Zegluxen

Package Leaflet: Information for the User

ZEGLUXEN, 6 mg/mL, Solution for Injection in a Pre-Filled Pen

Liraglutide

Read All of This Leaflet Carefully Before Using This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medicine Has Been Prescribed for You. Do Not Pass It on to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Experience Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. See Section 4.

Contents of the Pack

• 1. What Zegluxen Is and What It Is Used For
• 2. Before You Use Zegluxen
• 3. How to Use Zegluxen
• 4. Possible Side Effects
• 5. How to Store Zegluxen
• 6. Contents of the Pack and Other Information

1. What Zegluxen Is and What It Is Used For

Zegluxen Contains the Active Substance Liraglutide. It Helps to Lower Your Blood Sugar Levels Only When They Are Too High. It Also Slows Down the Movement of Food from the Stomach to the Small Intestine, and It May Also Help to Prevent Heart Disease.

Zegluxen Is Used on Its Own as a Single Medicine for the Treatment of Type 2 Diabetes in Adults When Diet and Exercise Alone Do Not Provide Adequate Control of Blood Sugar Levels, and When the Use of Metformin (Another Anti-Diabetic Medicine) Is Not Suitable.

Zegluxen Is Used in Combination with Other Anti-Diabetic Medicines in Adults When These Medicines Alone Do Not Provide Adequate Control of Blood Sugar Levels. These Medicines Include:

• •Oral Anti-Diabetic Medicines (Such as Metformin, Pioglitazone, Sulfonylureas, and SGLT2 Inhibitors) and/or Insulin.

2. Before You Use Zegluxen

When Not to Use Zegluxen

• If You Are Allergic to Liraglutide or Any of the Other Ingredients of This Medicine (Listed in Section 6).

Warnings and Precautions

Before Starting Treatment with Zegluxen, Tell Your Doctor, Pharmacist, or Nurse:

• •If You Have Ever Had Pancreatitis (Inflammation of the Pancreas).

If You Are Going to Have an Operation, Tell Your Doctor That You Are Using Zegluxen. This Medicine Should Not Be Used If You Have Type 1 Diabetes (When Your Body Does Not Produce Any Insulin) or Diabetic Ketoacidosis (A Complication of Diabetes with High Blood Sugar Levels and Increased Breathing Rate). This Medicine Is Not Insulin and Should Not Be Used as a Substitute for Insulin.

The Use of Zegluxen Is Not Recommended in Patients Undergoing Dialysis. The Use of Zegluxen Is Not Recommended in Patients with Severe Liver Disease. The Use of Zegluxen Is Not Recommended in Patients with Severe Heart Failure. The Use of Zegluxen Is Not Recommended in Patients with Severe Gastrointestinal Disorders, Such as Gastroparesis (Delayed Emptying of the Stomach) or Inflammatory Bowel Disease.

If You Experience Symptoms of Acute Pancreatitis, Such as Persistent, Severe Abdominal Pain, You Should Contact Your Doctor Immediately (See Section 4). If You Have Thyroid Disease, Including Thyroid Nodules or Enlargement of the Thyroid Gland, You Should Consult Your Doctor.

In the Initial Treatment Period with Zegluxen, You May Experience Fluid Loss (Dehydration), for Example, Due to Vomiting, Nausea, and Diarrhea. You Should Drink Plenty of Fluids to Avoid Dehydration. If You Have Any Questions or Concerns, You Should Consult Your Doctor.

Children and Adolescents

Zegluxen Can Be Used in Adolescents and Children Aged 10 Years and Above. There Is Limited Data on the Use of This Medicine in Children Below the Age of 10.

Interaction with Other Medicinal Products

Tell Your Doctor, Pharmacist, or Nurse About All Medicines You Are Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.

In Particular, Tell Your Doctor, Pharmacist, or Nurse If You Are Taking Medicines That Contain Any of the Following Active Substances:

• •Sulfonylureas (Such as Glimepiride or Glibenclamide) or Insulin. The Risk of Hypoglycemia (Low Blood Sugar Levels) May Increase When Zegluxen Is Used with a Sulfonylurea or Insulin, as These Medicines Increase the Risk of Hypoglycemia. When Starting These Medicines for the First Time, Your Doctor May Reduce the Dose of the Sulfonylurea or Insulin. Symptoms of Low Blood Sugar Levels – See Section 4.
• •Warfarin or Other Oral Anticoagulants – More Frequent Blood Tests to Monitor Blood Clotting May Be Necessary.

Pregnancy and Breast-Feeding

If You Are Pregnant, Think You May Be Pregnant, or Plan to Have a Baby, Ask Your Doctor for Advice Before Taking This Medicine. This Medicine Should Not Be Used During Pregnancy, as It May Harm the Unborn Child.

It Is Not Known If Liraglutide Passes into Breast Milk, and Therefore, This Medicine Should Not Be Used During Breast-Feeding.

Driving and Using Machines

Low Blood Sugar Levels (Hypoglycemia) May Affect Your Ability to Concentrate. You Should Avoid Driving or Operating Machinery If You Experience Symptoms of Hypoglycemia. See Section 4 – Symptoms of Low Blood Sugar Levels. For Further Information, Consult Your Doctor.

Zegluxen Contains Sodium

This Medicine Contains Less Than 1 Mmol (23 Mg) of Sodium per Dose, Which Is Essentially Sodium-Free.

3. How to Use Zegluxen

Always Use This Medicine Exactly as Your Doctor Has Told You. If You Are Not Sure, Ask Your Doctor, Pharmacist, or Nurse.

• •The Initial Dose Is 0.6 Mg Once a Day for at Least One Week.
• •Your Doctor Will Tell You When to Increase the Dose to 1.2 Mg Once a Day.
• •Your Doctor May Later Increase the Dose to 1.8 Mg Once a Day if You Do Not Achieve Adequate Control of Blood Sugar Levels with the 1.2 Mg Dose. Do Not Change the Dose Without Consulting Your Doctor.

Zegluxen Is Injected Under the Skin (Subcutaneously). It Should Not Be Injected into a Vein or Muscle.

The Best Places to Inject Yourself Are the Front of Your Thighs, the Front of Your Waist (Abdomen), or the Upper Arm.

You Can Inject Zegluxen at Any Time of the Day, with or Without Food. Once You Have Chosen Your Injection Time, Try to Inject at the Same Time Every Day.

Before the First Use, Your Doctor or Nurse Will Show You How to Use the Pen.

A Detailed User Manual Is Provided on the Back of This Leaflet.

The Pen Does Not Contain Needles. It Can Be Used with, for Example, BD Ultra-Fine or NovoFine 32 G, 8 Mm Needles.

Overdose

If You Have Used More Zegluxen Than You Should, Contact Your Doctor Immediately. You May Need Treatment. You May Experience Nausea, Vomiting, Diarrhea, or Low Blood Sugar Levels (Hypoglycemia). Symptoms of Low Blood Sugar Levels – See Section 4.

Missed Dose

If You Miss a Dose, Inject Zegluxen as Soon as You Remember.

If It Is More Than 12 Hours Since You Should Have Injected Zegluxen, Skip the Missed Dose and Inject the Next Dose at the Regular Time.

Do Not Take a Double Dose to Make Up for a Forgotten Dose.

Stopping Treatment

Do Not Stop Using Zegluxen Without Consulting Your Doctor. If You Stop Using Zegluxen, Your Blood Sugar Levels May Increase.

If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

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

• •Hypoglycemia (Low Blood Sugar Levels). Symptoms of Low Blood Sugar Levels May Come On Suddenly and May Include: Cold Sweats, Cool Pale Skin, Headache, Fast Heartbeat, Nausea, Feeling of Extreme Hunger, Blurred Vision, Drowsiness, Weakness, Nervousness, Anxiety, Confusion, Difficulty Concentrating, Shaking. Your Doctor Will Tell You How to Treat Low Blood Sugar Levels and What to Do If You Experience Symptoms of Low Blood Sugar Levels. The Risk of Low Blood Sugar Levels Is Higher If You Are Taking a Sulfonylurea or Insulin. Your Doctor May Reduce the Dose of the Sulfonylurea or Insulin Before You Start Using Zegluxen.

Uncommon: May Affect Up to 1 in 100 People

• •Severe Allergic Reaction (Anaphylaxis), Including Additional Symptoms Such as Difficulty Breathing, Swelling of the Throat and Face, Rapid Heartbeat, Etc. If You Experience Any of These Symptoms, Seek Medical Attention Immediately and Contact Your Doctor.
• •Intestinal Obstruction. A Severe Form of Constipation, Accompanied by Symptoms Such as Abdominal Pain, Bloating, Vomiting, Etc.

Rare: May Affect Up to 1 in 1,000 People

• •Pancreatitis (Inflammation of the Pancreas). Pancreatitis Can Be Severe and Life-Threatening. Stop Using Zegluxen and Contact Your Doctor Immediately If You Experience Any of the Following Serious Side Effects: Severe and Persistent Abdominal Pain (in the Stomach Area) That May Radiate to the Back, as Well as Nausea and Vomiting, as These May Be Symptoms of Pancreatitis.

Other Side Effects

Very Common: May Affect More Than 1 in 10 People

• •Nausea. Usually Transient.
• •Diarrhea. Usually Transient.

Common

• •Vomiting.

In the Initial Treatment Period with Zegluxen, You May Experience Fluid Loss (Dehydration), for Example, Due to Vomiting, Nausea, and Diarrhea. You Should Drink Plenty of Fluids to Avoid Dehydration.

