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.
Contents of the pack
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:
It is important that you continue with the diet and exercise plan indicated by your doctor, pharmacist, or nurse.
Do not use Ozempic
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:
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:
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”.
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
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.
On the other side of this leaflet, you will find detailed instructions for use.
When to use Ozempic
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:
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.
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)
Uncommon(may affect up to 1 in 100 people)
Rare(may affect up to 1 in 1,000 people)
Frequency not known(cannot be estimated from the available data)
Other side effects
Very common(may affect more than 1 in 10 people)
Common(may affect up to 1 in 10 people)
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.
Uncommon(may affect up to 1 in 100 people)
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.
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)
Ozempic 1 mg (8-dose pen)
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.
Ozempic Composition
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. | |
Important Information Pay special attention to these notes, as they are important for the safe use of the pen. | |
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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.
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Make sure to attach the needle correctly.
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The needle is covered by two caps. You must remove both caps.If you forget to remove both caps, you will notinject solution.
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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. | |
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. | |
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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. | |
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. | |
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Continue turning until the dose counter stops and shows 1 mg. | |
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 | |
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. | |
If there is not enough solution in the pen for a full dose, do not use it. Instead, use a new Ozempic pen. | |
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If blood appears at the injection site, press lightly. | |
A drop of solution may appear on the tip of the needle after the injection. This is normal and does not affect your dose. | |
How to tell if the needle is clogged or damaged
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. | |
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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.
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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 | |
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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. | |
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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. | |
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. | |
| |
| |
| |
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.
| |
Make sure to place the needle correctly.
| |
The needle is covered by two caps. You must remove both caps.If you forget to remove both caps, youwill notinject the solution.
| |
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. | |
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. | |
| |
| |
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. | |
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. | |
| |
Continue turning until the dose counter stops and shows 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 | |
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. | |
If there is not enough solution in the pen for a full dose, do not use it. Instead, use a new Ozempic pen. | |
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| |
| |
| |
If blood appears at the injection site, press lightly. | |
A drop of solution may appear at the tip of the needle after the injection. This is normal and does not affect your dose. | |
How to tell if the needle is clogged or damaged
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. | |
| |
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.
| |
| |
| |
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 | |
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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. | |
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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.