Prospect: Information for the user

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

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Efavirenz/Emtricitabina/Tenofovir disoproxilo Aurovitas and for what it is used

2.What you need to know before starting to take Efavirenz/Emtricitabina/Tenofovir disoproxilo Aurovitas

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

4.Possible adverse effects

5.Storage of Efavirenz/Emtricitabina/Tenofovir disoproxilo Aurovitas

6.Contents of the package and additional information

Efavirenz/Emtricitabina/Tenofovir disoproxilo Aurovitas contains three active ingredients that 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, also known as antiretroviral medications, act by interfering with the normal functioning of an enzyme (reverse transcriptase) essential for the virus to multiply.

Efavirenz/emtricitabina/tenofovir disoproxilo is a treatment for human immunodeficiency virus (HIV) infection in adults aged 18 years or older who 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 Aurovitas

•If you are allergicto efavirenz, emtricitabina, tenofovir, tenofovir disoproxil, or any of the other components of this medication (listed in section 6).

•If you have severe liver disease.

•If you have a heart condition, such as an abnormal electrical signal 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 medications (see alsoOther Medications and Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitas):

-astemizol 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).

-alcaloides del cornezuelo(such as ergotamine, dihidroergotamina, ergonovina, and metilergonovina) (used to treat migraines and histamine headaches).

-midazolam or triazolam(used to facilitate sleep).

-pimozida, imipramina, amitriptilina, or clomipramina(used to treat certain mental health problems).

-hierba de San Juan(Hipérico) (Hypericum perforatum) (herbal medicine used to treat depression and anxiety).

-voriconazol(used to treat fungal infections).

-flecainida, metoprolol(used to treat irregular heartbeats).

-ciertos antibióticos(macrólidos, fluoroquinolonas, imidazólicos).

-antifúngicos triazólicos.

-ciertos antimaláricos.

-metadona(used to treat opioid addiction).

•If you are taking any of these medications, inform your doctor immediately.Taking these medications withefavirenz/emtricitabina/tenofovir disoproxilmay cause severe side effects and/or potentially fatal effects or may cause these medications to stop working correctly.

Warnings and Precautions

Consult your doctor or pharmacist before starting this medication.

•While taking this medicationyou may still transmit HIV to others, although effective antiretroviral treatment reduces the risk. Consult your doctor about the necessary precautions to avoid infecting others. This medication is not a cure for HIV infection. While takingefavirenz/emtricitabina/tenofovir disoproxilyou may still experience infections or other diseases associated with HIV infection.

•While takingefavirenz/emtricitabina/tenofovir disoproxilyou must remain under the supervision of your doctor.

•Inform your doctor:

-If you are taking other medicationsthat contain efavirenz, emtricitabina, tenofovir disoproxil, tenofovir alafenamida, lamivudina, or adefovir dipivoxil. Do not takeefavirenz/emtricitabina/tenofovir disoproxilwith any of these medications.

-If you have or have had kidney disease, or if your blood tests have shown kidney problems.Efavirenz/emtricitabina/tenofovir disoproxilis not recommended if you have moderate to severe kidney disease.

Efavirenz/emtricitabina/tenofovir disoproxilmay affect your kidneys. Before starting treatment, your doctor may request blood tests to check your kidney function. Your doctor may also request blood tests during treatment to monitor your kidney function.

Efavirenz/emtricitabina/tenofovir disoproxilis normally not taken with other medications that may damage your kidneys (seeOther Medications and Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitas). If this is unavoidable, your doctor will monitor your kidney function once a week.

-If you have a heart condition, such as a prolonged QT interval.

-If you have a history of mental illness, including depression, or substance abuse. Inform 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 carbamazepina, fenobarbital, and phenytoin. If you are taking any of these medications, your doctor may need to check the level of anticonvulsant medication in your blood to ensure it is not affected while takingefavirenz/emtricitabina/tenofovir disoproxil. Your doctor may prescribe a different anticonvulsant medication.

-If you have a history of liver disease, including active chronic hepatitis.Patients with liver disease, including chronic hepatitis B or C, treated with combined antiretrovirals, have a higher risk of severe and potentially fatal liver complications. Your doctor may perform blood tests to monitor your liver function or switch you to a different medication.If you have severe liver disease, do not take efavirenz/emtricitabina/tenofovir disoproxil(see before, in section 2,Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitas).

