Efavirenz Teva 600 mg film-coated tablets

Introduction

Package Leaflet: Information for the User

Efavirenz Teva 600 mg film-coated tablets EFG

efavirenz

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 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.

Contents of the pack and other information

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

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

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

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

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

2. What you need to know before you take Efavirenz Teva

Do not take Efavirenz Teva

• to efavirenz or any of the other ingredients of this medicine (listed in section 6). Contact your doctor or pharmacist for any query you may have;
• ;
• any of the following medicines (see also ‘Other medicines and Efavirenz Teva’):
• astemizole or terfenadine(used to treat allergic symptoms)
• bepridil(used to treat heart disease)
• cisapride(used to treat stomach acid)
• ergot alkaloids(e.g., 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 herbal medicine used for depression and anxiety)
• flecainide, metoprolol(used to treat irregular heartbeat)
• certain antibiotics(macrolides, fluoroquinolones, imidazole)
• antifungal agents (triazoles)
• certain antimalarial treatments
• methadone(used to treat opioid addiction)

If you are taking any of these medicines, inform your doctor immediately.Taking these medicines with Efavirenz Teva could cause serious and/or potentially life-threatening side effects or prevent Efavirenz Teva from working properly.

Warnings and precautions

Consult your doctor before starting 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 multiplication of the virus, you will need to take another medicine that you have not taken before at the same time.
• This medicine is not a cure for HIV infectionand you may continue to develop infections or other diseases associated with HIV.
• You must remain under the supervision of your doctor while taking Efavirenz Teva.
• Tell your doctor:
• , including depression, or alcohol or drug abuse. Inform your doctor immediately if you feel depressed, have suicidal thoughts, or strange thoughts (see section 4, Possible side effects).
• 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 taking Efavirenz Teva. Your doctor may give you a different anticonvulsant.
• , including chronic active hepatitis. Patients with chronic hepatitis B or C and treated with a combination of antiretroviral medicines have a higher risk of developing serious and potentially life-threatening liver side effects. Your doctor may perform blood tests to monitor your liver function or may switch you to another medicine. If you have severe liver disease, do not take Efavirenz Teva(see section 2, Do not take Efavirenz Teva).

• Once you have started taking Efavirenz Teva, be careful with:
• signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams.These side effects may start on the first or second day of treatment and usually 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 inflammation of previous infections may appear shortly after starting anti-HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which enables it to fight infections that were present without any apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to 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 for the treatment of your HIV infection. Autoimmune disorders may appear many months after the start of treatment. If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending towards the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.
• bone problems.Some patients who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combination antiretroviral therapy, 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 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 under the heading “Do not take Efavirenz Teva” at the beginning of Section 2. They include some common medicines and a herbal medicine (St. John's Wort) that may cause serious interactions.

Tell your doctoror 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 preparations such as Ginkgo bilobaextracts. As a result, the amount of Efavirenz Teva or other medicines in your blood may be affected. This may prevent the medicines from working properly or 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:

• Other medicines used for 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 the protease inhibitors.
• Maraviroc
• The tablet that contains efavirenz, emtricitabine, and tenofovir must not be taken with Efavirenz Teva unless your doctor recommends it, as it contains efavirenz, the active substance 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 combinations for treating tuberculosis and Mycobacterium avium complex (MAC) infection related to AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may consider changing the 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 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 reduce the amount of artemether/lumefantrine in your blood.
• atovaquone/proguanil: Efavirenz Teva may reduce the amount of atovaquone/proguanil in your blood.
• Praziquantel(a medicine used to treat parasitic infections). Efavirenz Teva may reduce 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 that Efavirenz Teva will work. Your doctor may consider giving you another anticonvulsant.
• Medicines used to lower blood fat (also called statins):atorvastatin, pravastatin, simvastatin. Efavirenz Teva may reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and consider changing the dose of your statin if necessary.
• Methadone(a medicine used to treat opioid addiction): your doctor may recommend alternative treatment.
• Metamizole, 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 blockers, which are medicines used 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 cyclosporine, 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.
• Hormonal contraceptives, such as birth control pills, injectable contraceptives (e.g., Depo-Provera), or contraceptive implants (e.g., Implanon):you should also use a reliable barrier contraceptive method (see Pregnancy, breast-feeding, and fertility). Efavirenz Teva may make hormonal contraceptives less effective. Pregnancies have occurred in women taking Efavirenz Teva while using a contraceptive implant, although it has not been established that treatment with Efavirenz Teva caused the contraceptive failure.
• Warfarin or acenocoumarol(a medicine used to prevent blood clots): your doctor may need to change your dose of warfarin or acenocoumarol.
• Extracts of Ginkgo biloba(a herbal preparation)
• Medicines with an impact on 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 imidazole.

