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

• 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.

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

Talk to your doctor, pharmacist or nurse before using liraglutide:

• if you ever had pancreatitis (inflammation of the pancreas which may cause severe pain in the stomach and back which does not go away; (see section 4).

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 with high blood sugar and increase in effort to breathe). It is not an insulin and should therefore not be used as a substitute for insulin.

The use of Zegluxen is not recommended if you are on dialysis. The use of Zegluxen is not recommended if you have severe liver disease.

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

This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or inflammatory bowel disease.

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

If you know that you are due to have surgery where you will be under anesthesia (sleeping), please tell your doctor that you are taking Zegluxen.

When initiating treatment with Zegluxen you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any questions or concerns.

Zegluxen can be used to treat type 2 diabetes in adolescents and children aged 10 years and above. No data are available in children below 10 years of age.

Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

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

• Sulfonylurea (such as glimepiride or glibenclamide) or insulin. You may get hypoglycaemia (low blood sugar) when using Zegluxen together with a sulfonylurea or insulin, as sulfonylureas and insulin increase the risk of hypoglycaemia. When you first start using these medicines together, your doctor may tell you to lower the dose of the sulfonylurea or insulin. Please see section 4 for the warning signs of low blood sugar. If you are also taking a sulfonylurea (such as glimepiride or glibenclamide) or insulin, your doctor may tell you to test your blood sugar levels. This will help your doctor to decide if the dose of the sulfonylurea or insulin needs to be changed.
• If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
• Warfarin or other oral anti-coagulation medicines. More frequent blood testing to determine the ability of your blood to clot may be required.

Tell your doctor if you are, you think you might be, or are planning to become pregnant. Zegluxen should not be used during pregnancy because it is not known if it may harm your unborn child.

It is not known if Zegluxen passes into breast milk, therefore do not use this medicine if you are breastfeeding.

Low blood sugar (hypoglycaemia) may reduce your ability to concentrate. Avoid driving or using machines if you experience signs of hypoglycaemia. Please see section 4 for the warning signs of low blood sugar. Please consult your doctor for further information on this topic.

This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially ‘sodium free’.

If you use more Zegluxen than you should, talk to your doctor straight away. You may need medical treatment. You may experience nausea, vomiting, diarrhoea or low blood sugar (hypoglycaemia). Please refer to section 4 for warning signs of low blood sugar.

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

However, if it is more than 12 hours since you should have used Zegluxen, skip the missed dose. Then take your next dose as usual the following day. Do not take an extra dose or increase the dose on the following day to make up for the missed dose.

Do not stop using Zegluxen without talking to your doctor. If you stop using it, your blood sugar levels may increase.

Common: may affect up to 1 in 10 people

• Hypoglycaemia (low blood sugar). The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, nervous, anxious, confused, difficulty concentrating, shaking (tremor). 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 also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using Zegluxen.

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

• A severe form of allergic reaction (anaphylactic reaction) with additional symptoms such as breathing problems, swelling of throat and face, fast heartbeat, etc. If you experience these symptoms you should seek immediate medical help and inform your doctor as soon as possible.
• Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

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

• Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. This is a serious, potentially life-threatening condition. You should see a doctor immediately if you experience such symptoms.
• Stop using this medicine and seek urgent medical help if you experience: Severe, persistent pain in the abdomen (stomach area) which might reach through to your back, with or without nausea and vomiting. This could be a sign of acute pancreatitis, which is serious and potentially life-threatening.

Very common: may affect more than 1 in 10 people

• Nausea (feeling sick). This usually goes away over time.
• Diarrhoea. This usually goes away over time.

Common: may affect up to 1 in 10 people

• Vomiting.

When initiating treatment with Zegluxen, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids.

• Headache
• Indigestion
• Inflamed stomach (gastritis). The signs include stomach ache, nausea and vomiting.
• Gastro-oesophageal reflux disease (GORD). The signs include heartburn.
• Painful or swollen tummy (abdomen)
• Abdominal discomfort
• Constipation
• Wind (flatulence)
• Decreased appetite
• Bronchitis
• Common cold
• Dizziness
• Increased pulse
• Tiredness
• Toothache
• Injection site reactions (such as bruising, pain, irritation, itching and rash)
• Increase of pancreatic enzymes (such as lipase and amylase).

Uncommon: may affect up to 1 in 100 people

• Allergic reactions like 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 how things taste
• A delay in the emptying of the stomach

Not known: frequency cannot be estimated from the available data

• Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known).

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 via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

Store in a refrigerator (2˚C-8˚C). Do not freeze. Keep away from the freezer compartment.

You can keep the pen for 1 month when stored at a temperature below 30˚C or in a refrigerator (2˚C-8˚C), away from the freezer compartment. Do not freeze.

When you are not using the pen, keep the pen cap on in order to protect from light.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

• The active substance is liraglutide. 1 ml solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide.
• The other ingredients are sodium citrate dihydrate, propylene glycol, phenol and water for injection. In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.

Zegluxen is supplied as a clear, and colourless or almost colourless, solution for injection in a pre-filled pen. Each pen contains 3 ml of solution, delivering 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, 5 or 10 pens.

Not all pack sizes may be marketed. Needles are not included.

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