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OZEMPIC 1 mg SOLUTION FOR INJECTION IN PRE-FILLED PEN

OZEMPIC 1 mg SOLUTION FOR INJECTION IN PRE-FILLED PEN

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use OZEMPIC 1 mg SOLUTION FOR INJECTION IN PRE-FILLED PEN

Introduction

Package Leaflet: Information for the Patient

Ozempic 1mg solution for injection in pre-filled pen

semaglutide

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 further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Ozempic and what is it used for

Ozempic contains the active substance semaglutide. It helps your body to lower the level of sugar in the blood only when the level of sugar in the blood is too high and can help prevent a heart disease in patients with type 2 diabetes mellitus (T2DM). It also helps to slow down the worsening of kidney function in patients with T2DM through a mechanism separate from lowering blood sugar levels.

Ozempic is used to treat adults (18 years or older) with T2DM when diet and exercise are not enough:

  • as the only diabetes medicine when you cannot use metformin (another diabetes medicine) or
  • with other diabetes medicines: when these are not enough to control your blood sugar levels. These can be medicines that you take by mouth or inject, such as insulin.

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

2. What you need to know before you use Ozempic

Do not use Ozempic

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

Warnings and precautions

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

This medicine is not the same as insulin and should not be used if:

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

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

If you are going to have surgery and will be under anesthesia (put to sleep), tell your doctor that you are taking Ozempic.

Effects on the digestive system

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

Severe and persistent stomach pain that can be due to acute pancreatitis

If you have severe and persistent stomach pain, go to the doctor immediately, as it could be a symptom of acute pancreatitis (inflammation of the pancreas). See section 4 for warning signs of pancreatitis.

Low blood sugar levels (hypoglycemia)

Taking a sulfonylurea or insulin with this medicine may increase the risk of experiencing low blood sugar levels (hypoglycemia). See section 4 for warning signs of low blood sugar levels. Your doctor may ask you to measure your blood sugar levels. This will help your doctor decide if it is necessary to change the dose of sulfonylurea or insulin to reduce the risk of low blood sugar levels.

Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medicine may cause your vision to worsen, and you may need treatment. Tell your doctor if you have diabetic eye disease or experience eye problems during treatment with this medicine. If you have potentially unstable diabetic eye disease, the use of Ozempic 2 mg is not recommended.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age, as the safety and efficacy have not been established in these age groups.

Other medicines and Ozempic

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

In particular, tell your doctor, pharmacist, or nurse if you are using medicines that contain any of the following ingredients:

  • warfarin or other similar oral medicines to prevent blood clotting (oral anticoagulants). You may need to have regular blood tests to check how quickly your blood clots.
  • if you are using insulin, your doctor will tell you how to reduce the dose of insulin and recommend that you monitor your blood sugar levels more frequently, in order to avoid high blood sugar levels (hyperglycemia) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough insulin).

Pregnancy and breastfeeding

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

This medicine should not be used during pregnancy, as it is not known if it affects the fetus. Therefore, the use of contraceptive methods is recommended during the use of this medicine. If you wish to become pregnant, consult your doctor about how to change your treatment, as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, consult your doctor immediately, as your treatment will need to be changed.

Do not use this medicine during breastfeeding, as it is not known if it passes into breast milk.

Driving and using machines

Ozempic is unlikely to affect your ability to drive or use machines. If you use this medicine in combination with a sulfonylurea or insulin, you may experience low blood sugar levels (hypoglycemia), which can reduce your ability to concentrate. Do not drive or use machines if you experience any symptoms of low blood sugar levels. See section 2, “Warnings and precautions” for information on the increased risk of experiencing low blood sugar levels and section 4 for warning signs of low blood sugar levels. Talk to your doctor for more information.

Sodium content

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to use Ozempic

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, talk to your doctor, pharmacist, or nurse again.

How much to use

  • The initial 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 levels are not adequately controlled with a dose of 0.5 mg once a week.
  • Your doctor may increase the dose to 2 mg once a week if your blood sugar levels are not adequately controlled with a dose of 1 mg once a week.

Do not change your dose unless your doctor tells you to.

How to administer Ozempic

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

  • The best injection sites are the front of your thigh, the front of your waist (abdomen), or the upper arm.
  • Before using the pen for the first time, your doctor or nurse will show you how to use it.

On the other side of this leaflet, you will find detailed instructions for use.

When to use Ozempic

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

To help you remember to inject this medicine only once a week, it is a good idea to note on the carton the day of the week you have chosen (e.g., Wednesday) and the date of each injection.

