Efavirenz/emtricitabine/tenofovir disoproxil Aurovitas 600 mg/200 mg/245 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas is and what it is used for
2. What you need to know before taking Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas
3. How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas
4. Possible side effects
5. How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas
6. Contents of the pack and other information

1. What Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas is 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 function of an enzyme (reverse transcriptase) that is essential for the virus to replicate.

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

2. What you need to know before taking 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 ingredients 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 prolongation, which puts you at high risk of serious heart rhythm problems (Torsade de Pointes).
• If any of your close relatives (parents, grandparents, siblings) died suddenly due to a heart problem or were born with heart defects.
• 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 medicines (see also Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas):
  • astemizole or terfenadine (used to treat hay fever or other allergies).
  • bepridil (used to treat heart conditions).
  • cisapride (used to treat heartburn).
  • elbasvir/grazoprevir (used to treat hepatitis C).
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches).
  • midazolam or triazolam (used to help sleep).
  • pimozide, imipramine, amitriptyline, or clomipramine (used to treat certain mental health conditions).
  • St. John’s wort (Hypericum perforatum) (a herbal 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 medicines, inform your doctor immediately. Taking these medicines with efavirenz/emtricitabine/tenofovir disoproxil may cause serious and/or potentially fatal side effects or may cause these medicines to stop working properly.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

• While taking this medicine, you may still transmit HIV to others, although effective antiretroviral treatment reduces this risk. Consult your doctor about the necessary precautions to avoid infecting others. This medicine is not a cure for HIV infection. While taking efavirenz/emtricitabine/tenofovir disoproxil, you may still develop infections or other conditions associated with HIV infection.

• While taking efavirenz/emtricitabine/tenofovir disoproxil, you must remain under your doctor’s supervision.

• Inform your doctor:

• If you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. Efavirenz/emtricitabine/tenofovir disoproxil must not be taken with any of these medicines.

• If you have or have had kidney disease, or if blood tests have shown kidney problems. 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 request blood tests to check your kidney function. Your doctor may also request blood tests during treatment to monitor your kidneys.

Efavirenz/emtricitabine/tenofovir disoproxil is generally not taken with other medicines that may harm your kidneys (see Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas). If this is unavoidable, your doctor will monitor your kidney function weekly.

• If you have a heart condition, such as an abnormal electrical signal called QT prolongation.

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

• If you have a history of seizures (spasms or fits) or are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital, or phenytoin. If you are taking any of these medicines, your doctor may need to check your anticonvulsant blood levels to ensure they are 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 serious and potentially fatal liver complications. Your doctor may perform blood tests to monitor your liver function or switch you to another medicine. If you have severe liver disease, do not take efavirenz/emtricitabine/tenofovir disoproxil (see above, section 2, Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas).

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 substances in efavirenz/emtricitabine/tenofovir disoproxil, show some activity against the hepatitis B virus, although emtricitabine is not approved for the treatment of hepatitis B infection. Your hepatitis symptoms may worsen after stopping efavirenz/emtricitabine/tenofovir disoproxil. Your doctor may perform regular blood tests to monitor your liver (see section 3, If you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas).

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

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

•Once you start taking efavirenz/emtricitabine/tenofovir disoproxil, be alert for:

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

• Any sign of skin rash. Efavirenz/emtricitabine/tenofovir disoproxil may cause skin rashes. If you notice signs of a severe rash with blisters or fever, stop taking efavirenz/emtricitabine/tenofovir disoproxil and contact your doctor immediately. If you previously had a rash while taking another NNRTI, you may have a higher risk of developing a 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 from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, allowing the body to fight infections that were previously asymptomatic. If you notice any signs of infection, inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition where the immune system attacks healthy body tissue) may also occur after you start taking medicines for your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upward toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

• Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures) due to kidney tubule cell damage (see section 4, Possible side effects). Inform your doctor if you experience bone pain or fractures.

Tenofovir disoproxil may also cause bone mineral 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.

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

Some HIV-positive adults receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Numerous risk factors for developing this condition include duration of combination antiretroviral therapy, corticosteroid use, 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.

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 medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas

You must not take efavirenz/emtricitabine/tenofovir disoproxil with certain medicines. These are listed under Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas at the beginning of section 2. These include some commonly used medicines and some herbal medicines (including St. John’s wort) that may cause serious interactions.

