Liraglutide Zentiva 6 mg/ml solution for injection in pre-filled pen

Spain
Brand name Liraglutide Zentiva 6 mg/ml solution for injection in pre-filled pen
Form solution for injection in pre-filled pen
Active substance / Dosage
LIRAGLUTIDE · 6 mg/ml
Prescription type Prescription Only Medicine
ATC code
A10B A10BJ A10BJ02
Registration number 90096
Manufacturer Zentiva K.S.
Liraglutide Zentiva 6 mg/ml solution for injection in pre-filled pen solution for injection in pre-filled pen

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Liraglutide Zentiva 6 mg/ml solution for injection in pre-filled pen

Read the entire leaflet carefully before you start using this medicine, because 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Liraglutida Zentiva is and what it is used for

Liraglutida Zentiva contains the active substance liraglutide. It helps your body reduce your blood sugar level only when this sugar level is too high. In addition, it slows down the passage of food from your stomach.

Liraglutide is used alone if your blood sugar level is not adequately controlled by diet and exercise alone, and you cannot use metformin (another diabetes medicine).

Liraglutide is used in combination with other diabetes medicines when these are not sufficient to control your blood sugar level. These may include:

  • oral antidiabetic medicines (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter 2 inhibitor (SGLT2i)) and/or insulin.

2. What you need to know before starting to use Liraglutide Zentiva

Do not use Liraglutide Zentiva

  • 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 starting to use liraglutide.
  • if you have or have had a disease of the pancreas.

If you know you are going to undergo surgery under anaesthesia (a state of sleep), inform your doctor that you are taking this medicine.

This medicine must not be used if you have type 1 diabetes (your body produces no insulin) or diabetic ketoacidosis (a complication of diabetes characterised by high blood sugar levels and increased breathing effort). It is not insulin and therefore must not be used as a substitute for insulin.

The use of liraglutide is not recommended if you are on dialysis.

The use of liraglutide is not recommended if you have severe liver disease.

The use of liraglutide is not recommended if you have severe heart failure.

This medicine is not recommended if you have a serious stomach or bowel problem causing delayed stomach emptying (called gastroparesis), or inflammatory bowel disease.

If you experience symptoms of acute pancreatitis, such as severe and persistent stomach pain, you must consult your doctor immediately (see section 4).

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

In some cases, when starting treatment with liraglutide, you may experience dehydration (loss of fluids), for example, if you have vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any doubts.

Children and adolescents

Liraglutide may be used in adolescents and children from 10 years of age. There is no available data in children under 10 years of age.

Other medicines and Liraglutide Zentiva

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might need to take any other medicines.

Specifically, inform your doctor, pharmacist or nurse if you are taking medicines containing any of the following active substances:

  • Sulphonylureas (such as glimepiride or glyburide) or insulin. You may experience hypoglycaemia (low blood sugar levels) when using liraglutide together with a sulphonylurea or insulin, as sulphonylureas and insulin increase the risk of hypoglycaemia. When you first start using these medicines together, your doctor may advise you to reduce the dose of sulphonylurea or insulin. To check for warning symptoms of low blood sugar, see section 4. If you are also taking a sulphonylurea (such as glimepiride or glyburide) or insulin, your doctor may request blood tests to monitor your blood sugar levels. This will help your doctor decide whether the dose of sulphonylurea or insulin needs to be changed.
  • If you are receiving insulin, your doctor will advise you on how to reduce the insulin dose and recommend that you monitor your blood sugar levels more frequently to prevent hyperglycaemia (high blood sugar levels) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose due to insufficient insulin).
  • Warfarin or other anticoagulant medicines. More frequent blood tests may be needed to determine your blood's clotting ability.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant. This medicine must not be used during pregnancy because it is unknown whether it could harm the foetus.

It is unknown whether liraglutide passes into breast milk; therefore, do not use this medicine during breastfeeding.

Driving and using machines

Low blood sugar levels (hypoglycaemia) can reduce your ability to concentrate. Avoid driving or using machines if you experience symptoms of hypoglycaemia. See section 4 for warning symptoms of low blood sugar. Consult your doctor for further information.

Liraglutide Zentiva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; essentially “sodium-free”.

3. How to use Liraglutida Zentiva

Follow exactly the instructions given by your doctor for using this medicine. If in doubt, consult your doctor, pharmacist, or nurse again.

