Active ingredient
- semaglutide
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/17/1251/005 .
Ozempic 1 mg
Package leaflet: Information for the patient
Ozempic® 1 mg
Solution for injection in pre-filled pen
semaglutide
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in 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. It helps your body reduce your blood sugar level only when blood sugar is too high and can help prevent heart disease.
Ozempic® is used:
It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.
2. What you need to know before you use Ozempic®
Do not use Ozempic®
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine.
This medicine is not an insulin and should not be used if:
Ozempic® is not an insulin and should therefore not be used as a substitute for insulin.
Effects on the digestive system
During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can 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. Talk to your doctor if you have any questions or concerns.
Severe and on-going stomach pain which could be due to acute pancreatitis
If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of acute pancreatitis (inflamed pancreas).
Hypoglycaemia
Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.
Diabetic eye disease (retinopathy)
If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you experience eye problems during treatment with this medicine.
Children and adolescents
This medicine is not recommended in children and adolescents under 18 years as the safety and efficacy in this age group have not yet been established.
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 you bought without a prescription.
In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might 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 may affect your unborn child. Therefore, it is recommended to use contraception while using this medicine. If you wish to become pregnant, you should stop using this medicine at least two months in advance. If you become pregnant when using this medicine, talk to your doctor right away, as your treatment will need to be changed.
Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.
Driving and using machines
If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
3. How to use Ozempic®
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much to use
Do not change your dose unless your doctor has told you to.
How Ozempic® is given
Ozempic® is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
Detailed instructions for use are on the other side of this leaflet.
When to use Ozempic®
To help you remember to inject this medicine once a week only, it is recommended to note the chosen weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have injected it.
If necessary you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week dosing.
If you use more Ozempic® than you should
If you use more Ozempic® than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea).
If you forget to use Ozempic®
If you forgot to inject a dose and:
Do not take a double dose to make up for a forgotten dose.
If you stop using Ozempic®
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar levels may increase.
If you have any further questions on 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
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
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 may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
Ireland
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Malta
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 which is stated on the pen label and carton after ’EXP’. The expiry date refers to the last day of that month.
Before opening:
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. Protect from light.
During use:
Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ozempic® contains
What Ozempic® looks like and contents of the pack
Ozempic® is a clear and colourless or almost colourless solution for injection in a pre-filled pen. Each pen contains 3 ml solution, delivering 4 doses of 1 mg.
Ozempic® 1 mg solution for injection is available in the following pack sizes:
1 pen and 4 disposable NovoFine® Plus needles.
3 pens and 12 disposable NovoFine® Plus needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 09/2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Ozempic®, NovoFine® and NovoTwist® are trademarks owned by Novo Nordisk A/S, Denmark
© 2020
Novo Nordisk A/S
Instructions on how to use Ozempic® 1 mg solution for injection in pre-filled pen
Please read these instructions carefully before using your Ozempic® pre-filled pen.
Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains Ozempic® 1 mg, then look at the illustrations below to get to know the different parts of your 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. Get help from a person with good eyesight who is trained to use the Ozempic® pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 4 mg of semaglutide, and you can only select doses of 1 mg. Your pen is designed to be used with NovoFine® and NovoTwist® disposable needles up to a length of 8 mm.
NovoFine® Plus needles are included in the pack.
1. Prepare your pen with a new needle
A drop of solution may appear at the needle tip. This is normal, but you must still check the flow, if you use a new pen for the first time. See step 2 ‘Check the flow’.
Do not attach a new needle to your pen until you are ready to take your injection.
Always use a new needle for each injection.
This reduces the risk of blocked needles, contamination, infection and inaccurate dosing.
Never use a bent or damaged needle.
2. Check the flow
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 ‘Check the flow’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow’ once more.
If a drop still does not appear, dispose of the pen and use a new one.
Always make sure that a drop appears at the needle tip before you use a new pen for the first time. This makes sure that the solution flows.
If no drop appears, you will not inject any medicine even though the dose counter may move. This may indicate a blocked or damaged needle.
If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Ozempic®.
3. Select your dose
Only the dose counter and dose pointer will show that 1 mg has been selected.
The dose selector clicks differently when turned forwards, backwards or past 1 mg. Do not count the pen clicks.
Always use the dose counter and the dose pointer to see that 1 mg has been selected before injecting this medicine.
Do not count the pen clicks.
1 mg in the dose counter must line up precisely with the dose pointer to ensure that you get a correct dose.
How much solution is left
If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic® pen.
4. Inject your dose
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose.
Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter shows 0.
How to identify a blocked or damaged needle
How to handle a blocked needle
Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.
Never touch the dose counter when you inject. This can interrupt the injection.
5. After your injection
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles. If the needle is blocked, you will not inject any medicine.
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always remove the needle from your pen immediately after each injection.
This reduces the risk of blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Further important information
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might not get the intended effect of this medicine.
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