Plyzari 6 mg/ml solution for injection in pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Plyzari 6 mg/ml solution for injection in pre-filled pen
liraglutide
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 adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Plyzari is and what it is used for
- What you need to know before using Plyzari
- How to use Plyzari
- Possible side effects
- How to store Plyzari
- Contents of the pack and other information
1. What Plyzari is and what it is used for
What Plyzari is
Plyzari is a weight-loss medicine that contains the active substance liraglutide. It is similar to a naturally occurring hormone called glucagon-like peptide-1 (GLP-1), which is released in the intestine after eating. Liraglutide acts on receptors in the brain that regulate appetite, making you feel fuller and less hungry. This can help you eat less and reduce your body weight.
What Plyzari is used for
Liraglutide is used for weight loss in combination with a proper diet and increased physical activity in adults over 18 years of age with:
- a body mass index (BMI) of 30 kg/m² or higher (obesity), or
- a BMI of 27 kg/m² up to less than 30 kg/m² (overweight) and weight-related health problems (such as diabetes, high blood pressure, abnormal blood lipid levels, or sleep-related breathing disorders known as “obstructive sleep apnea”).
BMI (body mass index) is a measure of weight in relation to height.
You should only continue using this medicine if you have lost at least 5% of your initial body weight after 12 weeks of treatment at a daily dose of 3.0 mg (see section 3). Consult your doctor before continuing.
Liraglutide can be used in combination with healthy nutrition and increased physical activity for weight management in adolescents aged 12 years and older who have:
- obesity (diagnosed by your doctor)
- body weight above 60 kg
You should only continue using this medicine if you have lost at least 4% of your BMI after 12 weeks of treatment with a dose of 3.0 mg/day or the maximum tolerated dose (see section 3). Consult your doctor before continuing.
This medicine is indicated in combination with healthy nutrition and increased physical activity for weight management in patients aged 6 to less than 12 years with:
- obesity (diagnosed by your doctor)
- body weight ≥45 kg
You should only continue using this medicine if you have lost at least 4% of your BMI after 12 weeks of treatment with a dose of 3.0 mg/day or the maximum tolerated dose (see section 3). Consult your doctor before continuing.
Diet and exercise
Your doctor will prescribe a diet and recommend an exercise program, which you must follow while being treated with liraglutide.
2. What you need to know before using Plyzari
Do not use Plyzari
- 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.
The use of this medicine is not recommended if you have severe heart failure.
There is limited experience with this medicine in patients aged 75 years and older. It is not recommended if you are 75 years of age or older.
There is limited experience with this medicine in patients with kidney problems. If you have kidney disease or are on dialysis, consult your doctor.
There is limited experience with this medicine in patients with liver problems. If you have liver disease, consult your doctor.
This medicine is not recommended if you have a serious stomach or intestinal condition causing delayed stomach emptying (called gastroparesis), or if you have inflammatory bowel disease.
If you know you are going to undergo surgery under anesthesia (a state of sleep), inform your doctor that you are taking this medicine.
People with diabetes
If you have diabetes, do not use this medicine as a substitute for insulin.
Pancreatitis
Consult your doctor if you have or have had a pancreatic disease.
Gallbladder inflammation and gallstones
If you lose weight rapidly, you may be at risk of developing gallstones and, as a result, gallbladder inflammation. Stop using this medicine and contact your doctor immediately if you experience severe pain in the upper abdomen, usually worse on the right side, under the ribs. The pain may radiate to your back or right shoulder. See section 4.
Thyroid disease
Consult your doctor if you have thyroid disease, including thyroid nodules and enlargement of the thyroid gland.
Heart rate
Consult your doctor if you experience palpitations (awareness of your heartbeat) or a sensation of increased pulse rate at rest during treatment with this medicine.
Fluid loss and dehydration
When starting treatment with this medicine, you may lose fluids or become dehydrated. This may be due to nausea, vomiting, or diarrhea. It is important to prevent dehydration by drinking plenty of fluids. If you have any questions or concerns, consult your doctor, pharmacist, or nurse. See section 4.
Children and adolescents
The safety and efficacy of liraglutide have not been studied in children under 12 years of age.
Other medicines and Plyzari
Inform 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 diabetes medications called “sulfonylureas” (such as glimepiride or glyburide) or if you are receiving insulin. Your blood sugar level may drop (hypoglycemia) if you use these medicines with liraglutide. Your doctor may adjust the dose of your diabetes medication to prevent episodes of hypoglycemia. See section 4 for symptoms indicating low blood sugar. If you adjust your insulin dose, your doctor may recommend more frequent monitoring of your blood sugar levels.
- you are taking warfarin or other oral medicines that reduce blood clotting (anticoagulants). More frequent blood tests may be needed to monitor your blood’s clotting ability.
Pregnancy and breastfeeding
Do not use this medicine if you are pregnant, think you might be pregnant, or are planning to become pregnant, because it is unknown whether liraglutide may affect the fetus.
If you are using this medicine, you should avoid breastfeeding, as it is unknown whether liraglutide is excreted in breast milk.
Driving and using machines
It is unlikely that liraglutide will affect your ability to drive or operate machinery.
Some patients may experience dizziness when taking this medicine, mainly during the first 3 months of treatment (see section “Possible side effects”). If you feel dizzy, take extra care when driving or operating machinery. If you need further information, consult your doctor.
Plyzari contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free”.
3. How to use Plyzari
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.
Your doctor will place you on a diet and will advise an exercise program, which you should follow while on treatment with this medicine.
Dose to be injected
Adults
Treatment will start with a low dose, which will gradually increase over the first five weeks of treatment.
- When you start using this medicine, the initial dose is 0.6 mg once daily for at least one week.
- Your doctor will instruct you to gradually increase the dose, usually by 0.6 mg each week, until reaching the recommended dose of 3.0 mg once daily.
Your doctor will tell you how much of this medicine you should use each week. Normally, you will be instructed 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 |
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 until the end of the treatment period. Do not increase the dose further.
Your doctor will periodically evaluate your treatment.
Children and adolescents (6 to 18 years of age)
For children and adolescents from 6 years up to but less than 18 years of age, a gradual dose increase should be followed as in adults (see the dose escalation table for adults above). The dose should be increased up to 3.0 mg (maintenance dose) or until the maximum tolerated dose is reached. Daily doses higher than 3.0 mg are not recommended.
How and when to use Plyzari
- Before using the pen for the first time, your doctor or nurse will show you how to use it.
- You may take this medicine at any time of day, with or without food and drink.
- Use this medicine at approximately the same time each day: choose the time that best suits you.
Where to inject
Liraglutide is administered as an injection under the skin (subcutaneous injection).
- The best injection sites are the abdominal area, the front of the thigh, or the upper arm.
- Change the injection site each day to reduce the risk of developing lumps under the skin.
- Do not inject into a vein or into muscle.
Injection needles are not included with the pen. For example, disposable BD Ultra-Fine™ or NovoFine® needles as fine as up to 32 G gauge and up to 8 mm in length may be used.
Detailed instructions for use are provided on the reverse side of this leaflet.
People with diabetes
Inform your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medication to prevent episodes of hypoglycemia.
- Do not mix liraglutide with other injectable medications (e.g., insulins).
- Do not use liraglutide in combination with other medications containing GLP-1 receptor agonists (such as exenatide or lixisenatide).
If you use more Plyzari than you should
If you use more liraglutide than you should, speak to a doctor or go immediately to a hospital. Take the medicine package with you. You may require medical treatment. The following effects may occur:
- nausea
- vomiting
- low blood sugar (hypoglycemia). See the warning signs of low blood sugar under “Frequent adverse effects”.
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 Plyzari
- If you miss a dose and remember within 12 hours of your usual injection time, inject the missed dose as soon as you remember.
- However, if more than 12 hours have passed since you should have taken this medicine, skip the missed dose and inject the next dose the following day at your usual time.
- Do not use a double dose or increase the next day’s dose to make up for missed doses.
If you stop treatment with Plyzari
Do not stop treatment with liraglutide without consulting your doctor.
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 experiences them.
Serious adverse effects
Severe allergic reactions (anaphylaxis) have rarely been reported in patients using liraglutide. Seek immediate medical attention if you experience symptoms such as breathing difficulties, swelling of the face and throat, or palpitations.
Very rare cases of inflammation of the pancreas (pancreatitis) have been reported in patients using liraglutide. Pancreatitis is a serious and potentially life-threatening condition.
Stop using this medicine and contact your doctor immediately if you experience any of the following serious adverse effects:
- Severe, persistent abdominal (stomach area) pain that may extend to the back, along with nausea and vomiting, as this could be a sign of inflammation of the pancreas (pancreatitis).
Other adverse effects
Very common: may affect more than 1 in 10 people
- Nausea, vomiting, diarrhoea, constipation, headache; these usually resolve after a few days or weeks.
Common: may affect 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, bloating, gas (flatulence), burping, and dry mouth
- Feeling weak or tired
- Changes in taste sensation
- Dizziness
- Difficulty sleeping (insomnia). This usually occurs during the first 3 months of treatment
- Gallstones
- Rash
- Injection site reactions (such as bruising, pain, irritation, itching, and rash)
- Low blood sugar (hypoglycaemia). Warning signs of low blood sugar may appear suddenly and include: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, visual disturbances, drowsiness, feeling weak, nervousness, anxiety, confusion, difficulty concentrating, and tremors. Your doctor will advise you on how to treat low blood sugar and what to do if you experience these warning symptoms
- Increased levels of pancreatic enzymes such as lipase and amylase.
Uncommon: may affect up to 1 in 100 people
- Fluid loss (dehydration). This is more likely at the beginning of treatment and may be due to vomiting, nausea, and diarrhoea
- Delayed gastric emptying
- Inflamed gallbladder
- Allergic reactions including skin rashes
- General feeling of being unwell
- Faster heartbeat.
Rare: may affect up to 1 in 1,000 people
- Reduced kidney function
- Acute kidney failure. Symptoms may include reduced urine volume, metallic taste in the mouth, and increased tendency to bruise easily.
Frequency not known: cannot be estimated from available data
- Intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.
- 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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Plyzari
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 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 up to 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 must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Plyzari
- 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 sodium citrate dihydrate, propylene glycol, phenol, and water for injections. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH.
Appearance of the product and contents of the pack
Plyzari is supplied as a clear, colourless or almost colourless injectable solution in a pre-filled pen. Each pen contains 3 ml of solution and can deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg.
Plyzari is available in packs of 1, 3, or 5 pens. Only certain pack sizes may be marketed.
Needles are not included.
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 Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000
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 Member States of the European Economic Area under the following names:
Austria: Luntin 6 mg/ml Injektionslösung in einem Fertigpen
Sweden, Norway, Germany: Nevolat
Netherlands: Nevolat 6 mg/ml oplossing voor injectie in een voorgevulde pen
Hungary: Nevolat 6 mg/ml oldatos injekció előretöltött injekciós tollban
Spain: Plyzari 6 mg/ml solución inyectable en pluma precargada
Poland, Czech Republic, Italy, Portugal: Plyzari
France: LIENDAX 6 mg/mL, solution injectable en stylo prérempli
Date of the most recent revision of this leaflet: February 2026
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 PLYZARI 6 MG/ML INJECTABLE SOLUTION IN A PRE-FILLED PEN
Instructions for using Plyzari 6 mg/ml pre-filled pen injector solution Read these instructions carefully before using the Plyzari pre-filled pen. Do not use the pen without proper training from your doctor or nurse. Begin by checking the pen to ensure it contains Plyzari 6 mg/ml, then review the illustrations to become familiar with the different parts of the pen and the needle. If you are blind or have low vision and cannot read the dose counter on the pen, do not use this pen without assistance. Seek help from someone with good eyesight who has been trained in using the Plyzari pre-filled pen. Your pen is a pre-filled dosing pen. 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. It is recommended to use disposable BD Ultra fine™ or NovoFine® needles with this device. Needles are not included in the package. Important information Pay special attention to these notes, as they are important for the safe use of the pen. | Plyzari pre-filled pen and needle (example)
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1 Preparing the pen with a new needle
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A drop of solution may appear at the tip of the needle. This is normal, but even so, you should check the flow if 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 helps prevent needle blockage, contamination, infections, and inaccurate dosing.
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2 Checking the flow
Press and hold the dose button until the dose counter returns to 0. The 0 must align with the dose marker. A drop of solution should appear at the tip of the needle. A small drop may remain at the needle tip, but it will not be injected. If no drop appears, repeat step 2 “Checking the flow” up to 6 times. If still no drop appears, change the needle and repeat step 2 “Checking the flow” once more. If, despite this, no drop appears, discard the pen and use a new one. Always ensure a drop appears at the needle tip before using a new pen for the first time. This ensures the solution is flowing. If no drop appears, no medication will be injected, even if the dose counter moves. This may indicate that the needle is blocked or damaged. If you do not check the flow before the first injection with each new pen, the prescribed dose may not be administered, and the medicine may not have the intended effect. |
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3 Selecting the dose
If you select the wrong dose, you can turn the dose selector forward or backward to select the correct dose. The pen can select up to a maximum of 3.0 mg. The dose selector changes the dose. Only the dose counter and dose marker show how many mg have been selected for each administration. You can select up to 3.0 mg per dose. When the pen contains less than 3.0 mg, the dose counter will stop before reaching 3.0. The dose selector clicks differently when turned forward, backward, or past the remaining mg amount. Do not count the pen clicks. Always use the dose counter and dose marker to verify how many mg you have selected before injecting this medicine. Do not count the pen clicks. Do not use the pen scale, as it only shows the approximate amount of solution remaining 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 exactly with the dose marker to ensure the correct dose is injected. |
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How much solution remains?
Turn the dose selector until the dose counter stops. If it shows 3.0, this means there are at least 3.0 mg remaining in the pen. If the dose counter stops before 3.0 mg, this means there is not enough solution left for a full 3.0 mg dose. If you need more medication than remains in the pen If advised by your doctor or nurse and trained to do so, you may split the dose between the current pen and a new one. Use a calculator to plan the dose as instructed by your doctor or nurse. Be very careful to calculate correctly. If you are unsure how to split the dose using two pens, select and inject the required dose using a new pen. |
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4 Injecting the dose
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If bleeding occurs at the injection site, apply light pressure. Do not rub the area. A drop of solution may appear at the needle tip after injection. This is normal and does not affect the dose. Always observe the dose counter to confirm how many mg are injected. Press and hold the dose button until the dose counter reads 0. How to detect if the needle is blocked or damaged?
What to do if the needle is blocked? Change the needle as described in step 5 “After injection” and repeat all steps from step 1 “Preparing the pen with a new needle”. Be sure to select the full required dose. Never touch the dose counter during injection. This may interrupt the injection. |
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5 After injection
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Always discard the needle after each injection to ensure comfortable injections and prevent blocked needles. If the needle is blocked, no medication will be injected. When the pen is empty, dispose of it without the needle attached, following instructions from your doctor, nurse, pharmacist, or local authorities. Never attempt to reattach the inner needle cap. You could prick yourself. Always remove the needle from the pen after each injection. This helps prevent blocked needles, contamination, infections, solution leakage, and inaccurate dosing. |
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Additional important information
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Pen care
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