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

Additionally, efavirenz/emtricitabine/tenofovir disoproxil must not be taken with any other medicine containing efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Inform your doctor if you are taking other medicines that may harm your kidneys. Examples include:

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

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

• Medicines containing didanosine (for HIV infection): taking efavirenz/emtricitabine/tenofovir disoproxil with other antiviral medicines containing didanosine may increase didanosine blood levels and reduce CD4 cell count. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal, have been reported when medicines containing tenofovir disoproxil and didanosine are taken together. Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
• Other medicines used for HIV infection: the following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or ritonavir-boosted atazanavir 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 virus infection: elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
• Medicines used to lower blood fat (also called statins): atorvastatin, pravastatin, simvastatin. Efavirenz/emtricitabine/tenofovir disoproxil may reduce statin blood levels. Your doctor will check cholesterol levels and consider adjusting the statin dose if necessary.
• Medicines used to treat seizures/episodes (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz/emtricitabine/tenofovir disoproxil may reduce anticonvulsant blood levels. Carbamazepine may reduce efavirenz levels, one of the components of efavirenz/emtricitabine/tenofovir disoproxil. Your doctor may need to consider prescribing a different anticonvulsant.
• Medicines used to treat bacterial infections, including tuberculosis and Mycobacterium avium complex associated with AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may need to adjust the dose or prescribe 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 (antifungals): itraconazole or posaconazole. Efavirenz/emtricitabine/tenofovir disoproxil may reduce itraconazole or posaconazole blood levels. Your doctor may need to consider prescribing a different antifungal.
• Medicines used to treat malaria: atovaquone/proguanil or artemether/lumefantrine. Efavirenz/emtricitabine/tenofovir disoproxil may reduce atovaquone/proguanil or artemether/lumefantrine blood levels.
• Hormonal contraceptives, such as birth control pills, injectable contraceptives (e.g., Depo-Provera), or contraceptive implants (e.g., Implanon): you should also use a reliable barrier method (see Pregnancy and breastfeeding). Efavirenz/emtricitabine/tenofovir disoproxil may affect the effectiveness of hormonal contraceptives. Cases of pregnancy have been reported in women taking efavirenz, a component of efavirenz/emtricitabine/tenofovir disoproxil, while using a contraceptive implant, although a causal link has not been established.
• Sertraline, a medicine used to treat depression, as your doctor may need to adjust the sertraline dose.
• Bupropion, a medicine used to treat depression or help quit smoking, as your doctor may need to adjust the bupropion dose.
• Diltiazem or similar medicines (called calcium channel blockers): when starting efavirenz/emtricitabine/tenofovir disoproxil treatment, your doctor will need to adjust your calcium channel blocker dose.
• Medicines used to prevent organ transplant rejection (also called immunosuppressants) such as cyclosporine, sirolimus, or tacrolimus. When starting or stopping efavirenz/emtricitabine/tenofovir disoproxil treatment, your doctor will closely monitor your immunosuppressant blood levels and may need to adjust your dose.
• Warfarin or acenocoumarol (medicines used to reduce blood clotting): your doctor may need to adjust your warfarin or acenocoumarol dose.
• Ginkgo biloba extracts (herbal medicine).
• Metamizole, a medicine used to treat pain and fever.
• Praziquantel (a medicine for parasitic worm infections).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 within 12 weeks after stopping treatment. Your doctor may perform a pregnancy test to ensure you are not pregnant before starting efavirenz/emtricitabine/tenofovir disoproxil treatment.

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

Inform your doctor immediately if you become pregnant or plan 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 unborn animals and newborn children of women treated with efavirenz during pregnancy.

Consult your doctor or pharmacist before using any medicine.

If you have taken efavirenz/emtricitabine/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 NRTIs during pregnancy, the benefit of protection against HIV outweighed the risk of adverse effects.

Do not breastfeed while taking efavirenz/emtricitabine/tenofovir disoproxil. Both HIV and the components of efavirenz/emtricitabine/tenofovir disoproxil can pass into breast milk and cause serious harm to the baby.

Driving and using machines

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

Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas contains sodium

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

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

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

One tablet daily, taken 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 (for example, dizziness, drowsiness) less troublesome. Swallow the efavirenz/emtricitabine/tenofovir disoproxil tablet whole with a glass of water.

Efavirenz/emtricitabine/tenofovir disoproxil must be taken daily.

If your doctor decides to discontinue one of the components of efavirenz/emtricitabine/tenofovir disoproxil, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil separately or with other medicines for the treatment of HIV infection.

If you take more Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas than you should

If you accidentally take too many tablets of efavirenz/emtricitabine/tenofovir disoproxil, you may be at an increased risk of experiencing possible adverse effects with this medicine (see section 4, Possible side effects). Contact your doctor or go to the nearest emergency department. Take the tablet pack with you so that you can clearly describe what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas

It is important that you do not miss a dose of efavirenz/emtricitabine/tenofovir disoproxil.

