Efavirenz Teva

Package leaflet: Information for the user

Efavirenz Teva 600 mg film-coated tablets

efavirenz
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Efavirenz Teva is and what it is used for
2. What you need to know before taking Efavirenz Teva
3. How to take Efavirenz Teva
4. Possible side effects
5. How to store Efavirenz Teva
6. Contents of the pack and other information

1. What Efavirenz Teva is and what it is used for

Efavirenz Teva contains the active substance efavirenz and 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 virus in the blood. It is used in adults, adolescents, and children from 3 years of age onwards.
Your doctor has prescribed Efavirenz Teva because you have HIV infection. When taken in combination with other antiretroviral medicines, Efavirenz Teva reduces the amount of virus in the blood. This will strengthen your immune system and reduce the risk of developing HIV-related illnesses.

2. What you need to know before taking Efavirenz Teva

Do not take Efavirenz Teva

• if you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6). Consult your doctor or pharmacist for advice.
• if you have severe liver disease.
• if you have a heart condition, such as an abnormal heart rhythm or heartbeat frequency, a slow heartbeat, or severe heart disease.
• if any of your family members (parents, grandparents, siblings) have suddenly died due to a heart problem or were born with heart defects.
• if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
• if you are currently taking any of the following medicines (also see “Other medicines and Efavirenz Teva”):
• astemizole or terfenadine (used to treat allergy symptoms)
• bepridil (used to treat heart disorders)
• cisapride (used to treat heartburn)
• ergot alkaloids (e.g., ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headache)
• midazolam or triazolam (used to help you sleep)
• pimozide, imipramine, amitriptyline, or clomipramine (used to treat certain mental conditions)
• elbasvir or grazoprevir (used to treat hepatitis C)
• St. John’s wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
• flecainide, metoprolol (used to treat irregular heartbeat)
• some antibiotics (macrolides, fluoroquinolones, imidazoles)
• triazole antifungal agents
• some antimalarial treatments
• methadone (used to treat opioid dependence)

If you are taking any of these medicines, tell your doctor immediately. Taking these
medicines together with Efavirenz Teva may result in serious and/or potentially fatal side effects or may
prevent Efavirenz Teva from working properly.

Warnings and precautions
Talk to your doctor before taking Efavirenz Teva

• Efavirenz Teva must always be taken together with other medicines that act against the HIV virus. If you are starting Efavirenz Teva because your current treatment has not prevented the virus from multiplying, you must also start taking another medicine alongside Efavirenz Teva that you have never taken before.

• This medicine is not a cure for HIV infection, and you may still develop infections or other AIDS-related diseases.

• While taking Efavirenz Teva, you must remain under medical supervision.

• Tell your doctor:

• if you have had mental health problems, including depression, or substance or alcohol abuse. Inform your doctor immediately if you feel depressed, have suicidal thoughts, or experience unusual thoughts (see section 4, Possible side effects).

• if you have had seizures (fits or convulsions) or have been treated with anticonvulsants such as carbamazepine, phenobarbital, or phenytoin. If you are taking any of these medicines, your doctor may need to monitor the level of anticonvulsant in your blood to ensure it is not altered while taking Efavirenz Teva. Your doctor may prescribe a different anticonvulsant.

• if you have had liver disease, including active chronic hepatitis. Patients with chronic hepatitis B or C who are treated with a combination of antiretroviral medicines have an increased risk of serious and potentially fatal liver problems. Your doctor may perform blood tests to monitor liver function or prescribe another medicine. Do not take Efavirenz Teva if you have severe liver disease (see section 2, Do not take Efavirenz Teva).

• if you have heart disorders, such as an abnormal electrical signal known as QT interval prolongation.

• When starting Efavirenz Teva, be aware of:

• dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or strange dreams. These side effects may begin within the first one or two days of treatment and usually disappear after the first 2–4 weeks.

• any signs of skin rash. If you notice any signs of a severe rash with skin eruption or fever, stop taking Efavirenz Teva and inform your doctor immediately. If you previously developed a rash while taking another non-nucleoside reverse transcriptase inhibitor, you may be at high risk of developing a rash with Efavirenz Teva.

