Liraglutide Mylan

Patient Information Leaflet

Ejulir 6 mg/mL injection solution in a pre-filled pen
liraglutide
Equivalent medicine
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Ejulir is and what it is used for
2. What you need to know 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 medicine used for weight loss that contains the active substance liraglutide. It is similar to a naturally occurring hormone called glucagon-like peptide-1 (GLP-1), which is released from the intestine after a meal. Ejulir acts on receptors in the brain that regulate appetite, leading to a greater feeling of fullness and reduced hunger. This can help you eat less food and lose body weight.

What Ejulir is used for
Ejulir is used for weight loss in addition to diet and exercise in adults aged 18 years and older with:

• a body mass index (BMI) of 30 kg/m² or higher (obesity), or
• a body mass index (BMI) of 27 kg/m² and below 30 kg/m² (overweight) and weight-related health problems (such as diabetes, high blood pressure, abnormal blood lipid levels, or breathing problems known as 'obstructive sleep apnoea'). BMI is a measure of weight relative to height.

Continue using Ejulir only if you have lost at least 5% of your body weight after 12 weeks of treatment with a daily dose of 3.0 mg (see section 3). Consult your doctor before continuing.

Ejulir is used for weight loss in addition to a healthy diet and exercise in adolescents aged 12 years and older with:

• obesity (diagnosed by a doctor)
• body weight above 60 kg

Continue using Ejulir only if you have lost at least 4% of your BMI after 12 weeks of treatment with a daily dose of 3.0 mg or with the maximum tolerated dose (see section 3). Consult your doctor before continuing.

Ejulir is indicated in addition to a healthy diet and exercise for weight management in children aged 6 to <12 years with:

• obesity (diagnosed by a doctor)
• body weight ≥45 kg

Continue using Ejulir only if you have lost at least 4% of your BMI after 12 weeks of treatment with a daily dose of 3.0 mg or with the maximum tolerated dose (see section 3). Consult your doctor before continuing.

Diet and exercise
Your doctor will advise you to follow a healthy diet and exercise programme. Continue this programme while using Ejulir.

2. What you need to know before using Ejulir

Do not use Ejulir

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ejulir.
The use of Ejulir is not recommended if you have severe heart failure.
Experience with this medicine in patients aged 75 years and older is limited. The use of Ejulir is not recommended if you are 75 years of age or older.
Experience with this medicine in patients with kidney problems is limited. If you have kidney disease or are on dialysis, consult your doctor.
Experience with this medicine in patients with liver problems is limited. If you have liver problems, consult your doctor.
The use of this medicine is not recommended if you have severe stomach or intestinal problems, such as delayed stomach emptying (called gastroparesis), or if you have inflammatory bowel disease.
If you are scheduled for surgery under anesthesia, inform your doctor that you are taking Ejulir.

Diabetic patients
If you have diabetes, do not use Ejulir as a substitute for insulin.

Pancreatitis
Talk to your doctor if you have or have had pancreatic disease.

Gallbladder inflammation and gallstones
If you lose weight substantially, you may be at risk of developing gallstones, which can lead to inflammation of the gallbladder. Stop treatment with Ejulir and contact your doctor immediately if you experience severe pain in the upper abdomen, on the right side under the ribs, which usually worsens. The pain may radiate to your back or right shoulder. See section 4.

Thyroid disease
If you have thyroid diseases, including nodules or enlargement of the thyroid gland, consult your doctor.

Heart rate
Talk to your doctor if you experience palpitations (awareness of your heartbeat) or a sensation of increased resting heart rate during treatment with Ejulir.

Fluid loss and dehydration
When starting treatment with Ejulir, you may lose body fluids or become dehydrated. This may be due to nausea, vomiting, and diarrhea. It is important to prevent dehydration by drinking plenty of fluids. If you have any questions or concerns, talk to your doctor, pharmacist, or nurse. See section 4.

Children
The safety and efficacy of Ejulir have not been studied in children under 6 years of age.

Other medicines and Ejulir
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, talk to your doctor, pharmacist, or nurse if:

• you are taking diabetes medicines called 'sulfonylureas' (such as glimepiride or glibenclamide) or if you are taking insulin – your blood sugar level may decrease (hypoglycemia) when using these medicines with Ejulir. Your doctor may adjust the dose of your diabetes medicines to prevent low blood sugar. See section 4 for signs of low blood sugar. If your insulin dose is adjusted, your doctor will recommend that you monitor your blood glucose levels more frequently.
• you are taking warfarin or other oral medicines to reduce blood clotting (anticoagulants). More frequent blood tests may be needed to monitor your blood's ability to clot.

Pregnancy and breastfeeding
Do not use Ejulir if you are pregnant, suspect you may be pregnant, or are planning to become pregnant, as it is unknown whether liraglutide may affect the fetus.
Do not breastfeed while using Ejulir, as it is unknown whether liraglutide passes into breast milk.

Driving and using machines
It is unlikely that liraglutide will impair your ability to drive or operate machinery. However, some patients may experience dizziness while taking Ejulir, especially during the first 3 months of treatment (see section "Possible side effects"). If you experience dizziness, exercise particular caution when driving or operating machinery. For further information, consult your doctor.

Important information about some ingredients of Ejulir
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially 'sodium-free'.

3. How to use Ejulir

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
Your doctor will start you on a diet and exercise program. Continue following this program
during treatment with Ejulir.
Dose to inject
Adults
Treatment will start at a low dose, which will be gradually increased over the first five
weeks of treatment.

• When you first start using Ejulir, the initial dose is 0.6 mg once daily for at least one week.
• Your doctor will instruct you to gradually increase the dose by 0.6 mg, usually every week, until reaching the recommended dose of 3.0 mg once daily.

Your doctor will tell you how much Ejulir to use each week. Typically, you will be advised to follow the
table below.
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 onwards 3.0 mg once daily
Once the recommended dose of 3.0 mg is reached in week 5 of treatment, continue using
this dose for the remainder of the treatment period. Do not increase the dose further.
Your doctor will regularly review your treatment.
Children and adolescents (from 6 to 18 years)
For children and adolescents aged 6 to less than 18 years, the dose should be increased in a similar manner
as described in the table above for adults. The dose should be increased until reaching 3.0 mg (maintenance dose) or the maximum tolerated dose. Daily doses above 3.0 mg are not recommended.
How and when to use Ejulir

• Before using the pen for the first time, your doctor or nurse will show you how to do it.
• You may use Ejulir at any time of day, with or without food and drink.
• Use this medicine at approximately the same time each day; choose a time that is convenient for you.

Where to inject
Ejulir is administered by subcutaneous injection (injected under the skin).

• The best injection sites are the waist (abdomen), the front of the thighs, or the upper arms.
• Change the injection site each day to reduce the risk of lumps forming.
• Do not inject the medicine into a vein or muscle.

Detailed instructions for use are provided on the reverse side of this leaflet.
For diabetic patients
Inform your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines
to prevent low blood sugar levels.

• Do not mix Ejulir with other injectable medicines (e.g. insulins).
• Do not use this medicine together with other medicines containing GLP-1 receptor agonists (such as exenatide or lixisenatide).

If you use more Ejulir than you should
If you use more Ejulir than prescribed, contact your doctor immediately or go to the hospital. Take
the medicine pack with you. You may require medical treatment. The following effects may occur:

• nausea
• vomiting
• low blood sugar (hypoglycaemia). See “Common side effects” for warning signs of low blood sugar.

If you forget to use Ejulir

• If you miss a dose and remember within 12 hours of your usual dosing time, inject the missed dose as soon as you remember.
• However, if more than 12 hours have passed since you were supposed to take the medicine, skip the missed dose and inject the next dose the following day at your usual time.
• Do not inject a double dose or increase the dose the next day to make up for the missed dose.

If you stop using Ejulir
Do not stop treatment with this medicine without first discussing it with your doctor.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Rarely, some serious allergic reactions (anaphylaxis) have been reported in patients using Ejulir. Seek immediate medical attention if you experience symptoms such as breathing difficulties, swelling of the face and throat, or rapid heartbeat.
Pancreatic inflammation (pancreatitis) has been reported uncommonly in patients using Ejulir. Pancreatitis is a serious condition that may be life-threatening.
If you notice any of the following serious side effects, stop taking this medicine and contact your doctor immediately:

• Severe and persistent pain in the stomach area (abdomen) that may extend to the back, along with nausea and vomiting, may be a sign of inflammation of the pancreas (pancreatitis).

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

• nausea, vomiting, diarrhoea, constipation, headache – these generally disappear after a few days or weeks

Common: affects up to 1 in 10 people

• stomach and intestinal problems such as indigestion (dyspepsia), inflammation of the stomach lining (gastritis), stomach discomfort, upper abdominal pain, heartburn, abdominal swelling, gas (flatulence), belching, and dry mouth
• feeling weak or tired
• altered taste sensation
• dizziness
• difficulty sleeping (insomnia). This usually occurs during the first 3 months of treatment
• gallstones
• skin rash
• injection site reactions (such as bruising, pain, irritation, itching, and skin rash)
• low blood sugar level (hypoglycaemia). Signs of low blood sugar may occur suddenly and may include: cold sweat, cold and pale skin, headache, rapid heartbeat, nausea, feeling very hungry, vision changes, drowsiness, feeling weak, nervousness, anxiety, confusion, difficulty concentrating, and tremor. Your doctor will advise you on how to treat low blood sugar levels and what to do if you notice these signs
• increased pancreatic enzymes, such as lipase and amylase.

