Efavirenz Teva
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 Efavirenz Teva is and what it is used for
What you need to know before you take Efavirenz Teva
How to take Efavirenz Teva
Possible side effects
How to store Efavirenz Teva
Contents of the pack and other information
Efavirenz Teva, 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 years of age and older.
Your doctor has prescribed Efavirenz Teva for you because you have HIV infection. Efavirenz Teva 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.
St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
certain antimalarial treatments
Talk to your doctor before taking Efavirenz Teva
You must remain under the care of your doctor while taking Efavirenz Teva.
- if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
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. 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.
Efavirenz Teva film-coated tablets are not recommended for children under the age of 3 years or weighing less than 40 kg.
Efavirenz Teva may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. As a result, the amounts of Efavirenz Teva 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 Efavirenz Teva unless recommended by your doctor since it contains efavirenz, the active ingredient of Efavirenz Teva.
- Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.
voriconazole. Efavirenz Teva may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of efavirenz 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. Efavirenz Teva may reduce the amount of itraconazole in your blood.
posaconazole. Efavirenz Teva may reduce the amount of posaconazole in your blood.
artemether/lumefantrine: Efavirenz Teva may reduce the amount of artemether/lumefantrine in your blood
atovaquone/proguanil: Efavirenz Teva may reduce the amount of atovaquone/proguanil in your blood.
Efavirenz Teva 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.
- Bupropion (a medicine used to treat depression or to help you stop smoking): your doctor may need to change your dose of bupropion.
prevent organ transplant rejection): when you start or stop taking Efavirenz Teva, your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
Ginkgo biloba extracts (a herbal preparation)
Taking Efavirenz Teva on an empty stomach may reduce the undesirable effects. Grapefruit juice should be avoided when taking Efavirenz Teva.
for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking Efavirenz Teva.
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 Efavirenz Teva 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.
This medicine contains 9.98 mg lactose (as monohydrate) per tablet.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium- free’.
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 Efavirenz Teva may need to be increased or decreased if you are also taking certain medicines (see Other medicines and Efavirenz Teva).
Efavirenz Teva is for oral use. It 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 tablet be swallowed whole with water.
Efavirenz Teva must be taken every day.
Efavirenz Teva should never be used alone to treat HIV. It must always be taken in combination with other anti-HIV medicines.
Efavirenz Teva film-coated tablets are not suitable for children weighing less than 40 kg.
The dose for children weighing 40 kg or more is 600 mg once daily.
If you take too much Efavirenz Teva, 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.
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 Efavirenz Teva 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 efavirenz 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 Efavirenz Teva. Rash was more common in children than in adults treated with efavirenz.
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 Efavirenz Teva 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 Efavirenz Teva.
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 triglycerides (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 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.
Each Efavirenz Teva film-coated tablet contains 600 mg of the active substance efavirenz.
The other ingredients are cellulose microcrystalline, hydroxypropylcellulose, sodium laurilsulfate, sodium starch glycolate (Type A), poloxamer 407 and magnesium stearate in the core. The film-coating agent contains hypromellose, lactose monohydrate, titanium dioxide, macrogol/PEG 3350, triacetin and iron oxide yellow.
Film-coated tablet: yellow, capsule-shaped, film-coated tablet debossed with “Teva” on one side and “7541” on the other
Efavirenz Teva is available in pack sizes of 30, 90 film-coated tablets or 30 x 1 / 90 x 1
film-coated tablets (in perforated unit dose blisters) or a multi-pack bundle or carton containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablet). Not all pack sizes may be marketed.
Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 | Lietuva UAB Teva Baltics Tel: +370 52660203 |
България Тева Фарма ЕАД Тел: +359 24899585 | Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 38207373 |
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 | Magyarország Teva Gyógyszergyár Zrt. Tel: +36 12886400 |
Danmark Teva Denmark A/S Tlf: +45 44985511 | Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 |
Deutschland TEVA GmbH Tel: +49 73140208 | Nederland Teva Nederland B.V. Tel: +31 8000228400 |
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 | Norge Teva Norway AS Tlf: +47 66775590 |
Ελλάδα Specifar A.B.E.E. Τηλ: +30 2118805000 | Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
España Teva Pharma, S.L.U. Tel: +34 913873280 | Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
France Teva Santé Tél: +33 155917800 | Portugal Teva Pharma - Produtos Farmacêuticos, Lda. Tel: +351 214767550 |
Hrvatska Pliva Hrvatska d.o.o. Tel: + 385 13720000 | România Teva Pharmaceuticals S.R.L. Tel: +40 212306524 |
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390 |
Ísland Teva Pharma Iceland ehf. Sími: +354 5503300 | Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 |
Κύπρος Specifar A.B.E.E. Ελλάδα Τηλ: +30 2118805000 | Sverige Teva Sweden AB Tel: +46 42121100 |
Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |