Ejulir

Package leaflet: Information for the patient

Ejulir, 6 mg/mL, solution for injection in a pre-filled pen
Liraglutidum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Ejulir is and what it is used for
2. Important information before using Ejulir
3. How to use Ejulir
4. Possible side effects
5. How to store Ejulir
6. Contents of the pack and other information

1. What Ejulir is and what it is used for

What Ejulir is
Ejulir is a weight-reducing medicine containing the active substance liraglutide.
This substance mimics a naturally occurring hormone, glucagon-like peptide-1 (GLP-1),
which is released from the intestines after a meal. Ejulir works by acting on receptors in the brain that
regulate appetite, causing a feeling of fullness and reducing hunger sensations. This may help
reduce food intake and lead to weight loss.

What Ejulir is used for
Ejulir is a weight-loss aid used in combination with diet and physical exercise in adults aged 18 years and above who:

• Have a BMI of 30 kg/m² or higher (obesity), or
• Have a BMI between 27 kg/m² and less than 30 kg/m² (overweight) and have weight-related conditions (such as diabetes, high blood pressure, abnormal blood lipid levels, or sleep-disordered breathing known as “obstructive sleep apnoea”). Body Mass Index (BMI) is a measure of body weight relative to height.

Treatment with Ejulir should only be continued if at least a 5% reduction in initial body weight is achieved after 12 weeks of treatment at a dose of 3.0 mg per day (see section 3). To continue treatment, consult your doctor.

Ejulir may be used as an adjunct to a healthy diet and increased physical activity for weight management in adolescents aged 12 years and above who have:

• Obesity (diagnosed by a doctor)
• Body weight above 60 kg

Treatment with Ejulir may be continued only if at least a 4% reduction in BMI is achieved after 12 weeks of treatment at a dose of 3.0 mg per day or at the maximum tolerated dose by the patient (see section 3). To continue treatment, consult your doctor.

Ejulir is indicated as an adjunct to a healthy diet and increased physical activity for weight management in children aged 6 to <12 years who have:

• Obesity (diagnosed by a doctor)
• Body weight ≥ 45 kg

Treatment with Ejulir may be continued if at least a 4% reduction in BMI is achieved after 12 weeks of treatment at a dose of 3.0 mg per day or at the maximum tolerated dose by the patient (see section 3). To continue treatment, consult your doctor.

Diet and exercise
Your doctor will initiate a diet and exercise programme. You should follow these recommendations during treatment with Ejulir.

2. Important information before using the medicine

When not to use Ejulir

• if the patient is allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Ejulir, discuss this with your doctor, pharmacist or nurse.
Use of Ejulir is not recommended in patients with severe heart failure.
Data on use in patients aged 75 years and older are limited; therefore, use of this medicine is not recommended in patients aged 75 years and older.
Available data on use of this medicine in patients with renal impairment are limited.
Patients with kidney dysfunction or patients on dialysis should consult their doctor.
Available data on use of this medicine in patients with hepatic impairment are limited.
Patients with liver dysfunction should consult their doctor.
Use of this medicine is not recommended in patients with severe gastrointestinal disorders causing delayed gastric emptying (so-called gastroparesis) or inflammatory bowel disease.
If the patient is to undergo surgery under anaesthesia, the patient should inform the doctor that they are taking Ejulir.
Patients with diabetes
Patients with diabetes should not use Ejulir as a substitute for insulin.
Pancreatitis
If the patient has or has had pancreatic disease in the past, they should consult their doctor.
Gallbladder inflammation and gallstones
During significant weight loss, patients are at increased risk of developing gallstones and consequently gallbladder inflammation. Treatment with Ejulir should be discontinued and immediate medical advice sought if sudden severe pain occurs in the upper abdomen, usually more intense on the right side under the ribs. The pain may radiate to the back or right shoulder. See section 4.
Thyroid disease
In case of thyroid disease, including nodules or thyroid enlargement, consult your doctor.
Heart rate
If palpitations (awareness of heartbeat) or a sensation of increased heart rate at rest occur during treatment with Ejulir, consult your doctor.
Fluid loss and dehydration
After starting treatment with Ejulir, loss of body fluids or dehydration may occur. This may be caused by nausea, vomiting and diarrhoea. Patients should drink plenty of fluids to avoid dehydration. If you have any questions or doubts, consult your doctor, pharmacist or nurse. See section 4.
Children
The safety and efficacy of Ejulir in children under 6 years of age have not been studied.
Ejulir with other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor, pharmacist or nurse if:

• the patient is taking antidiabetic medicines of the sulfonylurea class (such as glimepiride or glibenclamide) or insulin – there may be a risk of low blood sugar (hypoglycaemia) when Ejulir is used together with these antidiabetic medicines. To prevent low blood sugar, the doctor may adjust the dose of the antidiabetic medicine. See section 4 – symptoms indicating low blood sugar. If insulin dose adjustment is needed, the doctor may recommend more frequent blood sugar monitoring.
• the patient is taking warfarin or other oral anticoagulant medicines (blood thinners). More frequent blood clotting tests may be required.

Pregnancy and breastfeeding
Do not use Ejulir if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant. There are no data on the effects of liraglutide on the health of the unborn child.
Do not breastfeed during treatment with Ejulir. There is no information on whether liraglutide passes into human milk.
Driving and using machines
Liraglutide probably does not affect the ability to drive or operate machinery.
However, in some patients treated with Ejulir, dizziness may occur, mainly during the first 3 months of treatment (see section "Possible side effects"). If dizziness occurs, particular caution should be exercised when driving or operating machinery. For further information, consult your doctor.
Important information about certain ingredients of Ejulir
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use Ejulir

This medicine should always be used exactly as your doctor has told you. If you are unsure,
you should consult your doctor, pharmacist, or nurse.
Your doctor will start by recommending a diet and exercise programme. You should follow
these recommendations throughout treatment with Ejulir.
What dose of medicine should be injected
Adults
Treatment starts with a low dose, which should be gradually increased over the first
five weeks of treatment.

• The initial dose of Ejulir is 0.6 mg once daily for at least one week.
• The dose should then be gradually increased by 0.6 mg, as directed by your doctor, usually once a week, until the recommended dose of 3.0 mg once daily is reached.

Your doctor will inform you of the amount of Ejulir to take in the following weeks of treatment.
The following dosing schedule is usually recommended:
Week Injected dose
Week 1. 0.6 mg once daily
Week 2. 1.2 mg once daily
Week 3. 1.8 mg once daily
Week 4. 2.4 mg once daily
From Week 5 3.0 mg once daily
After reaching the recommended dose of 3.0 mg in Week 5, this dose should be maintained for the remainder of treatment. The dose should not be increased further.
Your doctor will regularly assess your treatment results.
Children and adolescents (aged 6 to 18 years)
Children and adolescents aged 6 to 18 years should follow a similar dose-escalation schedule as adults (see table above under adults). The dose should be gradually increased until reaching a dose of 3.0 mg (maintenance dose) or the maximum dose tolerated by the patient. Doses higher than 3.0 mg per day are not recommended.
How and when to use Ejulir

• Before using the injection pen for the first time, your doctor or nurse will show you how to use it.
• Ejulir can be taken at any time of day, with or without food or drink.
• Ejulir should be taken approximately at the same time each day – you may choose the most convenient time for yourself.

Injection site
Ejulir should be injected under the skin (subcutaneous injection).

• The best injection sites are the front of the waist (abdomen), front of the thighs, and upper arms.
• You should change the injection site each day to reduce the risk of lumps forming.
• The medicine should not be injected into a vein or muscle.

Detailed instructions are provided on the reverse of this leaflet.
Patients with diabetes
If you have diabetes, you should inform your doctor. To prevent low blood sugar, your doctor may adjust the dose of your anti-diabetic medicines.

• Ejulir should not be mixed with other injectable medicines (e.g. insulin).
• This medicine should not be used together with other GLP-1 receptor agonists (such as exenatide or lixisenatide).

Use of a higher than recommended dose of Ejulir
If you use more Ejulir than you should, contact your doctor or go to a hospital immediately. Bring the medicine pack with you. You may require treatment. The following symptoms may occur:

• nausea,
• vomiting,
• low blood sugar (hypoglycaemia). Symptoms indicating low blood sugar – see section on "Common" side effects.

Missed dose of Ejulir

• If less than 12 hours has passed since the scheduled time for taking the Ejulir dose, take the medicine as soon as possible.
• However, if more than 12 hours have passed since the time you should have taken the medicine, skip the missed dose. On the following day, inject the next dose as usual.
• Do not take a double dose or increase the dose the next day to make up for a missed dose.

Stopping Ejulir treatment
Do not stop using this medicine without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Serious side effects
Severe allergic reactions (anaphylaxis) have been reported rarely in patients treated with Ejulir.
If symptoms such as difficulty breathing, swelling of the throat and face,
or rapid heartbeat occur, seek medical attention immediately.
Inflammation of the pancreas (pancreatitis) has been reported not frequently in patients treated
with Ejulir. Pancreatitis may be severe and potentially life-threatening. You should stop taking this medicine and contact your doctor immediately if any of the following serious side effects occur:

• severe and persistent abdominal pain (in the stomach area) radiating to the back, along with nausea and vomiting, as these may be symptoms of pancreatitis.

Other side effects
Very common: may affect more than 1 in 10 people

• nausea, vomiting, diarrhoea, constipation, headache. These symptoms usually resolve after a few days or weeks.

Common: may affect up to 1 in 10 people

• gastrointestinal disorders such as indigestion (dyspepsia), inflammation of the stomach lining, stomach discomfort, upper abdominal pain, heartburn, bloating, gas, belching, and dry mouth
• feeling of weakness or fatigue
• taste disturbances
• dizziness
• difficulty sleeping (insomnia). These symptoms usually occur during the first 3 months of treatment.
• gallstones
• rash
• injection site reactions (such as bruising, pain, irritation, itching, and rash)
• low blood sugar (hypoglycaemia). Symptoms of low blood sugar may appear suddenly. These include cold sweats, cold pale skin, headache, palpitations, nausea, intense hunger, blurred vision, drowsiness, weakness, nervousness, restlessness, confusion, difficulty concentrating, and tremor. Your doctor will provide information on how to treat symptoms caused by low blood sugar and what to do if such symptoms occur.
• increased activity of pancreatic enzymes such as lipase and amylase.

Uncommon: may affect up to 1 in 100 people

• fluid loss (dehydration). These symptoms are more likely at the beginning of treatment and may be caused by vomiting, nausea, and diarrhoea.
• delayed gastric emptying
• inflammation of the gallbladder
• allergic reactions, including skin rash
• general malaise
• rapid heartbeat.

Rare: may affect up to 1 in 1,000 people

• kidney function disorder
• acute kidney failure. Symptoms may include reduced urine volume, metallic taste in the mouth, and easy bruising.

Frequency not known: cannot be estimated from available data

• intestinal obstruction. Severe constipation with additional symptoms such as abdominal pain, bloating, vomiting, etc.
• subcutaneous nodules may be caused by accumulation of a protein called amyloid (cutaneous amyloidosis; frequency not established).

Reporting of side effects
If any side effects occur, including any side effects not listed
in this leaflet, tell your doctor, pharmacist, or nurse. Side effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02 222 Warsaw, tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to provide more information on the
safety of the medicine.
Side effects can also be reported to the marketing authorisation holder.

5. How to store Ejulir

Keep this medicine out of the sight and reach of children.
Do not use Ejulir after the expiry date stated on the label of the injection pen after "EXP" and on the cardboard packaging after "Expiry". The expiry date refers to the last day of the stated month.
Before first use:
Store in a refrigerator (2°C to 8°C). Do not freeze.
After starting to use the injection pen:
The injection pen may be stored for up to one month at temperatures below 30°C or in the refrigerator (2°C to 8°C). Do not freeze.
When the injection pen is not in use, replace the cap to protect it from light.
Do not use Ejulir if the solution is not clear and colourless.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ejulir contains

• The active substance is liraglutide. 1 mL of injection solution contains 6 mg of liraglutide. One pen contains 18 mg of liraglutide.
• The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid (concentrated), sodium hydroxide (for pH adjustment), and water for injections.