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

If you use more Ozempic than you should

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

If you forget to use Ozempic

If you forget to inject a dose and:

  • it has been 5 days or less since you should have used Ozempic, use it as soon as you remember. Then, give the next dose as usual, on the scheduled day.
  • it has been more than 5 days since you should have used Ozempic, skip the missed dose. Then, give the next dose as usual, on the scheduled day.

Do not use a double dose to make up for a missed dose.

If you stop using Ozempic

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

If you have any other questions about the use of this medicine, ask 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(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

  • inflamed pancreas (acute pancreatitis) that can cause severe and persistent stomach pain. If you experience such symptoms, go to the doctor immediately.

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

  • severe allergic reactions (anaphylactic reactions, angioedema). You should get medical help and tell your doctor immediately if you experience symptoms such as breathing difficulties, swelling of the face, lips, tongue, and/or throat with difficulty swallowing and palpitations.

Frequency not known(cannot be estimated from the available data)

  • intestinal obstruction. A severe form of constipation with other symptoms such as stomach pain, abdominal swelling, vomiting, etc.

Other side effects

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

  • nausea; this side effect usually goes away over time
  • diarrhea; this side effect usually goes away over time
  • low blood sugar levels (hypoglycemia) when this medicine is used with medicines that contain sulfonylurea or insulin

Common(may affect up to 1 in 10 people)

  • vomiting
  • low blood sugar levels (hypoglycemia), when this medicine is used with oral diabetes medicines that are not sulfonylureas or insulin

The warning signs of low blood sugar levels can appear suddenly. Some of these signs are: cold sweat, cool pale skin, headache, fast heartbeat, nausea or excessive hunger, changes in vision, drowsiness or feeling of weakness, nervousness, anxiety, or confusion, difficulty concentrating or tremors.

Your doctor will tell you how to treat low blood sugar levels and what to do if you notice these warning signs.

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

  • indigestion
  • inflamed stomach (gastritis); symptoms include stomach pain, nausea, or vomiting
  • reflux or heartburn; also called “gastroesophageal reflux disease” (GERD)
  • stomach pain
  • stomach swelling
  • constipation
  • belching
  • gallstones
  • dizziness
  • fatigue
  • weight loss
  • decreased appetite
  • gas (flatulence)
  • increased pancreatic enzymes (such as lipase and amylase)
  • headache

Uncommon(may affect up to 1 in 100 people)

  • changes in the taste of food and drinks
  • fast heartbeat
  • reactions at the injection site, such as bruising, pain, irritation, itching, and rash
    • allergic reactions such as rash, itching, or hives
    • a delay in emptying the stomach.

Reporting of side effects

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

5. Storage of Ozempic

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

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

Before opening:

Store in a refrigerator (2°C to 8°C). Do not freeze. Keep away from the freezer compartment. Keep the pen with the cap on to protect it from light.

After first opening:

Ozempic 1 mg (4-dose pen)

  • You can store the pen for 6 weeks if stored below 30°C or in a refrigerator (2°C to 8°C), away from the freezer compartment. Do not freeze Ozempic and do not use it if it has been frozen.

Ozempic 1 mg (8-dose pen)

  • You can store the pen for 8 weeks if stored below 30°C or in a refrigerator (2°C to 8°C), away from the freezer compartment. Do not freeze Ozempic and do not use it if it has been frozen.
  • When not in use, keep the pen with the cap on to protect it from light.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Ozempic Composition

  • The active ingredient is semaglutide.
  • 1 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 1 mg of semaglutide in 0.74 ml.
  • 1 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 1 mg of semaglutide in 0.37 ml.
  • The other components are: disodium phosphate dihydrate, propylene glycol, phenol, water for injectable preparations, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2 "Sodium content".

Product Appearance and Container Contents

Ozempic is a clear and colorless or almost colorless injectable solution in a pre-filled pen.

Each pre-filled pen contains 3 ml of solution, allowing for 4 doses of 1 mg.

Each pre-filled pen contains 3 ml of solution, allowing for 8 doses of 1 mg.

Ozempic 1 mg injectable solution 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.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

Manufacturer

Ozempic 1 mg (4 and 8 doses)

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

Ozempic 1 mg (4 doses)

Novo Nordisk Production SAS

45, Avenue d’Orléans

28000 Chartres

France

Date of Last Revision of this Leaflet:

Other Sources of Information

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

Instructions for Use

Ozempic 1 mg Solution for Injection in Pre-filled Pen allowing for 4 doses

semaglutide

Instructions for Use of Ozempic 1 mg Solution for Injection in Pre-filled Pen

Read these instructions carefullybefore using your Ozempic pre-filled pen.

