Fuzeon 108mg powder and solvent for solution for injection vials

Fuzeon is an anti-HIV medicine that is used in the treatment of infection with human immunodeficiency virus ( HIV). It is used in combination with other anti-HIV medicines.

HIV weakens the body's immune system and reduces the body's ability to fight infections. Anti-HIV medicines do not kill the virus but they slow down or stop the HIV virus from making copies of itself. This allows the body's immune system to keep working and gives the body a chance to fight other infections. Anti-HIV medicines do not cure HIV infections or prevent you from getting other infections.

Anti-HIV medicines are most effective when taken in combination with other anti-HIV medicines. Combination therapy reduces the chances of the virus becoming resistant to a single medicine. Resistance to medicines makes HIV treatment more difficult. For HIV therapy to be effective and to reduce the chances of developing resistance to your medicine, it is important you have the full daily dose and take your medicines exactly as prescribed by your doctor.

Treatment with anti-HIV medicines does not reduce the risk of passing the virus on to other people through sexual contact or through contact with blood. It is important you take precautions against passing HIV to other people.

Women who are infected with HIV should not breast-feed their babies as the virus may be passed to the baby.

Fuzeon 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 Fuzeon.

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 Fuzeon:

If you have any concerns about this medicine or about the process of having it you should talk to someone who is involved in your medical care.

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.

If you are having any problems taking your medicine you must speak to your prescriber. If you are not having any problems taking this medicine then do not stop taking it, even if you feel better, unless advised to do so by your prescriber.

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 Fuzeon 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 Fuzeon:

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.

Fuzeon 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 six 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 Fuzeon can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Fuzeon 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 Fuzeon:

• injection site problems such as redness, swelling, hardening of the skin, itching, bruising, pain or discomfort
• neuropathy of the extremities
• weight loss

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

• abnormal laboratory test results
• acne
• anorexia
• benign skin tumour
• blocked nose
• blood in the urine
• concentration problems
• diabetes
• dry skin
• ear infections
• eczema
• eye infections
• feeling anxious
• feeling irritable
• flu or flu-like symptoms
• gastro-oesophageal reflux
• high levels of lipids in the blood
• hypoaesthesia
• infections
• kidney stones
• loss of appetite
• lymphadenopathy
• muscle pain or tenderness
• nightmares
• pancreatitis
• pneumonia
• redness of the skin
• sinusitis
• tremors
• vertigo
• weakness

The frequency of these side-effects is unknown:

• diarrhoea
• hypersensitivity reactions - stop using Fuzeon and seek immediate medical advice if you get signs and symptoms of a hypersensitivity reaction such as breathing difficulties, a rash, fever, chills, rigors, nausea or vomiting
• immune reactivation syndrome - this may occur shortly after starting treatment with Fuzeon. Seek medical advice if you get signs and symptoms of an infection shortly after starting anti-HIV therapy
• osteonecrosis - seek medical advice if you have joint aches, pain, stiffness or difficulty in moving

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.

There are no known important interactions between Fuzeon and other medicines. If you experience any unusual symptoms while having Fuzeon and other medicines you should tell your prescriber.

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 Fuzeon.

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.

Like all medicines Fuzeon can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, 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 Fuzeon:

Alcohol can interact with certain medicines.

In the case of Fuzeon:

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 Fuzeon:

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Fuzeon, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

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

In the case of Fuzeon:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. 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.

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.

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