0.25 mg solution for injection in pre-filled pen semaglutide
What Ozempic is and what it is used for
Ozempic contains the active substance semaglutide. It helps the body lower your blood sugar, but only when your blood sugar is too high. It can also help prevent heart disease.
Ozempic is used:
- as the only medicine – unless diet and exercise alone are enough to get your blood sugar under control, and you can not use metformin (another diabetes medicine) or
- together with other diabetes medicines – when these are not enough to get your blood sugar under control. These other medicines can be diabetes medicines that you swallow (such as metformin, a thiazolidinedione, sulphonylurea, sodium-glucose transporter 2 (SGLT2) inhibitors) or insulin.
You must continue to follow the advice on diet and exercise given to you by your doctor, pharmacist, or nurse.
What you need to know before you use Ozempic
Do not use Ozempic
- if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using this medicine.
This medicine is not insulin and should not be used if:
- you have type 1 diabetes – a condition in which the body does not produce any insulin
- you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, difficulty breathing, confusion, excessive thirst, sweet breath, or a sweet or metallic taste in the mouth.
Ozempic is not insulin and should therefore not be used as a replacement for insulin.
Effects on the digestive system
During treatment with this medicine, you may feel unwell, vomit, or have diarrhea. These side effects can cause dehydration (fluid loss). It is important to drink plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to a doctor if you have any questions or concerns.
Severe and persistent abdominal pain that may be due to acute inflammation of the pancreas
If you have severe and persistent stomach pain – see a doctor immediately as this may be a sign of acute pancreatitis ( inflammation of the pancreas).
See section 4 for warning signs of the inflamed pancreas.
Hypoglycemia
Combining sulphonylurea or insulin with this medicine may increase the risk of low blood sugar (hypoglycemia). See section 4 for information on warning signs of low blood sugar. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if a dose of sulphonylurea 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 use insulin, this medicine may lead to your vision deteriorating, which may require treatment. Tell your doctor if you have diabetic eye disease or if you experience eye problems during treatment with this medicine. If you have a diabetic eye disease that may be unstable, we do not recommend that you take Ozempic 2 mg.
Children and young people
This medicine is not recommended for children and adolescents under 18 years of age, as safety and efficacy in this age group have not 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 have bought without a prescription.
Especially if you are taking medicines that contain any of the following, tell your doctor, pharmacist, or nurse:
- Warfarin or similar medicines are taken orally to reduce blood clotting capacity (oral anticoagulants ). You may be required to have frequent check-ups of your blood clotting capacity.
- If you are taking insulin, your doctor will tell you how to lower your insulin dose and recommend that you measure your blood sugar more often to avoid hyperglycemia (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 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 using this medicine.
This medicine should not be used during pregnancy as it is not known if it may affect your fetus. Therefore, you should use a contraceptive when using this medicine. If you want to get pregnant, stop using this medicine at least two months in advance. If you become pregnant while taking this medicine, talk to your doctor immediately as your treatment may need to be changed.
Do not use this medicine if you are 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 together with a sulphonylurea or insulin, low blood sugar (hypoglycemia) may occur which may lower your ability to concentrate. Avoid driving or using machines if you get signs of low blood sugar. Section 2, “Warnings and precautions” provides information on the increased risk of low blood sugar and Section 4 provides information on the warning signs for low blood sugar. For more information, talk to your doctor.
Sodium content
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How to use Ozempic
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
How much to use
- The starting dose is 0.25 mg once a week for four weeks.
- After four weeks, the doctor increases the dose one to 0.5 mg once a week.
- Your doctor may increase your dose one to 1 mg once a week if your blood sugar is not kept sufficiently under control at a dose of 0.5 mg once a week.
- Your doctor may increase the dose to one to 2 mg once a week if your blood sugar is not kept under sufficient control at a dose of 1 mg once a week.
The dose may only be changed as directed by a physician.
How Ozempic should be given
Ozempic is given as an injection under the skin ( subcutaneous injection ). Do not inject the medicine directly into a blood vessel or muscle.
- The best places to inject are the front of the thighs, the front of the waist (abdomen), or the upper arm.
- Before using the pen for the first time, tell your doctor or nurse how to use it.