Efavirenz Teva with food and drinks

Taking Efavirenz Teva on an empty stomach may reduce side effects. You should avoid grapefruit juice while taking Efavirenz Teva.

Pregnancy, breast-feeding, and fertility

Women must not become pregnant during treatmentwith Efavirenz Teva or in the 12 weeks following treatment.Your doctor may request a pregnancy test to ensure that you are not pregnant before starting treatment with Efavirenz Teva.

If you could become pregnant while taking Efavirenz Teva, you will need to use a reliable barrier contraceptive method (e.g., a condom) along with other contraceptive methods, including oral contraceptives or other hormonal contraceptives (e.g., 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.

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

Severe birth defects have been seen in animal fetuses and in newborns whose mothers were treated with efavirenz or a medicine that contains a combination of efavirenz, emtricitabine, and tenofovir during pregnancy. If you have taken Efavirenz Teva or the tablet that contains the combination of efavirenz, emtricitabine, and tenofovir during your pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor the development of your baby.

You must not breast-feed your childif you are taking Efavirenz Teva.

It is not recommendedthat HIV-positive women breast-feed their babies because HIV infection can be transmitted to the baby through breast milk.

If you are breast-feeding or thinking of breast-feeding,you must consultyour doctor as soon as possible.

Driving and using machines

Efavirenz Teva contains efavirenz and may cause dizziness, difficulty concentrating, and drowsiness.If you notice these symptoms, do not drive or use tools or machines.

Efavirenz Teva contains lactose

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

If your doctor has told you that you have an intolerance to some sugars,consult your doctor before taking this medicine.

Efavirenz Teva contains sodium

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

3. How to take Efavirenz Teva

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

• The dose for adults is 600 mg once a day.
• It may be necessary 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 bedtime. This can make some adverse effects (such as dizziness, drowsiness) cause fewer problems. An empty stomach is normally defined as 1 hour before or 2 hours after a meal.
• It is recommended to swallow the tablet whole with water.
• Efavirenz Teva should be taken every day.
• Efavirenz Teva should never be used as the only medication for the treatment of HIV. It should always be taken in combination with other anti-HIV medications.

Use in children and adolescents

Efavirenz Teva film-coated tablets are not suitable for children who weigh less than 40 kg.

• The dose for children who weigh 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 medicine package with you, so you can easily describe what you have taken.

If you forget to take Efavirenz Teva

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

If you stop treatment with Efavirenz Teva

When your supply of Efavirenz Teva is about to run out, ask your doctor or pharmacist for more. This is very important, because the amount of virus can start to increase if you stop taking the medication, even if it's only for a short time. If this happens, the virus may become more difficult to treat.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

When treating HIV infection, it's not always possible to say which unwanted effects have been caused by Efavirenz Teva or by other medications 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 the recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

The most relevant unwanted effects reported with the use of efavirenz in combination with other anti-HIV medications are skin rash and nervous system symptoms.

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

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

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

Very common (affect more than 1 in 10 patients)

• skin rash

Common (affect 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 of anxiety, feeling of depression

Lab tests may show:

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

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

• nervousness, amnesia, confusion, convulsions, abnormal thoughts
• blurred vision
• feeling of movement or tilting (vertigo)
• abdominal pain (stomach) caused by pancreas inflammation
• allergic reaction (hypersensitivity) that can cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome)
• yellowing of the skin and eyes, itching, or abdominal pain (stomach) caused by liver inflammation
• breast enlargement in men
• irritability, mood swings, seeing and hearing things that are not really there (hallucinations), mania (mental condition characterized by overactivity, euphoria, or irritability), paranoia, suicidal thoughts, catatonia (condition in which the patient remains immobile and speechless for a period of time)
• wheezing (high-pitched whistling sound when breathing), buzzing, or other continuous noise in the ears
• tremors (shakes)
• flushing

Lab tests may show:

• increase in blood cholesterol

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

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it's a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Efavirenz Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Efavirenz Teva

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

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

Appearance and package contents

• Film-coated tablet: yellow, capsule-shaped, film-coated tablet 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 multipack or carton containing 90 film-coated tablets (3 packs of 30x1 film-coated tablets). Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet

Other sources of information

Detailed information about this medication is available on the European Medicines Agency website http://www.ema.europa.eu/.