If you have hepatitis B infection, your doctor will carefully consider the best treatment plan for you. Tenofovir disoproxil and emtricitabina, two of the active ingredients inefavirenz/emtricitabina/tenofovir disoproxil, show some activity against the hepatitis B virus, although emtricitabina is not authorized for the treatment of hepatitis B infection. Your liver symptoms may worsen after stoppingefavirenz/emtricitabina/tenofovir disoproxil. Your doctor may perform blood tests at regular intervals to monitor your liver function (see section 3,Discontinuation of Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitas).

-Regardless of the presence 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 prescribedefavirenz/emtricitabina/tenofovir disoproxil, your doctor will monitor you closely.

•Once you start takingefavirenz/emtricitabina/tenofovir disoproxil, 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/emtricitabina/tenofovir disoproxilmay cause skin rashes. If you notice any sign of a severe skin rash with blisters or fever, stop takingefavirenz/emtricitabina/tenofovir disoproxiland inform your doctor immediately. If you have had a skin rash while taking another medication, you may be at higher risk of developing a skin rash withefavirenz/emtricitabina/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, inform your doctor immediately.

Additionally, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may appear after you start taking medications for HIV treatment. 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, inform your doctor immediately to receive necessary treatment.

-Bone problems.Some patients receiving combination antiretroviral treatment may develop a bone disease called osteonecrosis (bone tissue death 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 immunosuppression, and high body mass index. Symptoms of osteonecrosis include joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, inform your doctor.

Bone problems (manifesting as persistent or worsening bone pain 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 experience 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 administer efavirenz/emtricitabina/tenofovir disoproxil to children and adolescents under 18 years old.Efavirenz/emtricitabina/tenofovir disoproxilhas not been studied in children and adolescents.

Other Medications and Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitas

You should not take efavirenz/emtricitabina/tenofovir disoproxil with certain medications.These are listed underDo not take Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitasat the beginning of section 2. Among these are some common medications and some herbal medicines (including St. John's Wort) that may cause severe interactions.

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

Additionally, do not take efavirenz/emtricitabina/tenofovir disoproxil with any other medication that contains efavirenz (unless your doctor recommends it), emtricitabina, tenofovir disoproxil, tenofovir alafenamida, lamivudina, or adefovir dipivoxil.

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

•Aminoglucósides, vancomycin (medications for bacterial infections).

•Foscarnet, ganciclovir, cidofovir (medications for viral infections).

•Amfotericina B, pentamidina (medications for fungal infections).

•Interleucina-2 (to treat cancer).

•Anti-inflammatory non-steroidal (NSAIDs, to relieve bone or muscle pain).

Efavirenz/emtricitabina/tenofovir disoproxil may interact with other medications, including herbal medicines such asGinkgo bilobaextracts. This may result in the affected levels of efavirenz/emtricitabina/tenofovir disoproxil or other medications in your blood, which may prevent the medications 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:

•Medications containing didanosina (for HIV infection):Taking efavirenz/emtricitabina/tenofovir disoproxil with other antiviral medications containing didanosina may increase didanosina levels in your blood and reduce CD4 cell count. When taken together, medications containing tenofovir disoproxil and didanosina have been associated, in rare cases, with pancreatitis and lactic acidosis (excess lactic acid in the blood) in some cases fatal. Your doctor will carefully consider whether to treat you with medications containing tenofovir and didanosina.

•Other medications used to treat HIV infection:The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or atazanavir or saquinavir boosted with ritonavir. Your doctor may consider prescribing a different medication or adjusting the dose of protease inhibitors. Also, inform your doctor if you are taking maraviroc.

•Medications used to treat hepatitis C infection:elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.

•Medications used to lower cholesterol (also called statins):atorvastatina, pravastatina, simvastatina. Efavirenz/emtricitabina/tenofovir disoproxil may reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and consider adjusting the dose of statin, if necessary.