Uncommon: affects up to 1 in 100 people

• fluid loss (dehydration). This is more likely to occur at the beginning of treatment and may be caused by vomiting, nausea, and diarrhoea
• delayed stomach emptying
• inflammation of the gallbladder
• allergic reactions including skin rash
• general feeling of being unwell
• rapid heartbeat.

Rare: affects up to 1 in 1,000 people

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

Not known (frequency cannot be estimated from the available data)

• intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.
• subcutaneous nodules may be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of this occurrence is not known).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

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 pen label and carton after 'Exp.'. The expiry date refers to the last day of that month.
Before first use:
Store in a refrigerator (2°C-8°C). Do not freeze.
After starting to use the pen:
The pen can be stored for 1 month at a temperature below 30°C or in the refrigerator (2°C-8°C). Do not freeze.
When not in use, keep the pen with the cap on to protect the medicine from light.
Do not use Ejulir if the solution is not clear and colourless.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ejulir contains

• The active substance is liraglutide. 1 mL of injectable solution contains 6 mg of liraglutide. A pre-filled pen contains 18 mg of liraglutide.
• The other components are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Ejulir and contents of the pack
Ejulir is supplied as a clear, colourless injectable solution in a pre-filled pen (injection).
Each pen contains 3 mL of solution and is capable of delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg,
10 doses of 1.8 mg, 7 doses of 2.4 mg or 6 doses of 3.0 mg.
Ejulir is available in packs containing 1, 3, 5 or 10 pens.
Not all pack sizes may be marketed.
Needles are not included.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturer
Betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg, Germany
Rual Laboratories SRL, 313, Splaiul Unirii, Building H, 1st floor, sector 3, Bucharest, 030138, Romania
DR. REDDY’S LABORATORIES ROMÂNIA S.R.L., Str. Daniel Danielopolu, 30-32, Space 2, 5th
floor, Sector 1, Bucharest, 014134, Romania
Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola PLA 3000, Malta

Instructions for the use of Ejulir 6 mg/mL solution for injection in a prefilled pen

Read these instructions carefully before using the Ejulir prefilled pen.
Do not use the pen without having received adequate training from your doctor or nurse. Begin
by checking the pen to ensure it contains Ejulir 6 mg/mL, then refer to the illustrations below
to learn about the different parts of the pen and the needle.
If you are blind or have severe visual impairment and cannot read the dose counter on the
pen, do not use this pen without assistance. Ask for help from a person with good vision who has
been trained in the use of the Ejulir prefilled pen.

The pen is a prefilled pen with adjustable dosing. It contains 18 mg of liraglutide and delivers doses of
0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg. The pen is designed to be used with single-use needles up
to 8 mm in length and as thin as 32 G. Needles are not included in the package.

Important information

Pay close attention to these notes, as they are essential for the safe use of the pen.
Prefilled pen of Ejulir with needle (example)

1 Preparing the pen with a new needle

A

• Check the name and colored label of the pen to ensure it contains Ejulir. This is particularly important if you use more than one type of injectable medicine. Using the wrong medicine may be harmful to your health.
• Remove the cap from the pen.

Check that the solution in the pen is clear and colorless.
B
Look through the window of the pen. If the solution appears
opalescent, do not use the pen.

• Take a new needle and remove the protective seal.

C
Ensure you attach the needle correctly.
D

• Press the needle straight onto the pen firmly.
• Rotate it until it is securely tightened.

The needle is covered by two caps. Both caps must be removed.
E
If you forget to remove both caps, no solution will be injected.

• Remove the outer needle cap and keep it for later use. You will need it after the injection to safely remove the needle from the pen.

• Remove the inner needle cap and discard it. If you attempt to

reinsert it, you may accidentally prick yourself with the needle.
F

• A drop of solution may appear at the tip of the needle. This is normal, but you should still perform a flow check if you are using a new pen for the first time.
• Do not attach a new needle to the pen until you are ready to administer the injection.

Always use a new needle for each injection.

This prevents needle blockage, contamination,
infection, and incorrect dosing.

F
Never use a bent or damaged needle.

2 Flow check with each new pen
A

• If the pen has already been used, go directly to step 3, “Selecting the dose”. Perform the flow check only

before the first injection with each new pen.

• Rotate the dose selector to the flow check symbol ( ) immediately after 0. Ensure that the flow check symbol is aligned with the indicator.

• Hold the pen with the needle pointing upward.

Press and hold the injection button until
the dose counter resets to 0. The 0 must align with the dose indicator.
A drop of solution should appear at the tip of the needle.