• •Headache
• •Indigestion
• •Gastritis (Inflammation of the Stomach). Symptoms Include Abdominal Pain, Nausea, and Vomiting.
• •Gastroesophageal Reflux Disease. Symptoms Include Heartburn.
• •Abdominal Pain or Bloating
• •Discomfort in the Abdomen
• •Constipation
• •Bloating with Gas
• •Decreased Appetite
• •Bronchitis
• •Common Cold
• •Dizziness
• •Rapid Heartbeat
• •Fatigue
• •Toothache
• •Injection Site Reactions (Such as Bruising, Pain, Redness, Itching, and Rash)
• •Increased Activity of Pancreatic Enzymes (Such as Lipase and Amylase).

Uncommon: May Affect Up to 1 in 100 People

• •Allergic Reactions Such as Itching (Pruritus) and Hives (Urticaria)
• •Dehydration, Sometimes with Kidney Problems
• •Feeling Unwell
• •Gallstones
• •Cholecystitis (Inflammation of the Gallbladder)
• •Change in Taste
• •Delayed Gastric Emptying.

Reporting of Side Effects

If You Experience Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. Side Effects Can Also Be Reported to the Regulatory Authority. By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Zegluxen

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 Label and Carton. The Expiry Date Refers to the Last Day of the Month.

Before Use:

Store in a Refrigerator (2°C – 8°C). Do Not Freeze.

During Use:

The Pen Can Be Stored for up to One Month at a Temperature Below 30°C or in a Refrigerator (2°C – 8°C). Do Not Freeze.

When Not in Use, to Protect from Light, Replace the Pen Cap.

Do Not Use This Medicine If the Solution Is Not 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 Protect the Environment.

6. Contents of the Pack and Other Information

What Zegluxen Contains

• The Active Substance Is Liraglutide. 1 Ml of Solution for Injection Contains 6 Mg of Liraglutide. One Pre-Filled Pen Contains 18 Mg of Liraglutide.
• The Other Ingredients Are: Disodium Citrate Dihydrate, Propylene Glycol, Phenol, and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide May Be Added to Adjust the pH.

What Zegluxen Looks Like and Contents of the Pack

Zegluxen Is a Clear and Colorless or Almost Colorless Solution for Injection in a Pre-Filled Pen.

Each Pen Contains 3 Ml of Solution, Providing 30 Doses of 0.6 Mg, 15 Doses of 1.2 Mg, or 10 Doses of 1.8 Mg.

Zegluxen Is Available in Packs Containing 1, 2, 3, 5 Pens or a Multipack Containing 2 Packs of 5 Pens.

Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva, k.s.

U kabelovny 130

Dolní Měcholupy

102 37 Prague 10

Czech Republic

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

This Medicine Is Authorized in the Member States of the European Economic Area Under the Following Names

Austria: Zegluxen 6 mg/ml Injektionslösung in einem Fertigpen

Bulgaria: ЗЕГЛУКСЕН

Croatia: Zegluxen 6 mg/ml otopina za injekciju u napunjenoj brizgalici

Poland, Czech Republic: ZEGLUXEN

Romania: ZEGLUXEN 6mg/ml solutie injectabila in stilou preumplut

For Any Information About This Medicine, Please Contact the Local Representative of the Marketing Authorization Holder:

Zentiva Polska Sp. z.o.o.

ul. Bonifraterska 17

00-203 Warsaw, Poland

tel.: +48 22 375 92 00

Date of Last Revision of the Leaflet:

INSTRUCTIONS FOR USE OF THE ZEGLUXEN PEN

Read This Instruction Carefully Before Using the Pen.

The Pen Contains 18 Mg of Liraglutide. You Can Choose Doses of 0.6 Mg, 1.2 Mg, and 1.8 Mg.

The Pen Is Designed for Use with a Single-Use Needle. Needles Are Not Included in the Package.

It Is Recommended to Use This Pen with BD Ultra-Fine or NovoFine Needles.

Liraglutide Pen

Preparing the Pen

Check the Name and Colorful Label on the Pento Make Sure It Contains Liraglutide.

Using the Wrong Medicine Can Cause Serious Harm.

Remove the Pen Cap.

Remove the Paper Tab from the New Single-Use Needle. Tighten the Needle onto the Pen by Turning It Clockwise.

Remove the Outer Needle Cap and Save It for Later.
Remove the Inner Needle Cap and Dispose of It.
Always Use a New Needle for Each Injection. This Reduces the Risk of Contamination, Infection, Liraglutide Leakage, Needle Blockage, and Incorrect Dosing.

Be Careful Not to Bend or Damage the Needle.

Never Put the Inner Needle Cap Back On. You May Stick Yourself with the Needle.

Checking the Flow

For Each New Pen, Check the Flow Before the First Injection.

