Label:information for the user

Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva 600 mg/200 mg/245 mg film-coated tablets EFG

Read this label carefully before starting to take this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult yourdoctororpharmacist.

-This medicine has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this label. See section 4.

1.What is Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva and how is it used

2.What you need to knowbeforestarting totake Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva

3.How to take Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva

4.Possible adverse effects

5.Storage of Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva

6.Contents of the package and additional information

Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva contains three active ingredientsthat are used to treat human immunodeficiency virus (HIV) infection.

- Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)

- Emtricitabina is a nucleoside reverse transcriptase inhibitor (NRTI)

- Tenofovir is a nucleotide reverse transcriptase inhibitor

Each of these active ingredients is also known as an antiretroviral medication, acting by interfering with the normal functioning of an enzyme (reverse transcriptase) essential for the virus to multiply.

Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva is a treatment for human immunodeficiency virus (HIV) infectionin adults aged 18 years or olderwho have been treated previously with other antiretroviral medications and have HIV-1 infection under control for at least three months. Patients should not have experienced failure of a previous HIV treatment.

Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Teva

• if you are allergicto efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients ofthis medicine (listed in section 6).

• if you have severe liver disease.

• if you have a heart condition, such as an abnormal heart rhythm called prolonged QT interval that puts you at high risk of serious heart rhythm problems (Torsade de Pointes).
• if any of your family members (parents, grandparents, brothers, or sisters) have died suddenly from a heart problem or were 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“Taking Efavirenz/Emtricitabina/Tenofovir disoproxil Teva with other medicines”:

• astemizole or terfenadine(used to treat hay fever or other allergies)
• bepridil(used to treat heart diseases)
• cisaprida(used to treat heartburn)
• elbasvir/grazoprevir(used to treat hepatitis C)
• alkaloids of ergot(such as ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and histamine headaches)
• midazolam or triazolam(used to help sleep)
• pimozide, imipramine, amitriptyline, or clomipramine(used to treat certain mental health problems)
• St. John's Wort(Hypericum perforatum) (herbal preparation used to treat depression and anxiety)
• voriconazole(used to treat fungal infections)
• flecainide, metoprolol(used to treat irregular heartbeats)
• certain antibiotics(macrolides, fluoroquinolones, imidazoles)
• triazole antifungals
• certain antimalarials
• methadone(used to treat opioid addiction).

??If you are taking any of these medicines, tell your doctor immediately.Taking these medicines withEfavirenz/Emtricitabina/Tenofovir disoproxil Tevamay cause severe or potentially life-threatening side effects or may cause these medicines to stop working properly.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeEfavirenz/Emtricitabina/Tenofovir disoproxil Teva.

• While taking this medicineyou can still transmit HIV to others,although effective antiretroviral treatment reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. This medicine is not a cure for HIV infection. While you are taking efavirenz/emtricitabine/tenofovir disoproxil, you may still experience infections or other diseases associated with HIV infection.
• While taking efavirenz/emtricitabine/tenofovir disoproxil, you must remain under your doctor's supervision.

• Consult your doctor:

• if you are taking other medicinesthat contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. Do not take this medicine with any of these medicines.

• if you have or have had kidney disease,or if your blood tests have shown problems with your kidneys. Efavirenz/emtricitabine/tenofovir disoproxil is not recommended if you have moderate to severe kidney disease.

Efavirenz/emtricitabine/tenofovir disoproxil may affect your kidneys. Before starting treatment, your doctor may ask you to have blood tests to check your kidney function. Your doctor may also ask you to have blood tests during treatment to monitor your kidneys.

Efavirenz/emtricitabine/tenofovir disoproxil is usually not taken with other medicines that can damage your kidneys (seeTaking Efavirenz/Emtricitabina/Tenofovir disoproxil Teva with other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.

• if you have a heart condition, such as an abnormal heart rhythm called prolonged QT interval.

