Package leaflet: Information for the user

Polidia, 6 mg/ml, solution for injection in a pre-filled pen
Liraglutide
Please read all of this leaflet carefully before 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Polidia is and what it is used for
What you need to know before using Polidia
How to use Polidia
Possible side effects
How to store Polidia
Contents of the pack and other information

1. What Polidia is and what it is used for

What Polidia is
Polidia is a weight-reducing medicine containing the active substance liraglutide. This substance mimics a naturally occurring hormone, glucagon-like peptide-1 (GLP-1), which is released from the intestines after a meal. Polidia works by acting on receptors in the brain that regulate appetite, promoting a feeling of fullness and reducing hunger. This may help reduce food intake and lead to weight loss.

What Polidia is used for
Polidia is a weight-loss aid used in combination with diet and physical exercise in adults aged 18 years and older who:

Have a BMI of 30 kg/m² or higher (obesity), or
Have a BMI between 27 kg/m² and less than 30 kg/m² (overweight) and have weight-related conditions (such as diabetes, high blood pressure, abnormal blood lipid levels, or sleep-disordered breathing known as "obstructive sleep apnoea"). Body Mass Index (BMI) is a measure of body weight relative to height.

Treatment with Polidia should only be continued if at least a 5% reduction in initial body weight has been achieved after 12 weeks of treatment at a dose of 3.0 mg daily (see section 3). To continue treatment, consult your doctor.

Polidia may be used as an adjunct to a healthy diet and increased physical activity for weight management in adolescents aged 12 years and older who have:

Obesity (diagnosed by a doctor)
Body weight above 60 kg.

Treatment with Polidia may be continued only if at least a 4% reduction in Body Mass Index (BMI) has been achieved after 12 weeks of treatment at a dose of 3.0 mg daily or at the maximum tolerated dose (see section 3). To continue treatment, consult your doctor.

Polidia is indicated as an adjunct to a healthy diet and increased physical activity for weight management in children aged 6 to <12 years who have:

Obesity (diagnosed by a doctor)
Body weight ≥45 kg.

Diet and exercise
Your doctor will initiate a dietary and physical exercise programme. You should follow these recommendations during treatment with Polidia.

2. Important information before using Polidia

When not to use Polidia

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

Warnings and precautions
Before starting treatment with Polidia, discuss this with your doctor, pharmacist, or
nurse.
Use of Polidia in patients with severe heart failure is not recommended.
Experience with use in patients aged 75 years and older is limited; therefore, use of this medicine is not recommended in patients aged 75 years and above.
Limited data are available on the use of this medicine in patients with renal impairment.
Patients with impaired kidney function or those on dialysis should consult their doctor.
Limited data are available on the use of Polidia in patients with hepatic impairment. Patients with impaired liver function should consult their doctor.
Use of Polidia is not recommended in patients with severe stomach or intestinal disorders causing delayed gastric emptying (so-called gastroparesis) or inflammatory bowel disease.
If the patient is to undergo surgery under anaesthesia (general anaesthesia), they should inform the doctor that they are taking Polidia.
Patients with diabetes
Patients with diabetes should not use Polidia as a substitute for insulin.
Pancreatitis
If the patient has or has had a disease of the pancreas, they should consult their doctor.
Gallbladder inflammation and gallstones
During significant weight loss, patients are at increased risk of developing gallstones and consequently gallbladder inflammation. Treatment with Polidia should be stopped and medical advice sought immediately if sudden severe pain occurs in the upper abdomen, usually more intense on the right side under the ribs. The pain may radiate to the back or right shoulder. See section 4.
Thyroid disease
In case of thyroid disease, including nodules and goitre, consult your doctor.
Heart rate
If palpitations (awareness of heartbeat) or a sensation of increased heart rate at rest occur during treatment with Polidia, consult your doctor.
Fluid loss and dehydration
After starting treatment with Polidia, loss of body fluids or dehydration may occur. This may be caused by nausea, vomiting, and diarrhoea. It is important to drink plenty of fluids to avoid dehydration. If you have any questions or doubts, consult your doctor, pharmacist, or nurse. See section 4.
Children
The safety and efficacy of Polidia in children under 6 years of age have not been studied.
Polidia with other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
In particular, inform your doctor, pharmacist, or nurse if:

the patient is taking antidiabetic sulfonylurea derivatives (such as glimepiride or glyburide) or insulin – there is a possibility of low blood sugar (hypoglycaemia) when Polidia is used together with these antidiabetic medicines. To prevent low blood sugar, the doctor may adjust the dose of the antidiabetic medicine. See section 4 – symptoms indicating low blood sugar. If insulin dose adjustment is needed, the doctor may recommend more frequent blood sugar monitoring.
the patient is taking warfarin or other oral anticoagulant medicines that reduce blood clotting. More frequent blood clotting tests may be required.

Pregnancy and breastfeeding
Do not use Polidia if the patient is pregnant, suspects she may be pregnant, or is planning to have a child. There are no data on the effects of liraglutide on the health of the unborn child.
Do not breastfeed while taking Polidia. There is no information available on whether liraglutide passes into human milk.
Driving and operating machinery
Liraglutide is unlikely to affect the ability to drive or operate machinery.
However, dizziness may occur in some patients taking Polidia, mainly during the first 3 months of treatment (see "Possible side effects"). If dizziness occurs, exercise particular caution when driving or operating machinery. For further information, consult your doctor.
Important information about certain ingredients of Polidia
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is considered "sodium-free".

3. How to use Polidia

This medicine should always be used exactly as your doctor has told you. If you are unsure, you should
contact your doctor, pharmacist, or nurse.
Your doctor will start with introducing a diet and exercise programme. You must follow these
recommendations during treatment with Polidia.
How much medicine should be injected
Adults
Treatment starts with a low dose, which should be gradually increased over the first
five weeks of treatment.

The initial dose of Polidia is 0.6 mg once daily for at least one week.
The dose should then be gradually increased by 0.6 mg, as directed by your doctor, usually once a week, until the recommended dose of 3.0 mg once daily is reached.

Your doctor will advise you on the amount of Polidia to take in the following weeks of treatment.
The usual dosing schedule is shown in the table below.
Injected dose
Week
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
After reaching the recommended dose of 3.0 mg in week 5, this dose should be maintained for the duration of treatment. Do not increase the dose further.
Your doctor will regularly assess your treatment results.
Children and adolescents (aged 6 to 18 years)
For children and adolescents aged 6 to 18 years, a similar dose-escalation schedule as for adults should be used (see table above under Adults). The dose should be gradually increased until a dose of 3.0 mg (maintenance dose) is reached or until the maximum dose tolerated by the patient is achieved. Daily doses higher than 3.0 mg are not recommended.
How and when to use Polidia

Before using the injection device for the first time, your doctor or nurse will show you how to use it.
Polidia can be taken at any time of day, with or without food or drink.
You should take this medicine at approximately the same time each day – you may choose the most convenient time for yourself.

Injection site
Polidia should be injected under the skin (subcutaneous injection).

The best places for injection are the front of the waist (abdomen), the front of the thigh, or the upper arm.
You should change the injection site each day to reduce the risk of developing lumps.
Do not inject the medicine into a vein or into a muscle. Detailed instructions are provided on the reverse of this leaflet.

Patients with diabetes
If you have diabetes, you should inform your doctor. To prevent low blood sugar levels, your doctor may adjust the dose of your anti-diabetic medicines.

Polidia must not be mixed with other injectable medicines (e.g. insulin).
This medicine should not be used in combination with other medicines that are GLP-1 receptor agonists (such as exenatide or lixisenatide).

Use of a higher than recommended dose of Polidia
If you use more than the recommended dose of Polidia, contact your doctor immediately or go to hospital. Take the medicine pack with you.
You may require treatment. The following symptoms may occur:

nausea,
vomiting,
low blood sugar (hypoglycaemia). Symptoms indicating low blood sugar – see the section on side effects under "Common".

Missed dose of Polidia

If less than 12 hours have passed since the scheduled time for taking the dose, take the medicine as soon as possible.
However, if more than 12 hours have passed since the time you should have taken the medicine, skip the missed dose and take the next dose the following day as usual.
Do not take a double dose or increase the dose the next day to make up for a missed dose.

Stopping treatment with Polidia
Do not stop using this medicine without consulting your doctor.
If you have any further questions about the use of this medicine, contact your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Severe allergic reactions (anaphylaxis) have been reported rarely in patients treated with Polidia.
If symptoms such as difficulty breathing, throat and facial swelling, or rapid heartbeat occur,
seek immediate medical attention.
Inflammation of the pancreas (pancreatitis) has been reported not uncommonly in patients treated
with Polidia. Pancreatitis may be severe and potentially life-threatening.
This medicine should be discontinued and immediate medical advice sought if any of the following
serious adverse reactions occur:

severe and persistent abdominal pain (in the stomach area) which may radiate to the back, along with nausea and vomiting, as these may be symptoms of pancreatitis.

Other adverse reactions
Very common: may affect more than 1 in 10 patients:

nausea, vomiting, diarrhoea, constipation, headache – these symptoms usually resolve after a few days or weeks.

Common: may affect up to 1 in 10 patients:

gastrointestinal disorders such as indigestion (dyspepsia), inflammation of the stomach lining, stomach discomfort, upper abdominal pain, heartburn, bloating, gas, belching, and dry mouth;
feeling of weakness or fatigue;
taste disturbances;
dizziness;
difficulty falling asleep (insomnia). These symptoms usually occur during the first 3 months of treatment;
gallstones;
rash;
injection site reactions (such as bruising, pain, irritation, itching, and rash);
low blood sugar (hypoglycaemia). Symptoms of low blood sugar may appear suddenly and include cold sweats, cold pale skin, headache, palpitations, nausea, intense hunger, blurred vision, drowsiness, weakness, nervousness, anxiety, confusion, difficulty concentrating, and tremor. Your doctor will provide information on how to manage symptoms caused by low blood sugar and what to do if such symptoms occur;
increased activity of pancreatic enzymes such as lipase and amylase.

Uncommon: may affect up to 1 in 100 patients:

fluid loss (dehydration); these symptoms are more likely at the beginning of treatment and may result from vomiting, nausea, and diarrhoea;
delayed gastric emptying;
inflammation of the gallbladder;
allergic reactions, including skin rash;
general malaise;
rapid heartbeat.

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

kidney dysfunction;
acute kidney failure; symptoms may include reduced urine volume, metallic taste in the mouth, and easy bruising.

Frequency not known: frequency cannot be estimated from available data:

intestinal obstruction. Severe constipation with additional symptoms such as abdominal pain, bloating, vomiting, etc.
subcutaneous nodules may be caused by accumulation of a protein called amyloid (cutaneous amyloidosis; frequency not established).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Polidia

Keep the medicine out of the sight and reach of children.
Do not use Polidia after the expiry date stated on the injector label and cardboard box after "EXP". The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Before first use:
Store in a refrigerator (2°C - 8°C). Do not freeze.
After first use of the injector:
The injector may be stored for up to 1 month at temperatures below 30°C or in the refrigerator (2°C - 8°C). Do not freeze.
When the injector is not in use, it should be kept closed with its cap to protect it from light.
Do not use Polidia if the solution is not clear and colourless.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Polidia contains

The active substance is liraglutide. 1 ml of injection solution contains 6 mg of liraglutide. One pre-filled automatic injector contains 18 mg of liraglutide.
Other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid concentrated and sodium hydroxide (for pH adjustment), water for injections.

What Polidia looks like and contents of the pack
Polidia is supplied as a clear, colourless solution for injection in a pre-filled injector. Each injector contains 3 ml of solution and allows administration of 30 doses of 0.6 mg, 15 doses of 1.2 mg, 10 doses of 1.8 mg, 7 doses of 2.4 mg and 6 doses of 3.0 mg.
Polidia is available in packs containing 1, 3, 5 or 10 injectors, in a cardboard box.
Not all pack sizes may be marketed.
The pack does not contain needles.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
{logo of the marketing authorisation holder}

Manufacturer/Importer
betapharm Arzneimittel GmbH
Kobelweg 95, 86156 Augsburg, Germany
Rual Laboratories SRL
313, Splaiul Unirii, Building H, 1 floor, sector 3,
Bucuresti, 030138, Romania
DR. REDDY’S LABORATORIES ROMÂNIA S.R.L.
Str. Daniel Danielopolu, nr. 30-32, Spațiul
2, Etaj 5, Sectorul 1, Bucureşti, cod poștal 014134, Romania
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic: Sudaclin
Poland: Polidia
Slovakia: Sudaclin 6 mg/ml mg/ml injekčný roztok naplnený v injekčnom pere
Sweden: Polidia

Instructions for the use of Polidia, 6 mg/ml, solution for injection in a pre-filled pen Before using the Polidia pen, please read carefully the information contained in the following instructions. Do not use the pen without prior training from a doctor or nurse. Start by checking that the pen contains Polidia, 6 mg/ml, then review the illustrations below to become familiar with the individual parts of the pen and the needle. Blind or visually impaired individuals who are unable to read the dose counter on the pen should not use the pen without assistance. Please seek help from a person with good vision who has been trained in the use of the Polidia pen. The pen allows dose setting. It contains 18 mg of liraglutide and enables administration of doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg. The pen is intended to be used with single-use needles up to 8 mm in length and 32 G in thickness. Needles are not included in the packaging. Important information Please read this information carefully, as it is essential for the safe use of the pen.
Polidia pen and needle (example)
1. Preparing the pen with a new needle Check the name and color of the label on the pen to ensure it contains Polidia. This is particularly important when using multiple injectable medications. Using the wrong medication may pose a health risk. Remove the pen cap.
Check whether the solution in the pen is clear and colourless. Look through the viewing window of the pen. If the solution is cloudy, do not use the pen.
Take a new needle and peel off the paper tab.
Ensure the needle is correctly attached. Place the needle directly onto the pen. Screw it on until it is securely fastened.
The needle is protected by two caps. Both caps must be removed. If the patient does not remove both caps, the solution will not be injected. Remove the outer needle cap and keep it for later. It will be needed after injection for safe needle removal from the pen.
Remove the inner needle cap and dispose of it. Attempting to reattach it may result in accidental needlestick injury. A drop of solution may appear at the needle tip. This is normal, but during the first use of the pen, the flow of solution should be checked. Do not attach a new needle to the pen until ready to inject. Always use a new needle for each injection. This helps prevent needle blockage, contamination, infection, and inaccurate dosing.
Never use a bent or damaged needle.
2. Checking solution flow before using each new pen If the pen is already in use, proceed to point 3 “Setting the dose”. Flow check is required only before the first injection with each new pen. Turn the dose selector knob to the flow check position symbol ( ), just below the 0 position. Ensure the flow check symbol is aligned with the dose indicator.
Hold the pen with the needle pointing upwards. Press and hold the injection button until the dose counter returns to 0. The 0 mark must align with the dose indicator. A drop of liraglutide solution should appear at the needle tip. A small drop may remain at the tip, but it will not be injected. If no drop appears, repeat step 2 “Checking solution flow before using each new pen” up to 6 times. If no drop appears after 6 attempts, replace the needle and repeat step 2 again. If still no drop appears, discard the pen and use a new one. Before first use of a new pen, always ensure a drop of solution appears at the needle tip. This confirms that the solution flow is not blocked. If no drop appears, the medication will not be injected even though the dose counter may move. This may indicate a blocked or damaged needle. Using a new pen without checking flow before the first injection may result in failure to receive the prescribed dose and lack of intended therapeutic effect of Polidia.
When the injection button is held, if the dose counter does not return to 0, the needle may be blocked or damaged. This means the medication has not been administered, even if the dose counter has moved and shows a different dose than initially set.
3. Setting the dose Turn the dose selector knob until the dose counter displays the required dose (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg). If an incorrect dose is selected, the knob can be turned forward or backward to correct it. The pen allows setting doses up to 3.0 mg. The dose selector knob allows dose adjustment. Only the dose counter and dose indicator show the number of mg selected. Doses up to 3.0 mg can be set. If the pen contains less than 3.0 mg of medication, the dose counter will stop before reaching 3.0. The clicking sound of the dose selector knob differs when turning forward or backward and when exceeding the remaining mg of medication. Do not count clicks. Always verify the selected mg dose using the dose counter and dose indicator before injection. Do not count clicks. Do not use the pen scale. The scale only shows an approximate amount of solution remaining in the pen. Use the dose selector knob to select only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg. The selected dose must be exactly aligned with the dose indicator to ensure correct dosing.
How much solution remains? The pen scale shows an approximate amount of solution remaining in the pen.
To accurately check how much solution remains, use the dose counter: turn the dose selector knob until the dose counter stops. If 3.0 is visible, at least 3.0 mg of medication remains in the pen. If the dose counter stops before 3.0 mg, the pen does not contain enough solution to deliver a full 3.0 mg dose. If more medication is needed than remains in the pen, the dose may be split between the current and a new pen only if trained by a doctor or nurse or given specific instructions. Use a calculator to determine doses according to instructions provided by the doctor or nurse. Perform calculations very carefully. If in doubt about 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 under the skin as instructed by your doctor or nurse. Ensure the dose counter is visible. Do not cover it with fingers, as this may interrupt the injection.
Press and hold the injection button. Observe the dose counter returning to 0. The 0 mark must align with the dose indicator. You may hear or feel a click.
Keep holding the injection button pressed while the needle is in the skin. While keeping the injection button pressed, slowly count to 6. If the needle is removed earlier, solution may leak from the needle tip, indicating that the full dose was not delivered.
Remove the needle from the skin. Then release the injection button. If bleeding occurs at the injection site, press gently. After injection, a drop of solution may appear at the needle tip. This is normal and does not affect the administered dose. Always observe the dose counter to monitor the number of mg injected. Keep the injection button pressed until the dose counter shows 0.
How to check if the needle is blocked or damaged? If, after holding the injection button, the dose counter does not return to 0, the needle may be blocked or damaged. This means the medication was not administered at all, even if the dose counter moved and shows a different dose than initially set.
What to do if the needle is blocked? Replace the needle as described in point 5 “After injection” and repeat all steps starting from point 1 “Preparing the pen with a new needle”. Ensure the full required dose is selected. Never touch the dose counter during injection. This may interrupt the injection process.
5. After injection Always remove the needle after each injection to ensure comfortable future injections and prevent needle blockage. If the needle is blocked, the medication will not be injected. Place the needle tip into the outer needle cap on a flat surface, without touching the needle or the outer cap.
After inserting, carefully push the outer needle cap fully onto the needle. Unscrew the needle and dispose of it properly according to instructions from your doctor, nurse, pharmacist, or local authorities.
After each use, replace the cap on the pen to protect the solution from light. When the pen is empty, dispose of it without the needle attached, according to instructions from your doctor, nurse, pharmacist, or local authorities. Never attempt to reattach the inner cap to the needle. This may result in accidental needlestick injury. Always remove the needle from the pen after each injection. This helps prevent needle blockage, contamination, infection, leakage of solution, and inaccurate dosing.
Other important information Always store the pen and needles out of sight and reach of others, especially children. Never share your pen or needles with other people. Caregivers must exercise particular caution when removing and disposing of used needles to eliminate the risk of needlestick injury and cross-infection. Change the injection site daily to reduce the risk of developing lumps.
Caring for the pen Do not leave the pen in a car or any place where it may be exposed to excessively high or low temperatures. Do not inject Polidia if it has been frozen. In such cases, the intended therapeutic effect may not be achieved. Do not expose the pen to dust, dirt, or liquids. Do not wash, soak, or lubricate the pen. The pen may be cleaned with a cloth dampened with mild detergent.
Clean the pen with a cloth dampened with mild detergent. Do not drop the pen or strike it against hard surfaces. If the pen is dropped or suspected of malfunctioning, always attach a new needle and check solution flow before injection. Do not refill the pen. After emptying, dispose of it properly. Do not attempt to repair or disassemble the pen.