If the Pen Is Already in Use, Go to Section H "Setting the Dose".

Turn the Dose Selector Until the Flow Check Symbol Is in Line with the Dose Indicator.

Hold the Pen with the Needle Pointing Upwards and Gently Tap the Cartridge with Your Finger Several Times. This Will Make Any Air Bubbles Collect at the Top of the Cartridge.
Hold the Pen with the Needle Pointing Upwards and Press the Dose Button Until the Dose Indicator Is in Line with the 0 Mg Mark.
A Drop of Liraglutide Should Appear at the Needle Tip. If a Drop of Liraglutide Does Not Appear, Repeat the Steps from E to G Up to Four Times.
If a Drop of Liraglutide Still Does Not Appear, Change the Needle and Repeat the Steps from E to G Again.
Do Not Use the Pen If a Drop of Liraglutide Does Not Appear, as This Indicates That the Pen Is Defective. Use a New Pen Instead.

Caring for the Pen

Do Not Try to Repair or Disassemble the Pen.

Store the Pen Away from Dust, Dirt, and Any Liquid.

Clean the Pen with a Soft Cloth Dampened with Mild Soap Solution.

Do Not Try to Wash, Soak, or Lubricate the Pen, as This May Damage It.

Important Information

Do Not Share the Pen or Needles with Others.

Store the Pen in a Safe Place, Out of the Reach of Others, Especially Children.

Setting the Dose

Always Make Sure the Dose Indicator Is in Line with the 0 Mg Mark.

Turn the Dose Selector Until the Correct Dose (0.6 Mg, 1.2 Mg, or 1.8 Mg) Is in Line with the Dose Indicator.

If You Have Accidentally Set the Wrong Dose, Turn the Dose Selector Backwards or Forwards Until the Correct Dose Is in Line with the Dose Indicator.

When Turning the Dose Selector Backwards, Be Careful Not to Press the Dose Button, as This May Cause Liraglutide to Leak Out.

If the Dose Selector Stops Before the Correct Dose Is in Line with the Dose Indicator, This Means That There Is Not Enough Liraglutide Left in the Pen to Deliver the Full Dose.

You Can Then:

Selected 0.6 Mg Divide the Dose into Two Injections:

Turn the Dose Selector in Either Direction Until the 0.6 Mg or 1.2 Mg Mark Is in Line with the Dose Indicator. Inject the Dose. Then Prepare a New Pen and Inject the Remaining Milligrams Needed to Complete the Dose.

Selected 1.2 Mg

The Dose Can Be Divided Between the Current Pen and a New Pen Only If You Have Received Training from a Healthcare Professional. You Should Use a Calculator to Plan the Dose. If the Dose Is Divided Incorrectly, You May Receive Too Much or Too Little Liraglutide.

Selected 1.8 Mg Inject the Full Dose with a New Pen:

If the Dose Selector Stops Before the 0.6 Mg Mark Is in Line with the Dose Indicator, Prepare a New Pen and Inject the Full Dose with the New Pen.

Do Not Try to Set Doses Other Than 0.6 Mg, 1.2 Mg, or 1.8 Mg. The Numbers in the Dose Window Must Be Exactly in Line with the Dose Indicator to Ensure the Correct Dose Is Delivered.

When Turning the Dose Selector, You Will Hear a Clicking Sound. Do Not Use This Sound to Set the Dose.

Do Not Use the Cartridge Scale to Measure the Dose of Liraglutide to Be Injected, as It Is Not Accurate Enough.

Injecting the Dose

Insert the Needle into the Skin as Instructed by Your Doctor or Nurse. Then Follow the Instructions Below:

To Inject the Dose, Press the Dose Button Until the Dose Indicator Is in Line with the 0 Mg Mark.

Be Careful Not to Touch the Dose Window or Press the Dose Button from the Side. This May Block the Injection.

Hold the Dose Button Down and Keep the Needle in the Skin for at Least 6 Seconds. This Ensures That the Full Dose Is Delivered.

Remove the Needle.

A Drop of Liraglutide May Appear at the Needle Tip.

This Is Normal and Does Not Affect the Delivered Dose.

Put the Needle Tip into the Outer Needle Cap Without Touching the Needle or the Outer Needle Cap.

Gently Push the Outer Needle Cap onto the Needle Until It Clicks. Then Remove the Needle. Carefully Dispose of the Needle and Put the Pen Cap Back On.

If the Pen Is Empty, Dispose of It Carefully Without the Attached Needle. Dispose of the Pen and Needle According to Local Regulations.

After Each Injection, Remove the Needle and Store the Pen Without the Attached Needle.

This Reduces the Risk of Contamination, Infection, Liraglutide Leakage, Needle Blockage, and Incorrect Dosing.

Carers Must Be Very Careful When Handling Used Needles to Avoid Accidental Needlestick Injury and Transmission of Infection.