• if you have a history of mental illness,including depression, or substance abuse. Tell your doctor immediately if you feel depressed, have suicidal thoughts, or have abnormal thoughts (see section 4,Adverse reactions).
• if you have a history of seizures (convulsions or fits)or if you are being treated with anticonvulsant therapy 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 it is not affected while taking efavirenz/emtricitabine/tenofovir disoproxil. Your doctor may prescribe a different anticonvulsant.

• if you have a history of liver disease, including active chronic hepatitis.Patients with liver disease, including chronic hepatitis B or C, treated with combination antiretrovirals, have a higher risk of severe and potentially life-threatening liver complications. Your doctor may perform blood tests to monitor your liver function or switch you to a different medicine.If you have severe liver disease, do not take efavirenz/emtricitabine/tenofovir disoproxil(see above, in section 2,Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Teva).

If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. Tenofovir disoproxil and emtricitabine, two of the active ingredients in Efavirenz/Emtricitabina/Tenofovir disoproxil Teva, have some activity against the hepatitis B virus, although emtricitabine is not authorized for the treatment of hepatitis B infection. Your symptoms of hepatitis may worsen after stopping efavirenz/emtricitabine/tenofovir disoproxil. Your doctor may perform blood tests at regular intervals to monitor your liver function (see section 3,Discontinuing treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Teva).

• Regardless of a history of liver disease, your doctor will consider regular blood tests to monitor your liver function.

• if you are over 65 years old.The number of patients over 65 years old who have been studied is insufficient. If you are over 65 years old and have been prescribed efavirenz/emtricitabine/tenofovir disoproxil, your doctor will monitor you closely.

• Once you start taking Efavirenz/Emtricitabina/Tenofovir disoproxil Teva, be aware of:

• dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams.These side effects may begin in the first 1 or 2 days of treatment and usually disappear after the first 2 to 4 weeks.

• any sign of skin rash.Efavirenz/emtricitabine/tenofovir disoproxil may cause skin rashes. If you notice any sign of a severe skin rash with blisters or fever, stop taking efavirenz/emtricitabine/tenofovir disoproxil and tell your doctor immediately. If you have had a skin rash while taking another NNRTI, you may be at higher risk of having a skin rash with efavirenz/emtricitabine/tenofovir disoproxil.

• any sign of inflammation or infection.In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, symptoms and signs 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, allowing it to fight off infections that were present without apparent symptoms. If you notice any symptoms of infection, please tell 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 start taking medicines to treat your HIV infection. Autoimmune disorders may appear many months after starting 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 trunk of the body, palpitations, tremors, or hyperactivity, report it to your doctor immediately to receive necessary treatment.

• Bone problems.Some patients receiving 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 numerous risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. The symptoms of osteonecrosis are: joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, tell your doctor.

Bone problems (manifesting as persistent bone pain or worsening and sometimes resulting in fractures) may also occur due to damage to renal tubular cells (see section 4,Adverse reactions).

Inform your doctor if you have bone pain or fractures.

Tenofovir disoproxil may also cause bone loss. The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

In general, the effects of tenofovir disoproxil on long-term bone health and the future risk of fractures in adult and pediatric patients are imprecise.

Inform your doctor if you know you have osteoporosis.

Patients with osteoporosis have a higher risk of fractures.

Children and adolescents

• Do not give efavirenz/emtricitabine/tenofovir disoproxil to children and adolescentsunder 18 years of age. The use ofefavirenz/emtricitabine/tenofovir disoproxilin children and adolescents has not yet been studied.

Taking Efavirenz/Emtricitabina/Tenofovir disoproxil Teva with other medicines

You should not take Efavirenz/Emtricitabina/Tenofovir disoproxil Teva with certain medicines.These are listed underDo not take Efavirenz/Emtricitabina/Tenofovir disoproxil Teva, at the beginning of section 2. Among these are some common medicines and some herbal preparations (including St. John's Wort) that may cause serious interactions.

