Do not take Atripla
- if you are allergic (hypersensitive) to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil fumarate, or any of the other ingredients of Atripla listed at the end of this leaflet.
- if you have severe liver disease.
- if you are currently taking any of the following medicines:
- astemizole or terfenadine (used to treat hay fever or other allergies)
- bepridil (used to treat heart disease)
- cisapride (used to treat heartburn)
- ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)
- midazolam or triazolam (used to help you sleep)
- pimozide (used to treat certain mental conditions)
- St. John?s wort ( Hypericum perforatum) (a herbal remedy used for depression and anxiety)
- voriconazole (used to treat fungal infections)
If you are taking any of these medicines, tell your doctor immediately. Taking these medicines with Atripla could cause serious or life-threatening side effects or stop these medicines from working properly.
Take special care with Atripla
- Do not give Atripla to children and adolescents under 18 years of age. The use of Atripla in children and adolescents has not yet been studied.
- You can still pass on HIV when taking this medicine, so it is important to take precautions to avoid infecting other people through sexual contact or blood transfer. This medicine is not a cure for HIV infection. While taking Atripla you may still develop infections or other illnesses associated with HIV infection.
- You must remain under the care of your doctor while taking Atripla.
- Tell your doctor:
- if you are taking other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, or lamivudine or adefovir dipivoxil. Atripla should not be taken with any of these medicines.
- if you have or have had kidney disease, or if tests have shown problems with your kidneys. Atripla is not recommended if you have moderate to severe kidney disease.
Atripla may affect your kidneys. Before starting treatment, your doctor may order blood tests to assess kidney function. Your doctor may also order blood tests during treatment to monitor your kidneys.
Atripla is not usually taken with other medicines that can damage your kidneys (see Taking other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.
- if you have a history of mental illness, including depression, or of substance or alcohol abuse. Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see Section 4, Possible side effects).
- if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin. If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Atripla. Your doctor may give you a different anticonvulsant.
- if you have a history of liver disease, including chronic active hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with combination antiretrovirals, have a higher risk of severe and potentially life-threatening liver problems. Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine. If you have severe liver disease, do not take Atripla (see earlier in Section 2, Do not take Atripla).
If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. Tenofovir disoproxil and emtricitabine, two of the active substances in Atripla, show some activity against hepatitis B virus although emtricitabine is not approved for the treatment of hepatitis B infection. Symptoms of your hepatitis may become worse after discontinuation of Atripla. Your doctor may then conduct blood tests at regular intervals in order to check how well your liver is working (see Section 3, If you stop taking Atripla).
- Independent of a history of liver disease, your doctor will consider regular blood tests to check how your liver is working.
- if you are diabetic, overweight or have high cholesterol. Combination antiretroviral therapies (including Atripla) may raise blood sugar levels, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see Section 4, Possible side effects).
- if you are over 65. Insufficient numbers of patients over 65 years of age have been studied. If you are over 65 years of age and are prescribed Atripla, your doctor will monitor you carefully.
- Once you start taking Atripla, look out for:
- possible signs of lactic acidosis. Some HIV medicines, including Atripla, that contain nucleoside analogues can cause lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver. Deep, rapid breathing, drowsiness, and symptoms such as feeling sick (nausea), vomiting and stomach pain, might indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more often in women, particularly if they are very overweight, and people with liver disease. While you are being treated with Atripla, your doctor will monitor you closely for any signs that you may be developing lactic acidosis. If you notice any symptoms of lactic acidosis, please tell your doctor immediately.
- signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming. These side effects may start in the first 1 or 2 days of treatment and usually go away after the first 2 to 4 weeks.
- any signs of skin rash. Rashes may be caused by Atripla. If you see any signs of a severe rash with blistering or fever, stop taking Atripla and tell your doctor at once. If you had a rash while taking another NNRTI, you may be at higher risk of getting a rash with Atripla.
- any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to improvement in the body?s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please tell your doctor at once.
- bone problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.
Bone problems (sometimes resulting in fractures) may also occur in patients who develop damage to kidney tubule cells (see Section 4, Possible side effects).
Taking other medicinesYou must not take Atripla with certain medicines.
These are listed under Do not take Atripla,
at the start of Section 2. They include some common medicines and some herbal remedies (including St. John?s wort) which can cause serious interactions.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes non-prescription medicines and herbal remedies.
Also, Atripla should not be taken with any other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, or lamivudine or adefovir dipivoxil.
Tell your doctor if youare taking other medicines which may damage your kidneys. Some examples include:
- aminoglycosides, vancomycin (medicines for bacterial infections)
- foscarnet, ganciclovir, cidofovir (medicines for viral infections)
- amphotericin B, pentamidine (medicines for fungal infections)
- interleukin-2 (to treat cancer)
Atripla may interact with other medicines. As a result, the amounts of Atripla or other medicines in your blood may be affected. This may stop your medicines from working properly, or may make any side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels. It is important to tell your doctor if you are taking any of the following:
- Medicines containing didanosine (for HIV infection): taking Atripla with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts. Inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported rarely when medicines containing tenofovir disoproxil fumarate and didanosine were taken together. Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
- Other medicines used for HIV infection: the following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or ritonavir boosted atazanavir or saquinavir. Your doctor may consider giving you an alternative medicine or changing the dose of the protease inhibitors. Also, tell your doctor if you are taking maraviroc.
- Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin. Atripla can reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
- Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Atripla can reduce the amount of the anticonvulsant in your blood. Carbamazepine can reduce the amount of efavirenz, one of the components of Atripla, in your blood. Your doctor may need to consider giving you a different anticonvulsant.
- Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin. Your doctor may need to consider changing your dose or giving you an alternative antibiotic. In addition, your doctor may consider giving you an additional dose of efavirenz to treat your HIV infection.
- Medicines used to treat fungal infections (antifungals): itraconazole or posaconazole. Atripla can reduce the amount of itraconazole or posaconazole in your blood. Your doctor may need to consider giving you a different antifungal.
- Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): you must also use a reliable barrier method of contraception (see Pregnancy and breast-feeding). Atripla may make hormonal contraceptives less likely to work. Pregnancies have occurred in women taking efavirenz, a component of Atripla, while using a contraceptive implant, although it has not been established that the efavirenz therapy caused the contraceptive to fail.
- Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
- Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
- Diltiazem or similar medicines (called calcium channel blockers): when you start taking Atripla, your doctor may need to adjust your dose of the calcium channel blocker.
- Medicines used to prevent organ transplant rejection (also called immunosuppressants), such as cyclosporine, sirolimus or tacrolimus. When you start or stop taking Atripla your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
- Warfarin (amedicine used to reduce clotting of the blood): your doctor may need to adjust your dose of warfarin.
Pregnancy and breast-feedingWomen should not get pregnantduring treatment
with Atripla and for 12 weeks thereafter
. Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with Atripla.
If you could get pregnant while receiving Atripla, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection). Efavirenz, one of the active components of Atripla, may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking Atripla.
Tell your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant, you should take Atripla only if you and your doctor decide it is clearly needed.
Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz during pregnancy. If you have taken Atripla during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Ask your doctor or pharmacist for advice before taking any medicine.
Do not breast-feed during treatment with Atripla. Both HIV and the ingredients of Atripla may pass through breast milk and cause serious harm to your baby.
Driving and using machinesAtripla may cause dizziness, impaired concentration and drowsiness.
If you are affected, do not drive and do not use any tools or machines.
Important information about some of the ingredients of Atripla
This medicine contains 1 mmol (23.6 mg) of sodium per tablet which should be taken into consideration if you are on a controlled sodium diet.