If you miss a dose of efavirenz/emtricitabine/tenofovir disoproxil within 12 hours of when you usually take it, take it as soon as possible, then take your next dose at the usual time.

If it is almost time for your next dose (less than 12 hours away), do not take the missed dose. Wait and take your next dose at the 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 for your 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 stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas

Do not stop treatment with efavirenz/emtricitabine/tenofovir disoproxil without first talking to your doctor. Stopping treatment with efavirenz/emtricitabine/tenofovir disoproxil may seriously affect your response to future treatments. If treatment with efavirenz/emtricitabine/tenofovir disoproxil is stopped, consult your doctor before restarting the tablets. Your doctor may consider giving you 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 is running low, request a refill from your doctor or pharmacist. This is extremely important because the amount of virus may start to increase if you stop taking the medicine, even for a short time. In this case, the virus may become more difficult to treat.

If you have both HIV infection and hepatitis B infection, it is especially important not to stop 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 worsened after stopping emtricitabine or tenofovir disoproxil (two of the three components of efavirenz/emtricitabine/tenofovir disoproxil). If you stop treatment with efavirenz/emtricitabine/tenofovir disoproxil, your doctor may recommend that you restart treatment for hepatitis B. You may need blood tests to monitor liver function for four months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as this may cause worsening of hepatitis, which could be life-threatening.

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

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

4. Possible adverse effects

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

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Serious possible adverse effects: inform your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare but serious adverse effect (may affect up to 1 in 1,000 patients), which can be life-threatening. 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 have lactic acidosis, contact your doctor immediately.

Other possible serious adverse effects

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

• allergic reaction (hypersensitivity) that may 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 disturbances, seeing or hearing things that are not really there (hallucinations), suicide attempts, personality changes (psychosis), catatonia (a condition in which the patient becomes immobile and unable to speak for a period of time).
• abdominal (stomach) pain caused by inflammation of the pancreas.
• memory loss, confusion, spasms (seizures), incoherent speech, tremor (shaking).
• yellowing of the skin or eyes, itching, or abdominal (stomach) pain caused by inflammation of the liver.
• kidney tubule damage.

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

Liver-related adverse effects: if you are also infected with hepatitis B virus, you may experience a worsening of hepatitis after stopping treatment (see section 3).

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

• liver failure, which in some cases leads to death or liver transplantation. Most cases occurred in patients who already had liver disease, but there have been some reports in patients without prior liver disease.
• inflammation of the kidney, increased urine volume, and feeling thirsty.
• back pain due to kidney problems, including renal failure. Your doctor may perform blood tests to check whether your kidneys are functioning properly.
• weakening of the bones (with bone pain and sometimes leading to fractures), which may occur due to damage to the kidney tubule cells.
• fatty liver.

If you think you may have any of these serious adverse effects, speak with your doctor.

More frequent adverse effects

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

• dizziness, headache, diarrhea, feeling unwell (nausea), vomiting.
• skin rashes (including red spots or pimples, sometimes with blisters and skin swelling), which may be allergic reactions.
• weakness.

Blood tests may also show:

• decreased phosphate levels in the blood.
• increased blood levels of creatine kinase, which may cause muscle pain and weakness.

Other possible effects

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

• allergic reactions.
• balance and coordination disorders.
• feelings of anxiety or depression.
• difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness.
• pain, stomach ache.
• digestive problems with discomfort after meals, feeling bloated (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.
• loss of bone mass.

Blood tests may also show:

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

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

• muscle rupture, muscle pain, muscle weakness.
• anemia (low red blood cell count).
• sensation 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.

Blood tests may also show:

• decreased potassium levels in blood.
• increased creatinine in blood.
• protein in urine.
• increased cholesterol in blood.

If there is damage to the kidney tubule cells, muscle rupture, weakening of the bones (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased levels of potassium or phosphate in blood may occur.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Triple-layer cold-form Al-Al blister: Store below 30°C.

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas

• The active substances 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: croscarmellose sodium, microcrystalline cellulose (Grade-101), low-substituted hydroxypropyl cellulose, low-viscosity-grade hydroxypropyl cellulose, sodium lauryl sulfate (see section 2 “Efavirenz/Emtricitabine/Tenofovir Disoproxil Aurovitas contains sodium”), microcrystalline cellulose (Grade-102), hypromellose 2910 and magnesium stearate.

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

Appearance of the product and contents of the pack

Film-coated pink, oval-shaped, biconvex tablets, marked with “EET” on one side and plain on the other.

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

Pack sizes:

Blister packs: 30 and 90 film-coated tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under 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 most recent review of this leaflet: April 2025

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