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

In addition, do not take efavirenz/emtricitabine/tenofovir disoproxil with any other medicine that contains efavirenz (unless your doctor recommends it), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Inform your doctorif you are taking other medicines that may damage your kidneys. Examples include:

• aminoglycosides, vancomycin (antibiotics for bacterial infections)
• foscarnet, ganciclovir, cidofovir (medicines for viral infections)
• amphotericin B, pentamidine (medicines for fungal infections)
• interleukin-2 (to treat cancer)
• nonsteroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

Efavirenz/emtricitabine/tenofovir disoproxil may interact with other medicines, including herbal preparations such as Ginkgo biloba extract. This may result in the levels of efavirenz/emtricitabine/tenofovir disoproxil or other medicines in your blood being affected. This may prevent the medicines from working properly, or may worsen some side effects. In some cases, your doctor may need to adjust your dose or check blood levels.It is essential to inform your doctor or pharmacist if you are taking some of the following:

• Medicines that contain didanosine (for HIV infection):Taking efavirenz/emtricitabine/tenofovir disoproxil with other antiviral medicines that contain didanosine may increase didanosine levels in your blood and reduce CD4 cell counts. When taken together, medicines that contain tenofovir disoproxil and didanosine have been associated with rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) in some cases, fatal. Your doctor will carefully consider whether to treat you with medicines that contain tenofovir and didanosine.
• Other medicines used to treat HIV infection:Los following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or atazanavir boosted with ritonavir or saquinavir. Your doctor may consider prescribing a different medicine or adjusting the dose of protease inhibitors. Also, inform your doctor if you are taking maraviroc.
• Medicines used to treat hepatitis C infection:Glecaprevir/pibrentasvir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
• Medicines used to lower cholesterol (also called statins):Atorvastatin, pravastatin, simvastatin. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the levels of statins in your blood. Your doctor will check your cholesterol levels and consider adjusting the dose of statin, if necessary.
• Medicines used to treat seizures/convulsions (anticonvulsants):Carbamazepine, phenytoin, phenobarbital. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the levels of anticonvulsants in your blood. Carbamazepine may reduce the levels of efavirenz, one of the components of efavirenz/emtricitabine/tenofovir disoproxil, in your blood. Your doctor may need to consider prescribing a different anticonvulsant.
• Medicines used to treat bacterial infections,including tuberculosis and Mycobacterium avium complex (MAC) related to AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may need to consider adjusting the dose or prescribing an alternative antibiotic. Additionally, your doctor may consider prescribing an additional dose of efavirenz to treat your HIV infection.
• Medicines used to treat fungal infections (antimycotics):Itraconazole or posaconazole. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the levels of itraconazole or posaconazole in your blood. Your doctor may need to consider prescribing a different antimycotic.
• Medicines used to treat malaria:Atovacuone/proguanil or artemether/lumefantrine. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the levels of atovacuone/proguanil or artemether/lumefantrine in your blood.
• Birth control pills, an injectable contraceptive (e.g., Depo-Provera), or an implantable contraceptive (e.g., Implanon):You should also use a reliable barrier method of contraception (seePregnancy and breastfeeding). Efavirenz/emtricitabine/tenofovir disoproxil may affect the functioning of hormonal contraceptives. Cases of pregnancy have been reported in women taking efavirenz, a component of efavirenz/emtricitabine/tenofovir disoproxil, while using an implantable contraceptive, although it has not been established that efavirenz treatment was the cause of contraceptive failure.
• Sertraline, a medicine used to treat depression, as your doctor may need to adjust the dose of sertraline.
• Bupropion, a medicine used to treat depression or to help you quit smoking, as your doctor may need to adjust the dose of bupropion.
• Diltiazem or similar medicines (calcium channel blockers):When starting treatment with efavirenz/emtricitabine/tenofovir disoproxil, your doctor will need to adjust the dose of the calcium channel blocker.
• Medicines used to prevent organ rejection after transplantation (also called immunosuppressants)such as ciclosporin, sirolimus, or tacrolimus. Both when starting treatment with efavirenz/emtricitabine/tenofovir disoproxil and when stopping it, your doctor will closely monitor your blood levels of the immunosuppressant, possibly adjusting the dose you receive.
• Warfarin or acenocoumarol(medicines used to reduce blood clotting): Your doctor may need to adjust your dose of warfarin or acenocoumarol.
• Extracts of Ginkgo biloba(herbal preparation).
• Metamizole,a medicine used to treat pain and fever.
• Praziquantel, a medicine used to treat parasitic infections.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Women should not become pregnant during treatment with efavirenz/emtricitabine/tenofovir disoproxil or in the 12 weeks following.

Your doctor may ask you to have a pregnancy test to ensure you are not pregnant before starting treatment with efavirenz/emtricitabine/tenofovir disoproxil.

If you could become pregnant while taking efavirenz/emtricitabine/tenofovir disoproxil, you should use a reliable barrier method of contraception (e.g., a condom) together with other methods of contraception, including oral contraceptives or other hormonal contraceptives (e.g., implants, injections). Efavirenz, one of the active ingredients in efavirenz/emtricitabine/tenofovir disoproxil, may remain in your blood for some time after stopping treatment. Therefore, you should continue using contraceptive measures, as indicated above, for 12 weeks after stopping efavirenz/emtricitabine/tenofovir disoproxil.

Inform your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant, you should only take efavirenz/emtricitabine/tenofovir disoproxil if both you and your doctor decide it is clearly necessary.

Severe birth defects have been observed in animal fetuses and human newborns of women treated with efavirenz during pregnancy.

Consult your doctor or pharmacist before taking any medicine.

If you have taken efavirenz/emtricitabine/tenofovir disoproxil during pregnancy, your doctor may ask you to have blood tests and other diagnostic tests to monitor your baby's development. In children whose mothers took ITINs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Do not breastfeed your baby while taking efavirenz/emtricitabine/tenofovir disoproxil.HIV and the ingredients of efavirenz/emtricitabine/tenofovir disoproxil may pass into breast milk and cause severe harm to the baby.

Driving and operating machinery

Efavirenz/emtricitabine/tenofovir disoproxil may cause dizziness, difficulty concentrating, and drowsiness.If you are affected, do not drive and do not operate tools or machinery.

Efavirenz/Emtricitabina/Tenofovir disoproxil Teva contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

One tablet per day, taken orally. Efavirenz/emtricitabina/tenofovir disoproxil should be taken on an empty stomach (usually defined as one hour before or two hours after a meal) preferably at bedtime. This may make some of the adverse effects (e.g., dizziness, drowsiness) less problematic. Swallow efavirenz/emtricitabina/tenofovir disoproxil whole with a glass of water.

Efavirenz/emtricitabina/tenofovir disoproxil should be taken daily.

If your doctor decides to discontinue one of the components of efavirenz/emtricitabina/tenofovir disoproxil, they may give you efavirenz, emtricitabina, and/or tenofovir disoproxil separately or with other medications for the treatment of HIV infection.

If you take more Efavirenz/Emtricitabina/Tenofovir disoproxil Teva than you should

If you accidentally take too many tablets of efavirenz/emtricitabina/tenofovir disoproxil, you may be at a higher risk of experiencing possible adverse effects with this medication (see section 4, Possible Adverse Effects). Consult your doctor or advise you to go to the nearest emergency service. Bring the packaging of tablets with you so that you can easily describe what you have taken.

If you forgot to take Efavirenz/Emtricitabina/Tenofovir disoproxil Teva

It is essential that you do not forget a dose of efavirenz/emtricitabina/tenofovir disoproxil.