  • The starting dose is 0.6 mg once daily for at least one week.
  • Your doctor will tell you when to increase the dose to 1.2 mg once daily.
  • Your doctor may instruct you to further increase the dose to 1.8 mg once daily if your blood glucose is not adequately controlled with a 1.2 mg dose.

Do not change the dose unless your doctor tells you to do so.

Liraglutide is administered as an injection under the skin (subcutaneously). Do not inject into a vein or muscle. The best injection sites are the front of the thigh, the front of the waist (abdomen), or the upper arm. Change the injection site each day to reduce the risk of developing lumps under the skin.

The injection can be given at any time of day, regardless of meals. Once you have chosen the most convenient time of day, it is preferable to inject liraglutide around the same time each day.

Before using the pen for the first time, your doctor or nurse will show you how to use it.

Detailed instructions for use can be found on the other side of this leaflet.

Injection needles are not included with the pen. For example, BD Ultra-Fine™ or NovoFine® disposable needles as fine as 32 G and up to 8 mm in length may be used.

If you use more Liraglutida Zentiva than you should

If you use more liraglutide than you should, contact your doctor immediately. You may require medical treatment. You may experience nausea, vomiting, diarrhoea, or low blood sugar (hypoglycaemia). See the warning signs of low blood sugar in section 4.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Liraglutida Zentiva

If you forget a dose, use liraglutide as soon as you remember.

However, if more than 12 hours have passed since you were supposed to use liraglutide, skip the missed dose. Take the next dose the following day as usual.

Do not use a double dose or increase the next day’s dose to make up for missed doses.

If you stop using Liraglutida Zentiva

Do not stop treatment with this medicine without consulting your doctor. If you stop, your blood sugar levels may increase.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Frequent: may affect up to 1 in 10 people

  • Hypoglycaemia (low blood sugar level). Warning symptoms of low blood sugar may appear suddenly and include: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, visual disturbances, drowsiness, feeling of weakness, nervousness, anxiety, confusion, difficulty concentrating, and tremors. Your doctor will advise you on how to treat low blood sugar levels and what to do if you experience any of these warning symptoms. This is more likely to occur if you are also taking a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using liraglutide.

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

  • A severe allergic reaction (anaphylactic reaction) with additional symptoms such as breathing difficulties, swelling of the throat and face, palpitations, etc. If you notice any of these symptoms, seek medical help immediately and consult your doctor as soon as possible.
  • Intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.

Very rare: may affect up to 1 in 10,000 people

  • Cases of inflammation of the pancreas (pancreatitis). Pancreatitis can be a serious and potentially life-threatening condition. Stop using liraglutide and contact your doctor immediately if you experience any of the following serious adverse effects:

Severe and persistent pain in the abdomen (stomach area) that may radiate to the back, as well as nausea and vomiting, as these could be signs of inflammation of the pancreas (pancreatitis).

Other adverse effects

Very common: may affect more than 1 in 10 people

  • Nausea (feeling unwell). This effect usually resolves over time.
  • Diarrhoea. This effect usually resolves over time.

Common

  • Vomiting.

When starting treatment with liraglutide, fluid loss/dehydration may occur in some cases, for example due to vomiting, nausea, and diarrhoea. It is important to prevent dehydration by drinking plenty of fluids.

  • Headache
  • Indigestion
  • Stomach inflammation (gastritis). Symptoms include stomach pain, nausea, and vomiting.
  • Gastroesophageal reflux disease (GERD). Symptoms include heartburn.
  • Bloating or abdominal pain
  • Abdominal discomfort
  • Constipation
  • Gas (flatulence)
  • Decreased appetite
  • Bronchitis
  • Common cold
  • Dizziness
  • Rapid pulse
  • Fatigue
  • Toothache
  • Injection site reactions (bruising, pain, irritation, itching, and rash).
  • Increased pancreatic enzymes (such as lipase and amylase).

Uncommon: may affect up to 1 in 100 people

  • Allergic reactions such as pruritus (itching) and urticaria (a type of skin rash)
  • Dehydration, sometimes with a decrease in kidney function
  • Malaise (feeling unwell)
  • Gallstones
  • Inflamed gallbladder
  • Change in taste
  • Delayed gastric emptying.

