Ozempic 0,25 mg solucion inyectable en pluma precargada
Introduction
Patient Information Leaflet
Ozempic 0.25 mg pre-filled pen injectable solution
semaglutide
Read this leaflet carefully before you start using this medicine, as 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
1.What Ozempic is and what it is used for
2.What you need to know before you start using Ozempic
3.How to use Ozempic
4.Possible side effects
5.Storage of Ozempic
6.Contents of the pack and additional information
1. What is Ozempic and how is it used
Ozempic contains the active ingredient semaglutide. It helps your body reduce blood sugar levels only when these levels are too high and may help prevent heart disease in patients with type 2 diabetes (DMT2). It also helps slow down kidney function decline in patients with DMT2 through a mechanism separate from blood sugar reduction..
Ozempic is usedto treat adults (18 years of age and older) with DMT2 when diet and exercise are not enough:
- as the sole diabetes medication when you cannot use metformin (another diabetes medication) or
- with other diabetes medications: when these are not enough to control your blood sugar levels. These may be oral medications or injectable medications, such as insulin.
It is essential that you continue with the diet and exercise plan that your doctor, pharmacist, or nurse has recommended.
2. What you need to know before starting to use Ozempic
Do not use Ozempic
- if you are allergic to semaglutide or any of the other ingredients of this medication (listed in section6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use this medication.
This medication is notthe same asinsulin 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 characterized by high blood sugar, difficulty breathing, confusion, excessive thirst, sweet-smelling breath, or a metallic taste in the mouth.
Ozempic is not an insulin and should not be used as a substitute for insulin.
If you are scheduled to undergo surgery under anesthesia, inform your doctor that you are taking Ozempic.
Gastrointestinal effects
During treatment with this medication, you may experience nausea, vomiting, or diarrhea. These adverse effects can cause dehydration (loss of fluids). It is essential to drink plenty of fluids to avoid dehydration, especially if you have kidney problems. If you have any doubts, consult your doctor.
Severe and persistent stomach pain that may be due to acute pancreatitis
If you experience severe and persistent stomach pain, seek medical attention immediately, as it may be a symptom of acute pancreatitis (inflammation of the pancreas).Consult section4 to learn about the warning signs of pancreatitis.
Low blood sugar (hypoglycemia)
The combination of a sulfonylurea or insulin with this medication may increase the risk of experiencing low blood sugar (hypoglycemia). Consult section4 to learn about the warning signs of low blood sugar. Your doctor may ask you to measure your blood sugar levels. This will help your doctor decide if you need to adjust the dose of sulfonylurea or insulin to reduce the risk of low blood sugar.
Diabetic retinopathy
If you have diabetic retinopathy and are using insulin, this medication may worsen your vision, and you may need treatment. Inform your doctor if you have diabetic retinopathy or experience eye problems during treatment with this medication. If you have potentially unstable diabetic retinopathy, the use of Ozempic 2 mg is not recommended.
Children and adolescents
This medication is not recommended for children and adolescents under 18years of age, as the safety and efficacy have not yet been established in these age groups.
Other medications and Ozempic
Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication, including herbal medications or over-the-counter medications.
Particularly, inform your doctor, pharmacist, or nurse if you are using medications that contain any of the following components:
- Warfarin or other oral anticoagulants. You may need frequent blood tests to check how quickly your blood clots.
- If you are using insulin, your doctor will inform you how to reduce the dose of insulin 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 because there is not enough insulin).
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor before using this medication.
This medication should not be used during pregnancy, as its effects on the fetus are unknown. Therefore, the use of contraceptive methodsis recommendedduring the use of this medication. If you wish to become pregnant,consult with your doctor on how to change your treatment, asyou should discontinue the use of this medication at least 2 months in advance. If you become pregnant while using this medication, consult your doctor immediately, as you will need to change your treatment.
This medication should not be used during breastfeeding, as its passage into breast milk is unknown.
Driving and operating machinery
Ozempic is unlikely to affect your ability to drive and operate machinery.However, if you are taking this medication in combination with a sulfonylurea or insulin, you may experience low blood sugar (hypoglycemia), which can reduce your concentration. Do not drive or operate machinery if you experience any symptoms of low blood sugar. Consult section2, “Warnings and precautions” for information on the increased risk of experiencing low blood sugar and section4 to learn about the warning signs of low blood sugar. Consult your doctor for more information.
Sodium content
This medication contains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free.”
3. How to use Ozempic
Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor, pharmacist or nurse again.
How much to use
- The initial dose is 0.25mg once a week for four weeks.
