Sustiva
efavirenz
efavirenz
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What SUSTIVA is and what it is used for
What you need to know before you take SUSTIVA
How to take SUSTIVA
Possible side effects
How to store SUSTIVA
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 any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
Sustiva”):
methylergonovine) (used to treat migraine and cluster headaches)
conditions)
St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
certain antimalarial treatments
Talk to your doctor before taking SUSTIVA
You must remain under the care of your doctor while taking SUSTIVA.
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 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).
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
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.
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:
protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/saquinavir. Your doctor may consider giving you an alternative medicine or changing the dose of the protease inhibitors.
- maraviroc
- the combination tablet containing efavirenz, emtricitabine, and tenofovir should not be taken with SUSTIVA unless recommended by your doctor since it contains efavirenz, the active ingredient of SUSTIVA.
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.
artemether/lumefantrine: SUSTIVA may reduce the amount of artemether/lumefantrine in your blood.
atovaquone/proguanil: SUSTIVA may reduce the amount of atovaquone/proguanil in your blood.
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.
women taking SUSTIVA while using a contraceptive implant, although it has not been established that the SUSTIVA therapy caused the contraceptive to fail.
Ginkgo biloba extracts (a herbal preparation)
Taking SUSTIVA on an empty stomach may reduce the undesirable effects. Grapefuit juice should be avoided when taking SUSTIVA.
Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with SUSTIVA.
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.
If you are affected, do not drive and do not use any tools or machines.
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.
The dose for adults is 600 mg once daily.
The dose for SUSTIVA may need to be increased or decreased if you are also taking certain medicines (see Other medicines and SUSTIVA).
SUSTIVA is for oral use. SUSTIVA is recommended to be taken on an empty stomach
preferably at bedtime. This may make some side effects (for example, dizziness, drowsiness) less troublesome. An empty stomach is commonly defined as 1 hour before or 2 hours after a meal.
It is recommended that the capsule be swallowed whole with water.
SUSTIVA must be taken every day.
SUSTIVA should never be used alone to treat HIV. SUSTIVA must always be taken in combination with other anti-HIV medicines.
SUSTIVA 50 mg hard capsules can be taken by children and adolescents 3 months of age and
older and weighing at least 3.5 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.
The dose for children and adolescents is calculated by body weight and is taken once daily as
shown below:
Body Weight kg | SUSTIVA Dose (mg) | Number of Capsules or Tablets and Strength to Administer |
3.5 to < 5 | 100 | one 100 mg capsule |
5 to < 7.5 | 150 | one 100 mg capsule + one 50 mg capsule |
7.5 to < 15 | 200 | one 200 mg capsule |
15 to < 20 | 250 | one 200 mg capsule + one 50 mg capsule |
20 to < 25 | 300 | three 100 mg capsules |
25 to < 32.5 | 350 | three 100 mg capsules + one 50 mg capsule |
32.5 to < 40 | 400 | two 200 mg capsules |
≥ 40 | 600 | one 600 mg tablet OR three 200 mg capsules |
For children who are not able to swallow the capsules, the doctor may recommend opening the hard capsule and mixing the contents with a small amount (1-2 teaspoons) of food (e.g., yogurt ). The capsules must be opened carefully so that the contents do not spill or escape into the air. Hold the capsule with the cap facing up and pull the cap away from the body of the capsule. Use a small container for mixing. Give the mixture to the child as soon as possible, but no more than 30 minutes after mixing. Make sure the child eats the full amount of the mixture of food and capsule contents. Add another small amount (approximately 2 teaspoons) of the food to the empty mixing container, stirring to make sure there is no drug residue remaining in the container, and have the child eat the full amount again. The child should not be given any additional food for 2 hours. The doctor may also recommend this method of taking SUSTIVA for adults who cannot swallow capsules.
1 | Avoid giving the daily SUSTIVA dose within 1 hour after a feeding or meal. |
2 | Wash and dry your hands before and after preparing the capsule sprinkle. |
3 | Choose a soft food the child likes. Examples of soft foods are applesauce, grape jelly, yogurt, or infant formula. In a taste preference study in adults, SUSTIVA mixed with grape jelly received the best rating. |
4 | Place 1-2 teaspoons of the food in a small container (illustration a). | ||
5 | SUSTIVA capsules must be opened carefully over the food container, as described in steps 6-7, so that the contents do not spill. | ||
6 | With your hands over the container, hold the capsule with the cap facing up (see illustration b). | ||
7 | Carefully pull the cap away from the body of the capsule (illustration c). | ||
8 | Sprinkle the contents of the capsule on the food (illustration d). | ||
9 | If the daily dose consists of more than one capsule, follow steps 5-8 for each capsule. Do not add more food. | ||
10 | Mix the capsule contents and food together (illustration e). | ||
Steps 11-14 must be completed within 30 minutes of mixing: | |||
11 | Give the mixture of food and capsule contents to the child, making sure he or she eats the full amount (illustration f). | ||
12 | Add another small amount (approximately 2 teaspoons) of the food to the empty mixing container (illustration a). | ||
13 | Stir to make sure there is no drug residue remaining in the container (illustration e). | ||
14 | Have the child eat the full amount again (illustration f). | ||
15 | Do not give the child any additional food for 2 hours. |
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.
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.
skin rash
abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, problems with coordination or balance
stomach pain, diarrhoea, feeling sick (nausea), vomiting
itching
tiredness
feeling anxious, feeling depressed
Tests may show:
increased liver enzymes in the blood
increased trigycerides (fatty acids) in the blood
nervousness, forgetfulness, confusion, fitting (seizures), abnormal thoughts
blurred vision
a feeling of spinning or tilting (vertigo)
pain in the abdomen (stomach) caused by inflammation of the pancreas
allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome)
yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver
breast enlargement in males
angry behaviour, mood being affected, seeing or hearing things that are not really there (hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts, catatonia (condition in which the patient is rendered motionless and speechless for a period)
whistling, ringing or other persistent noise in the ears
tremor (shaking)
flushing
Tests may show:
increased cholesterol in the blood
itchy rash caused by a reaction to sunlight
liver failure, in some cases leading to death or liver transplant, has occurred with efavirenz.
Most cases occurred in patients who already had liver disease, but there have been a few reports
in patients without any existing liver disease.
unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly
suicide
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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 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.
Each SUSTIVA hard capsule contains 50 mg of the active substance efavirenz.
The other ingredients of the powder contained in the hard capsule are: sodium laurilsulfate, lactose monohydrate, magnesium stearate and sodium starch glycolate.
The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172), titanium
dioxide (E171) and silicon dioxide.
The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
SUSTIVA 50 mg hard capsules are supplied in bottles of 30 capsules.
Blanchardstown Corporate Park 2 Dublin 15
D15 T867
Ireland
Bristol-Myers Squibb S.r.l.
Contrada Fontana del Ceraso 03012 Anagni (FR)
Italy
Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL
United Kingdom
Aesica Pharmaceuticals GmbH - Monheim, Alfred-Nobel-Straße 10,
40789 Monheim, Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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