Ozempic 0.25 mg solution for injection in pre-filled pen: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ozempic 0.25 mg solution for injection in pre-filled pen

semaglutide

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

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

What Ozempic is and what it is used for
What you need to know before using Ozempic
How to use Ozempic
Possible side effects
How to store Ozempic
Contents of the pack and other information

1. What Ozempic is and what it is used for

Ozempic contains the active substance semaglutide. It helps your body reduce blood sugar levels only when these levels are too high, and can help prevent heart disease in patients with type 2 diabetes mellitus (T2DM). It also helps slow the decline in kidney function in patients with T2DM through a mechanism separate from glucose reduction.

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

as the only antidiabetic medication when you cannot use metformin (another diabetes medicine), or
with other diabetes medicines: when these are not sufficient to control your blood sugar levels. These may be medicines taken orally or by injection, such as insulin.

It is important that you continue to follow the diet and exercise plan 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 starting to use this medicine.

This medicine is not the same as insulin and you should not use it if:

you have type 1 diabetes, a condition in which the body produces no insulin at all
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 insulin and therefore should not be used as a substitute for insulin.

If you know you are going to undergo surgery under anesthesia (a state of unconsciousness), inform your doctor that you are taking Ozempic.

Gastrointestinal problems and dehydration

While being treated with this medicine, you may experience nausea, vomiting, or diarrhea. These side effects may 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, consult your doctor.

Severe and persistent stomach pain which may be due to acute pancreatitis

If you have severe and persistent pain in the stomach area, contact your doctor immediately, as this could be a sign of acute pancreatitis (inflammation of the pancreas). See section 4 for warning signs of pancreatitis.

Low blood sugar (hypoglycemia)

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

Diabetic eye disease (retinopathy)

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

Sudden changes in vision

If you experience sudden loss of vision or rapid worsening of vision during treatment with this medicine, consult your doctor immediately for advice. This could be due to a very rare side effect called non-arteritic anterior ischemic optic neuropathy (NAION) (see section 4: Serious side effects). Your doctor may perform an eye examination and you may need to stop treatment with this medicine.

Patients with delayed gastric emptying (gastroparesis)

If you have delayed gastric emptying, known as gastroparesis, using Ozempic may cause severe or serious gastrointestinal side effects. Consult your doctor before using Ozempic.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not yet 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 need to take any other medicines, including herbal preparations or other medicines obtained without a prescription.

In particular, inform your doctor, pharmacist, or nurse if you are taking medicines containing any of the following ingredients:

Warfarin or other similar oral anticoagulants (medicines to reduce blood clotting). You may need frequent blood tests to monitor how quickly your blood clots.
If you are using insulin, your doctor will advise you on how to reduce your insulin dose and recommend more frequent monitoring of your blood sugar levels to avoid hyperglycemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose due to insufficient insulin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

This medicine should not be used during pregnancy because it is unknown whether it affects the fetus. Therefore, the use of contraceptive methods is recommended while taking this medicine. If you plan to become pregnant, consult your doctor about changing your treatment, as you must stop using this medicine at least 2 months beforehand. 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 while breastfeeding, as it is unknown whether it passes into breast milk.

Driving and use of 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 sulfonylurea or insulin, you may experience low blood sugar (hypoglycemia), which may impair your concentration. Do not drive or operate machinery if you experience any symptoms of low blood sugar. See section 2, “Warnings and precautions,” for information about the increased risk of low blood sugar, and section 4 for symptoms of low blood sugar. Consult your doctor for further information.

Sodium content

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

3. How to use Ozempic

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

How much to use

The starting dose is 0.25 mg once 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 a 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 a 1 mg once-weekly dose.

Do not change your dose unless instructed by your doctor.

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 the 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.

Detailed instructions on how to use it can be found on the other side of this leaflet.

When to use Ozempic

You should use this medicine once a week, preferably on the same day each week.
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 advisable to write down on the carton the chosen day of the week (for example, Wednesday) as well as the date of each injection.

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 the new administration day has been selected, continue with the weekly dosing schedule.

If you use more Ozempic than you should

If you use more Ozempic than you should, contact 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 should have used Ozempic, take it as soon as you remember. Then take your next dose as usual on the scheduled day.
more than 5 days have passed since you should have used Ozempic, skip the missed dose. Then take your next dose as usual on the scheduled day.

