WARNING: RISK OF THYROID C-CELL TUMORS

·         Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in rodents. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies.

·         Victoza is contraindicated in patients with a personal or family history of MTC or in patients with

Multiple Endocrine Neoplasia syndrome type 2.

Victoza^® contains the active substance liraglutide. It helps your body reduce your blood sugar level only when blood sugar is too high. It also slows food passage through your stomach and can help prevent heart disease.

Victoza^® is used on its own if your blood sugar is not properly controlled by diet and exercise alone, and you cannot use metformin (another diabetes medicine).

Victoza^® is used with other medicines for diabetes when they are not enough to control your blood sugar levels. These may include:

•        oral antidiabetics (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter 2 inhibitor (SGLT2i)) and/or insulin.

Do not use Victoza^®

–        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 using Victoza^®.

•        if you have or have had a disease of the pancreas.

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 Victoza^® is not recommended if you are on dialysis.

The use of Victoza^® is not recommended if you have severe liver disease.

The use of Victoza^® 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 symptoms of acute pancreatitis, such as persistent, severe stomach ache, you should consult your doctor immediately (see section 4).

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

When initiating treatment with Victoza^®, 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.

Kidney Problems (Kidney Failure):

In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. This can happen in people who have never had kidney problems before.

Gallbladder Problems:

Gallbladder problems have happened in some people who take Victoza^®.

Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:

·         Pain in the right or middle upper stomach area

·         Nausea and vomiting

·         Fever

·         Your skin or the white part of your eyes turns yellow

It is also important to tell your healthcare provider if you had stones in your gallbladder (gallstones) in the past.

Children and adolescents

Victoza^® can be used in adolescents and children aged 10 years and above. No data are available in children below 10 years of age.

Other medicines and Victoza^®

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 Victoza^® 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.

Pregnancy and breast-feeding

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

It is not known if Victoza^® passes into breast milk, therefore do not use this medicine if you are breast‑feeding.

Driving and using machines

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.

Important information about some of the ingredients of Victoza^®

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

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

•        The starting dose is 0.6 mg once a day, for at least one week.

•        Your doctor will tell you when to increase it 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 glucose is not adequately controlled with a dose of 1.2 mg.

Do not change your dose unless your doctor has told you to.

Victoza^® is given as an injection under the skin (subcutaneous). Do not inject it into a vein or muscle. The best places to give yourself the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.

You can give yourself the injection at any time of the day, regardless of meals. When you have found the most convenient time of the day it is preferred that you inject Victoza^® around the same time of the day.

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

Always use a new needle for each injection to prevent contamination. Needles must not be shared.

Detailed instructions for use are provided on the other side of this leaflet.

If you use more Victoza^® than you should

If you use more Victoza^® 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 to use Victoza^®

If you forget a dose, use Victoza^® as soon as you remember.

However, if it is more than 12 hours since you should have used Victoza^®, 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.

If you stop using Victoza^®

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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

•        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 Victoza^®.

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

•        Cases of inflammation of the pancreas (pancreatitis). Pancreatitis can be a serious, potentially life-threatening medical condition. Stop taking Victoza^® and contact a doctor immediately if you notice any of the following serious side effects:

          Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).

Other side effects

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

•        Vomiting.

When initiating treatment with Victoza^®, 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.

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.

To report any side effect(s):

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 pen label and carton after ‘Expiry’. The expiry date refers to the last day of that month.

Before opening:

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

During use:

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.