Ask your doctor, nurse, or pharmacist to show you how to inject Ozempic correctly.

Start by checking the pen to make sure it contains Ozempic 1 mgand then look at the following pictures to familiarize yourself with the different parts of the pen and needle.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.Ask someone who can see well and is familiar with the Ozempic pre-filled pen to help you.

Your pen is a pre-filled dose counter pen. It contains 4 mg of semaglutide and you can only select doses of 1 mg. A new pen contains four doses of 1 mg.

Use the table on the carton to keep track of how many injections you have taken and when you took them.

The pen is designed to be used with NovoFine Plus disposable needles, 30G, 31G, and 32G, up to 8 mm in length.

The package includes NovoFine Plus needles.

Pre-filled Ozempic pen with its components: outer cap, inner cap, needle, paper tab, window, label, dose counter, and flow symbol

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 color of your pen's label to make sure it contains Ozempic 1 mg. This is especially important if you use more than one type of injectable medication. Using the wrong medication could be harmful to your health.
  • Remove the pen cap.

Hand holding a blue device applicator with a visible needle and an arrow indicating the direction of insertion

  • 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.

Hand holding a silver and blue auto-injector with the plunger extended and ready for injection

  • Take a new needle.

Check that the paper tab and outer cap of the needle are not damaged, which could affect the sterility. If you notice any damage, use a new needle.

  • Remove the paper tab.

Two hands holding a device with a cylinder and a transparent plunger, arrow indicates direction of movement

Make sure to attach the needle correctly.

  • Put the needle straight onto the pen.
  • Screw it on until it is tight.

Hand holding an auto-injector with the protective cap partially removed, showing the retracted plunger

The needle is covered by two caps. You must remove both caps.If you forget to remove both caps, you will notinject solution.

  • Remove the outer needle cap and set it aside for later. You will need it after the injection to safely remove the needle from the pen.

Hand holding an auto-injector with the exposed needle and an arrow indicating the direction of insertion

  • Remove the inner needle cap and discard it. If you try to put it back on, you could accidentally stick yourself with the needle.

A drop of solution may appear on the tip of the needle. This is normal, but you must still check the flow if it is a new pen and you are using it for the first time. See step 2 "Checking the flow with each new pen".

Do not put a new needleon the pen until you are ready to take the injection.

Hand holding an auto-injector with the needle pointing upwards and an arrow indicating the direction of injection

Always use a new needle for each injection.

This can help prevent needles from becoming clogged, contamination, infection, and inaccurate dosing.

Never use a bent or damaged needle.

  1. Checking the flow with each new pen
  • If the pen is already in use, go to step 3, "Selecting the dose". Check the flow only before the first injection with each new pen.
  • Turn the dose selector until the flow check symbol () is just after the '0'. Make sure the flow check symbol is aligned with the dose marker.

Auto-injector device with button pressed upwards, showing the flow confirmation symbol selected

  • Hold the pen with the needle pointing upwards.

Press and hold the dose buttonuntil the dose counter returns to '0'. The '0' must be aligned with the dose marker.

A drop of solution should appear on the tip of the needle.

Light blue auto-injector held by a hand with an arrow pointing upwards, indicating the direction

It is possible that a small drop remains on the tip of the needle, but it will not be injected.

If no drop appears,repeat step 2 "Checking the flow with each new pen" up to 6 times. If still no drop is seen, change the needle and repeat step 2 "Checking the flow with each new pen" one more time.

Discard the pen and use a new one if, despite this, no drop of solution appears.

Always make sure a drop appearson the tip of the needle before using a new pen for the first time. This ensures that the solution flows.

If no drop appears, you will notinject medication, even though the dose counter moves. This may indicate that the needle is clogged or damaged.

If you do not check the flow before the first injection with each new pen, you may not receive the prescribed dose or achieve the intended effect of Ozempic.

  1. Selecting the dose
  • Turn the dose selector until 1 mg is selected.

Continue turning until the dose counter stops and shows 1 mg.

Hands holding an injection device with a blue arrow indicating the upward direction and a 1 mg indicator written below

Only the dose counter and dose marker will show that 1 mg has been selected.

You can only select 1 mg per dose. When your pen contains less than 1 mg, the dose counter will stop before showing 1.

The dose selector clicks differently when turned forward, backward, or past 1 mg. Do not count the clicks of the pen.

