Do not take SUSTIVA
-- if you are allergic (hypersensitive) to efavirenz or any of the other ingredients of SUSTIVA listed at the end of this leaflet. Contact your doctor or pharmacist for advice.
--- if you have severe liver disease.
if you are currently taking any of the following medicines astemizole or terfenadine used to treat allergy symptoms bepridil used to treat heart disease cisapride used to treat heartburn ergot alkaloids for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine used to treat migraine and cluster headaches midazolam or triazolam used to help you sleep pimozide used to treat certain mental conditions St. Johns wort Hypericum perforatum a herbal remedy used for depression and anxiety
If you are taking any of these medicines, tell your doctor immediately. Taking these medicines with SUSTIVA could create the potential for serious and/or life-threatening side-effects or stop SUSTIVA from working properly.
Take special care with SUSTIVA
SUSTIVA must be taken with other medicines that act against the HIV virus. If SUSTIVA is started because your current treatment has not prevented the virus from multiplying, another medicine you have not taken before must be started at the same time.
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 and you may continue to develop infections or other illnesses associated with HIV disease.
You must remain under the care of your doctor while taking SUSTIVA. Tell your doctor
- 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 SUSTIVA. Your doctor may give you a different anticonvulsant.
- if you have a history of liver disease, including active chronic hepatitis. Patients with chronic hepatitis B or C and treated with combination antiretroviral agents have a higher risk for 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 SUSTIVA (see section 2, Do not take SUSTIVA).
Once you start taking SUSTIVA, look out for
- 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. If you see any signs of a severe rash with blistering or fever, stop taking SUSTIVA and tell your doctor at once. If you had a rash while taking another NNRTI, you may be at a higher risk of getting a rash with SUSTIVA.
- 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 an 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 immediately.
- changes in body fat. Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Tell your doctor if you notice changes in your body fat.
- 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.
Use in children
SUSTIVA 50 mg hard capsules can be taken by children and adolescents 3 years of age and older and weighing at least 13 kg who are able to swallow the capsules. Opening the capsule and taking the contents with a small amount of food may be considered for children who cannot swallow the hard capsule and cannot tolerate the oral solution (see How to take SUSTIVA).
Taking other medicines
You must not take SUSTIVA with certain medicines. These are listed under Do not take SUSTIVA, at the start of Section 2. They include some common medicines and a herbal remedy (St. John?s wort) which can cause serious interactions.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.
SUSTIVA may interact with other medicines. As a result, the amounts of SUSTIVA or other medicines in your blood may be affected. This may stop the 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:
Other medicines used for HIV infection protease inhibitors darunavir, indinavir, lopinavirritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavirsaquinavir. Your doctor may consider giving you an alternative medicine or changing the dose of the protease inhibitors. maraviroc a combination medicine containing efavirenz, emtricitabine and tenofovir, which is currently known as ATRIPLA. SUSTIVA should not be taken with ATRIPLA since it contains efavirenz, the active ingredient of SUSTIVA.
Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex clarithromycin, rifabutin, rifampicin. Your doctor may consider changing your dose or giving you an alternative antibiotic. In addition, your doctor may prescribe a higher dose of SUSTIVA.
Medicines used to treat fungal infections antifungals voriconazole. SUSTIVA may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of SUSTIVA in your blood. If you take these two medicines together, the dose of voriconazole must be increased and the dose of efavirenz must be reduced. You must check with your doctor first. itraconazole. SUSTIVA may reduce the amount of itraconazole in your blood. posaconazole. SUSTIVA may reduce the amount of posaconazole in your blood.
Medicines used to treat convulsionsseizures anticonvulsants carbamazepine, phenytoin, phenobarbital. SUSTIVA can reduce or increase the amount of anticonvulsant in your blood. Carbamazepine may make SUSTIVA less likely to work. Your doctor may need to consider giving you a different anticonvulsant.
Medicines used to lower blood fats also called statins atorvastatin, pravastatin, simvastatin. SUSTIVA 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.
--- Methadone (a medicine used to treat opiate addiction): your doctor may need to change your dose of methadone.
Sertraline a medicine used to treat depression your doctor may need to change your dose of sertraline.
--- Diltiazem or similar medicines (called calcium channel blockers): when you start taking SUSTIVA, your doctor may need to adjust your dose of the calcium channel blocker.
Immunosuppressants such as cyclosporine, sirolimus, or tacrolimus medicines used to prevent organ transplant rejection when you start or stop taking SUSTIVA, your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
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. SUSTIVA may make hormonal contraceptives less likely to work. Pregnancies have occurred in women taking SUSTIVA while using a contraceptive implant, although it has not been established that the SUSTIVA therapy caused the contraceptive to fail.
Warfarin a medicine used to reduce clotting of the blood your doctor may need to adjust your dose of warfarin.
Taking SUSTIVA with food and drink
Taking SUSTIVA on an empty stomach may reduce the undesirable effects.
Pregnancy and breast-feeding
Women should not get pregnant during treatment with SUSTIVA, 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 SUSTIVA.
If you could get pregnant while receiving SUSTIVA, 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 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 SUSTIVA.
Tell your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant, you should take SUSTIVA only if you and your doctor decide it is clearly needed. Ask your doctor or pharmacist for advice before taking any medicine.
Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz during pregnancy. If you have taken SUSTIVA during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
You should not breast feed your baby if you are taking SUSTIVA.
Driving and using machines
SUSTIVA 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 SUSTIVA
This medicinal product contains 342 mg of lactose in each 600-mg daily dose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Individuals with these conditions may take SUSTIVA oral solution, which is free from lactose.