If you forget a dose of efavirenz/emtricitabina/tenofovir disoproxil within 12 hours of when you normally take it, take it as soon as possible, and then take your next dose at your usual time.

If it is almost time for your next dose (less than 12 hours),do not take the missed dose. Wait and take the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

If you vomit the tablet (within 1 hour after taking efavirenz/emtricitabina/tenofovir disoproxil),you should take another tablet. Do not wait until the time to take the next dose. You do not need to take another tablet if you vomited more than one hour after taking efavirenz/emtricitabina/tenofovir disoproxil.

If you interrupt the treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Teva

Do not interrupt the treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Teva without first speaking with your doctor.The interruption of treatment with efavirenz/emtricitabina/tenofovir disoproxil may severely affect your response to future treatments. If you interrupt the treatment with efavirenz/emtricitabina/tenofovir disoproxil, consult with your doctor before restarting the intake of tablets of efavirenz/emtricitabina/tenofovir disoproxil. Your doctor may consider administering the components of efavirenz/emtricitabina/tenofovir disoproxil separately if you have problems or if you need to adjust your dose.

When you run out of Efavirenz/Emtricitabina/Tenofovir disoproxil Teva, request more from your doctor or pharmacist. This is extremely important, because the amount of virus may start to increase if you stop taking the medication, even for a short period of time. In this case, the virus may become more difficult to treat.

If you have HIV and hepatitis B at the same time,it is especially important not to suspend your treatment with efavirenz/emtricitabina/tenofovir disoproxil without first speaking with your doctor. Some patients have had blood tests or symptoms indicating that their hepatitis had worsened after suspending emtricitabina or tenofovir disoproxil (two of the three components of this medication). If you suspend the treatment with efavirenz/emtricitabina/tenofovir disoproxil, your doctor may recommend that you resume the treatment for hepatitis B. You may need blood tests to check liver function for 4 months after suspending treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to suspend treatment, as this may lead to worsening of hepatitis, which may put your life at risk.

Speak with your doctor immediately about new or unusual symptoms after suspending treatment, particularly symptoms you associate with hepatitis B virus infection.

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

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

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

Severe side effects: report to your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare but severe side effect (can affect up to 1 in 1,000 patients) that can be fatal. The following side effects may be signs of lactic acidosis:
• Deep and rapid breathing
• Drowsiness
• Nausea, vomiting, and stomach pain

If you think you may have lactic acidosis, contact your doctor immediately.

Other possible severe side effects

The following side effects areinfrequent(can affect up to 1 in 100 patients):

• Severe allergic reaction (hypersensitivity) that can cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
• Swelling of the face, lips, tongue, or throat
• Aggressive behavior, suicidal thoughts, abnormal thoughts, paranoia, inability to think clearly, mood changes, visual or auditory hallucinations, suicidal attempts, personality changes (psychosis), catatonia (a condition in which the patient becomes immobile and unable to speak for a time)
• Abdominal pain (stomach) caused by pancreatitis inflammation
• Forgetfulness, confusion, seizures (convulsions), incoherent speech, tremors
• Yellow skin or eyes, itching, or abdominal pain (stomach) caused by liver inflammation
• Kidney damage

Psychiatric side effects in addition to those listed above include delusions (false beliefs), neurosis. Some patients have committed suicide. These problems tend to occur more often in those with a history of mental illness. Always report immediately to your doctor if you experience these symptoms.

Side effects in the liver: if you are also infected with the hepatitis B virus, you may experience a worsening of hepatitis after stopping treatment (see section 3).

Other possible severe side effects

The following side effects areinfrequent(can affect up to 1 in 1,000 patients):

• Liver failure, which in some cases can lead to death or liver transplant. Most cases occurred in patients with pre-existing liver disease, but there have been some reports in patients without previous liver disease
• Renal inflammation, increased urine volume, and sensation of thirst
• Back pain due to renal problems, including renal failure. Your doctor may perform blood tests to see if your kidneys are functioning properly.
• Renal tubular damage, which can cause bone weakening (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased levels of potassium or phosphate in the blood.
• Fatty liver

If you think you may have any of these severe side effects, speak with your doctor.

