Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ozempic

Document Subject

Generated Narrative: MedicinalProductDefinition mpd321e28009e316a0922b3b06c7400fef

identifier: http://ema.europa.eu/identifier/EU/1/17/1251/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

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

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d321e28009e316a0922b3b06c7400fef

identifier: http://ema.europa.eu/identifier/EU/1/17/1251/002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ozempic

Attesters

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

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 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.

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.
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). Please see section 4 for the warning signs of inflamed pancreas.

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 2 mg.

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 sulphonylurea 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 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

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 0.25 mg once a week for four weeks.
• After four weeks your doctor will increase your dose to 0.5 mg once a week.
• Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled well enough with a dose of 0.5 mg once a week.
• Your doctor may increase your dose to 2 mg once a week if your blood sugar is not controlled well enough with a dose of 1 mg 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.

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. 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). 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.

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).

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.

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 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 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. Keep the pen cap on in order to 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 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.

What Ozempic contains

• The active substance is semaglutide. One ml solution for injection contains 1.34 mg semaglutide. One pre-filled pen contains 2 mg semaglutide in 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 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 1.5 ml of solution, delivering 4 doses of 0.25 mg.

Ozempic 0.25 mg solution for injection is available in the following pack size: 1 pen and 4 disposable NovoFine Plus needles.

Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S Novo All
DK-2880 Bagsv rd Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: