EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL AUROVITAS 600 mg/200 mg/245 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas 600 mg/200 mg/245 mg Film-Coated Tablets EFG

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 or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas and what it is used for
2. What you need to know before you take Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas
3. How to take Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas
4. Possible side effects
5. Storage of Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas
6. Package Contents and Additional Information

1. What is Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas and what it is used for

Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas contains three active substances used to treat human immunodeficiency virus (HIV) infection.

• Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
• Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI).
• Tenofovir is a nucleotide reverse transcriptase inhibitor.

Each of these active substances, also known as antiretroviral medicines, works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to multiply.

Efavirenz/emtricitabine/tenofovir disoproxil is a treatment for human immunodeficiency virus (HIV) infection in adults aged 18 years or older who have been previously treated with other antiretroviral medicines and have controlled HIV-1 infection for at least three months. Patients should not have experienced failure of a previous HIV treatment.

2. What you need to know before starting to take Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas

Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas

• If you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other components of this medicine (listed in section 6).
• If you have severe liver disease.
• If you have a heart condition, such as an abnormal electrical signal called QT interval prolongation 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 due to 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 taking any of the following medications (see also Other medications and Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas):
• astemizole or terfenadine (used to treat hay fever or other allergies).
• bepridil (used to treat heart disease).
• cisapride (used to treat stomach upset).
• elbasvir/grazoprevir (used to treat hepatitis C).
• ergot alkaloids (e.g., ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and histamine headaches).
• midazolam or triazolam (used to facilitate sleep).
• pimozide, imipramine, amitriptyline, or clomipramine (used to treat certain mental problems).
• St. John's Wort (Hypericum perforatum) (a plant-based medicine 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 medications, inform your doctor immediately. Taking these medications with efavirenz/emtricitabine/tenofovir disoproxil may cause serious and/or potentially life-threatening side effects or may cause these medications to stop working properly.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• While taking this medicine, you 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 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 the supervision of your doctor.

• Tell your doctor:

• If you are taking other medications that contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. You must not take efavirenz/emtricitabine/tenofovir disoproxil with any of these medications.

• If you have or have had kidney disease, or if 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 not normally taken with other medications that can harm your kidneys (see Other medications and Efavirenz/Emtricitabine/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 an abnormal electrical signal called QT interval prolongation.

• If you have a history of mental illness, including depression, or alcohol or substance abuse. Tell your doctor immediately if you feel depressed, have suicidal thoughts, or abnormal thoughts (see section 4, Possible side effects).

• If you have a history of seizures (fits or attacks) or are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital, and phenytoin. If you are taking any of these medications, 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 chronic active hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with combination antiretrovirals, have a higher risk of serious and potentially life-threatening liver complications. Your doctor may perform blood tests to monitor your liver or change you to another medication. If you have severe liver disease, do not take efavirenz/emtricitabine/tenofovir disoproxil (see above, in section 2, Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas).

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

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

• 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/emtricitabine/tenofovir disoproxil, be aware of:

• Signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams. These side effects may start 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 can cause skin rashes. If you notice any sign of a severe skin rash with blisters or fever, stop taking efavirenz/emtricitabine/tenofovir disoproxil and inform 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, signs and symptoms of inflammation of previous infections may appear shortly after starting antiviral treatment. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight infections that were present without any apparent symptoms. If you notice any symptoms of infection, 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 have started taking medications for your HIV infection. Autoimmune disorders can appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves towards the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

• Bone problems (which manifest as persistent or worsening bone pain and sometimes end in fractures) due to damage to the renal tubule cells (see section 4, Possible side effects). Inform your doctor if you have bone pain or fractures.

Tenofovir disoproxil can also cause bone mass 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 risk of future fractures in adult and pediatric patients are uncertain.

Some adult patients with HIV who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by lack 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 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, inform your doctor.

Talk to your doctor if you have osteoporosis, a history of bone fractures, or bone problems.

Children and adolescents

• Do not administer efavirenz/emtricitabine/tenofovir disoproxil to children and adolescents under 18 years of age. The use of efavirenz/emtricitabine/tenofovir disoproxil has not been studied in children and adolescents.

Other medications and Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas

You must not take efavirenz/emtricitabine/tenofovir disoproxil with certain medications.These are listed under Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas, at the beginning of section 2. These include some common medications and some plant-based medications (including St. John's Wort) that can cause serious interactions.

Tell your doctoror pharmacist if you are taking, have recently taken, or might take any other medication.

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

Tell your doctorif you are taking other medications that can harm your kidneys. Some examples include:

• Aminoglycosides, vancomycin (medications for bacterial infections).
• Foscarnet, ganciclovir, cidofovir (medications for viral infections).
• Amphotericin B, pentamidine (medications for fungal infections).
• Interleukin-2 (for cancer treatment).
• Non-steroidal anti-inflammatory drugs (NSAIDs, for bone or muscle pain relief).