•Medications used to treat seizures/attacks (anticonvulsants):carbamazepina, fenitoína, fenobarbital. Efavirenz/emtricitabina/tenofovir disoproxil may reduce the amount of anticonvulsant in your blood. Carbamazepina may reduce the amount of efavirenz, one of the components of efavirenz/emtricitabina/tenofovir disoproxil, in your blood. Your doctor may need to consider prescribing a different anticonvulsant medication.

•Medications used to treat bacterial infections,including tuberculosis and Mycobacterium avium complex associated with AIDS: claritromicina, rifabutina, rifampicina. 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.

•Medications used to treat fungal infections (antimycotics):itraconazol or posaconazol. Efavirenz/emtricitabina/tenofovir disoproxil may reduce the amount of itraconazol or posaconazol in your blood. Your doctor may need to consider prescribing a different antimycotic medication.

•Medications used to treat malaria:atovacuona/proguanil or arteméter/lumefantrina. Efavirenz/emtricitabina/tenofovir disoproxil may reduce the amount of atovacuona/proguanil or arteméter/lumefantrina in your blood.

•Contraceptive hormones, such as birth control pills, an injectable contraceptive (e.g., Depo-Provera), or an implantable contraceptive (e.g., Implanon):You should also use a reliable barrier contraceptive method (see Pregnancy and Breastfeeding). Efavirenz/emtricitabina/tenofovir disoproxil may alter the functioning of hormonal contraceptives. There have been cases of pregnancy in women taking efavirenz, a component of efavirenz/emtricitabina/tenofovir disoproxil, while using an implantable contraceptive, although it has not been established that efavirenz treatment was the cause of contraceptive failure.

•Sertralina, a medication used to treat depression, as your doctor may need to adjust the dose of sertralina.

•Bupropión, a medication used to treat depression or to help you quit smoking, as your doctor may need to adjust the dose of bupropión.

•Diltiazem or similar medications (called calcium channel blockers):When you start taking efavirenz/emtricitabina/tenofovir disoproxil, your doctor will need to adjust the dose of the calcium channel blocker.

•Medications used to prevent organ rejection after transplantation (also called immunosuppressants)such as ciclosporina, sirolimus, or tacrolimus. Both when you start taking efavirenz/emtricitabina/tenofovir disoproxil and when you stop, your doctor will closely monitor your immunosuppressant levels, which may require adjusting the dose you receive.

•Warfarina or acenocumarol(medications used to reduce blood coagulation): your doctor may need to adjust your dose of warfarina or acenocumarol.

•Extracts ofGinkgo biloba(herbal medicine).

•Metamizol, a medication used to treat pain and fever.

•Praziquantel(a medication to treat parasitic worm infections).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Women should not become pregnant during treatment with efavirenz/emtricitabina/tenofovir disoproxil or in the 12 weeks following.Your doctor may request a pregnancy test to ensure you are not pregnant before starting treatment with efavirenz/emtricitabina/tenofovir disoproxil.

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

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

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

Consult your doctor or pharmacist before using any medication.

If you have taken efavirenz/emtricitabina/tenofovir disoproxil during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child'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 child during treatment with efavirenz/emtricitabina/tenofovir disoproxil.Both HIV and the components of efavirenz/emtricitabina/tenofovir disoproxil may pass into breast milk and cause severe harm to the baby.

Driving and Operating Machines

Efavirenz/emtricitabina/tenofovir disoproxil may cause dizziness, concentration problems, and drowsiness.If you are affected, do not drive and do not operate tools or machines.

Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

The recommended dose is:

One tablet per day, taken orally. Efavirenz/emtricitabina/tenofovir disoproxilo 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 disoproxilo whole with a glass of water.

Efavirenz/emtricitabina/tenofovir disoproxilo should be taken daily.

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

If you take moreEfavirenz/Emtricitabina/Tenofovir disoproxilo Aurovitasthan you should

If you accidentally take too many tablets of efavirenz/emtricitabina/tenofovir disoproxilo, 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeEfavirenz/Emtricitabina/Tenofovir disoproxilo Aurovitas

It is essential not to forget a dose of efavirenz/emtricitabina/tenofovir disoproxilo.

If you forget a dose of efavirenz/emtricitabina/tenofovir disoproxilo 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 disoproxilo),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 disoproxilo.