What Ejulir looks like and contents of the pack
Ejulir is supplied as a clear, colourless solution for injection in a pre-filled pen (injection). Each pen contains 3 mL of solution and allows administration of the medicine in 30 doses of 0.6 mg, 15 doses of 1.2 mg, 10 doses of 1.8 mg, 7 doses of 2.4 mg, and 6 doses of 3.0 mg.
Ejulir is available in packs containing 1, 3, 5 or 10 pens, in a cardboard carton. Not all pack sizes may be marketed.
The pack does not contain needles.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN, Ireland

Manufacturer/Importer
betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg, Germany

Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola PLA 3000, Malta
For further information on this medicinal product, please contact the local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel.: +48 22 546 64 00
This medicinal product is authorized for marketing in the European Economic Area Member States under the following names:

Instructions for use of the Ejulir 6 mg/mL injection solution in the pen injector
Before using the pen injector containing Ejulir medicine, carefully read the following
instructions.
Do not use the pen injector without prior training provided by a doctor or nurse. Start by checking whether the pen injector contains Ejulir 6 mg/mL, then review the illustrations below to become familiar with the individual parts of the pen injector and the needle.
Blind or visually impaired individuals who are unable to read the dose counter on the
pen injector should not use the pen injector without assistance. Assistance must be obtained from a person with good vision who has been trained in the use of the Ejulir pen injector.
This pen injector is a dose-setting device. It contains 18 mg of liraglutide and allows administration of doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg. The pen injector is intended for use with single-use needles up to 8 mm in length and 32 G in thickness. Needles are not included in the package.
Important information

Carefully read these instructions, as they are essential for the safe use of the pen injector.
Ejulir pen injector and needle (example)

1. Preparing the pen injector with a new needle

• Check the name and color of the label on the pen injector to ensure it contains Ejulir medicine. This is particularly important when using multiple types of injectable medicines. Using the wrong medicine may pose a health risk.
• Remove the pen injector cap.

Check whether the solution in the injector is clear and colourless. Look through the viewing window of the injector. If the solution is cloudy, do not use the injector.
Take a new needle and remove the paper tab.
Ensure the needle is properly attached Screw the needle directly onto the injector. Twist until it is securely fastened.
The needle is protected by two caps. Both caps must be removed. If the patient does not remove both caps, the solution will not be injected. Remove the outer needle cap and keep it for later. It will be needed after injection for safe removal of the needle from the injector.
Remove the inner needle cap and dispose of it. Attempting to re-cover the needle may result in accidental needle stick. A drop of solution may appear at the tip of the needle. This is normal, but when using the injector for the first time, the flow of solution should be checked. Do not attach a new needle to the injector until ready to administer the injection. Always use a new needle for each injection. This helps prevent needle blockage, contamination, infection, and inaccurate dosing. Never use a bent or damaged needle.
2 Check solution flow before using each new injector If the injector is already in use, proceed to step 3 "Setting the dose". Flow should only be checked before the first injection with each new injector. Turn the dose selector knob to the flow check symbol ( ) just below the 0 position. Ensure the flow check symbol is aligned with the dose indicator.
Hold the injector with the needle pointing upward. Press and hold the dose button until the dose counter returns to 0. The 0 mark must align with the dose indicator. A drop of solution should appear at the needle tip. A small drop may remain at the needle tip but will not be injected. If no drop appears, repeat step 2 "Check solution flow before using each new injector" up to 6 times. If no drop appears, replace the needle and repeat step 2 "Check solution flow before using each new injector". If still no drop appears, discard the injector and use a new one. Before first use of a new injector, always ensure a drop of solution appears at the needle tip. This ensures that the solution flow is not blocked. If no drop appears, the medication will not be delivered, even though the dose counter may move. This may indicate that the needle is blocked or damaged. Using a new injector without checking flow before the first injection may result in the prescribed dose not being administered, leading to lack of the intended therapeutic effect of Ejulir.