Efavirenz/emtricitabine/tenofovir disoproxil can interact with other medications, including plant-based medications such as Ginkgo bilobaextracts. This can result in the amounts of efavirenz/emtricitabine/tenofovir disoproxil or other medications in your blood being affected. This can prevent the medications from working properly or can worsen some side effects. In some cases, your doctor may need to adjust your dose or check the levels in your blood. It is important that you tell your doctor or pharmacist if you are taking any of the following:

• Medications that contain didanosine (for HIV infection): taking efavirenz/emtricitabine/tenofovir disoproxil with other antiviral medications that contain didanosine may increase the levels of didanosine in your blood and may reduce the CD4 cell count. When medications that contain tenofovir disoproxil and didanosine are taken together, pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported in some cases, which can be fatal. Your doctor will carefully consider whether to treat you with medications that contain tenofovir and didanosine.
• Other medications used for HIV infection: the following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or atazanavir or saquinavir boosted by ritonavir. Your doctor may consider prescribing a different medication or changing the dose of the protease inhibitors. Also, inform your doctor if you are taking maraviroc.
• Medications used to treat hepatitis C virus infection: elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
• Medications used to lower cholesterol in the blood (also called statins): atorvastatin, pravastatin, simvastatin. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and consider changing the dose of the statin if necessary.
• Medications used to treat seizures/attacks (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the amount of anticonvulsant in your blood. Carbamazepine may reduce the amount of efavirenz, one of the components of efavirenz/emtricitabine/tenofovir disoproxil, in your blood. Your doctor may need to consider prescribing a different anticonvulsant.
• Medications used to treat bacterial infections, including tuberculosis and Mycobacterium avium complex related to AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may need to consider changing 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): itraconazole or posaconazole. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the amount of itraconazole or posaconazole in your blood. Your doctor may need to consider prescribing a different antimycotic.
• Medications used to treat malaria: atovaquone/proguanil or artemether/lumefantrine. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in your blood.
• Hormonal contraceptives, such as birth control pills, an injectable contraceptive (e.g., Depo-Provera), or a contraceptive implant (e.g., Implanon): you must also use a reliable barrier contraceptive method (see Pregnancy and breastfeeding). Efavirenz/emtricitabine/tenofovir disoproxil may affect the functioning of hormonal contraceptives. There have been reports of pregnancies in women taking efavirenz, a component of efavirenz/emtricitabine/tenofovir disoproxil, while using a contraceptive implant, although it has not been established that efavirenz treatment was the cause of the contraceptive failure.
• Sertraline, a medication used to treat depression, as your doctor may need to change the dose of sertraline.
• Bupropion, a medication used to treat depression or to help you stop smoking, as your doctor may need to change the dose of bupropion.
• Diltiazem or similar medications (called calcium channel blockers): when you start treatment with efavirenz/emtricitabine/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 cyclosporine, sirolimus, or tacrolimus. Both when you start and when you stop treatment with efavirenz/emtricitabine/tenofovir disoproxil, your doctor will closely monitor your blood levels of the immunosuppressant and may need to adjust the dose you receive.
• Warfarin or acenocoumarol (medications used to reduce blood clotting): your doctor may need to adjust your dose of warfarin or acenocoumarol.
• Ginkgo bilobaextracts (a plant-based medicine).
• Metamizole, a medication used to treat pain and fever.
• Praziquantel (a medication used to treat parasitic worm infections).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Women must not become pregnant during treatment with efavirenz/emtricitabine/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/emtricitabine/tenofovir disoproxil.

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

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

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

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

The recommended dose is:

One tablet a day, orally. Efavirenz/emtricitabine/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/emtricitabine/tenofovir disoproxil whole with a glass of water.

Efavirenz/emtricitabine/tenofovir disoproxil should be taken daily.

If your doctor decides to suspend one of the components of efavirenz/emtricitabine/tenofovir disoproxil, they may give you efavirenz, emtricitabine, and/or tenofovir disoproxil 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/emtricitabine/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 it is advised that you go to the nearest emergency service. Bring the tablet package with you so you can easily describe what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology 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 that you do not forget a dose of efavirenz/emtricitabine/tenofovir disoproxil.

If you forget a dose of efavirenz/emtricitabine/tenofovir disoproxil within 12 hours of when you normally take it,take it as soon as you can, 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 make up for missed doses.

If you vomit the tablet (within 1 hour after taking efavirenz/emtricitabine/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/emtricitabine/tenofovir disoproxil.

If you interrupt treatment withEfavirenz/Emtricitabina/Tenofovir disoproxilo Aurovitas

Do not interrupt treatment with efavirenz/emtricitabine/tenofovir disoproxil without speaking to your doctor first.Interrupting treatment with efavirenz/emtricitabine/tenofovir disoproxil can severely affect your response to future treatments. If you interrupt treatment with efavirenz/emtricitabine/tenofovir disoproxil, consult your doctor before resuming the intake of efavirenz/emtricitabine/tenofovir disoproxil tablets. Your doctor may consider administering the components of efavirenz/emtricitabine/tenofovir disoproxil separately if you have problems or if your dose needs to be adjusted.