If you interrupt the treatment withEfavirenz/Emtricitabina/Tenofovir disoproxilo Aurovitas

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

When your supplies of efavirenz/emtricitabina/tenofovir disoproxilo start to run out,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. 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 disoproxilo 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 disoproxilo (two of the three components of efavirenz/emtricitabina/tenofovir disoproxilo). If you suspend the treatment with efavirenz/emtricitabina/tenofovir disoproxilo, your doctor may recommend that you resume the treatment for hepatitis B. You may need blood tests to check liver function for four 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 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 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 serious side effect (can affect up to 1 in 1,000 patients), which 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 havelactic acidosis, contact your doctor immediately.

Other possible severe side effects

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

•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, suicide attempts, personality changes (psychosis), catatonia (a condition in which the patient remains immobile and unable to speak for a time).

•Abdominal pain (stomach) caused by pancreatitis inflammation.

•Forgetfulness, confusion, spasms (seizures), incoherent speech, tremors.

•Yellow skin or eyes, itching, or abdominal pain (stomach) caused by liver inflammation.

•Kidney damage.

Side effects in addition to those mentioned 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 hepatitis B virus, you may experience a worsening of hepatitis after stopping treatment (see section 3).

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

•Liver failure, which in some cases leads to death or liver transplant. Most cases occurred in patients with pre-existing liver disease, but there have been some reports in patients without prior 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.

•Bone weakening (with bone pain and sometimes leading to fractures) that can occur due to damage to renal tubular cells.

•Fatty liver.

If you think you may have any of these severe side effects, talk to your doctor.

More frequent side effects

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

•Dizziness, headache, diarrhea, feeling unwell (nausea), vomiting.

•Rashes (including red patches or spots, sometimes with blisters and swelling of the skin), which can be allergic reactions.

•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(these can affect up to 1 in 10 patients):

•Allergic reactions.

•Balance and coordination disorders.

•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:

•Decreased 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(these can affect up to 1 in 100 patients):

•Muscle rupture, muscle pain, muscle 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.

•Male breast enlargement.

•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 damage to renal tubular cells, 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 arerare(these can affect up to 1 in 1,000 patients):

•Skin 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 Vigilance 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.

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

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

Triple laminated cold-formed Al-Al blister:Store below 30°C.

Transparent PVC/PE/PVdC-Aluminum blister:Store below 25°C.

HDPE bottle:Store below 30°C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas

-The active ingredients are efavirenz, emtricitabine, and tenofovir disoproxil. Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine, and 245 mg of tenofovir disoproxil (as fumarate).

-The other components are:

Core of the tablet:croscarmellose sodium, microcrystalline cellulose (Grade-101),low-substituted hydroxypropyl cellulose, low-viscosity hydroxypropyl cellulose,sodium lauryl sulfate(see section 2 “Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas contains sodium), microcrystalline cellulose (Grade-102), hypromellose 2910, andmagnesium stearate.

Coating of the tablet:polyvinyl alcohol, titanium dioxide (E171),macrogol 3350, talc, red iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the package

Film-coated tablets of pink color, oval, biconvex, with the mark “EET” on one face and smooth on the other.

Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas film-coated tabletsare available inblister pack and in HDPE bottles.

Pack sizes:

Blister pack:30 and 90 film-coated tablets.

HDPE bottles:30 and 90 film-coated tablets, with silica gel desiccant.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Efavirenz/Emtricitabin/Tenofovirdisoproxil PUREN 600 mg/200 mg/245 mg Filmtabletten

Belgium:Efavirenz/Emtricitabine/Tenofovir disoproxil AB 600 mg-200 mg-245 mg filmomhulde tabletten

Spain:Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas 600 mg/200 mg/245 mg film-coated tablets EFG

France:EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL Arrow 600 mg/200 mg/245 mg, film-coated tablet

Italy:Efavirenz e Emtricitabina e Tenofovir Disoproxil Aurobindo

Netherlands:Efavirenz/ Emtricitabine/ Tenofovir disoproxil Aurobindo, 600 mg/200 mg/245 mg filmomhulde tabletten

Poland:Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

Portugal:Efavirenz + Emtricitabina + Tenofovir Generis

Last review date of this leaflet: February 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).