Always use the dose counter and dose markerto see that you have selected 1 mg.

Do not count the clicks of the pen.

Only select 1 mg doseswith the dose selector. 1 mg must be exactly aligned with the dose marker to ensure you receive the correct dose.

How much solution is left

  • To see how much solution is left, use the dose counter: turn the dose selector until the dose counter stops.

If it shows 1, there is at least 1 mgleft in the pen.

If the dose counter stops before 1 mg, there is not enough solution for a full 1 mg dose.

Pre-filled pen with dose counter showing the number zero and an arrow indicating the correct dose of 1 mg

If there is not enough solution in the pen for a full dose, do not use it. Instead, use a new Ozempic pen.

  1. Injecting the dose
  • Insert the needle under the skin as your doctor or nurse has shown you.
  • Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.

Hand holding a blue auto-injector with an arrow indicating the direction of injection into light skin

  • Press and hold the dose button. Watch while the dose counter returns to '0'. The '0' must be aligned with the dose marker. You may hear or feel a click.
  • Continue to press the dose button while keeping the needle under the skin.

Hand holding a blue auto-injector with an arrow indicating downward pressure on abdominal skin with a window showing the number zero

  • Count slowly to 6 while keeping the dose button pressed.
  • If you withdraw the needle too early, you may see solution coming out of the needle tip. In this case, you may not have received a full dose.

Hand holding a blue auto-injector with numbers 1-2-3-4-5-6 in a speech bubble over the arm

  • Remove the needle from the skin. You can then release the dose button.

If blood appears at the injection site, press lightly.

Injection needle descending with a blue arrow indicating the direction on a white surface

A drop of solution may appear on the tip of the needle after the injection. This is normal and does not affect your dose.

  • Always check the dose counterto see how many mg you inject. Hold the dose button down until the dose counter returns to '0'.

How to tell if the needle is clogged or damaged

  • If the '0' does not appear on the dose counter after continuously pressing the dose button, you may have used a clogged or damaged needle.
  • In this case, you will not have received any medication, even though the dose counter moved.

What to do if the needle is clogged

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

Never touch the dose counterduring the injection. This could interrupt the injection.

  1. After the injection

Always discard the needleafter each injection to ensure that injections are administered correctly and to prevent needles from becoming clogged. If the needle is clogged, you will notinject any medication.

  • Put the needle tip into its outer cap, placed on a flat surface, without touching the needle or the outer cap.

Protective needle cap removed from the pre-filled syringe, showing the plunger and exposed needle tip, arrow indicates direction

  • When the needle is covered, carefully press the outer cap of the needle down to the end.
  • Unscrew the needle and carefully discard it according to the instructions of your doctor, nurse, pharmacist, or local authorities.

Hand holding a cylinder with a metal tip and inserting it into a white tube with an arrow indicating the direction

  • Put the pen cap back on the pen after each use to protect the solution from light.

Hand holding a pre-filled injection device with a transparent needle ready for use on the skin

When the pen is empty, discard it withoutthe needle attached, following the instructions of your doctor, nurse, pharmacist, or local authorities.

Never try to put the inner cap back on the needle.You could stick yourself with the needle.

Always remove the needlefrom the pen immediately after each injection.

This can help prevent needles from becoming clogged, contamination, infection, loss of solution, and inaccurate dosing.

Other Important Information

  • Always keep the pen and needles out of the sight and reach of other people, especially children.
  • Never share the pen or needles with other people.
  • People caring for patients must be careful when handling used needles to avoid accidental needlestick injuries and infections.

Maintenance of Your Pen

Treat the pen with care. Rough handling or misuse can cause inaccurate dosing. If this happens, you may not achieve the intended effect of this medication.

  • Do not leave the pen in a car or other places where it can get too hot or too cold.
  • Do not inject Ozempic that has been frozen. If you do, you may not achieve the intended effect of this medication.
  • Do not inject Ozempic that has been exposed to direct sunlight. If you do, you may not achieve the intended effect of this medication.
  • Do not expose the pen to dust, dirt, or liquids.
  • Do not wash, wet, or lubricate the pen. It can be cleaned with a damp cloth and a mild detergent.
  • Make sure the pen does not fall or hit hard surfaces. If you drop the pen or suspect it has a problem, put a new needle on and check the flow before injecting.
  • Do not try to refill the pen. Once empty, it must be discarded.
  • Do not attempt to repair the pen or take it apart.

