Package Insert: Information for the User

Efavirenz Teva 600 mg Film-Coated Tablets EFG

efavirenz

Read this package insert carefully before you start taking the medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Efavirenz Teva,which contains the active ingredient efavirenz,is part of a class of antiretroviral medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is areverse transcriptase inhibitor antiretroviral medication that acts against the infection caused by the human immunodeficiency virus (HIV-1)by reducing the amount of the virus in the blood.It is used in adults, adolescents, and children 3 years of age or older.

Your doctor has prescribed Efavirenz Teva because you have an HIV infection. Efavirenz Teva, taken in combination with other antiretroviral medications, reduces the amount of the virus in the blood.

This may strengthen your immune system and reduce the risk of developing diseases associated with HIV infection.

Do not take Efavirenz Teva

• if you are allergicto efavirenz or to any of the other ingredients of this medicine (listed in section 6). Contact your doctor or pharmacist for any queries you may have about this;
• if you have severe liver disease;
• if you have any heart problems, such as changes in heart rhythm or heart rate, or severe heart disease;
• 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;
• if you are currently takingany of the following medicines(see also ‘Other medicines and Efavirenz Teva’):
• astemizol or terfenadine(used to treat allergic symptoms)
• bepridil(used to treat heart disease)
• cisaprida(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, imipramine, amitriptyline or clomipramine(used to treat certain mental illnesses)
• elbasvir or grazoprevir(used to treat hepatitis C)
• St. John’s Wort(Hypericum perforatum) (a medicinal plant used to treat depression and anxiety)
• flecainide, metoprolol(used to treat irregular heartbeat)
• certain antibiotics(macrolides, fluoroquinolones, imidazoles)
• triazole antifungals
• certainantimalarial treatments
• metadone(used to treat opioid addiction)

If you are taking any of these medicines, inform your doctor immediately.Taking these medicines with Efavirenz Teva could produce severe and/or potentially fatal adverse reactions or prevent Efavirenz Teva from acting properly.

Warnings and precautions

Consult your doctor before starting to take Efavirenz Teva.

• Efavirenz Teva must be taken with other medicines that act against the HIV virus. If you are prescribed Efavirenz Teva because your current treatment has not prevented the virus from multiplying, you will need to receive another medicine that you have not taken before at the same time.
• This medicine is not a cure for HIV infection and you may continue to develop infections or other diseases associated with HIV infection.
• You must remain under the supervision of your doctor while taking Efavirenz Teva.
• Inform your doctor:
• sif you have a history of mental illness, including depression, or alcohol or drug abuse. Inform your doctor immediately if you feel depressed, have suicidal thoughts or strange thoughts (see section 4,Adverse reactions).
• if you have a history of seizures (fits or convulsions)or if you are being treated with anticonvulsants such as carbamazepine, phenobarbital and phenytoin. If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant in your blood to ensure that it is not affected while you are taking Efavirenz Teva. Your doctor may give you a different anticonvulsant.
• sif you have a history of liver disease,including chronic hepatitis. Patients with chronic hepatitis B or C and treated with a combination of antiretroviral medicines have a higher risk of developing severe and potentially fatal liver-related adverse reactions. Your doctor may perform blood tests to monitor the function of your liver or may change you to another medicine.If you have severe liver disease, do not take Efavirenz Teva(see section 2, Do not take Efavirenz Teva).
• if you have a heart problem, such as an abnormal electrical signal known as prolonged QT interval.

