SUSTIVA 600 mg film-coated tablets
1. What SUSTIVA is and what it is used for
2. What you need to know before you take SUSTIVA
3. How to take SUSTIVA
4. Possible side effects
5. How to store SUSTIVA
6. Contents of the pack and other information
SUSTIVA, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood. It is used by adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg.
Your doctor has prescribed SUSTIVA for you because you have HIV infection.
SUSTIVA taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood. This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection.
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.
Talk to your doctor before taking SUSTIVA
SUSTIVA is not recommeded for children under the age of 3 months or weighing less than 3.5 kg because it has not been adequately studied in these patients
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.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
SUSTIVA may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. 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 or pharmacist if you are taking any of the following:
Taking SUSTIVA on an empty stomach may reduce the undesirable effects. Grapefuit juice should be avoided when taking SUSTIVA.
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 or a combination medicine containing efavirenz, emtricitabine and tenofovir during pregnancy. If you have taken SUSTIVA or the combination tablet containing efavirenz, emtricitabine, and tenofovir 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.
SUSTIVA contains efavirenz and may cause dizziness, impaired concentration, and drowsiness. If you are affected, do not drive and do not use any tools or machines.
SUSTIVA contains 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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will give you instructions for proper dosing.
If you take too much SUSTIVA, contact your doctor or nearest emergency department for advice. Keep the medicine container with you so that you can easily describe what you have taken.
Try not to miss a dose. If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose. If you need help in planning the best times to take your medicine, ask your doctor or pharmacist.
When your SUSTIVA supply starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The virus may then become harder to treat.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by SUSTIVA or by other medicines that you are taking at the same time, or by the HIV disease itself.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
The most notable unwanted effects reported with SUSTIVA in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with SUSTIVA. Rash was more common in children than in adults treated with SUSTIVA.
The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks. In one study, nervous system symptoms often occurred during the first 1-3 hours after taking a dose. If you are affected your doctor may suggest that you take SUSTIVA at bedtime and on an empty stomach. Some patients have more serious symptoms that may affect mood or the ability to think clearly. Some patients have actually committed suicide. These problems tend to occur more often in those who have a history of mental illness. Always notify your doctor immediately if you have these symptoms or any side effects while taking SUSTIVA.
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Tests may show:
Uncommon (affects 1 to 10 users in 1,000)
Tests may show:
Rare (affects 1 to 10 users in 10,000)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
3. UNITED KINGDOM
or search for MHRA Yellow Card in the Google Play or Apple App Store
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle or blister and on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
SUSTIVA 600 mg film-coated tablets are supplied in bottles of 30 tablets.
SUSTIVA 600 mg film-coated tablets are also supplied in packs containing 30 x 1 or multipacks of 90 (3 packs of 30 x 1) tablets in aluminium/PVC perforated unit dose blisters. Not all pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.