Instructions for Use

Ozempic 1 mg Solution for Injection in Pre-filled Pen allowing for 8 doses

semaglutide

Instructions for Use of Ozempic 1 mg Solution for Injection in Pre-filled Pen

Read these instructions carefullybefore using your Ozempic pre-filled pen. Ask your doctor, nurse, or pharmacist to show you how to inject Ozempic correctly.

Start by checking the pen to make sure it contains Ozempic 1 mgand then look at the following pictures to familiarize yourself with the different parts of the pen and needle.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.Ask someone who can see well and is familiar with the Ozempic pre-filled pen to help you.

Your pen is a pre-filled dose counter pen. It contains 8 mg of semaglutide and you can only select doses of 1 mg. A new pen contains eight doses of 1 mg.

After you have injected the prescribed doses, there will still be solution left in the pen. The pen must be discarded.

Use the table on the carton to keep track of how many injections you have taken and when you took them.

The pen is designed to be used with NovoFine Plus disposable needles, 30G, 31G, and 32G, up to 8 mm in length.

The package includes NovoFine Plus needles.

Pre-filled Ozempic pen with needle, showing outer cap, inner cap, label, dose counter, dose selector, and pen window

Important Information

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

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 color of the label on your pen to ensure it contains Ozempic 1 mg. This is especially important if you use more than one type of injectable medication. Using the wrong medication could be harmful to your health.
  • Remove the cap from the pen.

Hands holding a pre-loaded injection device with an arrow indicating the direction of use

  • 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.

Hand holding an applicator with the applicator tip pointing down and slightly to the right

  • Take a new needle.

Check that the paper tab and the outer cap of the needle are not damaged in a way that could affect sterility. If you notice any damage, use a new needle.

  • Remove the paper tab.

Hands holding a medical device with a transparent plunger and an arrow indicating the direction of pressure

Make sure to place the needle correctly.

  • Place the needle straight into the pen.
  • Tighten it until it is secure.

Hand holding an auto-injector with a curved arrow indicating the direction of injection into the skin

The needle is covered by two caps. You must remove both caps.If you forget to remove both caps, youwill notinject the solution.

  • Remove the outer cap of the needle and set it aside for later. You will need it after the injection to safely remove the needle from the pen.

Hand holding a medication cylinder connecting a syringe with an arrow indicating the direction of insertion

  • Remove the inner cap of the needle and discard it. If you try to put it back on, 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 it is a new pen and you are using it for the first time. See step 2 "Checking the flow with each new pen".

Do not put a new needleon the pen until you are ready to give the injection.

Hand holding an auto-injector with the needle pointing up and an arrow indicating the direction of injection

Always use a new needlefor each injection.

This can help prevent needles from becoming clogged, contamination, infection, and inaccurate dosing.

Never use a bent or damaged needle.

  1. Checking the flow with each new pen
  • If the pen is already in use, go to step 3, "Selecting the dose". Check the flow only before the first injection with each new pen.
  • Turn the dose selector until the flow check symbol () is just after the '0'. Make sure the flow check symbol is aligned with the dose marker.

Hands holding a blue applicator device with an arrow indicating the direction of insertion and text 'Flow check'

  • Hold the pen with the needle pointing up.

Press and hold the buttonuntil the dose counter returns to '0'. The '0' must be aligned with the dose marker.

A drop of solution should appear at the tip of the needle.

Hand holding a blue injector with an arrow pointing up indicating the direction

It is possible that a small drop will remain at the tip of the needle, but it will not be injected.

If no drop appears,repeat step 2 "Checking the flow with each new pen" up to 6 times. If still no drop appears, change the needle and repeat step 2 "Checking the flow with each new pen" one more time.

Discard the pen and use a new one if, despite this, no drop of solution appears.

Always make sure a drop appearsat the tip of the needle before using a new pen for the first time. This ensures that the solution is flowing.

If no drop appears, youwill notinject the medication, even if the dose counter moves. This may indicate that the needle is clogged or damaged.

If you do not check the flow before the first injection with each new pen, you may not receive the prescribed dose or achieve the intended effect of Ozempic.

  1. Selecting the dose
  • Turn the dose selector until 1 mg is selected.

Continue turning until the dose counter stops and shows 1 mg.

Hands holding an injection device with a blue arrow indicating the upward direction and label with text 1 mg

Only the dose counter and the dose marker will show that 1 mg has been selected.

You can only select 1 mg per dose. When your pen contains less than 1 mg, the dose counter will stop before showing 1.

The dose selector makes a different click when turned forward, backward, or past 1 mg. Do not count the clicks of the pen.