- After four weeks, your doctor will increase the dose to 0.5mg once a week.
- Your doctor may increase the dose to 1mg once a week if your blood sugar level is not adequately controlled with a dose of 0.5mg once a week.
- Your doctor may increase the dose to 2mg once a week if your blood sugar level is not adequately controlled with a dose of 1mg once a week.
Do not change your dose unless your doctor tells you to.
How to administer Ozempic
Ozempic is administered as a subcutaneous injection under the skin. Do not inject into a vein or muscle.
- The best areas for injection are the front of the thigh, the front of the abdomen or the upper arm.
- Before using the pen for the first time, your doctor or nurse will show you how to use it.
You will find detailed instructions on its use on the other side of this leaflet.
When to use Ozempic
- You should use this medication once a week, on the same day of the week if possible.
- You can administer the injection at any time of the day, regardless of meals.
To help you remember to inject this medication only once a week, it is advisable to note on the box the day of the week chosen (for example, Wednesday), as well as the date of each time you inject it.
If necessary, you can change the day of the weekly injection of this medication, provided that at least 3days have passed since the last injection. Once the new administration day has been selected, you must continue with the weekly dosing schedule.
If you use more Ozempic than you should
If you use more Ozempic than you should, consult 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:
- 5days or less have passed since you should have used Ozempic, use it as soon as you remember. Then, administer the next dose as usual, on the scheduled day.
- More than 5days have passed since you should have used Ozempic, skip the missed dose. Then, administer the next dose as usual, on the scheduled day.
Do not use a double dose to compensate for the missed dose.
If you interrupt treatment with Ozempic
Do not interrupt treatment with this medication without consulting your doctor. If you interrupt it, your blood sugar levels may increase.
If you have any other questions about the use of this medication, ask your doctor, pharmacist or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Severe side effects
Frequent (can 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 should inform your doctor.
Not common(can affect up to 1 in 100 people)
- inflamed pancreas (acute pancreatitis) that can cause intense pain that does not go away in the stomach and back. If you experience such symptoms, go immediately to see your doctor.
Rare (can affect up to 1 in 10,000 people)
- severe allergic reactions (anaphylactic reactions, angioedema). You should get medical help and inform your doctor immediately if you experience symptoms such as respiratory problems, swelling of the face, lips, tongue, and/or throat with difficulty swallowing and palpitations.
Frequency not known(cannot be estimated from available data)
- intestinal obstruction. A severe form of constipation with other symptoms such as stomach pain, abdominal swelling, vomiting, etc.
Other side effects
Very frequent(can affect more than 1 in 10 people)
- nausea; this effect usually disappears over time
- diarrhea; this effect usually disappears over time
- low blood sugar (hypoglycemia) when this medicine is used with medications containing sulfonilurea or insulin
Frequent(can affect up to 1 in 10 people)
- vomiting
- low blood sugar (hypoglycemia), when this medicine is used with oral diabetes medications that are not sulfonilureas or insulin
The warning signs of low blood sugar can appear suddenly. Some of these symptoms are: cold sweat, pale and cold skin, headache, palpitations, nausea or excessive appetite, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating or tremors.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
This low blood sugar is more likely to occur if you also use a sulfonilurea or insulin. Your doctor may reduce the dose of these medications before you start using this medicine.
- indigestion
- inflamed stomach (gastritis); symptoms include stomach pain, nausea or vomiting
- reflux or stomach burning; also known as "gastroesophageal reflux disease" (GERD)
- stomach pain
- stomach swelling
- constipation
- eructation
- gallstones
- dizziness
- fatigue
- weight loss
- loss of appetite
- gas (flatulence)
- increase in pancreatic enzymes (such as lipase and amylase).
Not common(can affect up to 1 in 100 people)
- changes in the taste of food and drinks
- rapid pulse
- reactions at the injection site, such as hematomas, pain, irritation, itching, and urticaria
- allergic reactions such as urticaria, itching, or hives
- delayed emptying of the stomach.
Reporting side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Ozempic
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the pen label and on the packaging after CAD. The expiration date is the last day of the month indicated.
Before opening:
Store in refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the refrigerator's cooling component.Store the pen with the cap on to protect it from light.
During use:
- You can store the pen for 6 weeks if it is stored below 30°C or in the refrigerator (between 2°C and 8°C), away from the refrigerator's cooling component. Do not freeze Ozempic and do not use it if it has frozen.
- When not in use, store the pen with the cap on to protect it from light.
Do not use this medication if you observe that the solution is not transparent and colorless or almost colorless.
Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Ozempic
- The active ingredient 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 injection, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2 “Sodium content”.
