Levemir Penfill 100units/ml solution for injection 3ml cartridges

Levemir is used as a substitute for the body's insulin in people with diabetes. Insulin is a hormone produced in the body. It helps the body to use the sugar in the blood properly and it helps to prevent the blood sugar level from becoming too high.

In diabetes, there is a problem with insulin. 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.

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. Very high blood sugar levels may lead to ketoacidosis; very low blood sugar levels may lead to coma – all of these may be fatal. 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 Levemir you need to control your blood sugar levels will be worked out by your prescriber or your diabetes team. You may be advised to measure your blood sugar regularly and vary the amount of Levemir that you use depending on the result of the measurement. Your prescriber or a member of your diabetes team will show you how to measure your blood sugar. If you are having problems controlling or measuring your blood sugar, you should contact your prescriber or a member of your diabetes team.

At times the amount of Levemir you need to use may change depending on your circumstances. These could include changes to your diet; irregular meal times, changes to your health during periods of illness or emotional stress; changes to the amount of physical activity that you are doing; or if you change to a different insulin. For more information about how to vary your dose when your circumstances change, make sure you have spoken to your prescriber or a member of your diabetes team.

Other information about Levemir:

Levemir 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.

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 Levemir.

In the case of Levemir:

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.

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.

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 Levemir 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 Levemir:

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.

Levemir 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 a child under two years of age.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

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

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.

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

• decreased blood sugar levels very low blood sugar levels may lead to loss of consciousness, impairment of brain function, convulsions or death. Symptoms of low blood sugar levels include cold sweats, cool pale skin, tiredness, tremors, feeling nervous, feeling anxious, weakness, confusion, concentration difficulties, drowsiness, excessive hunger, changes in vision, headache, nausea or palpitations. If your blood sugar levels are low or you are having warning signs of low blood sugar levels you will need to have some sugar. Suitable foods include dextrose tablets, sweets, biscuits, sugary fruit juice or sugar. Your prescriber may have also prescribed you glucagon. Glucagon is an emergency treatment for people with very low blood sugar levels. If you have been prescribed glucagon, make sure you or your carer knows when to use it, where it is stored and how to use it

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

• injection site problems - seek medical advice if you develop pain, redness, urticaria, inflammation, bruising, itching or swelling

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

• allergic reactions
• eye or eyesight problems
• lipodystrophy
• oedema
• skin problems
• skin rash or rashes
• urticaria

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

• neuropathy of the extremities

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

• hypersensitivity reactions or anaphylactic reactions such as itching, sweating, gastrointestinal problems, angioedema, palpitations or breathing difficulties
• lowered blood pressure

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.

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 Levemir:

The following types of medicine may interact with Levemir:

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

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 Levemir.

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.

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 Levemir:

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.

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 Levemir:

For more advice speak to your prescriber, nutritionist or pharmacist.

Alcohol can interact with certain medicines.

In the case of Levemir:

You must not drink any alcohol if you are taking this medicine.

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 Levemir:

If you are taking this medicine and become pregnant, make sure that everyone involved in your medical care knows that you are pregnant and are taking Levemir. For more information on managing your diet and your diabetes during your pregnancy, talk to your prescriber or a member of your diabetes or antenatal team.

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

In the case of Levemir:

If you are taking this medicine while breast-feeding, make sure that you tell everyone involved in your medical and postnatal care. For more information on managing your diet and your diabetes while breast-feeding, talk to your prescriber or a member of your diabetes or antenatal team.

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.

Levemir contains:

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 Levemir before, do not have Levemir. Talk to your prescriber, pharmacist or nurse as soon as possible.