabetic ketoacidosis, a diabetes complication involving high blood sugar levels, breathing difficulties, confusion, excessive thirst, sweet-smelling breath, or a sweet or metallic taste in the mouth.

Ozempic is not insulin and therefore must not be used as a substitute for insulin.
If you are undergoing surgery with anaesthesia, inform your doctor that you are taking Ozempic.
Gastrointestinal problems and dehydration
During treatment with this medicine, you may experience nausea, vomiting, or diarrhoea. These side effects may cause dehydration (loss of fluids). It is important that you drink plenty of fluids to prevent dehydration. This is particularly important if you have kidney problems. Contact your doctor if you have any concerns or questions.
Severe and persistent stomach pain that may be due to acute pancreatitis
If you have severe and persistent pain in the stomach area, contact a doctor immediately as this may be a sign of acute pancreatitis (inflammation of the pancreas). See section 4 for signs indicating inflammation of the pancreas.
Low blood sugar levels (hypoglycaemia)
Taking a sulphonylurea or insulin together with this medicine may increase the risk of low blood sugar levels (hypoglycaemia). See section 4 for warning signs of low blood sugar levels. Your doctor may ask you to monitor your blood sugar levels. This will help your doctor decide whether the dose of sulphonylurea or insulin needs to be changed to reduce the risk of low blood sugar levels.
Diabetic retinopathy (a diabetes complication affecting the eyes)
If you have had diabetic retinopathy and are using insulin, this medicine may lead to worsening eyesight, which may require treatment. Inform your doctor if you have diabetic retinopathy or if you develop eye problems during treatment with this medicine.
Use of Ozempic 2 mg is not recommended in patients with potentially unstable diabetic retinopathy.
Sudden changes in vision
If you notice sudden loss of vision or a rapid worsening of vision during treatment with this medicine, contact your doctor immediately for advice. This could be caused by a very rare side effect called non-arteritic anterior ischaemic optic neuropathy (NAION) (see section 4: Serious side effects). Your doctor may recommend an eye examination and may need to discontinue treatment with this medicine.
Patients with delayed gastric emptying (gastroparesis)
If you suffer from slow (delayed) gastric emptying (called gastroparesis), use of Ozempic may cause severe or serious gastrointestinal adverse events. Consult your doctor before using Ozempic.
Children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age since its efficacy and safety have not yet been established in this age group.
Other medicines and Ozempic
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other medicines purchased without a prescription.
In particular, inform your doctor, pharmacist, or nurse if you are taking medicines containing:

  • Warfarin or similar oral medicines taken to reduce blood clotting (oral anticoagulants). Frequent blood tests are needed to determine your blood clotting speed.
  • If you are using insulin, your doctor will tell you how to reduce your insulin dose and will advise you to monitor your blood glucose more frequently to avoid hyperglycaemia (high blood glucose) and diabetic ketoacidosis (a diabetes complication that occurs when the body cannot break down glucose due to insufficient insulin).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine.
This medicine must not be used during pregnancy because it is not known whether it could harm the unborn child. Therefore, you are advised to use a contraceptive method while using this medicine. If you plan to become pregnant, talk to your doctor about changing your therapy, as you must stop using this medicine at least 2 months before conception. If you become pregnant while using this medicine, contact your doctor immediately as your treatment will need to be changed.
Do not use this medicine if you are breastfeeding because it is not known whether Ozempic passes into breast milk.
Driving and using machines
It is unlikely that Ozempic will affect your ability to drive or operate machinery. However, if you use this medicine in combination with a sulphonylurea or insulin, low blood sugar levels (hypoglycaemia) may occur, which could impair your ability to concentrate. Do not drive or operate machinery if you experience signs of low blood sugar levels. See section 2, “Warnings and precautions”, for information on the increased risk of low blood sugar levels and section 4 for warning signs of low blood sugar levels. Consult your doctor for further information.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Ozempic

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.

How much medicine 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 the dose to 1 mg once a week if your blood sugar level is not adequately controlled with a 0.5 mg once-weekly dose.
  • Your doctor may increase the dose to 2 mg once a week if your blood sugar level is not adequately controlled with a 1 mg once-weekly dose.

Do not change the dose unless your doctor tells you to do so.

How Ozempic is administered
Ozempic is given by injection under the skin (subcutaneous injection). Do not inject it into a vein or a muscle.

  • The best sites for injection are the front of the thighs, the abdomen (tummy), or the upper arm.
  • Before you use the pen for the first time, your doctor or nurse will show you how to do it. Detailed instructions for use are provided on the back of this leaflet.

When to use Ozempic

  • You should use this medicine once a week, preferably on the same day each week.
  • You may inject it at any time of day, regardless of meals.