There is a detailed instruction manual on the back of this leaflet.
When to use Ozempic
- You should use this medicine once a week on the same day of the week if possible.
- You can inject one at any time during the day – regardless of meals
To help you remember to inject this medicine only once a week, you should write down the day of the week you have chosen (eg Wednesday) on the carton and write the date on the carton each time you have injected.
If needed, you can change the day of the week for the injection of one of these medicines as long as at least 3 days have passed since the last injection. Once you have selected a new dosing day, continue with the weekly dosing one.
If you use more Ozempic than you should
Contact a doctor immediately if you have used too much Ozempic. You can get 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 would have used Ozempic, you should take an injection as soon as you remember. Inject the next dose as usual on a regularly scheduled day.
- it has been more than 5 days since you would have used Ozempic, you should skip the missed dose one. Inject the next dose as usual on a regularly 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 first. If you stop using the medicine, your blood sugar level may rise.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Common ( may affect up to 1 in 10 people)
- Complications of diabetic eye disease ( retinopathy ) – you should tell your doctor if you experience eye problems, such as vision changes, during treatment with this medicine.
Uncommon (may affect up to 1 in 100 people)
- Inflamed pancreas ( acute pancreatitis ) can cause severe pain in the abdomen and back and which does not cease. You should see a doctor immediately if you experience such symptoms.
Rare (may affect up to 1 in 1,000 people)
- severe allergic reactions (anaphylactic reactions, angioedema ). Seek medical attention immediately and inform your doctor immediately if you experience symptoms such as difficulty breathing, swelling of the face, lips, tongue, and/or throat with difficulty swallowing, and palpitations.
Other side effects are
Very common (may affect more than 1 user in 10)
- nausea – this usually goes away over time
- diarrhea – this usually goes away with time
Common (may affect up to 1 in 10 people)
- vomiting
- low blood sugar (hypoglycemia) when used with another antidiabetic medicine
The warning signs of low blood sugar may come on suddenly. They may manifest themselves as cold sweat, cold and pale skin, headache, palpitations, nausea or strong hunger, changes in vision, drowsiness or weakness, nervousness, anxiety or confusion, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice any of the warning signs.
Low blood sugar is more likely to occur if you are also taking a medicine that contains sulphonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.
- indigestion
- gastritis ( gastritis ) – may manifest as abdominal pain, nausea, and vomiting
- acid reflux or heartburn – also known as gastroesophageal reflux disease ( GERD )
- abdominal pain
- swollen stomach
- constipation
- burp
- gallstone
- dizziness
- fatigue
- weight loss
- decreased appetite
- gases ( flatulence )
- increase in a pancreatic enzyme (such as lipase and amylase).
Uncommon (may affect up to 1 in 100 people)
- change in how food and drink taste
- fast pulse
- injection site reactions – such as bruising, pain, irritation, itching, and rash.
- allergic reactions such as rash, itching, or hives.
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 and carton after EXP. The expiration date is the last day of the specified month.
Unopened:
Store in a refrigerator (2 ° C to 8 ° C). Do not freeze. Do not store near the heat sink. Sensitive to light.
During use:
- The pen can be stored for 6 weeks at a maximum of 30 ° C or in a refrigerator (2 ° C to 8 ° C), not near the cooling element. Ozempic must not be frozen and if it has been frozen, it must not be used.
- When the pen is not in use, store it with the pen cap on. Sensitive to light.
The drug may only be used if the solution is 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 to protect the environment.
Contents of the pack and other information
Content declaration
Content declaration
- The active substance is semaglutide. One ml of solution for injection contains 1.34 mg of semaglutide. One pre-filled pen contains 2 mg of semaglutide in a 1.5 ml solution. Each dose contains 0.25 mg of semaglutide in 0.19 ml.
- 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 the medicine looks like and the contents of the pack
Ozempic is a clear and colorless or almost colorless solution for injection in a pre-filled pen. Each pre-filled pen contains 1.5 ml of solution, giving 4 doses of 0.25 mg.
Ozempic 0.25 mg solution for injection is available in the following pack sizes:
1 pen and 4 NovoFine Plus disposable needles.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A / S
Novo Allé
DK-2880 Bagsværd
Denmark