More frequent side effects

The following side effects arevery frequent(can affect more than 1 in 10 patients):

• Dizziness, headache, diarrhea, feeling unwell (nausea), vomiting
• Rashes (including red patches or blisters on the skin, sometimes with swelling)
• Weakness

Tests may also show:

• Decreased phosphate levels in the blood
• Increased creatine kinase levels in the blood, which can cause muscle pain and weakness

Other possible side effects

The following side effects arecommon(can affect up to 1 in 10 patients):

• Allergic reactions
• Balance and coordination problems
• Feeling anxious or depressed
• Difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
• Pain, stomach pain
• Digestive problems with discomfort after meals, feeling bloated (gas), gas (flatulence)
• Loss of appetite
• Fatigue
• Itching
• Changes in skin color, such as darkening of the skin in patches, often starting on the hands and feet

Tests may also show:

• Low white blood cell count (a reduced white blood cell count can make you more prone to infections)
• Problems with the liver and pancreas
• Increased triglycerides, bilirubin, or blood sugar levels

The following side effects areinfrequent(can affect up to 1 in 100 patients):

• Muscle rupture, muscle pain, or weakness
• Anemia (low red blood cell count)
• Sensation of spinning or moving to the sides (vertigo), ringing, buzzing, or other persistent sounds in the ears
• Blurred vision
• Chills
• Increased breast size in men
• Loss of sexual appetite
• Flush
• Dry mouth
• Increased appetite

Tests may also show:

• Decreased potassium levels in the blood
• Increased creatinine levels in the blood
• Protein in the urine
• Increased cholesterol levels in the blood

In the case of renal tubular damage, muscle rupture, bone weakening (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased levels of potassium or phosphate in the blood may occur.

The following side effects areinfrequent(can affect up to 1 in 1,000 patients):

• Rash with itching, caused by a reaction to sunlight

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

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

Blister: Store in the original packaging to protect it from moisture. This medication does not require any special storage temperature.

Bottle: Store in the original packaging to protect it from moisture. Keep the bottle perfectly closed. This medication does not require any special storage temperature.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and

medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, please ask your pharmacist how to dispose of the containers and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva

• The active ingredients are efavirenz, emtricitabina, and tenofovir disoproxilo. Each film-coated tablet of Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva contains 600 mg of efavirenz, 200 mg of emtricitabina, and 245 mg of tenofovir disoproxilo (equivalent to 291.22 mg of tenofovir disoproxilo phosphate or 136 mg of tenofovir).
• The other components are microcrystalline cellulose, sodium croscarmellose, mannitol (E421), hydroxypropyl cellulose, low-substitution hydroxypropyl cellulose, poloxamer 407, crospovidone, hypromellose, hydrogenated vegetable oil, and sodium stearate fumarate.
• The other components of the coating (Opadry II 85F240144 PINK) are partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, and carmine (E120).

Appearance of the product and contents of the package

The film-coated tablets of Efavirenz/Emtricitabina/Tenofovir disoproxilo Teva are pink, oval-shaped, marked with “TEE” on one side of the tablet and smooth on the other side. The bottles may contain an HDPE container with silica gel that must be kept in the bottle to help protect the tablets. The silica gel container should not be swallowed.

The following package sizes are available:

Blister: 10, 30, 90 film-coated tablets and a single-dose package of 30x1 film-coated tablets.

Bottle: 30 and a multi-pack containing 90 (3 bottles of 30) film-coated tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid

Spain

Responsible manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

31-546 Kraków

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren, Baden-Wuerttemberg

Germany

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25,

10000 Zagreb

Croatia

Last review date of thisleaflet:July 2022

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) (http://www.aemps.gob.es/)