Patient leaflet - Ozempic 0.25 mg solution for injection in Pre-filled pen
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 in patients with type 2 diabetes mellitus (T2DM). It also helps to slow down deterioration of kidney function in patients with T2DM by a mechanism beyond blood glucose lowering.
Ozempic is used to treat adults (aged 18 years and older) with type 2 diabetes when diet and exercise is not enough:
on its own – when you cannot use metformin (another diabetes
medicine) or
with other medicines for diabetes – when they are not enough to
control your blood sugar levels. These may be medicines you take by mouth or inject such as insulin.
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
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 using this medicine.
This medicine is not the same as insulin and you should not use it if:
you have type 1 diabetes – a condition where your body does not
produce any insulin
you develop diabetic ketoacidosis – a complication of diabetes with
high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth.
Ozempic is not an insulin and should therefore not be used as a substitute for insulin.
If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Ozempic.
Stomach and gut problems and dehydration
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 ever had pancreatitis (inflammation of the pancreas) which may cause severe pain in the stomach and back which does not go away; see section 4.
Low blood sugar (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. In case you have potentially unstable diabetic eye disease, it is not recommended that you use Ozempic 2mg.
Sudden changes to your eyesight
If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, urgently contact your doctor. This may be caused by a very rare side effect called non-arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor will refer you for an eye examination by an ophthalmologist and you may have to stop treatment with semaglutide.
Patients with delayed stomach emptying (gastroparesis)
If you have slow (delayed) stomach emptying (called gastroparesis), use of Ozempic may lead to serious or severe gastrointestinal adverse events. Talk to your doctor before using Ozempic.
Children and adolescents
This medicine is not recommended in children and adolescents aged 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:
Warfarin or other similar medicines taken by mouth to reduce
blood clotting (oral anti-coagulants). You may need frequent 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 will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
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 affects an unborn baby. Therefore, use of contraception is recommended while using this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while 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
Ozempic is unlikely to affect your ability to drive and use machines. If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warnings 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 1mmol sodium (23mg) per dose, that is to say 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
- The starting dose is 0.25mg once a week for four weeks.
- After four weeks your doctor will increase your dose to 0.5mg once a week.
- Your doctor may increase your dose to 1mg once a week if your blood sugar is not controlled well enough with a dose of 0.5mg once a week.
- Your doctor may increase your dose to 2mg once a week if your blood sugar is not controlled well enough with a dose of 1mg once a week.
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.
- The best places to give the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.
- Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Detailed instructions for use are on the other side of this package leaflet.
When to use Ozempic
- You should use this medicine once a week on the same day each week if possible.
- You can give yourself the injection at any time of the day – regardless of meals.
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:
- it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject your next dose as usual on your scheduled day.
Do not use 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)
Complications of diabetic eye disease (retinopathy) – you should
tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.
Uncommon (may affect up to 1 in 100 people)
Inflamed pancreas (acute pancreatitis) which could cause severe
pain in the stomach and back which does not go away. This is a serious, potentially life-threatening condition. You should see a doctor immediately if you experience such symptoms. Stop using this medicine and seek urgent medical help if you experience: Severe, persistent pain in the stomach area (abdomen), with or without nausea and vomiting. This could be a sign of acute pancreatitis, which is serious and potentially life-threatening.
Rare (may affect up to 1 in 1 000 people)
Severe allergic reactions (anaphylactic reactions, angioedema).
You must get immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing and a fast heartbeat.
Very Rare (may affect up to 1 in 10 000 people)
A medical condition of the eye called non-arteritic anterior
ischaemic optic neuropathy (NAION), which may cause loss of vision without any pain. You should urgently contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: ‘Sudden changes to your eyesight’).
Not known (frequency cannot be estimated from the available data)
Bowel obstruction. A severe form of constipation with additional
symptoms such as stomach ache, bloating, vomiting etc.
Other side effects
Very common (may affect more than 1 in 10 people)
- Feeling sick (nausea) – this usually goes away over time
- Diarrhoea – this usually goes away over time
Low blood sugar (hypoglycaemia) when this medicine is used with
medicines that contain a sulfonylurea or insulin
Common (may affect up to 1 in 10 people)
- Being sick (vomiting)
Low blood sugar (hypoglycaemia) when this medicine is used with
oral diabetes medicine other than sulfonylurea or insulin
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.
- Indigestion
Inflamed stomach (‘gastritis’) – the signs include stomach ache,
feeling sick (nausea) or being sick (vomiting)
Reflux or heartburn – also called ‘gastro-esophageal reflux
disease’ (GERD)
- Stomach pain
- Bloating of the stomach
- Constipation
- Burping
- Gall stones
- Dizziness
- Tiredness
- Weight loss
- Less appetite
- Gas (flatulence)
- Increase of pancreatic enzymes (such as lipase and amylase)
- Headache.
Uncommon (may affect up to 1 in 100 people)
- Change in the way food or drink tastes
- Fast pulse
Injection site reactions – such as bruising, pain, irritation, itching
and rash
- Allergic reactions like rash, itching or hives
- A delay in the emptying of the stomach.
Not known (frequency cannot be estimated from the available data)
- Change in skin sensation.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Ozempic
Keep out of the sight and reach of children.
Before opening:
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. Protect from light.
During use:
You can keep the pen for 6 weeks when stored at a temperature
below 30°C or in a refrigerator (2°C – 8°C) away from the cooling element. Do not freeze Ozempic and do not use it if it has been frozen.
When you are not using the pen, keep the pen cap on in order to
protect from light.
Do not use this medicine after the expiry date which is stated on the pen and carton labels after ‘Exp’. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.
If the injection becomes discoloured or shows any other signs of deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop using this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
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 to protect the environment.
6. Contents of the pack and other information
What Ozempic contains
The active ingredient in the Ozempic is semaglutide. One ml solution of injection contains 1.34mg semaglutide. One pre-filled pen contains 2mg semaglutide in 1.5ml solution. Each dose contains 0.25mg of semaglutide in 0.19ml.
The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2, 'Sodium content'.
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 pre-filled pen contains 1.5ml of solution, delivering 4 doses of 0.25mg.
It is available in the pack size of 1 pen and 4 disposable NovoFine Plus needles.
Manufactured by:
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Ozempic® 0.25mg solution for injection in pre-filled pen; PL 18799/4215
Leaflet Date: 06.08.2026
Ozempic is the registered trademark of Novo Nordisk A/S.
Blind or partially sighted? Is this leaflet hard to see or read? Call 0208 515 3763 to obtain the leaflet in a format suitable for you.
POM
Instructions on how to use Ozempic® 0.25mg solution for injection in pre-filled pen Please read these instructions carefully before using your Ozempic pre-filled pen. Talk to your doctor, nurse or pharmacist about how to inject Ozempic correctly. Only use the medicine in this pen as prescribed. Start by checking your pen to make sure that it contains Ozempic 0.25mg, 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 knows how to use the Ozempic pre-filled pen. Your pen is a pre-filled dial-a-dose pen. It contains 2mg of semaglutide, and you can only select doses of 0.25mg. One unused pen contains four doses of 0.25mg. After having injected the four doses, there will still be solution left in the pen. The pen should be disposed of. Use the table inside the lid of the carton to keep track of how many injections you have taken and when you took the injections. Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8mm. NovoFine Plus needles are included in the pack. Important information Pay special attention to these notes, as they are important for safe use of the pen. Ozempic pre-filled pen and needle (example) Pen cap Outer needle cap Inner needle cap Needle Paper tab Pen window Pen label Dose counter Dose pointer Dose selector Dose button Flow check symbol |
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 with each new pen’. 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 may prevent blocked needles, contamination, infection and inaccurate dosing. Never use a bent or damaged needle. C A B C D E F | A
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 with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow with each new pen’ once more. Dispose of the pen and use a new one if a drop of solution still does not appear. 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. Flow check symbol selected A B Flow check symbol selected |
Only the dose counter and dose pointer will show that 0.25mg has been selected. You can only select 0.25mg per dose. The dose selector clicks differently when turned forwards, backwards or past 0.25mg. Do not count the pen clicks. Always use the dose counter and the dose pointer to see that 0.25mg has been selected before injecting this medicine. Do not count the pen clicks. Only doses of 0.25 mg must be selected with the dose selector. 0.25 mg must line up precisely with the dose pointer to ensure that you get a correct dose. 0.25mg selected 0.25 A S |
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose. C Count slowly: 1-2-3-4-5-6 B A C D | Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter returns to ‘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.
| When the pen is to be disposed of, do it 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 may prevent 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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