Always use the dose counter and the dose marker to check that you have selected 1mg.

Do not count the clicks of the pen.

Only select 1mg doses with the dose selector.1 mg must be exactly aligned with the dose marker to ensure you receive the correct dose.

How much solution is left

  • To find out how much solution is left, use the dose counter: turn the dose selector until the dose counter stops.

If it shows 1, there is at least 1mgleft in the pen.

If the dose counter stops before 1mg,there is not enough solution for a full 1 mg dose.

Blue injector with visible needle and arrow indicating the direction of injection on light skin with text 'Dose counter stopped: needle 1 mg'

If there is not enough solution in the pen for a full dose, do not use it. Instead, use a new Ozempic pen.

  1. Injecting the dose
  • Insert the needle under the skin as your doctor or nurse has taught you.
  • Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.

Hand holding a blue pen injector with an arrow pointing down indicating the direction of injection into the skin

  • Press and hold the button. Watch as the dose counter returns to '0'. The '0' must be aligned with the dose marker. You may hear or feel a click.
  • Continue to press the button while keeping the needle under the skin.

Hand holding an auto-injector with a blue arrow indicating the direction of insertion into the abdominal skin

  • Count slowly to 6 while keeping the button pressed.
  • If you withdraw the needle too early, you may see solution coming out of the needle tip. In this case, you will not have administered the full dose.

Hand holding an auto-injector with serial number 1-2345-6 in a dialogue bubble over the device

  • Withdraw the needle from the skin. You can then release the button.

If blood appears at the injection site, press lightly.

Pre-filled syringe with transparent liquid showing a blue arrow pointing up indicating the direction of injection

A drop of solution may appear at the tip of the needle after the injection. This is normal and does not affect your dose.

  • Always check the dose counterto see how many mg you are injecting. Keep the button pressed until the dose counter returns to '0'.

How to tell if the needle is clogged or damaged

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

What to do if the needle is clogged

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

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

  1. After the injection

Always discard the needle after each injectionto ensure that injections are administered correctly and to prevent needles from becoming clogged. If the needle is clogged, youwill notinject any medication.

  • Insert the tip of the needle into its outer cap, which is placed on a flat surface, without touching the needle or the outer cap.

Needle connected to a transparent cylinder with a blue arrow pointing to the left indicating direction

  • When the needle is protected, carefully press the outer cap of the needle down to the bottom.
  • Unscrew the needle and discard it carefully according to the instructions of your doctor, nurse, pharmacist, or local authorities.

Hand holding a cylinder with a metal tip inserting into a white surface with a blue arrow indicating the direction of insertion

  • Put the cap back on the pen after each use to protect the solution from light.

Hand holding a pre-loaded injection device with an arrow indicating the direction of subcutaneous insertion

When the pen is empty, discard it withoutthe needle attached, following the instructions of your doctor, nurse, pharmacist, or local authorities.

Never try to put the inner cap back on the needle.You may prick yourself with the needle.

Always remove the needle from the pen immediately after each injection.

This can help prevent needles from becoming clogged, contamination, infection, loss of solution, and inaccurate dosing.

Other important information

  • Always keep the pen and needles out of sight and reach of other people, especially children.
  • Never share the pen or needles with other people.
  • People caring for patients should be very careful when handling used needles to avoid accidental needlestick injuries and infections.

Maintenance of your pen

Treat the pen with care. Rough handling or misuse can cause inaccurate dosing. If this happens, you may not achieve the intended effect of this medication.

  • Do not leave the pen in a car or other places where it can become too hot or too cold.
  • Do not inject Ozempic that has been frozen. If you do, you may not achieve the intended effect of this medication.
  • Do not inject Ozempic that has been exposed to direct sunlight. If you do, you may not achieve the intended effect of this medication.
  • Do not expose the pen to dust, dirt, or liquids.
  • Do not wash, wet, or lubricate the pen. It can be cleaned with a damp cloth and a mild detergent.
  • Make sure the pen does not fall or hit hard surfaces. If you drop the pen or suspect it may have a problem, put a new needle on and check the flow before injecting.
  • Do not try to refill the pen. Once empty, it must be discarded.
  • Do not attempt to repair the pen or take it apart.
About the medicine

How much does OZEMPIC 1 mg SOLUTION FOR INJECTION IN PRE-FILLED PEN cost in Spain ( 2025)?

The average price of OZEMPIC 1 mg SOLUTION FOR INJECTION IN PRE-FILLED PEN in October, 2025 is around 128.15 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

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