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The eMC  

Last Updated 13 May 2013

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Victoza 6mg/ml solution for injection 3ml pre-filled pen

Victoza (vik-toe-za) is a medicine which is used in diabetes mellitus. Victoza contains liraglutide. It is supplied by Novo Nordisk Limited.

The information in this Medicine Guide for Victoza varies according to the condition being treated and the particular preparation used.

Victoza 6mg/ml solution for injection 3ml pre-filled pen

Information specific to Victoza 6mg/ml solution for injection 3ml pre-filled pen when used in diabetes mellitus

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Your medicine

Victoza increases the amount of insulin produced by the body as blood sugar levels increase. Insulin helps the body to use the sugar in the blood properly and it prevents the blood sugar level from becoming too high. Victoza also slows the release of food from the stomach and this too may help reduce blood sugar levels. Victoza is used in addition with other medicines to control blood sugar levels.

In diabetes, the body may not be able to produce enough insulin or the insulin that it produces may not have the full effect. In some instances, the body may not be able to produce any insulin at all. These can all lead to problems controlling the blood sugar level.

It is very important that your blood sugar level is well controlled. Blood sugar levels which are too high or too low can be dangerous. Your prescriber or a member of your diabetes team will be able to give you information on how to recognise the warning signs of high and low blood sugar levels. They will also be able to tell you what to do if either of these occurs.

Warning signs can vary from person to person. If the usual warning signs of poorly controlled blood sugar levels change or disappear, you should contact your prescriber or a member of your diabetes team.

The amount of Victoza you need to control your blood sugar levels will be worked out by your prescriber or your diabetes team. They may also advise you to measure your blood sugar regularly - they will show you how to do this. If you are having problems controlling or measuring your blood sugar, you should contact your prescriber or a member of your diabetes team.

Other information about Victoza:

  • people starting treatment with this medicine will normally be prescribed a low dose. The dose will then be gradually increased. This is in order to reduce the chance of side-effects
  • Victoza is not a substitute for insulin

Victoza needs to be injected. Your prescriber will show you how to inject this medicine yourself.

There should also be instructions on how to inject this medicine in the Patient Information Leaflet that comes with this medicine or on the pharmacy label.

The pharmacy label on your medicine tells you how much medicine you should have. It also tells you how often you should have your medicine. This is the dose that you and your prescriber have agreed you should have. You should not change the dose of your medicine unless you are told to do so by your prescriber.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. If someone is giving you this injection, the person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

If you are injecting this medicine yourself, make sure that you find out from your prescriber the best time to have Victoza.

In the case of Victoza:

  • it is best to inject this medicine around the same time each day
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How to take your medicine

This medicine needs to be injected. Your medical team will train you how to inject the medicine yourself. For more information see the Patient Information Leaflet or contact one of your medical team.

In the case of Victoza:

  • before having your medicine, make sure that the solution is clear and colourless

If you have any concerns about this medicine or are having problems using it you should discuss these difficulties with your prescriber, diabetes nurse or pharmacist.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

The person who is responsible for giving you your medicine will make sure that you are given the correct dose of your medicine. If you inject the medicine yourself, make sure that you do not take any extra doses as this could cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

Suddenly stopping your medicine may cause very high blood sugar levels. This can be very dangerous. This is why you must speak to your prescriber or a member of your diabetes team if you are having any problems having your medicine.

If you are not having any problems taking this medicine, do not stop having it unless advised to do so by your prescriber or a member of your diabetes team.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

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Looking after your medicine

If you are injecting this medicine yourself, read the pharmacy label to find out how you should look after your medicine. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions.

Do not use the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Specific information about how to look after Victoza can be found in the Patient Information Leaflet that comes with this medicine. Make sure that the medicine is out of the sight and reach of children.

In the case of Victoza:

  • before you use a pen for the first time, it should be stored in a fridge at temperatures between 2 – 8°C. Once you have started to use a pen, you may either store it in the fridge between 2 - 8°C or you can keep it at room temperature below 30°C
  • you must not freeze this medicine. Also make sure that the pen or its packaging is stored away from the freezer compartment
  • keep the cap on the pen to protect Victoza from light
  • do not store the pen with the needle attached to it
  • you must dispose of this medicine one month after opening it. It is a good idea to make a note of the date when you opened it

Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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Whether this medicine is suitable for you

Victoza is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone under the age of 18 years.

Over time it is possible that Victoza can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Victoza has become unsuitable, it is important that the prescriber is contacted immediately.

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Side-effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

As part of treatment, this medicine may be used in combination with other medicines. There is no information available about the side-effects of Victoza when it is taken on its own. The information included here relates to the side-effects caused by the combination of this medicine with other medicines that it is usually given with. There may be more information on the side-effects of Victoza in the Patient Information Leaflet for Victoza.

Very common: More than 1 in 10 people who have Victoza:

Common: More than 1 in 100 people who have Victoza:

Uncommon: More than 1 in 1000 people who have Victoza:

Rare: More than 1 in 10,000 people who have Victoza:

  • anaphylactic reactions with symptoms such as lowered blood pressure, palpitations, breathing difficulties or oedema
  • angioedema

Very rare: Fewer than 1 in 10,000 people who have Victoza:

  • pancreatitis - seek medical advice if you have persistent or severe stomach pain

The frequency of these side-effects is unknown:

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

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Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Victoza:

The following types of medicine may interact with Victoza:

If you are taking Victoza and one of the above medicines or types of medicines, make sure your prescriber knows about it.

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Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Victoza.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

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Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Victoza:

  • your ability to drive or operate machinery may be affected if your blood sugar levels are low

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

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Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Victoza:

  • there are no specific foods that you must exclude from your diet when having Victoza
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Alcohol

Alcohol can interact with certain medicines.

In the case of Victoza:

  • there are no known interactions between alcohol and Victoza
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Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Victoza:

  • do not have this medicine during pregnancy
  • if you become pregnant, or think you have become pregnant while having Victoza, you must contact your prescriber
  • if you are having Victoza and are planning to have a baby you must contact your prescriber

You should discuss your personal circumstances with your doctor if you are pregnant or want to become pregnant. This is so that together you can make a decision about what treatment you may need during your pregnancy.

You should discuss whether there are any other medicines which you could take during pregnancy which would treat your condition.

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Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Victoza:

  • women who are breast-feeding must not have this medicine

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

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Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Victoza contains:

  • disodium phosphate dihydrate
  • propylene glycol
  • water for injections

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Victoza before, do not have Victoza. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Victoza, Version 11, last updated 13 May 2013