Frequency not known: cannot be estimated from available data

  • Lumps under the skin may occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency of occurrence is unknown).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Liraglutide Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pen label and the carton after "CAD". The expiry date refers to the last day of the month indicated.

Before first use:

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

After starting to use the pen:

The pen may be stored for one month either below 30 °C or in the refrigerator (between 2 °C and 8 °C). Do not freeze.

When not in use, keep the pen with the cap on to protect it from light.

Do not use this medicine if the solution is not clear and colourless or almost colourless.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to your pharmacy’s SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Liraglutide Zentiva

  • 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 (excipients) are: sodium citrate dihydrate, propylene glycol, phenol, and water for injectable preparations. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH.

Appearance of the product and contents of the pack

Liraglutide Zentiva is supplied as a clear, colourless or almost colourless injectable solution in a pre-filled pen. Each pen contains 3 ml of solution, capable of delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg, or 10 doses of 1.8 mg.

Liraglutide Zentiva is available in packs of 1, 2, 3, 5 or 10 pens, or a multiple pack containing two packs of 5 pre-filled pens (10 pre-filled pens). Needles are not included.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva, k.s.

U Kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola PLA 300

Malta

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Liraglutid Zentiva 6 mg/ml Injektionslösung in einem Fertigpen

Austria: Liraglutid Zentiva 6 mg/ml Injektionslösung in einem Fertigpen

Denmark, Norway, Sweden: Liraglutid Zentiva

Spain: Liraglutida Zentiva 6 mg/ml solución inyectable en pluma precargada

Estonia, Italy: Liraglutide Zentiva

France: LIRAGLUTIDE ZENTIVA 6 mg/ml solution injectable en stylo prérempli

Lithuania: Liraglutide Zentiva 6 mg/ml injekcinis tirpalas užpildytame švirkštiklyje

Latvia: Liraglutide Zentiva 6 mg/ml škidums injekcijam pildspalvveida pilnšlirce

Netherlands: Liraglutide Zentiva 6 mg/ml oplossing voor injectie in een voorgevulde pen

Portugal: Liraglutido Zentiva

Date of the most recent review of this leaflet: July 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

INSTRUCTIONS FOR USE OF LIRAGLUTIDE ZENTIVA PRE-FILLED PEN

Read these instructions carefully before using your pen.

Your pen contains 18 mg of liraglutide. You can select doses of 0.6 mg, 1.2 mg, and 1.8 mg.

The pen is designed to be used with disposable needles. Needles are not included.

Use of BD Ultra-Fine™ or NovoFine® disposable needles is recommended with this device.

Diagram of a needle with Spanish labels indicating the outer cap, inner cap, and the

Diagram of a Liraglutide injectable pen with labels indicating cap, cartridge, scale, dose selector, indicator, and button

Preparing the pen

Check the name and color of the label on your pen to ensure it contains liraglutide. Using the wrong medication could cause you serious harm.

Remove the cap from the pen.

Two hands placing a blue cap onto a transparent medical device showing numerical indicators 12 and 15, and a blue directional arrow

Remove the paper tab from a new disposable needle. Screw the needle straight and firmly onto the pen.

A yellow hand rotating the top of a transparent syringe with a graduated scale, following a blue curved arrow pointing to the right

Remove the outer needle cap and keep it for later use.

A hand rotating the white top part of a medical device attached to a transparent syringe with a graduated scale, moving to the right

Remove the inner needle cap and dispose of it.

A hand grasping the top of a transparent syringe with a blue arrow indicating the motion of removing the cap of the

Always use a new needle for each injection. This reduces the risk of contamination, infection, loss of liraglutide, needle blockage, and inaccurate dosing.

Be careful not to bend or damage the needle.

Never attempt to reinsert the inner needle cap. You could prick yourself with the needle.

Maintaining your pen

  • Do not attempt to repair or disassemble the pen.
  • Keep the pen away from dust, dirt, and liquids.
  • Clean the pen with a cloth dampened with mild detergent.
  • Do not attempt to wash, immerse, or lubricate it; this may damage the pen.

Important information

  • Do not share your pen or needles with anyone else.
  • Keep your pen out of reach of others, especially children.
    • Change your injection site daily to reduce the risk of developing lumps under the skin.

With each new pen, check the flow

Check the flow before the first injection with each new pen. If your pen is already in use, go to “Selecting the dose,” step H.

Turn the dose selector until the indicator points to the flow check symbol.

Two hands holding a blue and white injection pen with a display showing the number zero and a blue arrow indicating rotation

Hold the pen with the needle pointing upward. Gently tap the cartridge several times with your finger to collect air bubbles at the top of the cartridge.

Medical illustration of a hand approaching a transparent vial with a silver cap on a white background, with a blue letter F in the top left corner

Keep the needle pointing upward and press the injection button until the indicator shows 0 mg.

A drop of liraglutide should appear at the tip of the needle. If no drop appears, repeat steps E to G up to four times.

If still no drop appears, change the needle and repeat steps E to G once more.

Do not use the pen if a drop of liraglutide still does not appear. This indicates the pen is faulty and you should use a new one.

A hand holding a pre-filled syringe with a magnified detail of the cap and a blue indicator with an arrow pointing toward the

If the pen has been dropped on a hard surface or you suspect it is not working properly, always attach a new disposable needle and check the flow before using it.

Selecting the dose

Always check that the indicator shows 0 mg.

Turn the dose selector until the indicator points to the required dose (0.6 mg, 1.2 mg, or 1.8 mg).

If you accidentally select the wrong dose, simply turn the dose selector backward or forward until the indicator shows the correct dose.

Be careful not to press the injection button while turning the dose selector backward, as liraglutide may be released.

If the dose selector stops before the indicator reaches the required dose, this means there is not enough liraglutide left for a full dose. In this case, you may:

Split your dose into two injections:

Turn the dose selector in either direction until the indicator shows 0.6 mg or 1.2 mg. Inject the dose. Then prepare a new pen and inject the remaining number of mg to complete your dose.

You should only split your dose between the current pen and a new pen if you have received proper training or advice from your healthcare professional. Use a calculator to plan your doses. If you split the dose incorrectly, you may inject too much or too little liraglutide.

Inject the full dose with a new pen:

If the dose selector stops before the indicator reaches 0.6 mg, prepare a new pen and inject the full dose with it.

Two hands holding a blue and white injection pen with a dosage indicator set at 0 mg and a curved arrow indicating rotational movement

Detail of a medical device displaying '0.6 mg' on a white background, with the text '0.6 mg selected' adjacent on a blue and white background

Digital screen with a white button displaying '1.2 mg' on a blue background and the text '1.2 mg selected' in black on a white background

Blue box with a digital display indicating '1.8 mg' next to the text '1.8 mg selected' in black on a white background

Do not attempt to select doses other than 0.6 mg, 1.2 mg, or 1.8 mg. The numbers in the display must be exactly aligned with the indicator to ensure you receive the correct dose.

You will hear a click each time you turn the dose selector. Do not use these clicks to determine your dose.

Do not use the markings on the cartridge to measure the amount of liraglutide to be injected, as they are not sufficiently accurate.

Injecting the dose

Insert the needle under the skin according to the injection technique advised by your doctor or nurse. Then follow these instructions:

Press the injection button until the indicator shows 0 mg. Be careful not to touch the display with other fingers or press the side of the dose selector while injecting, as this may block the injection. Keep the button pressed and leave the needle under the skin for at least 6 seconds. This ensures the full dose is delivered.

A yellow hand holding a blue vial with a blue arrow pointing downward and a magnified detail showing the dosage of 0.6 mg

Remove the needle.

You may see a drop of liraglutide at the tip of the needle.

This is normal and does not affect your dose.

Blue arrow pointing toward the

Insert the needle tip into the outer needle cap without touching the needle or the outer cap.

Transparent syringe with a graduated scale being inserted into a white protective cap, indicated by a blue arrow pointing to the left

Once the needle is covered, carefully press the outer needle cap all the way on. Then unscrew the needle. Carefully dispose of the needle and replace the pen cap.

When the pen is empty, dispose of it carefully without any needle attached. Please dispose of the pen and needle according to local regulations.

A yellow hand rotating the top part of a white medical device to the right, indicated by a blue arrow on a light gray background

Always remove the needle after each injection and store your pen without a needle attached.

This reduces the risk of contamination, infection, loss of liraglutide, needle blockage, and inaccurate dosing.

People caring for patients should be very careful when handling used needles to avoid accidental needlestick injuries and infections.