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Last Updated 21 Mar 2012

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Prezista 400mg tablets

Prezista (pree-ziss-tar) is a medicine which is used in HIV infection. Prezista contains darunavir ethanolate. It is supplied by Janssen-Cilag Ltd.

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

There are 4 preparations of Prezista available. If Prezista 400mg tablets is not the preparation you are looking for, please select from the drop down list below.

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Prezista 400mg tablets

Information specific to Prezista 400mg tablets when used in HIV infection

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Your medicine

Prezista is an anti-HIV medicine that is used in the treatment of infection with human immunodeficiency virus ( HIV). It is used in combination with another anti-HIV medicine called ritonavir.

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 take 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 care not to pass on 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.

Other information about Prezista:

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

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

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. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Prezista:

  • you should take Prezista within 30 minutes of eating a meal
  • if you miss a dose of Prezista and notice within 12 hours, you must take the tablets immediately. If you notice after 12 hours, then skip the dose you missed and take the next doses as usual. Do not take a double dose to make up for a forgotten dose
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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Prezista:

If you are having problems taking this form of Prezista, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

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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. 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

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.

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. You should 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 take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Prezista:

  • there are no special instructions on how to look after your medicine

You must not take 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

Prezista 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:

Prezista is not used in children and adolescents.

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

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects
  • to check that this medicine is having the desired effect

Over time it is possible that Prezista can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Prezista 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 Prezista 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 Prezista in the Patient Information Leaflet for Prezista.

Very common: More than 1 in 10 people who take Prezista:

Common: More than 1 in 100 people who take Prezista:

Uncommon: More than 1 in 1000 people who take Prezista:

Rare: More than 1 in 10,000 people who take Prezista:

  • erythema multiforme
  • Stevens-Johnson syndrome - seek immediate medical advice if you develop signs or symptoms of severe skin reactions such as severe rash or rash accompanied with fever, general feeling of being unwell, tiredness, muscle or joint aches, blisters, oral lesions or red eyes

The frequency of these side-effects is unknown:

  • inflammation of the muscles
  • rhabdomyolysis
  • toxic epidermal necrolysis - seek immediate medical advice if you develop signs or symptoms of severe skin reactions such as severe rash or rash accompanied with fever, general feeling of being unwell, tiredness, muscle or joint aches, blisters, oral lesions or red eyes
  • worsening of bleeding problems in people with haemophilia
  • worsening of diabetes

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 Prezista:

The following types of medicine may interact with Prezista:

If you are taking Prezista 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.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Prezista:

If you have been prescribed Prezista you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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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 Prezista:

  • this medicine could affect your ability to drive or operate machinery

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 Prezista:

  • there are no specific foods that you must exclude from your diet when taking Prezista
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Alcohol

Alcohol can interact with certain medicines.

In the case of Prezista:

  • there are no known interactions between alcohol and Prezista
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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 Prezista:

  • you should only take this medicine during pregnancy if your doctor thinks that you need it

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 Prezista, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

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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 Prezista:

  • women who are taking Prezista should not breast-feed

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.

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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. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Prezista contains:

  • colloidal anhydrous silica
  • crospovidone
  • macrogol 3350
  • magnesium stearate
  • microcrystalline cellulose
  • partially hydrolyzed polyvinyl alcohol
  • sunset yellow FCF (E110)
  • talc
  • titanium dioxide (E171)

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 Prezista before, do not take Prezista. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Prezista, Version 11, last updated 21 Mar 2012