• Once you have started taking Efavirenz Teva, be careful with:
• signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams.These adverse reactions may begin on the first or second day of treatment and generally disappear within the first 2 to 4 weeks.
• any sign of skin rash.If you have any sign of severe rash, with blisters or fever, stop taking Efavirenz Teva and inform your doctor immediately. If you had a rash while taking any other NNRTI, you may have a high risk of developing a rash with Efavirenz Teva.
• any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of previous infections may appear shortly after starting antiretroviral treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight off infections that were present without any apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately.Aside from opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medicines to treat your HIV infection. Autoimmune disorders may appear many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the body trunk, palpitations, tremors or hyperactivity, inform your doctor immediately to receive the necessary treatment.
• bone problems. Some patients receiving combination antiretroviral treatment may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Among the numerous risk factors for developing this disease are the duration of combination antiretroviral treatment, the use of corticosteroids, alcohol consumption, severe immunodepression, and high body mass index. The symptoms of osteonecrosis are stiffness in the joints, pain and discomfort, especially in the hip, knee, and shoulder, and difficulty moving. If you notice any of these symptoms, inform your doctor.

Children and adolescents

Efavirenz Teva film-coated tablets are not recommendedfor children under 3 years or weighing less than 40kg.

Other medicines and Efavirenz Teva

You must not take Efavirenz Teva with certain medicines.These are listed under the title“Do not take Efavirenz Teva” at the beginning of section 2. This includes some common medicines and a medicinal plant (St. John’s Wort) that may produce severe interactions.

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may need to take any other medicine.

Efavirenz Teva may interact with other medicines,including herbal preparations such as extracts ofGinkgo biloba. As a result, the amount of Efavirenz Teva or other medicines in your blood may be affected. This may prevent the medicines from acting properly, or make one of their adverse reactions worse. In some cases, your doctor may need to adjust your dose or check your blood levels.It is essential to inform your doctor or pharmacist if you are taking any of the following:

• Other medicines used to treat HIV infection:
• protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, atazanavir boosted with ritonavir, saquinavir or fosamprenavir/saquinavir. Your doctor may consider giving you an alternative medicine or changing the dose of protease inhibitors.
• Maraviroc
• The tablet containing efavirenz, emtricitabine, and tenofovir should not be taken with Efavirenz Teva unless your doctor recommends it, as it contains efavirenz, the active ingredient of Efavirenz Teva.

• Medicines used to treat hepatitis C infection:boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.
• Medicines used to treat bacterial infections,including complexes to treat tuberculosis and Mycobacterium avium-related AIDS: clarithromycin, rifabutin, rifampicin.Your doctor may consider changing your dose or giving you 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 decrease 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 this with your doctor first.
• itraconazole. Efavirenz Teva may decrease the amount of itraconazole in your blood.
• posaconazole. Efavirenz Teva may decrease the amount of posaconazole in your blood.

• Medicines used to treat malaria:
• artemether/lumefantrine: Efavirenz Teva may decrease the amount of artemether/lumefantrine in your blood.
• atovaquone/proguanil: Efavirenz Teva may decrease the amount of atovaquone/proguanil in your blood.
• Praziquantel(a medicine used to treat parasitic infections). Efavirenz Teva may decrease the amount of praziquantel in your blood.
• Medicines used to treat seizures (anticonvulsants):carbamazepine, phenytoin, phenobarbital. Efavirenz Teva may decrease or increase the amount of anticonvulsant in your blood. Carbamazepine may make it less likely for Efavirenz Teva to act. Your doctor may consider giving you another anticonvulsant.
• Medicines used to lower cholesterol (also called statins):atorvastatin, pravastatin, simvastatin. Efavirenz Teva may decrease the amount of statins in your blood. Your doctor will check your cholesterol levels and may consider changing your dose of statin if necessary.
• Metadone(a medicine used to treat opioid addiction): your doctor may recommend an alternative treatment.
• Metamizol, a medicine used to treat pain and fever.
• Sertraline(a medicine used to treat depression): your doctor may need to change your dose of sertraline.
• Bupropion(a medicine used to treat depression or to help you stop smoking): your doctor may need to change your dose of bupropion.
• Diltiazem or similar medicines (called calcium channel blockersthat are medicines used normally to treat high blood pressure or heart problems):when you start treatment with Efavirenz Teva, your doctor may need to adjust your dose of calcium channel blocker.
• Immunosuppressants such as ciclosporin, sirolimus, or tacrolimus(medicines used to prevent rejection in organ transplants): when you start or stop taking Efavirenz Teva, your doctor will closely monitor your blood levels of immunosuppressants and may need to adjust your dose.
• Contraceptives, such as oral contraceptives, injectable contraceptives (for example, Depo-Provera) or implantable contraceptives (for example, Implanon):You must also use a reliable barrier contraceptive method (see Pregnancy, breastfeeding, and fertility). Efavirenz Teva may make hormonal contraceptives less effective. There have been pregnancies in women taking Efavirenz Teva while using an implantable contraceptive, although it has not been established that Efavirenz Teva treatment caused the contraceptive failure.
• Warfarin or acenocoumarol(a medicine used to reduce blood clotting): your doctor may need to change your dose of warfarin or acenocoumarol.
• Extracts ofGinkgo biloba(a herbal preparation)
• Medicines affecting 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 drinks

Taking Efavirenz Teva on an empty stomach may reduce adverse reactions.Avoid taking grapefruit juice while taking Efavirenz Teva.

Pregnancy, breastfeeding, and fertility

Women should not become pregnant during treatmentwith Efavirenz Teva or in the12 weeks following treatment.Your doctor may ask you to have a pregnancy test to ensure that you are not pregnant before starting treatment with Efavirenz Teva.

If you could become pregnant while taking Efavirenz Tevayou must always use a reliable barrier contraceptive method (such as a condom) together with other contraceptive methods, including oral contraceptives or other hormonal contraceptives (such as implants, injections). Efavirenz may remain in your blood for some time after stopping treatment. Therefore, you must continue to use contraceptive methods for about 12 weeks after stopping treatment with Efavirenz Teva.

Inform your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant, you should only take Efavirenz Teva if both you and your doctor decide that it is clearly necessary. Ask your doctor or pharmacist for advice before taking any medicine.

Severe malformations have been observed in animal fetuses and newborns whose mothers were treated with efavirenzor with a medicine containing a combination of efavirenz, emtricitabine, and tenofovirduring pregnancy. If you have taken Efavirenz Tevaor the tablet containing the combination of efavirenz, emtricitabine, and tenofovirduring pregnancy, your doctor may ask you to have periodic blood tests and other diagnostic tests to monitor the development of your baby.

Do not breastfeed your childif you are taking Efavirenz Teva.

It is not recommendedthat women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.

If you are breastfeeding or plan to breastfeed,you must consult your doctoras soon as possible.

Driving and operating machines

Efavirenz Teva contains efavirenz and may produce dizziness, concentration difficulties, and drowsiness. If you notice these symptoms, do not drive or operate tools or machines.

Efavirenz Teva contains lactose

This medicine contains 9.98mg of lactose (as monohydrate)per tablet.

If your doctor has told you that you are intolerant to certain sugars, consult with him before taking this medicine.

Efavirenz Teva contains sodium

This medicine contains less than 1mmol of sodium (23mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will give you instructions for taking the appropriate dose.

• The dose for adults is 600 mg once a day.
• You may need to increase or decrease the dose of Efavirenz Teva if you are also taking certain medications (see Taking Efavirenz Teva with Other Medications).
• Efavirenz Teva is administered orally. It is recommended to take it on an empty stomach and preferably before going to bed. This may make some side effects (e.g., dizziness, drowsiness) less problematic. An empty stomach is typically defined as 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 should never be used as the only medication for HIV treatment. It must always be taken in combination with other HIV medications.

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 or more is 600 mg once a day.

If You Take More Efavirenz Teva Than You Should

If you take too much Efavirenz Teva, contact your doctor or go to the nearest hospital. Keep the medication packaging with you, so you can easily describe what you have taken.

If You Forget to Take Efavirenz Teva

Try not to miss any doses. If you do , take the next dose as soon as possible, but do not take a double dose to compensate for the missed doses. If you need help scheduling better times to take the medication, consult your doctor or pharmacist.

