This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use LIRAGLUTIDE ZENTIVA 6 mg/ml INJECTABLE SOLUTION IN PRE-FILLED PEN

Introduction

Package Leaflet: Information for the User

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

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

What is Liraglutida Zentiva and what is it used for
What you need to know before you use Liraglutida Zentiva
How to use Liraglutida Zentiva
Possible side effects
Storage of Liraglutida Zentiva
Contents of the pack and other information

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

Liraglutida Zentiva contains the active substance liraglutide. It helps your body to lower your blood sugar level only when your blood sugar level is too high. It also slows down the movement of food from your stomach.

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

Liraglutide is used together with other diabetes medicines, when these are not enough to control your blood sugar level. These may be:

oral anti-diabetics (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter 2 (SGLT2) inhibitor) and/or insulin.

2. What you need to know before you use Liraglutida Zentiva

Do not use Liraglutida Zentiva

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse:

before you start using liraglutide.
if you have or have had pancreatitis.

If you know you are going to have surgery, tell your doctor that you are taking this medicine.

This medicine should not be used if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar and increased breathing rate). It is not an insulin and should 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 should not be used if you have a severe stomach or gut problem that causes a delay in emptying of the stomach (called gastroparesis), or inflammatory bowel disease.

If you get symptoms of acute pancreatitis, such as severe and persistent stomach pain, you should contact your doctor immediately (see section 4).

If you have thyroid disease, including thyroid nodules and increased size of the thyroid gland, talk to 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 diarrhea. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any doubts.

Children and adolescents

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

Other medicines and Liraglutida Zentiva

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

In particular, tell your doctor, pharmacist, or nurse if you are using medicines that contain any of the following active substances:

Sulfonylurea (such as glimepiride or glibenclamide) or insulin. You may get low blood sugar (hypoglycemia) when using liraglutide with a sulfonylurea or insulin, as sulfonylureas and insulin increase the risk of hypoglycemia. When you start using these medicines together for the first time, your doctor may tell you to reduce the dose of sulfonylurea or insulin. To see the warning signs of low blood sugar, see section 4. If you are also taking a sulfonylurea (such as glimepiride or glibenclamide) or insulin, your doctor may ask you to have your blood sugar levels tested. This will help your doctor decide if you need to change the dose of sulfonylurea or insulin.
If you are taking insulin, your doctor will tell you how to reduce the dose of insulin and recommend that you check your blood sugar level more often to avoid high blood sugar (hyperglycemia) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough insulin).
Warfarin or other anticoagulant medicines. You may need to have more frequent blood tests to check how well your blood is clotting.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. This medicine should not be used during pregnancy because it is not known if it could harm the baby.

It is not known if liraglutide passes into breast milk, so do not use this medicine during breast-feeding.

Driving and using machines

Low blood sugar (hypoglycemia) may reduce your ability to concentrate. Avoid driving or using machines if you experience symptoms of hypoglycemia. See section 4 for the warning signs of low blood sugar. Talk to your doctor for more information.

Liraglutida Zentiva contains sodium

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

3. How to use Liraglutida Zentiva

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, talk to your doctor, pharmacist, or nurse.

The starting 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 tell you to further increase the dose to 1.8 mg once a day if your blood sugar is not controlled with a dose of 1.2 mg.

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

Liraglutide is given as an injection under the skin (subcutaneously). Do not inject into a vein or muscle. The best areas for injection are the front of your thigh, the front of your waist (abdomen), or the top of your arm. Change the injection site every day to reduce the risk of developing lumps under the skin.

The injection can be given at any time of day, with or without food. Once you have decided on the best time of day for you, it is best to inject liraglutide at the same time every day.

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

On the other side of this leaflet, you will find detailed instructions on how to use it.

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

If you use more Liraglutida Zentiva than you should

If you use more liraglutide than you should, talk to your doctor immediately. You may need medical treatment. You may experience nausea, vomiting, diarrhea, or low blood sugar (hypoglycemia). See the warning signs of low blood sugar in section 4.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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 should have used liraglutide, skip the missed dose. Give the next dose at the usual time the next day.

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

If you stop using Liraglutida Zentiva

Do not stop using this medicine without talking to your doctor. If you stop, 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

Low blood sugar (hypoglycemia). The warning signs of low blood sugar may appear suddenly and include: cold sweat, cool pale skin, headache, fast heartbeat, nausea, excessive hunger, visual disturbances, drowsiness, weakness, nervousness, anxiety, confusion, difficulty concentrating, and shakiness. Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs. This is more likely to happen if you are also using 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 problems, swelling of the throat and face, fast heartbeat, etc. If you notice any of these symptoms, seek medical help immediately and talk to 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 pancreatitis (inflammation of the pancreas). Pancreatitis can be a serious and potentially life-threatening disease. Stop using liraglutide and contact your doctor immediately if you notice any of the following serious side effects:

Severe and persistent stomach pain (abdominal pain) that may radiate to the back, as well as nausea and vomiting, as it could be a sign of pancreatitis.

Other side effects

Very common: may affect more than 1 in 10 people

Nausea (feeling sick). This side effect usually goes away with time.
Diarrhea. This side effect usually goes away with time.

Common

Vomiting.

When starting treatment with liraglutide, in some cases, you may experience loss of fluids/dehydration. For example, if you have vomiting, nausea, and diarrhea. It is important to avoid dehydration by drinking plenty of fluids.

Headache
Indigestion
Stomach inflammation (gastritis). The symptoms include stomach pain, nausea, and vomiting.
Gastroesophageal reflux disease (GERD). The symptoms include heartburn.
Bloated stomach (abdomen) or abdominal pain
Abdominal discomfort
Constipation
Gas (flatulence)
Decreased appetite
Bronchitis
Common cold
Dizziness
Fast heartbeat
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 itching (pruritus) and hives (urticaria)
Dehydration, sometimes with decreased kidney function
Malaise (not feeling well)
Gallstones
Inflamed gallbladder
Change in taste
Delayed gastric emptying.

Frequency not known: cannot be estimated from the available data

Lumps under the skin may occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is not known).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Liraglutida Zentiva

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 of the pen and on the carton after “EXP”. The expiry date is the last day of the month stated.

Before first use:

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

When you start using the pen:

You can store the pen for a month if you keep it below 30 °C or in a refrigerator (2 °C to 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 you notice that 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. Container Contents and Additional Information

Composition of Liraglutida 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. Additionally, hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Appearance and Container Contents of the Product

Liraglutida Zentiva is supplied as a clear and colorless or almost colorless injectable solution in a pre-filled pen. Each pen contains 3 ml of solution, which can deliver 30 doses of 0.6 mg, 15 doses of 1.2 mg, or 10 doses of 1.8 mg.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 3000

Malta

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

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

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area 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 šķidrums injekcijām pildspalvveida pilnšļirce

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

Portugal: Liraglutido Zentiva

Date of the last revision 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 LIRAGLUTIDA 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. It is recommended to use disposable BD Ultra-FineTM or NovoFine® needles with this device.

Preparing the Pen Check the name and color of the labelon your pen to ensure it contains liraglutide. Using the wrong medicine could cause serious harm. Remove the cap from the pen.
Remove the paper flag from a new disposable needle. Screw the needle straight and firmly onto the pen.
Remove the outer cap of the needle and set it aside for later use.
Remove the inner cap of the needle and discard it.
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 put the inner cap back on the needle. You could stick yourself with the needle.
Maintenance of Your Pen Do not attempt to repair the pen or disassemble it. Keep the pen away from dust, dirt, and all types of liquids. Clean the pen with a damp cloth and a mild detergent. Do not attempt to wash, submerge, 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 other people, especially children. Change the injection site each day to reduce the risk of developing lumps under the skin.
Checking the Flow with Each New Pen 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.
Hold the pen with the needle pointing upwards. Gently tap the cartridge with your finger several times. This will concentrate any air bubbles in the top of the cartridge.
Hold the needle pointing upwards and press the injection button until the indicator points to 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 of liraglutide 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 that the pen is defective, and you should use a new one.
If you have dropped the pen onto a hard surface or suspect that it is not working correctly, always put a new disposable needle on and check the flow before using it.
Selecting the Dose Always check that the indicator points to 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, to change it, simply turn the dose selector backwards or forwards until the indicator points to the correct dose. Be careful not to press the injection button while turning the dose selector backwards, as liraglutide may be released. If the dose selector stops before the indicator points to the required dose, this means that there is not enough liraglutide left for a full dose. In this case, you can: *Divide your dose into two injections:* Turn the dose selector in any direction until the indicator points to 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 divide 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 divide your 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 points to 0.6 mg, prepare a new pen and inject the full dose with it.
Do not attempt to select doses other than 0.6 mg, 1.2 mg, or 1.8 mg. The numbers on the window 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 select your dose. Do not use the cartridge scale to measure the amount of liraglutide to be injected, as it is not accurate enough.
Injecting the Dose Insert the needle under the skin using the injection technique recommended by your doctor or nurse.Then follow these instructions: Press the injection button until the indicator points to 0 mg. Be careful not to touch the window with your other fingers or press the dose selector from the side while injecting, as this may block the injection. Keep the injection button pressed and keep the needle under the skin for at least 6 seconds. This ensures that the full dose is administered.
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.
Insert the needle tip into the outer cap of the needle without touching the needle or the outer cap of the needle.
When the needle is protected, carefully press the outer cap of the needle down to the bottom. Then unscrew the needle. Carefully dispose of the needle and replace the pen cap. When the pen is empty, carefully dispose of it without any needle attached. Please dispose of the pen and needle according to local regulations.
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. Healthcare providers must be careful when handling used needles to avoid accidental needlestick injuries and infections.