Zegluxen
Poland
Table of Contents
Package leaflet: Information for the user
ZEGLUXEN, 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 you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of the leaflet
- What ZEGLUXEN is and what it is used for
- What you need to know before using ZEGLUXEN
- How to use ZEGLUXEN
- Possible side effects
- How to store ZEGLUXEN
- Contents of the pack and other information
1. What ZEGLUXEN is and what it is used for
ZEGLUXEN contains the active substance liraglutide. It helps reduce blood glucose levels when they are too high. It also slows down the passage of food through the stomach.
ZEGLUXEN is used as a standalone antidiabetic medicine when diet and exercise alone are not sufficient to control blood glucose levels in patients who cannot take metformin (another antidiabetic medicine).
ZEGLUXEN is used in combination with other antidiabetic medicines when these medicines alone do not provide adequate control of blood glucose levels. These include:
- oral antidiabetic medicines (such as metformin, pioglitazone, sulfonylurea derivatives, sodium-glucose cotransporter 2 (SGLT2) inhibitors) and/or insulin.
2. Important information before using ZEGLUXEN
When not to use ZEGLUXEN
- if the patient is allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Please consult your doctor, pharmacist, or nurse:
- before starting treatment with ZEGLUXEN,
- if the patient has been diagnosed with or has a history of pancreatic disease.
If the patient is undergoing a surgical procedure requiring anesthesia (general anesthesia),
they should inform the doctor about taking this medicine.
This medicine must not be used in type 1 diabetes (i.e. when the body produces no insulin at all) or in diabetic ketoacidosis (a diabetes complication associated with high blood sugar levels and increased respiratory effort). This medicine is not insulin and therefore must not be used as a substitute for insulin.
Use of ZEGLUXEN is not recommended in patients undergoing dialysis.
Use of ZEGLUXEN is not recommended in patients with severe liver disease.
Use of ZEGLUXEN is not recommended in patients with severe heart failure.
This medicine is not recommended for patients with severe gastrointestinal motility disorders resulting in delayed gastric emptying (so-called gastroparesis) or inflammatory bowel disease.
If symptoms of acute pancreatitis occur, such as persistent severe abdominal pain, contact a doctor immediately (see section 4).
In case of thyroid disease, including thyroid nodules or goiter, consult a doctor.
During the initial period of treatment with ZEGLUXEN, fluid loss (dehydration) may occur in some cases, for example due to vomiting, nausea, or diarrhea. It is important to drink plenty of fluids to avoid dehydration. In case of any questions or doubts, consult a doctor.
Children and adolescents
ZEGLUXEN may be used in adolescents and children aged 10 years and older. There is insufficient data on the use of this medicine in children under 10 years of age.
ZEGLUXEN 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 medicines containing any of the following active substances:
- Sulfonylurea derivatives (such as glimepiride or glyburide) or insulin. Hypoglycemia (low blood sugar) may occur when ZEGLUXEN is used together with a sulfonylurea derivative or insulin, because sulfonylurea derivatives and insulin increase the risk of hypoglycemia. When starting treatment with these medicines together for the first time, the doctor may recommend reducing the dose of the sulfonylurea derivative or insulin. Symptoms indicating low blood sugar—see section 4. If the patient is also taking a sulfonylurea derivative (such as glimepiride or glyburide) or insulin, the doctor may recommend monitoring blood glucose levels. This will help the doctor decide whether the dose of the sulfonylurea derivative or insulin needs to be adjusted.
- If the patient is taking insulin, the treating doctor will advise how to reduce the insulin dose and recommend more frequent blood glucose monitoring to prevent hyperglycemia (high blood glucose) and diabetic ketoacidosis (a diabetes complication occurring when the body cannot break down glucose due to insufficient insulin).
- Warfarin or other oral anticoagulants—more frequent blood clotting tests may be required.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she might be pregnant, or is planning to become pregnant, she should inform her doctor. This medicine must not be used during pregnancy, as it is unknown whether it could harm the unborn child.