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

If you stop using Ozempic

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone may experience them.

Serious adverse effects

Frequent (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 must inform your doctor.

Uncommon (may affect up to 1 in 100 people)

Inflamed pancreas (acute pancreatitis), which may cause severe, persistent pain in the stomach and back. If you experience such symptoms, seek medical attention immediately.

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

Severe allergic reactions (anaphylactic reactions, angioedema). You must seek medical help 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 palpitations.

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

A condition affecting the eye called non-arteritic anterior ischemic optic neuropathy (NAION), which may cause painless vision loss in one eye. You should contact your doctor immediately if you experience sudden loss of vision or progressive worsening of vision (see section 2: “Sudden changes in vision”).

Frequency not known (cannot be estimated from available data)

Intestinal obstruction. A severe form of constipation with other symptoms such as stomach pain, abdominal distension, vomiting, etc.

Other adverse effects

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

Nausea; this effect usually resolves with time
Diarrhea; this effect usually resolves with time
Low blood sugar level (hypoglycaemia) when this medicine is used with medicines containing sulfonylurea or insulin

Common (may affect up to 1 in 10 people)

Vomiting
Low blood sugar level (hypoglycaemia), when this medicine is used with oral diabetes medicines other than sulfonylureas or insulin

Warning signs of low blood sugar may appear suddenly. Some of these symptoms include: cold sweat, cold and pale skin, headache, palpitations, nausea or excessive hunger, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating, or tremors.

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

Low blood sugar is more likely to occur if you are also taking 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 known as “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 taste of food and drinks
Rapid pulse
Reactions at the injection site, such as bruising, pain, irritation, itching, and rash
Allergic reactions such as rash, itching, or hives
Delayed stomach emptying

Frequency not known (cannot be estimated from available data)

Change in skin sensitivity

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V.

By reporting adverse 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 stated on the pen label and carton after EXP. The expiry date refers to the last day of the month shown.

Before first opening:

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Keep away from the cooling element of the refrigerator. Keep the pen in its cap to protect it from light.

After first opening:

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

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging no longer required. This will help protect the environment.

6. Package contents and other information

Composition of Ozempic

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 product and contents of the pack

Ozempic is a clear, colourless or almost colourless injectable solution in a pre-filled pen.

Each pre-filled pen contains 1.5 ml of solution, allowing administration of 4 doses of 0.25 mg.

Ozempic 0.25 mg solution for injection is available in the following pack size:

1 pen and 4 NovoFine Plus disposable needles.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website: 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 Solution for Injection in a Pre-filled Pen
Please read these instructions carefully before using your Ozempic pre-filled pen. Ask your doctor, nurse, or pharmacist how to correctly inject yourself with Ozempic. Use only the medicine in this pen as prescribed to you. Begin by checking the pen to ensure it contains Ozempic 0.25 mg, then review the following images to become familiar with the different parts of the pen and the needle. If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this pen without assistance. Seek help from someone with good eyesight who knows how to use the Ozempic pre-filled pen. Your pen is a pre-filled dosing pen. It contains 2 mg of semaglutide and allows only 0.25 mg doses to be selected. An unused pen contains four doses of 0.25 mg. After injecting all four doses, some solution will remain in the pen. The pen must be discarded. Use the table inside the box lid to keep a record of how many injections you have administered and when you administered them. The pen is designed to be used with disposable 30G, 31G, and 32G needles 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.
Preparing the pen with a new needle
Check the name and color of the label on your 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 could be harmful to your health. Remove the pen cap.
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.
Take a new needle. Check that the paper tab and the outer needle cap show no damage that could affect sterility. If you notice any damage, use a new needle. Remove the paper tab.
Ensure the needle is properly attached. Place the needle straight onto the pen. Screw it on firmly until tight.
The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, no solution will be injected. 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 to replace it, you could accidentally prick yourself with the needle. A drop of solution may appear at the tip of the needle. This is normal, but even so, you must check the flow if this is a new pen and it is the first time you are using it. See step 2, “Checking flow with each new pen”. Do not attach a new needle to the pen until you are ready to administer your injection.
Always use a new needle for each injection. This helps prevent needle blockage, contamination, infection, and inaccurate dosing.
Never use a bent or damaged needle.
Checking flow with each new pen
If the pen is already in use, go to step 3, “Selecting the dose”. Check flow only before the first injection with each new pen. Turn the dose selector to the flow check symbol () just after ‘0’. Make sure the flow check symbol aligns with the marker.
Hold the pen with the needle pointing upward. Press and hold the injection button until the dose counter returns to ‘0’. The ‘0’ must align with the dose marker. 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, “Checking flow with each new pen”, up to 6 times. If still no drop appears, change the needle and repeat step 2, “Checking flow with each new pen”, once more. Discard the pen and use a new one if no drop of solution appears despite these attempts.
Always ensure a drop appears at the needle tip before using a new pen for the first time. This ensures the solution flows properly. If no drop appears, no medicine will be injected, even if the dose counter moves. This may indicate the needle is blocked or damaged. If you do not check flow before the first injection with each new pen, you may not receive the prescribed dose and may not achieve the intended effect of Ozempic.
Selecting the dose
Turn the dose selector to select 0.25 mg. Continue turning until the dose counter stops and displays 0.25 mg.
Only the dose counter and dose marker will show that 0.25 mg has been selected. You can only select 0.25 mg per dose. The dose selector makes a different click when turned 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 marker 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 be exactly aligned with the dose marker to ensure you receive the correct dose.
Injecting the dose
Insert the needle under 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. This could interrupt the injection.
Press and hold the injection button. Watch as the dose counter returns to ‘0’. The ‘0’ must align with the dose marker. At this point, you may hear or feel a click. Continue holding the injection button while keeping the needle under the skin.
Count slowly to 6 while holding the injection button. If you remove the needle too early, you may see solution leaking from the needle tip. In this case, the full dose will not have been administered.
Remove the needle from the skin. You may then release the injection button. If bleeding occurs at the injection site, apply light pressure.
A drop of solution may appear at the needle tip after injection. This is normal and does not affect your dose.
Always observe the dose counter to know how many mg are injected. Hold the injection button pressed until the dose counter returns to ‘0’. How to detect if the needle is blocked or damaged If ‘0’ does not appear in the dose counter after continuously pressing the injection button, you may have used a blocked or damaged needle. In this case, you will not have received any medicine, even if the dose counter moved from the original dose you set. What to do if the needle is blocked Change the needle as described in step 5, “After the injection”, and repeat all steps from step 1, “Preparing the pen with a new needle”. Ensure you select the full dose you need. Never touch the dose counter during injection. This may interrupt the injection.
After the injection
Always discard the needle after each injection to ensure injections are administered correctly and to prevent needle blockage. If the needle is blocked, no medicine will be injected. Place the needle tip into its outer cap, placed on a flat surface, without touching the needle or the outer cap.
Once the needle is protected, carefully press the outer needle cap down firmly. Unscrew the needle and dispose of it carefully according to instructions from your doctor, nurse, pharmacist, or local authorities.
Replace the pen cap after each use to protect the solution from light.
When discarding the pen, do so without the needle attached, following instructions from your doctor, nurse, pharmacist, or local authorities.
Never attempt to reinsert the inner cap onto the needle. You could prick yourself with the needle. Always remove the needle from the pen immediately after each injection. This helps prevent needle blockage, contamination, infection, loss 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. Individuals caring for patients should be very careful when handling used needles to avoid accidental needlesticks and infections.
Maintaining Your Pen
Handle the pen with care. Rough handling or misuse may cause inaccurate dosing. If this occurs, you may not achieve the intended effect of this medicine.
Do not leave the pen in a car or other places where it could 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 medicine. Do not inject Ozempic that has been exposed to direct sunlight. If you do, you may not achieve the intended effect of this medicine. Do not expose the pen to dust, dirt, or liquids. Do not wash, wet, or lubricate the pen. It may be cleaned with a soft cloth dampened with mild detergent. Prevent the pen from falling or hitting hard surfaces. If the pen is dropped or you suspect it may be damaged, attach a new needle and check flow before injecting. Do not attempt to refill the pen. Do not attempt to repair or disassemble the pen.