3 Setting the Dose

• Turn the dose selector until the dose counter displays the appropriate dose (0.6 mg, 1.2 mg, 1.8 mg,

2.4 mg, or 3.0 mg).
If an incorrect dose is selected, you can turn the selector forward or backward to correct the dose.
The maximum dose that can be set on the injector is 3.0 mg.
The dose selector allows adjustment of the dose. Only the dose counter and dose indicator show how many mg have been selected for the dose.
A maximum of 3.0 mg can be set per dose. If the injector contains less than 3.0 mg of medication, the dose counter will stop before reaching 3.0.
The clicking sound of the dose selector differs when turning forward or backward, and when the number of remaining mg of medication has been exceeded. Do not count the clicks of the injector.
Before injecting this medicine, always check the number of mg selected by using the dose counter and dose indicator.
Do not count the clicks of the injector.
Do not use the injector scale. This scale only shows an approximate amount of solution remaining in the injector.
Use the dose selector only to select doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg.
The selected dose must be exactly aligned with the dose indicator to ensure the correct dose is administered.

How much solution remains?

• The injector scale shows the approximate amount of solution remaining in the injector.

To check exactly how much solution is left, use the dose counter: turn the dose setting knob until the dose counter stops. If the number 3.0 is visible, at least 3.0 mg of medicine remains in the injector. If the dose counter stops before reaching 3.0 mg, this means the injector does not contain enough solution to deliver a full 3.0 mg dose. If more medicine is needed than remains in the injector, the dose may be divided between the current and a new injector only if instructed by a doctor or nurse. Use a calculator to determine doses according to instructions provided by your doctor or nurse. Calculations must be performed very carefully. If you are unsure how to divide the dose between two injectors, select and inject the required dose using a new injector.
4 Administering the dose Insert the needle under the skin as instructed by your doctor or nurse. Ensure the dose counter is visible. Do not cover it with your fingers, as this may interrupt the injection.
Press and hold the dose button. Observe the dose counter returning to 0. The value 0 must align with the dose indicator. You may hear or feel a click.
Keep holding the dose button pressed while the needle is inserted in the skin. While holding the dose button pressed, slowly count to 6. If the needle is removed too early, you may see the solution leaking from the needle tip. This means the full dose of medicine has not been delivered.
Remove the needle from the skin, then release the dose button. If bleeding occurs at the injection site, gently press the area. A drop of solution at the needle tip after injection is normal and does not affect the delivered dose. Always observe the dose counter to monitor the number of mg administered. Hold the dose button pressed until the dose counter shows 0. How to check whether the needle is blocked or damaged? If after pressing and holding the dose button the dose counter does not reach 0, the needle may be blocked or damaged. This means the medicine has not been delivered, even if the dose counter has moved and shows a different dose than initially set.
What to do if the needle becomes blocked? Change the needle as described in section 5 "After injection" and repeat all steps starting from section 1 "Preparing the injector with a new needle". Ensure the full required dose is selected. Do not touch the dose counter during injection, as this may interrupt the injection process.
5 After injection Always remove the needle after each injection to ensure comfortable injections and prevent needle blockage. If the needle is blocked, the medicine will not be injected. Place the needle tip into the outer needle cap placed on a flat surface, without touching the needle or the outer needle cap.
After inserting the needle, carefully push the outer needle cap fully onto the needle. Unscrew the needle and carefully dispose of it according to instructions provided by your doctor, nurse, pharmacist, or local authorities.
After each use, place the cap on the injector to protect the solution from light. When the injector is empty, dispose of it without the needle attached, according to instructions from your doctor, nurse, pharmacist, or local authorities. Never attempt to reinsert the inner needle cap. This may result in accidental needlestick injury. Always remove the needle from the injector after each injection. This helps prevent needle blockage, contamination, infection, solution leakage, and inaccurate dosing.
Other important information Keep the injector and needles out of sight and reach of others, especially children. Never share your injector or needles with anyone else. Caregivers must exercise special caution when removing and disposing of used needles to avoid needlestick injuries and cross-infection. Change the injection site daily to reduce the risk of lumps forming.
Handling the injector Do not leave the injector in a car or any other place where it may be exposed to extremely high or low temperatures. Do not inject Ejulir if it has been frozen. In such cases, the intended effect of the medicine may not be achieved. Do not expose the injector to dust, dirt, or liquids. Do not wash, soak, or lubricate the injector. The injector may be cleaned with a cloth dampened with a mild detergent. Do not drop the injector or hit it against hard surfaces. If the injector has been dropped or is suspected of malfunctioning, always attach a new needle and check solution flow before administering an injection. Do not refill the injector. After it is empty, dispose of it properly. Do not attempt to repair or disassemble the injector.