B
A small drop may remain at the tip of the needle, but it will not be injected.
If no drop appears, repeat step 2 “Flow check with each new pen” up to 6 times. If still no drop appears, change the needle and repeat step 2 “Flow check with each new pen” once more.
If no drop appears, discard the pen and use a new one.

• Always ensure a drop appears at the tip of the needle before using a new pen for the first time. The presence of a drop confirms proper solution flow. If no drop appears, no medicine will be injected, even if the dose counter moves. This may indicate a blocked or damaged needle. If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and may not achieve the desired effect of Ejulir. 3 Selecting the dose
• Rotate the dose selector until the dose counter displays the dose (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or

A
3.0 mg).
If you select the wrong dose, you can correct it by rotating the
dose selector forward or backward.
The maximum dose selectable on the pen is 3.0 mg.
The dose selector changes the dose. Only the dose counter and the dose indicator show how many mg have been selected for each dose.
You can select up to 3.0 mg per dose. When the pen contains less than 3.0 mg, the dose counter stops before reaching 3.0. Example:
0.6 mg selected
The dose selector makes a different click sound when rotated
forward, backward, or when exceeding the remaining mg. Do not rely

on counting the clicks of the pen.

Before injecting the medicine, always use the dose counter
and the dose indicator to verify how many mg have been selected.
Do not count the clicks of the pen.
Do not use the pen scale, which only approximately indicates how much solution remains in the pen.
Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg should be selected
using the dose selector. The selected dose must align precisely with the dose indicator to ensure a correct dose is delivered.
How much solution is left?

Amount

• The pen scale shows approximately how much solution remains in the pen. solution left

• To see precisely how much solution is left, use the dose counter: rotate the dose selector until the dose counter stops.

If it shows 3.0, at least 3.0 mg remain in the pen. If the
dose counter stops before 3.0 mg, it means there is not enough solution left for a full 3.0 mg dose.
If you need more medicine than remains in the pen
Only after receiving specific training or
Example
instructions from your doctor or nurse, you may split the
Dose counter stopped:
dose between the pen currently in use and a new pen. Use
2.4 mg remaining
a calculator to plan doses according to your doctor’s or nurse’s instructions.
Be very careful to calculate the correct dose.

If you are unsure how to split the dose between two pens,
select and inject the required dose using a new pen.
4 Injecting the dose

• Insert the needle into the skin as shown to you by your doctor or nurse.
• Ensure you can see the dose counter. Do not cover it with your fingers to avoid interrupting the injection.

Press and hold the injection button. Watch
the dose counter return to 0. The 0 must align with the dose indicator. You may hear or feel a click.

• Continue holding the injection button while keeping the

Count slowly:

needle in the skin.

• Count slowly to 6 while holding the injection button.
• If the needle is removed before this, you may notice solution leaking from the tip of the needle. In this case, the full dose will not be delivered.
• Remove the needle from the skin. You may then release the injection button. If bleeding occurs at the injection site, apply light pressure.

After the injection, you may see a drop of solution at the

tip of the needle. This is normal and does not affect the dose administered.
Always watch the dose counter to know how many mg you are injecting.
Keep holding the injection button until the dose counter shows 0.
How to identify a blocked or damaged needle.

• If the dose counter does not show 0 after continuously pressing the injection button, you may have used a blocked or damaged needle.
• In this case - no medicine will have been administered - even if the dose counter moved from the originally set dose.

How to handle a blocked needle?
Replace the needle as described in step 5 “After injection” and repeat all steps starting from step 1 “Preparing the pen with a new needle”. Ensure you select the full required dose.
Never touch the dose counter during injection
to avoid interrupting the injection.
5 After injection

• Always dispose of the needle after each injection to ensure comfortable future injections and to prevent needle blockage. If the needle is blocked, no medicine will be injected.

• Place the tip of the needle into the outer cap placed on a flat surface, without touching the needle or the outer needle cap.

• When the needle is covered, press the outer cap fully down carefully.

• Unscrew the needle and dispose of it carefully, according to instructions from your doctor, nurse, pharmacist, or local authorities.

• Replace the pen cap on the pen after each use to protect the solution from light.

When the pen is empty, discard it without the needle attached, as per instructions from your doctor, nurse, pharmacist, or local authorities.
Never attempt to reinsert the inner needle cap.
You may prick yourself with the needle.
Always remove the needle from the pen after each injection.

This can prevent needle blockage, contamination,
infection, solution leakage, and incorrect dosing.
Additional important information

• Always keep the pen and needles out of sight and reach of others, especially children.
• Never share the pen or needles with other people.
• Exercise extreme caution when handling used needles to prevent needlestick injuries and cross-infections.
• Change the injection site daily to reduce the risk of developing lumps.