Appearance of the product and contents of the pack
Ozempic is a transparent and 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 injectable solution is available in the following pack size:
1 pre-filled pen and 4 disposable NovoFine Plus needles.
Marketing authorisation holder and responsible person for manufacturing
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Last update of the leaflet:
Other sources of information
The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
Instructions for use of Ozempic 0.25 mg injectable solution in a pre-filled pen | |
Read these instructions carefully before using your pre-filled pen Ozempic. Ask your doctor, nurse or pharmacist how to inject Ozempic correctly. Use only the medicine from this pen as prescribed. Start by checking the pen to ensure it contains Ozempic 0.25 mg and then observe the following images to familiarise yourself with the different parts of the pen and needle. If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this pen without help.Seek help from a person who can see well and knows how to use the pre-filled pen Ozempic. Your pen is a pre-filled dose pen. It contains 2 mg of semaglutide and can only select doses of 0.25 mg. A new pen contains four doses of 0.25 mg. After injecting the four doses, there will still be solution left 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 given and when you gave them. The pen is designed to be used with disposable needles of 30G, 31G and 32G of up to 8 mm in length. The pack includes NovoFine Plus needles. | |
Important information Pay special attention to these notes, as they are important for the safe use of the pen. | |
1. Preparation of the pen with a new needle | |
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Check that the paper clip and outer needle cap are not damaged and could affect sterility. If you see any damage, use a new needle.
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Make sure the needle is correctly placed.
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The needle is covered by two caps. You must remove both caps.If you forget to remove both caps,you will not inject any solution.
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You may see a drop of solution at the tip of the needle. This is normal, but despite this, you must check the flow if it is a new pen and you are using it for the first time. See the step2 “Checking the flowwith each new pen”. Do not put a new needlein the pen until you are ready to give the injection. | |
Always use a new needle for each injection. This can help prevent needles from becoming blocked, contamination, infection and inaccurate dosing. | |
Never use a bent or damaged needle. | |
2. Checking the flowwith each new pen | |
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Press and hold the plungeruntil the dose counter returns to ‘0’. The ‘0’must be aligned with the dose marker. A drop of solution should appear at the tip of the needle. | |
You may see a small drop left at the tip of the needle, but no solution will be injected. If no drop appears,repeat step2 “Checking the flowwith each new pen” a maximum of 6times. If still no drop appears, change the needle and repeat step2 “Checking the flowwith each new pen” once more. Discard the pen and use a newseven if no drop appearsof solution. | |
Always make sure a dropappears at the tip of the needle before using a new pen for the first time. This ensures the solution flows. If no drop appears,nomedicine will be injected, although the dose counter will move.This may indicate that the needle is blocked or damaged. If you do not check the flow before the first injection with each new pen, you may not receive the prescribed dose or achieve the desired effect of Ozempic. | |
3. Selecting the dose | |
Continue turning until the dose counter stops and shows 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 emits a different click when turned forward, backward or past 0.25 mg.Do not count the clicks of the pen. | |
Before injecting this medicine, always use the dose counter and dose marker to see that 0.25 mg has been selected. Do not count the clicks of the pen. Only select doses of 0.25 mg with the dose selector.0.25 mg must be exactly aligned with the dose marker to ensure you receive the correct dose. | |
4. Injecting the dose | |
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If blood appears at the injection site, press gently. | |
You may see a drop of solution at the needle tip after the injection. This is normal and will not affect your dose. | |
Always observe the dose counter to know how many mg is injected.Maintain pressure on the plunger until the dose countervreturns to ‘0’. How to detect if the needle is blocked or damaged
What to do if the needle is blocked Change the needle as described in step5 “After the injection” and repeat all the steps from step 1 “Preparing the pen with a new needle”. Make sure to select the full dose you need. Never touch the dose counter during the injection.This could interrupt the injection. | |
5. After the injection | |
Always discard the needle after each injectionto ensure injections are given correctly and prevent needles from becoming blocked. If the needle is blocked,nomedicine will be injected.
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When discarding the pen, do sowithoutthe needle attached, following the instructions of your doctor, nurse, pharmacist or local authorities. | |
Never try to put the inner needle cap back on the needle.You could accidentally prick yourself with the needle. Always remove the needle from the pen immediately after each injection. This can help prevent needles from becoming blocked, contamination, infection, solution loss and inaccurate dosing. | |
Other important information | |
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Maintenance of your pen | |
Treat the pen with care. Rough handling or misuse can cause inaccurate dosing. If this happens, you may not achieve the desired effect of this medicine. | |
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