To help you remember to inject this medicine only once a week, it is recommended that you write the chosen day of the week (e.g. Wednesday) on the box and record the date on the box each time you inject Ozempic.
If necessary, you may change the day of the weekly injection of this medicine, provided at least 3 days have passed since the last dose. Once you have chosen a new administration day, continue taking the medicine once a week on that day.

If you use more Ozempic than you should
If you use more Ozempic than you should, contact 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:

  • 5 days or fewer have passed since you were supposed to use Ozempic, inject the missed dose as soon as you remember. Then take the next dose on your usual scheduled day.
  • more than 5 days have passed since you were supposed to use Ozempic, skip the missed dose. Then inject the next dose on your usual scheduled day. Do not use a double dose to make up for the missed dose.

If you stop using Ozempic
Do not stop using this medicine without first talking to your doctor. If you stop treatment, your blood sugar levels may rise.

If you have any questions about using this medicine, speak to your doctor, pharmacist, or nurse.

4. Possible side effects

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

Serious side effects

Common (may affect up to 1 in 10 people)

  • Complications of retinopathy – you should speak with your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people)

  • Inflammation of the pancreas (acute pancreatitis) which could cause severe stomach and back pain that does not go away. You must consult a doctor immediately if you experience these symptoms.

Rare (may affect up to 1 in 1,000 people)

  • Severe allergic reactions (anaphylactic reactions, angioedema). You must seek immediate medical help and inform your doctor straight away if you experience symptoms such as breathing difficulties, swelling of the face, lips, tongue and/or throat with trouble swallowing, and rapid heartbeat.

Very rare (may affect up to 1 in 10,000 people)

  • A medical condition of the eye called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause vision loss in one eye without any pain. You must contact your doctor immediately if you notice sudden loss or gradual worsening of vision (see section 2: "Sudden changes in vision").

Not known (frequency cannot be estimated from the available data)

  • Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting, etc.

Other side effects

Very common (may affect more than 1 in 10 people)

  • Nausea – usually goes away with time
  • Diarrhoea – usually goes away with time
  • Low blood sugar levels (hypoglycaemia) when this medicine is used with other diabetes medicines containing sulphonylurea or insulin.

Warning signs of low blood sugar levels may occur suddenly. They may include: cold sweat, cold and pale skin, headache, rapid heartbeat, nausea or feeling very hungry, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating or tremor.
Your doctor will tell you how to treat low blood sugar levels and what to do if you notice these warning signs.
Low blood sugar levels are more likely if you are also taking a sulphonylurea or insulin. Before you start taking this medicine, your doctor may reduce the dose of these medicines.

  • Difficulty digesting
  • Inflammation of the stomach (gastritis). Signs include stomach pain, nausea and vomiting
  • Reflux or heartburn, also known as gastroesophageal reflux disease (GERD)
  • Stomach pain
  • Bloating of the stomach
  • Constipation
  • Belching
  • Gallstones
  • Dizziness
  • Tiredness
  • Weight loss
  • Decreased appetite
  • Intestinal gas (flatulence)
  • Increased levels of pancreatic enzymes (such as lipase and amylase)
  • Headache

Uncommon (may affect up to 1 in 100 people)

  • Change in taste of food or drinks
  • Rapid pulse
  • Reactions at the injection site, such as bruising, pain, irritation, itching or rash
  • Allergic reactions such as rash, itching or hives
  • Delayed stomach emptying

Not known (frequency cannot be estimated from the available data)

  • Changes in skin sensitivity

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ozempic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and on the box after 'Exp.'. The expiry date refers to the last day of that month.
Before first use:
Store in a refrigerator (2 °C–8 °C). Do not freeze. Keep away from refrigerating elements.
Keep the cap on the pen to protect the medicine from light.
After first use:

  • The pen may be stored for up to 6 weeks at a temperature below 30 °C or in the refrigerator (2 °C–8 °C), away from refrigerating elements. 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 the medicine from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ozempic contains

  • The active substance is semaglutide. One mL of injectable solution contains 2.68 mg of semaglutide. A pre-filled pen contains 8 mg of semaglutide in 3 mL of solution. Each dose contains 2 mg of semaglutide in 0.74 mL.
  • The other components are: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2, “Sodium content”.

Description of the appearance of Ozempic and contents of the pack
Ozempic is supplied as a clear, colourless or almost colourless injectable solution in a pre-filled pen. Each pen contains 3 mL of solution and delivers 4 doses of 2 mg.
Ozempic 2 mg injectable solution is available in the following pack sizes:
1 pen and 4 NovoFine Plus disposable needles.
3 pens and 12 NovoFine Plus disposable needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Instructions for use

Ozempic 2 mg solution for injection in pre-filled pen

semaglutide

Instructions for use of Ozempic 2 mg injection solution in a prefilled pen
Read these instructions carefully before using your prefilled Ozempic pen. Speak with your doctor, nurse, or pharmacist about how to correctly inject Ozempic. Do not use the pen without having received adequate instruction from your doctor or nurse. Begin by checking the pen to ensure it contains Ozempic 2 mg, then review the following illustrations to become familiar with the different parts of the pen and the needle. If you are blind or have severe vision problems and cannot read the dose counter, do not use this pen without assistance. Ask for help from someone with good eyesight who knows how to use the Ozempic prefilled pen. The pen is a prefilled pen with selectable dose. It contains 8 mg of semaglutide. You can select doses of 2 mg. An unused pen contains four doses of 2 mg. Use the table inside the box lid to keep track of how many injections you have administered and when you administered them. The pen is designed to be used with single-use 30G, 31G, and 32G needles up to 8 mm in length. NovoFine Plus needles are included in the package.Ozempic prefilled pen and needle (example) Pen cap Outer needle cap Inner needle cap Needle Protective seal Dose window Pen label Dose counter Dose indicator Dose selector Injection button Flow check symbol
Exploded diagram of the components of an Ozempic pen, labeled with pen body, caps, reservoir, and application devices
Important informationPay close attention to these notes, as they are important for the safe use of the pen.
  • 1. Preparing the pen with a new needle

  • Check the name and colored label on the pen to make sure it contains Ozempic 2 mg. This is particularly important if you use more than one type of injectable medicine. Using the wrong medicine may harm your health. • Remove the cap from the pen.
A
Two hands hold a blue and white cylindrical medical device, with a dark arrow indicating a rightward sliding movement

  • Check that the solution in the pen is clear and
Two illustrations show a hand holding an injection pen and two hands rotating a cap to remove or attach it

colourless. Look through the window of the pen. If the
solution appears cloudy or coloured, do not use the pen.

  • Take a new needle.

Check the protective seal and the outer needle cap for any damage that could affect
sterility. If you notice any damage,
use a new needle.

  • Remove the protective seal.

Make sure you attach the needle correctly

Two illustrations show a hand rotating and then removing a protective cap from the tip of a medical syringe
  • Push the needle straight onto the pen.
  • Rotate it until it is securely fixed.

The needle is covered by two caps. You must remove both
of them. If you forget to remove both caps,
you will not be able to inject the solution.

  • Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.
  • Remove the inner needle cap and dispose of it. If you try
A hand moves an injection pen to the right to attach it to

to reinsert it, you may accidentally prick yourself with the needle.
A drop of solution may appear at the tip of the needle. This
is normal, but you should still check the flow if you are using a
new pen for the first time. See step 2, "Checking the flow with each new pen".
Do not attach a new needle to the pen until you are ready to
give the injection.

Always use a new needle for each injection.
This prevents needle blockages, contamination, infections, and inaccurate dosing.

Never use a bent or damaged needle.

2. Flow check with every new pen

  • If the pen has already been used, go to
Two hands hold a blue injection pen with a numerical indicator set to 0, and a curved arrow indicates rotation of the device

section 3 "Dose selection". Perform the flow check only
before the first injection with a new pen.

  • Rotate the dose selector to the flow check symbol ( ) immediately after "0". Make sure the
    flow check symbol aligns with
    the dose indicator .

  • Hold the pen with the needle pointing upwards.

A hand holds a blue and gray injection pen with an arrow pointing toward the

Press and hold the injection button until the dose counter returns to 0.
The "0" must align with the dose indicator.
A drop of solution should appear at the tip of the needle.
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 "Flow check with every new pen" up to 6 times. If still no drop appears, replace the needle and repeat step 2 "Flow check with every new pen" once again.
Discard the pen and use a new one if no drop of solution appears.

Always make sure a drop appears at the needle tip before using a new pen for the first time. The presence of a drop confirms that the solution is flowing properly.
If no drop appears, no medicine will be injected, even though the dose counter may move. This situation may indicate a blocked or damaged needle.
If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and therefore may not achieve the intended effect of Ozempic.

3. Dose Selection

  • Rotate the dose selector to select 2 mg.
Two hands hold a blue injection pen with a curved arrow indicating rotation of the device toward 0 and a dosage of 1 mg Two hands hold a blue medical device with an indicator showing zero and a curved arrow pointing toward the

Rotate until the dose counter shows 2 mg.
Only the dose counter and dose indicator show that 2 mg have been selected.
You can only select 2 mg per dose. If the pen contains less than 2 mg, the dose counter will stop before reaching 2.
The dose selector makes a different click sound when rotated forward, backward, or beyond 2 mg. Do not count the clicks of the pen.

Before injecting this medicine, always use the dose counter and dose indicator
to confirm that 2 mg have been selected.
Do not count the clicks of the pen.
Only 2 mg doses must be selected using the dose selector. The 2 mg mark on the dose counter must align precisely with the dose indicator to ensure a correct dose is delivered.

How much solution is left

  • To accurately see how much solution remains,
Hands holding a blue medical device with a curved arrow indicating rotation of the device and a detail showing the number 1 mg Two hands grip a blue medical device with an arrow indicating rotational movement to set the dosage on the display

use the dose counter:
Rotate the dose selector until the dose counter stops.
If it shows 2, there are at least 2 mg left in the pen.
If the dose counter stops before 2 mg, there is not enough solution left for a full 2 mg dose.

If there is not enough solution left in the pen for a complete dose, do not use the pen. Use a new Ozempic pen.

4. Injecting the dose

  • Insert the needle into the skin as shown to you by your doctor
    Two illustrations show a hand holding an injection pen with an arrow pointing downward to indicate a pressing movement
    L
    or nurse.

  • Make sure you can see the dose counter. Do not cover it with your fingers, as this may cause the injection to stop.

  • Press and hold down the injection button.
    Watch as the dose counter returns to “0”.
    The “0” must align with the dose indicator. You may hear or feel a click.

  • Continue to hold down the injection button while the needle is inserted in the skin.

  • Continue to hold down the injection button
    Medical illustration showing a hand holding an injection pen above the skin, with a blue arrow pointing toward the
    while the needle is inserted in the skin.

  • If the needle is removed too early, you may notice a flow of solution leaking from the needle tip. In this case, the full dose will not have been delivered.

  • Remove the needle from the skin. Then release the injection button.
    If blood appears at the injection site, apply light pressure without rubbing the area.
    After the injection, you may see a drop of solution at the needle tip. This is normal and does not affect the delivered dose.

Always watch the dose counter to know how many mg you are injecting. Hold down the injection button until the dose counter returns to “0”.

How to identify a blocked or damaged needle

  • If a “0” does not appear on the dose counter after continuously pressing the injection button, you may have used a blocked or damaged needle.
  • In this case, no medication will have been delivered, even if the dose counter has moved from the originally set dose.

How to handle a blocked needle
Replace the needle as described in section 5 “After the injection” and repeat all steps starting from section 1 “Preparing the pen with a new needle”. Make sure to select the full required dose.
Never touch the dose counter during injection, otherwise the injection may stop.

5. After injection

Always dispose of the needle after each injection to ensure comfortable injections

A blue arrow indicates the motion of an injection pen being inserted toward a white protective cap against a blue background

and prevent needle blockages. If the needle is
blocked, no medicine will be injected

  • Place the tip of the needle into the outer needle cap placed on a flat surface, without touching the needle or the cap itself.
  • When the needle is covered, press down completely on the
Two illustrations show hands gripping and moving a cylindrical medical device with arrows indicating the direction of movement

outer needle cap carefully.

  • Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist, or local authorities.
  • Replace the pen cap on the pen after each use to protect the solution from light.
    When the pen is empty, dispose of it without the needle attached, as instructed by your doctor, nurse,
    pharmacist, or local authorities.

Never attempt to re-screw on the inner needle cap after removing it. You may injure yourself with the needle.
Always remove the needle from the pen immediately after each injection.
This reduces the risk of blocked needles, contamination, infections, leakage of solution, and inaccurate dosing.

Other important information

  • Always keep the pen and needles out of sight and reach of others, especially children.
  • Never share the pen or needles with other people.
  • Anyone assisting the patient must be very careful when handling used needles to prevent cross-infections and needle-stick injuries.

Pen maintenance
Handle the pen with care. Improper or careless use may result in inaccurate delivery. In such cases, the medicine may not have the intended effect.

  • Do not leave the pen in a car or in any place where it could become too hot or too cold.
  • Do not inject Ozempic if it has been frozen. If injected, the medicine may not have the intended effect.
  • Do not inject Ozempic if it has been exposed to direct sunlight. If injected, the medicine may not have the intended effect.
  • Do not expose the pen to dust, dirt, or liquids.
  • Do not wash, immerse in liquid, or lubricate the pen. If necessary, clean it with a mild detergent and a damp cloth.
  • Do not drop the pen or let it hit hard surfaces. If the pen is dropped or if you suspect a problem, attach a new needle and check the solution flow before injection.
  • Do not attempt to refill the pen. Once empty, it must be disposed of.
  • Do not attempt to repair or disassemble the pen.