When your supply of efavirenz/emtricitabine/tenofovir disoproxil starts to run out,request more from your doctor or pharmacist. This is extremely important because the amount of virus can start to increase if you stop taking the medication, even if only for a short 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/emtricitabine/tenofovir disoproxil without first talking to your doctor. Some patients have had blood tests or symptoms indicating that their hepatitis had worsened after suspending emtricitabine or tenofovir disoproxil (two of the three components of efavirenz/emtricitabine/tenofovir disoproxil). If you suspend treatment with efavirenz/emtricitabine/tenofovir disoproxil, your doctor may recommend that you resume hepatitis B treatment. 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 since this can cause worsening of hepatitis, which can be life-threatening.

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

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

4. Possible adverse effects

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

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

Possible serious adverse effects: inform your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare but serious adverse effect (it can affect up to 1 in 1,000 patients), which can be fatal. The following adverse 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 serious adverse effects

The following adverse effects are uncommon(they 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 alteration, vision or hearing things that are not really there (hallucinations), suicide attempts, personality change (psychosis), catatonia (a condition in which the patient remains immobile and unable to speak for a period).
• abdominal pain (stomach) caused by pancreas inflammation.
• forgetfulness, confusion, spasms (seizures), incoherent speech, tremor (shaking).
• yellow skin or eyes, itching, or stomach pain caused by liver inflammation.
• kidney tubule damage.

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

Adverse effects on the liver: if you are also infected with the hepatitis B virus, you may experience worsening of hepatitis after suspending treatment (see section 3).

The following adverse effects are rare(they 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 who already had liver disease, but there have been some reports in patients without prior liver disease.
• kidney inflammation, increased urine volume, and feeling of thirst.
• back pain due to kidney problems, including kidney failure. Your doctor may perform blood tests to see if your kidneys are working properly.
• weakening of the bones (with bone pain and which sometimes ends in fractures) that can occur due to damage to the kidney tubule cells.
• fatty liver.

If you think you may have any of these serious adverse effects, talk to your doctor.

More frequent adverse effects

The following adverse effects are very common(they can affect more than 1 in 10 patients):

• dizziness, headache, diarrhea, feeling of discomfort (nausea), vomiting.
• rash (including red spots or pimples, sometimes with blisters and skin swelling), which can be allergic reactions.
• weakness.

Tests may also show:

• decrease in phosphate levels in the blood.
• increased creatine kinase levels in the blood, which can cause muscle pain and weakness.

Other possible effects

The following adverse effects are common(they can affect up to 1 in 10 patients):

• allergic reactions.
• balance and coordination disorders.
• feeling of concern or depression.
• 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 soles of the feet.
• bone mass loss

Tests may also show:

• low white blood cell count (a reduced number of white blood cells can make you more prone to infections).
• liver and pancreas problems.
• increased triglycerides, bilirubin, or blood sugar levels.

The following adverse effects are uncommon(they can affect up to 1 in 100 patients):

• muscle rupture, muscle pain, muscle weakness.
• anemia (low red blood cell count).
• feeling of spinning or moving sideways (vertigo), ringing, buzzing, or other persistent noises in the ears.
• blurred vision.
• chills.
• breast enlargement in males.
• loss of sexual appetite.
• flushing.
• dry mouth.
• increased appetite.

Tests may also show:

• decrease in potassium levels in the blood.
• increase in creatinine levels in the blood.
• protein in the urine.
• increase in cholesterol levels in the blood.

In case of damage to the kidney tubule cells, muscle rupture, weakening of the bones (with bone pain and which sometimes ends in fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may appear.

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

• skin rash with itching, caused by a reaction to sunlight.

Reporting adverse effects

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

5. Conservation of Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitas

Keep this medication out of 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.

Cold-formed triple-layered 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.

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Efavirenz/Emtricitabina/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:

Tablet core:sodium croscarmellose, microcrystalline cellulose (Grade-101), low-substituted hydroxypropyl cellulose, low-viscosity hydroxypropyl cellulose, sodium lauryl sulfate (see section 2 "Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitas contains sodium"), microcrystalline cellulose (Grade-102), hypromellose 2910, and magnesium stearate.

Tablet coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172), black iron oxide (E172).

Appearance of the product and package contents

Film-coated tablets are pink, oval, biconvex, with the mark "EET" on one face and smooth on the other.

Efavirenz/Emtricitabina/Tenofovir disoproxil Aurovitas film-coated tablets are available in blister packs and HDPE bottles.

Package sizes:

Blister:30 and 90 film-coated tablets.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

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 medication 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/Emtricitabina/Tenofovir disoproxilo Aurovitas 600 mg/200 mg/245 mg comprimidos recubiertos con película EFG

France: EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL Arrow 600 mg/200 mg/245 mg, comprimé pelliculé

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

Date of the last revision of this leaflet: April 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).