Atripla 600mg/200mg/245mg tablets

Atripla is an anti-HIV medicine that is used in the treatment of infection with human immunodeficiency virus ( HIV). It contains three medicines – efavirenz, emtricitabine and tenofovir disoproxil fumarate.

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.

Some people with hepatitis B infection may find that their infection becomes worse when they stop taking Atripla. Your prescriber may arrange for you to have tests to monitor your hepatitis for at least four months after stopping treatment with Atripla.

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.

Other information about Atripla:

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.

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.

In the case of Atripla:

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 Atripla:

If you are having problems taking this medicine, 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 medicines that are easier for you to take.

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.

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.

In the case of Atripla:

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

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 Atripla:

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.

Atripla 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 18 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 Atripla can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Atripla 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.

As part of treatment, this medicine may be used in combination with other medicines. There may be more information about the side-effects caused by the combination of this medicine with other medicines in the Patient Information Leaflet or Summary of Product Characteristics for Atripla.

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

• abnormal laboratory test results
• diarrhoea
• feeling dizzy
• headaches
• metabolic problems - some of these metabolic problems may affect the liver or the kidneys and may be fatal. Seek medical advice if you have nausea, vomiting, stomach pain, loss of appetite, weight loss, muscle weakness, breathing problems or if you have a general feeling of being unwell
• skin rash or rashes - seek medical advice if you develop a fever and have a skin rash
• weakness

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

• allergic reactions
• balance problems
• blood problems
• concentration problems
• coordination problems
• depression - seek immediate medical advice if you have feelings of depression
• difficulty sleeping
• distension of the stomach
• feeling anxious
• flatulence
• high levels of lipids in the blood
• increased blood sugar levels
• indigestion
• itching
• pain
• skin colour changes
• sleepiness
• strange dreams
• tiredness
• urticaria

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

• abnormal thoughts or feelings
• aggressive behaviour
• angioedema
• appetite gain
• blurred vision
• breast enlargement in men
• confusion
• convulsions
• decreased libido
• dry mouth
• erythema multiforme
• euphoria
• feeling agitated
• feeling paranoid
• flushing
• hallucinations
• hypersensitivity reactions
• liver problems or worsening of liver problems - some of these liver problems may be fatal in people with hepatitis B or C infection. People with hepatitis B may find that the hepatitis B infection gets worse if Atripla is stopped
• mania or mania-like behaviour
• memory problems
• mood changes
• muscle pain or tenderness
• pancreatitis
• proteinuria
• psychiatric problems including delusions, psychosis or psychotic-like behaviour - seek immediate medical advice if you get any psychiatric problems
• rhabdomyolysis
• speech problems
• Stevens-Johnson syndrome
• suicide attempt or thoughts of committing suicide - seek immediate medical advice if you have thoughts of committing suicide
• tinnitus
• tremors
• vertigo

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

• bone problems
• diabetes insipidus
• Fanconi's syndrome
• kidney problems
• muscle problems
• photosensitivity skin reaction
• suicide

The frequency of these side-effects is unknown:

• brain or central nervous system problems
• immune reactivation syndrome - this may occur shortly after starting treatment with Atripla. Seek medical advice if you get signs and symptoms of an infection shortly after starting anti-HIV therapy
• lipodystrophy
• lowering of bone mineral density
• may affect the results for certain tests
• osteonecrosis - seek medical advice if you have joint aches, pain, stiffness or difficulty in moving
• seizures

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 Atripla:

The following types of medicine may interact with Atripla:

If you are taking Atripla 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.

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 Atripla:

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

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 Atripla:

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 Atripla:

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

Alcohol can interact with certain medicines.

In the case of Atripla:

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 Atripla:

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 Atripla, 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 Atripla:

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.

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.

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