If You Interrupt Treatment with Efavirenz Teva

When Your Efavirenz Teva Package is Almost Empty , request more from your doctor or pharmacist. This is extremely important, because the virus amount may start to increase if you stop taking the medication, even for a short time. If this happens, the virus may be more difficult to treat.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

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

When treating HIV infection, it is not always possible to say which unwanted side effects have been caused by Efavirenz Teva or by other medicines being taken at the same time or by the HIV disease itself.

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

The most relevant unwanted side effects reported from the use of efavirenz with other HIV medicines are skin rash and nervous system symptoms.

If you experience a rash, consult your doctor, as some rashes can be serious; however, most cases of rash disappear without the need to change treatment with Efavirenz Teva. Cases of rash were more frequent in children than in adults treated with efavirenz.

Nervous system symptoms usually occur at the start of treatment, but generally decrease during the first weeks. In one study, nervous system symptoms occurred frequently during the first 1-3 hours after taking a dose. If these symptoms affect you, your doctor may suggest that you take Efavirenz Teva at bedtime and on an empty stomach. Some patients experience more severe symptoms that can affect mood or thought processes. In fact, some patients have committed suicide. These problems usually occur more often in patients with a history of mental illness. Inform your doctor immediately if you experience these symptoms or any side effect while taking Efavirenz Teva.

Inform your doctor if you notice any of these side effects:

Very common (affects more than 1 in 10 patients)

• skin rash

Common (affects between 1 and 10 in 100 patients)

• abnormal dreams, concentration disorders, dizziness, headaches, difficulty sleeping, drowsiness, coordination or balance problems
• stomach pain, diarrhea, nausea, vomiting
• itching
• fatigue
• feeling anxious, feeling depressed

Tests may show:

• increased liver enzymes in the blood
• increased triglycerides (fats) in the blood

Uncommon (affects between 1 and 10 in 1,000 patients)

• nervousness, amnesia, confusion, convulsions, abnormal thoughts
• blurred vision
• sensation of movement or tilting (dizziness)
• abdominal pain (stomach) caused by pancreatitis inflammation
• severe skin reactions (erythema multiforme, Stevens-Johnson syndrome) that can cause skin and eye discoloration, itching, or abdominal pain (stomach) caused by liver inflammation
• breast enlargement in men
• colicky behavior, mood affected, seeing or hearing things that are not there (hallucinations), mania (a condition characterized by overactivity, euphoria, or irritability), paranoia, suicidal thoughts, catatonia (a condition in which the patient remains immobile and silent for a period of time)
• whistling or other continuous sounds in the ears
• tremors (shaking)
• flushing

Tests may show:

• increased cholesterol in the blood

Rare (affects between 1 and 10 in 10,000 patients)

• skin rash caused by a reaction to sunlight
• liver failure, which in some cases can cause death or liver transplant. In most cases, it occurred in patients who already had liver disease, but there have been some reports in patients without pre-existing liver disease.
• unexplained feelings of anxiety that are not associated with hallucinations, but may be difficult to think clearly and sensibly
• suicide

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report themdirectly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Efavirenz Teva

• Each film-coated tablet of Efavirenz Teva contains 600 mg of the active ingredient efavirenz.

• The other components are microcrystalline cellulose, hydroxypropylcellulose, sodium lauryl sulfate, sodium glycolate (Type A) starch, poloxamer 407, and magnesium stearate in the core. The film-coating component contains hypromellose, lactose monohydrate, titanium dioxide, macrogol/PEG 3350, triacetin, and yellow iron oxide.

Appearance of the product and contents of the pack

• Film-coated tablet: yellow film-coated tablet, capsule-shaped, engraved with “Teva” on one side and “7541” on the other.
• Efavirenz Teva is available in pack sizes of 30, 90 film-coated tablets or 30x1/90x1 film-coated tablets (in perforated unit dose blisters) or a multi-pack or a cardboard pack containing 90 film-coated tablets (3 packs of 30x1 film-coated tablets). Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Responsible Person

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/.