It is unknown whether liraglutide passes into human breast milk; therefore, this medicine should not be used during breastfeeding.
Driving and operating machinery
Low blood sugar (hypoglycemia) may impair concentration. Avoid driving and operating machinery when symptoms of hypoglycemia occur. See section 4—Symptoms indicating low blood sugar. For further information, consult your doctor.
ZEGLUXEN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free."
3. How to use ZEGLUXEN
This medicine should always be used exactly as your doctor has instructed. If you are unsure, please consult your doctor, pharmacist, or nurse.
- The starting dose is 0.6 mg once daily for at least one week.
- Your doctor will inform you when to increase the dose to 1.2 mg once daily.
- Your doctor may later recommend increasing the dose to 1.8 mg once daily if adequate blood sugar control has not been achieved with the 1.2 mg dose. Do not change the dose without your doctor's instruction.
ZEGLUXEN is administered by subcutaneous injection (under the skin). It must not be injected into a vein or into a muscle. The best sites for self-injection are the front of the thighs, the front of the waist (abdomen), or the upper arm. Change the injection site daily to reduce the risk of developing lumps.
You may administer the injection at any time of day, regardless of meals. Once you have chosen the most convenient time, it is recommended to inject ZEGLUXEN approximately at the same time each day.
Before first use of the injection pen, your doctor or nurse will show you how to use it.
Detailed instructions for use are provided on the reverse of this leaflet.
The injection pen does not include needles. It can be used with, for example, BD Ultra-Fine disposable needles or NovoFine disposable needles, 32 G in thickness and up to 8 mm in length.
Use of more than the recommended dose of ZEGLUXEN
If you use more than the recommended dose of ZEGLUXEN, contact your doctor immediately. You may require medical treatment. Possible symptoms include nausea, vomiting, diarrhoea, or low blood sugar (hypoglycaemia). Symptoms indicating low blood sugar – see section 4.
Missed dose of ZEGLUXEN
If you miss a dose, take ZEGLUXEN as soon as you remember.
However, if more than 12 hours have passed since the time you were supposed to take ZEGLUXEN, skip the missed dose. Take the next dose at the usual time the following day.
Do not take a double dose or increase the dose the next day to make up for a missed dose.
Stopping ZEGLUXEN treatment
Do not stop using ZEGLUXEN without consulting your doctor. If you stop treatment, your blood sugar levels may rise.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will get them.
Serious adverse effects
Common: may occur in fewer than 1 in 10 patients
- Hypoglycaemia (low blood sugar). Symptoms of low blood sugar may occur suddenly and may include: cold sweats, cold pale skin, headache, palpitations, nausea, intense hunger, vision disturbances, drowsiness, feeling of weakness, nervousness, restlessness, confusion, difficulty concentrating, trembling. Your doctor will advise you on how to treat symptoms caused by low blood sugar and what to do if you notice any such symptoms. The occurrence of these symptoms is more likely if a sulfonylurea derivative or insulin is used concomitantly. Your doctor may reduce the dose of these medicines before starting ZEGLUXEN.
Uncommon: may occur in fewer than 1 in 1,000 patients
- Severe allergic reaction (anaphylactic reaction), including additional symptoms such as difficulty breathing, swelling of the throat and face, rapid heartbeat, etc. If any of these symptoms occur, seek immediate medical help and contact your doctor without delay.
- Intestinal obstruction. Severe constipation accompanied by symptoms such as abdominal pain, bloating, vomiting, etc.
Rare: may occur in fewer than 1 in 10,000 patients
- Inflammation of the pancreas (pancreatitis). Pancreatitis may be severe and potentially life-threatening. You must stop taking ZEGLUXEN and contact your doctor immediately if any of the following serious adverse effects occur: severe and persistent abdominal pain (in the stomach area) radiating to the back, as well as nausea and vomiting, as these may be symptoms of pancreatitis.
Other adverse effects
Very common: may occur in more than 1 in 10 patients
- Nausea. Usually transient.
- Diarrhoea. Usually transient.
During the initial period of treatment with ZEGLUXEN, fluid loss (dehydration) may sometimes occur, for example due to vomiting, nausea and diarrhoea. You should drink plenty of fluids to avoid dehydration.
- Headache
- Indigestion
- Gastritis (inflammation of the stomach). Symptoms include: abdominal pain, nausea and vomiting.
- Gastro-oesophageal reflux. Symptoms include heartburn.
- Painful or bloated abdomen
- Feeling of discomfort in the abdominal cavity
- Constipation
- Bloating with flatulence
- Decreased appetite
- Bronchitis
- Common cold
- Dizziness
- Increased heart rate
- Fatigue
- Toothache
- Injection site reactions (such as bruising, pain, irritation, itching and rash)
- Increased activity of pancreatic enzymes (such as lipase and amylase).
Uncommon: may occur in fewer than 1 in 100 patients
- Allergic reactions such as itching and urticaria (a type of skin rash)
- Dehydration, sometimes with impaired kidney function
- Malaise
- Gallstones
- Cholecystitis (inflammation of the gallbladder)
- Taste disturbance
- Delayed gastric emptying.
Frequency not known: frequency cannot be estimated from the available data
- Subcutaneous nodules may be caused by accumulation of a protein called amyloid (cutaneous amyloidosis; frequency not known).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 effects can also be reported to the marketing authorisation holder. Reporting adverse effects helps to provide more information on the safety of this medicine.
5. How to store ZEGLUXEN
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the syringe label and
carton after "EXP". The expiry date refers to the last day of the specified month.
Before use:
Store in a refrigerator (2°C – 8°C). Do not freeze.
During use:
The syringe may be stored for up to one month at a temperature below 30°C or in a refrigerator
(2°C – 8°C). Do not freeze.
If the syringe is not in use, protect it from light by replacing the cap.
Do not use this medicine if the solution is not clear and colourless or almost colourless.
Medicines must not be disposed of via household waste or sewage systems. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect the environment.
6. Contents of the pack and other information
What ZEGLUXEN contains
- The active substance is liraglutide. 1 mL of injection solution contains 6 mg of liraglutide. One pre-filled semi-automatic injector contains 18 mg of liraglutide.
- Other ingredients are: disodium citrate dihydrate, propylene glycol, phenol, and water for injections. Additionally, hydrochloric acid and (or) sodium hydroxide may be added to adjust the pH.
What ZEGLUXEN looks like and contents of the pack
ZEGLUXEN is supplied as a clear, colourless or almost colourless solution for injection in a
pre-filled injector. Each injector contains 3 mL of solution, sufficient for 30 doses of 0.6 mg, 15
doses of 1.2 mg, or 10 doses of 1.8 mg.
ZEGLUXEN is available in packs containing 1, 2, 3, or 5 pre-filled semi-automatic injectors, or a
multipack containing 2 packs of 5 pre-filled semi-automatic injectors (10 pre-filled semi-automatic
injectors). Needles are not included in the pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
This medicinal product is authorised in the European Economic Area under the following
names:
Austria: Zegluxen 6 mg/ml Injektionslösung in einem Fertigpen
Bulgaria: ЗЕГЛУКСЕН
Croatia: Zegluxen 6 mg/ml otopina za injekciju u napunjenoj brizgalici
Poland, Czech Republic: ZEGLUXEN
Romania: ZEGLUXEN 6mg/ml solutie injectabila in stilou preumplut
For further information about this medicinal product, please contact the local representative of
the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00
INSTRUCTION FOR USE OF THE ZEGLUXEN INJECTOR
Before using the injector, please read carefully the
instructions below.
The injector contains 18 mg of liraglutide. Doses of
0.6 mg, 1.2 mg, and 1.8 mg can be selected.
The injector is intended for use with
disposable needles. Needles are not included in the pack.
It is recommended to use BD Ultra fine or NovoFine disposable
needles with this injector.
Preparing the injector
Check the name and the colour label on the injector
to make sure that the injector contains liraglutide.
Using the wrong medicine may cause serious harm.
Remove the cap from the injector.
Remove the paper tab from the new disposable needle. Firmly and carefully screw the needle onto the injector.
| Remove the outer needle cap and keep it for later use. | \ |
| Remove the inner needle cap and discard it. |  |
| Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of liraglutide, needle blockage, and inaccurate dosing. Take care not to bend or damage the needle. Never reattach the inner needle cap. You could prick yourself with the needle. | |
Caring for the injection pen
| |
Important information
| |
| Checking flow for each new injection pen For each new injection pen, check the flow before the first injection. If the injection pen is already in use, proceed to section H, "Setting the dose." Turn the dose knob until the flow check symbol lines up with the indicator. |   |
| Holding the injection pen with the needle pointing upward, gently tap the cartridge several times with your finger. This will cause any air bubbles to collect at the top of the cartridge. |  |
| Holding the injection pen with the needle pointing upward, press the dose button until the 0 mg mark aligns with the indicator. 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, replace the needle and repeat steps E to G once again. Do not use the injection pen if no drop of liraglutide appears. This indicates the pen is defective and a new pen should be used. |  |
| If the injection pen is dropped onto a hard surface or if you suspect it is not working properly, always attach a new single-use needle and check the flow before injecting. | |
Dose Setting
Always make sure that the pointer is aligned with the 0 mg mark.
Rotate the dose selector until the appropriate dose mark (0.6 mg, 1.2 mg, or 1.8 mg) lines up with the pointer.
If an incorrect dose has been selected by mistake, rotate the dose selector backward or forward until the correct dose mark aligns with the pointer.
When rotating the dose selector backward, be careful not to press the injection button, as this may cause leakage of liraglutide.
If the dose selector stops before the desired dose aligns with the pointer, this means that
Selected 0.6 mg
there is insufficient volume of liraglutide remaining to deliver the full dose. In this case, you may:
Divide the dose into two injections:
Rotate the dose selector in either direction until the 0.6 mg or 1.2 mg mark aligns with the pointer. Inject this dose. Then prepare a new pen and inject the remaining milligrams required to complete the total dose.
Selected 1.2 mg
Selected 1.8 mg
The dose may be split between the current pen and a new pen only if you have been trained to do so by a healthcare professional. Use a dose calculator to plan your dose. If the dose is divided incorrectly, too much or too little liraglutide may be administered.
Inject the full dose using a new pen:
If the dose selector stops before the 0.6 mg mark aligns with the pointer, prepare a new pen and use it to administer the full dose.
Do not attempt to set doses other than 0.6 mg, 1.2 mg, or 1.8 mg. The numbers in the display window must be exactly aligned with the pointer to ensure accurate dosing.
While rotating the dose selector, clicking sounds may be heard. These should not be used to determine the dose setting.
Do not use the cartridge scale markings to measure the amount of liraglutide to be injected, as they are not sufficiently precise.
Administering the Injection
Insert the needle into the skin, following the instructions provided by your doctor or nurse. Then proceed as follows:
To administer the injection, press the injection button until the 0 mg mark aligns with the pointer.
Be careful not to touch the viewing window with your fingers or press the side of the dose selector during injection, as this may block the injection.
Keep holding the injection button pressed and leave the needle in the skin for at least 6 seconds. This ensures that the full dose is delivered.
Remove the needle.
A drop of liraglutide may appear at the tip of the needle.
This is normal and does not affect the delivered dose.
Place the needle tip into the outer needle cap without touching the needle or the inside of the cap.
Once the needle is fully covered, gently but firmly push the outer needle cap on until it stops.
Then unscrew the needle. Carefully remove the used needle and replace the pen cap.
If the pen is empty, carefully dispose of it without the needle attached. Dispose of the pen and needle according to local regulations.
After each injection, remove the needle and store the pen without a needle attached.
This reduces the risk of contamination, infection, leakage of liraglutide, needle clogging, and inaccurate dosing.
Caregivers must handle used needles with extreme caution to avoid needlestick injuries and transmission of infections.