• any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, allowing the body to fight infections that may have been present without clear symptoms. If you notice any signs of infection, inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (a condition where the immune system attacks healthy body tissue) may also occur after starting treatment for HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading toward the trunk, palpitations, tremor, or hyperactivity, inform your doctor immediately to receive necessary treatment.

• bone problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Duration 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 condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in hips, knees, and shoulders) and difficulty moving. Contact your doctor if you experience any of these symptoms.

Children and adolescents
Efavirenz Teva film-coated tablets are not recommended for children under 3 years of age or weighing less than 40 kg.

Other medicines and Efavirenz Teva
You must not take Efavirenz Teva with certain medicines. These are listed at the beginning of section 2: Do not take Efavirenz Teva. Included among these are some common medicines and a herbal remedy (St. John’s wort) that may cause serious interactions.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Efavirenz Teva may interact with other medicines, including herbal remedies such as Ginkgo biloba extracts. This may alter the levels of Efavirenz Teva or other medicines in your blood. This could prevent the medicines from working properly or worsen side effects. In some cases, your doctor may need to adjust the dose or monitor blood levels. It is important to inform your doctor or pharmacist if you are taking:

• Other medicines used for HIV infection:
• protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir-boosted atazanavir, saquinavir, or fosamprenavir/saquinavir. Your doctor may decide to prescribe an alternative medicine or adjust the dose of protease inhibitors.
• maraviroc.
• a fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir must not be taken with Efavirenz Teva unless specifically recommended by your doctor, as it contains efavirenz, the active substance in Efavirenz Teva.
• Medicines used to treat hepatitis C virus infection: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.
• Medicines used to treat bacterial infections, including tuberculosis and AIDS-related Mycobacterium avium complex: clarithromycin, rifabutin, rifampicin. Your doctor may decide to change the dose or prescribe an alternative antibiotic. Additionally, your doctor may prescribe a higher dose of Efavirenz Teva.
• Medicines used to treat fungal infections (antifungals):
• voriconazole. Efavirenz Teva may reduce the amount of voriconazole in the blood, and voriconazole may increase the amount of efavirenz in the blood. If you take these two medicines together, the dose of voriconazole should be increased and the dose of efavirenz should be reduced. Check with your doctor first.
• itraconazole. Efavirenz Teva may reduce the amount of itraconazole in the blood.
• posaconazole. Efavirenz Teva may reduce the amount of posaconazole in the blood.
• Medicines used to treat malaria:
• artemether/lumefantrine: Efavirenz Teva may reduce the amount of artemether/lumefantrine in the blood.
• atovaquone/proguanil: Efavirenz Teva may reduce the amount of atovaquone/proguanil in the blood.
• Praziquantel (a medicine used to treat parasitic infections). Efavirenz Teva may reduce the amount of praziquantel in the blood.
• Medicines used to treat seizures/convulsions (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz Teva may reduce or increase the amount of anticonvulsant in the blood. Carbamazepine may reduce the effectiveness of Efavirenz Teva. Your doctor may decide to prescribe a different anticonvulsant.
• Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin. Efavirenz Teva may reduce the amount of statins in the blood. Your doctor will monitor your cholesterol levels and may consider adjusting the statin dose if necessary.
• Methadone (a medicine used to treat opioid dependence): your doctor may recommend an alternative treatment.
• Metamizole: a medicine used to treat pain and fever.
• Sertraline (a medicine used to treat depression): your doctor may adjust the dose of sertraline.
• Bupropion (a medicine used to treat depression or help you quit smoking): your doctor may adjust the dose of bupropion.
• Diltiazem or similar medicines (called calcium channel blockers, commonly used to treat high blood pressure or heart problems): when starting Efavirenz Teva, your doctor may need to adjust the dose of the calcium channel blocker.
• Immunosuppressants such as ciclosporin, sirolimus, or tacrolimus (medicines used to prevent organ transplant rejection): when starting or stopping Efavirenz Teva, your doctor will closely monitor your immunosuppressant blood levels and may need to adjust the dose.
• Hormonal contraceptives, such as birth control pills, injectable contraceptives (e.g., Depo-Provera), or implant contraceptives (e.g., Implanon): you must use a reliable mechanical contraceptive (see Pregnancy, breastfeeding, and fertility). Efavirenz Teva may make hormonal contraceptives less effective. Pregnancies have occurred in women using implant contraceptives while taking Efavirenz Teva, although it has not been established that Efavirenz Teva caused contraceptive failure.
• Warfarin or acenocoumarol (medicines used to reduce blood clots): your doctor may adjust the dose of warfarin or acenocoumarol.
• Ginkgo biloba extracts (a herbal remedy).
• Medicines that affect heart rhythm:
• Medicines used to treat heart rhythm problems: such as flecainide or metoprolol.
• Medicines used to treat depression: such as imipramine, amitriptyline, or clomipramine.
• Antibiotics, including the following types: macrolides, fluoroquinolones, or imidazoles.

Efavirenz Teva with food and drink
Taking Efavirenz Teva on an empty stomach may reduce side effects. Grapefruit juice must be avoided when taking Efavirenz Teva.

Pregnancy, breastfeeding, and fertility
Women must not become pregnant during treatment with Efavirenz Teva and for the following 12 weeks. Before starting treatment with Efavirenz Teva, your doctor may require a pregnancy test to confirm you are not pregnant.
If you are capable of becoming pregnant during treatment with Efavirenz Teva, you must use a reliable mechanical contraceptive (e.g., a condom) in addition to other contraceptive methods such as oral contraceptives (the pill) or other hormonal methods (e.g., subcutaneous implant, injection). For a certain period after stopping treatment, efavirenz may remain in the bloodstream. Therefore, after discontinuing Efavirenz Teva, you must continue using contraceptives as described above for 12 weeks.
Tell your doctor immediately if you are pregnant or plan to become pregnant.
If you are pregnant, you should take Efavirenz Teva only if you and your doctor decide it is absolutely necessary. Consult your doctor or pharmacist before taking any medicine.
Severe congenital malformations have been observed in fetuses of animals and in newborns of women treated with efavirenz or a combination medicine containing efavirenz, emtricitabine, and tenofovir during pregnancy. If you took Efavirenz Teva or the combination tablet containing efavirenz, emtricitabine, and tenofovir during pregnancy, your doctor may require regular blood tests and other diagnostic examinations to monitor your baby’s development.
If you are taking Efavirenz Teva, you must not breastfeed.
Breastfeeding is not recommended for HIV-positive women because HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or considering breastfeeding, discuss this with your doctor as soon as possible.

Driving and using machines
Efavirenz Teva contains efavirenz and may cause dizziness, difficulty concentrating, and drowsiness. If you experience these symptoms, do not drive and do not operate tools or machinery.

Efavirenz Teva contains lactose
This medicine contains 9.98 mg of lactose (as monohydrate) per tablet.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Efavirenz Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free”.

3. How to take Efavirenz Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Your doctor will determine the appropriate dose for you.

• The adult dose is 600 mg once daily.
• If you are also taking other medicines, the dose of Efavirenz Teva may need to be increased or decreased (see Other medicines and Efavirenz Teva).
• Efavirenz Teva is for oral use. It is recommended to take Efavirenz Teva on an empty stomach, preferably before going to bed. This may reduce certain undesirable effects (for example, dizziness, drowsiness). An empty stomach is generally considered to be 1 hour before or 2 hours after a meal.
• It is recommended to swallow the tablet whole with water.
• Efavirenz Teva must be taken every day.
• Efavirenz Teva must never be used alone to treat HIV, but always in combination with other anti-HIV medicines.

Use in children and adolescents

• Efavirenz Teva film-coated tablets are not suitable for children weighing less than 40 kg.
• The dose for children weighing 40 kg and above is 600 mg once daily.

If you take more Efavirenz Teva than you should
If you have taken too much Efavirenz Teva, contact your doctor or the nearest emergency department immediately.
Take the medicine container with you to help describe what you have taken.

If you forget to take Efavirenz Teva
Try not to miss any doses. If you do happen to miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for the missed one. If you need advice on the best times to take Efavirenz Teva, consult your doctor or pharmacist.

If you stop taking Efavirenz Teva
When your supply of Efavirenz Teva starts to run low, get a new supply from your doctor or pharmacist: this is very important because if you stop taking the medicine, even for a short time, the virus may start multiplying again, making it more difficult to control.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

When treating HIV infection, it is not always possible to determine whether certain side effects are caused by Efavirenz Teva, by other medicines the patient is taking, or by HIV itself.

During HIV treatment, an increase in weight and in blood lipid and glucose levels may occur. This is partly related to the recovery of health status and lifestyle, and in the case of blood lipids, sometimes also to the HIV medicines themselves. Your doctor will monitor these changes.

The most notable side effects reported with efavirenz, in combination with other anti-HIV medicines, are skin rashes and nervous system symptoms.

Always consult your doctor if you develop skin rashes, as some of them may be serious. However, most rashes resolve without the need to modify treatment with Efavirenz Teva. Skin rashes have been more frequent in children treated with efavirenz than in adults.

Nervous system symptoms tend to occur soon after starting treatment but usually diminish within the first few weeks. In one study, nervous system symptoms often occurred within the first 3 hours after administration. If you experience these symptoms, your doctor may suggest taking Efavirenz Teva at bedtime and on an empty stomach. Some patients may experience more severe symptoms that can affect their mood or ability to think clearly. In some cases, patients have committed suicide. These problems tend to occur more frequently in patients with a history of mental illness. Always inform your doctor immediately if you experience these symptoms or any other side effects while taking Efavirenz Teva.

Inform your doctor if you notice any of the following side effects:

Very common (affects more than 1 in 10 people)

• Skin rash

Common (affects from 1 to 10 in 100 people)

• Disturbed dreams, difficulty concentrating, dizziness, headache, insomnia, drowsiness, problems with coordination or balance
• Stomach ache, diarrhoea, feeling unwell (nausea), vomiting
• Itching
• Fatigue
• Feeling anxious, feeling depressed

Tests may show:

• Increased liver enzymes in the blood
• Increased triglycerides (fatty acids) in the blood

Uncommon (affects from 1 to 10 in 1,000 people)

• Nervousness, amnesia, confusion, seizures (convulsions), abnormal thoughts
• Blurred vision
• Sensation of spinning or swaying (vertigo)
• Abdominal (stomach) pain caused by inflammation of the pancreas
• Allergic reaction (hypersensitivity) which may cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome)
• Yellowing of the skin or eyes, itching or abdominal (stomach) pain caused by inflammation of the liver
• Breast enlargement in men
• Aggressive behaviour, mood disturbances, seeing or hearing things that are not really there (hallucinations), mania (a mental condition characterised by episodes of hyperactivity, elation, or irritability), paranoia, suicidal thoughts, catatonia (a condition in which the patient is immobile and mute for a period)
• Ringing, buzzing, or other persistent noises in the ears
• Tremor
• Redness

Tests may show:

• Increased cholesterol in the blood

Rare (affects from 1 to 10 in 10,000 people):

• Itchy rash caused by a reaction to sunlight
• Liver dysfunction has occurred with the use of efavirenz, which in some cases has led to death or liver transplantation. In many cases, patients already had liver disease, but there have been some reports in patients without pre-existing liver disease.
• Unexplained sense of unease not associated with hallucinations but which may make it difficult to think clearly or normally
• Suicide

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system detailed in Annex V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efavirenz Teva

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 the carton after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Efavirenz Teva contains

• Each Efavirenz Teva film-coated tablet contains 600 mg of the active substance efavirenz.
• The other components of the tablet core are microcrystalline cellulose, hydroxypropylcellulose, sodium lauryl sulfate, sodium carboxymethylstarch (Type A), poloxamer 407 and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, macrogol/PEG 3350, triacetin and iron oxide yellow.

Description of the appearance of Efavirenz Teva and package contents

• Film-coated tablet: yellow, capsule-shaped, film-coated tablet, marked with "Teva" on one side and "7541" on the other side.
• Efavirenz Teva is available in packs of 30 or 90 film-coated tablets or 30 x 1 / 90 x 1 film-coated tablets (in unit dose perforated blisters), or in multiple pack cartons containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablets). Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva BV, Swensweg 5, 2031GA Haarlem, The Netherlands
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.