Efavirenz + emtricitabine + tenofovir disoproxil aurovitas

Package leaflet: Information for the user

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, 600 mg + 200 mg + 245 mg,
film-coated tablets
Efavirenzum + Emtricitabinum + Tenofovirum disoproxilum
Please read all of this leaflet carefully before 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 symptoms are the same as yours.
• If you get 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 this leaflet:

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 (NtRTI).

Each of these active substances, also known as antiretroviral medicines, works by interfering with the normal function of an enzyme (reverse transcriptase), which is essential for the virus to replicate.
Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas is used to treat HIV-infected adults aged 18 years and older who have previously been treated with other antiretroviral medicines and whose HIV-1 infection has been controlled for at least three months. This medicine should be used in patients whose previous HIV treatment has not failed.

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 disoproxil, or any of the other ingredients of this medicine (listed in section 6).
• you have severe liver disease.
• you have heart rhythm problems such as abnormal electrical conduction, known as QT prolongation, which is associated with a high risk of a serious heart rhythm disorder (torsade de pointes).
• any member of your family (parents, grandparents, siblings) has died suddenly from heart disease or was born with a heart condition.
• your doctor has diagnosed you with low or high blood levels of electrolytes such as potassium or magnesium.
• you are currently taking any of the following medicines (see also “Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and other medicines”):
  • astemizole or terfenadine (used to treat hay fever or other allergy symptoms),
  • bepridil (used to treat heart conditions),
  • cisapride (used to treat heartburn),
  • elbasvir/grazoprevir (used to treat hepatitis C virus infection),
  • ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine, and methylergonovine, used to treat migraine or cluster headaches),
  • midazolam or triazolam (used to help you sleep),
  • pimozide, imipramine, amitriptyline, or clomipramine (used to treat certain psychiatric disorders),
  • St John’s wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety),
  • voriconazole (used to treat fungal infections),
  • flecainide, metoprolol (used to treat irregular heartbeat),
  • some antibiotics (macrolide antibiotics, fluoroquinolones, imidazole antifungals),
  • triazole antifungal medicines,
  • some antimalarial medicines,
  • methadone (used to treat opioid addiction).

If you are taking any of these medicines, you must tell your doctor immediately. Taking these medicines together with Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may result in serious, even life-threatening, side effects or may cause loss of effectiveness of the medicines used.

Warnings and precautions

Before starting Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, talk to your doctor or pharmacist if:

• You can still transmit HIV while taking this medicine, even though effective antiretroviral therapy reduces this risk. You should discuss with your doctor the precautions needed to avoid infecting others. This medicine does not cure HIV infection. Infections and other HIV-related illnesses may still occur while taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas.

• You must remain under regular medical supervision while taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas.

• Tell your doctor:

  • If you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas must not be taken together with any of these medicines.
  • If you have or have had kidney disease or if tests indicate kidney problems. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas is not recommended for patients with moderate or severe kidney disease. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may harm the kidneys. Before starting treatment, your doctor may order blood tests to assess kidney function. During treatment, your doctor may also order blood tests to monitor kidney function.
  • Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas is generally not used together with other medicines that may harm the kidneys (see Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and other medicines). If this cannot be avoided, your doctor will monitor kidney function weekly.
  • If you have had heart rhythm problems, such as abnormal electrical conduction, known as QT prolongation.
  • If you have had psychiatric disorders in the past, including depression or substance or alcohol dependence. You should inform your doctor immediately if you experience depression, suicidal thoughts, or other unusual thoughts (see section 4, Possible side effects).
  • If you have had seizures (epilepsy or convulsions) or if you are taking anticonvulsant medicines such as carbamazepine, phenobarbital, or phenytoin. If you are taking any of these medicines, your doctor may check the blood level of the anticonvulsant to ensure it has not changed during treatment with Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas. Your doctor may prescribe a different anticonvulsant.
  • If you have had liver disease in the past, including chronic active hepatitis. Patients with liver disease, including chronic hepatitis B or C, who are taking antiretroviral medicines are at increased risk of serious and potentially fatal liver-related side effects. Your doctor may perform blood tests to monitor liver function or may change your medicine. Patients with severe liver disease should not take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas (see section 2, Do not take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas).
  • If you have hepatitis B, your doctor will carefully consider the best treatment option. Tenofovir disoproxil and emtricitabine, two of the active substances in Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, have some activity against hepatitis B virus, although emtricitabine is not approved for the treatment of hepatitis B. Symptoms of hepatitis may worsen after stopping Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas. Your doctor may perform regular blood tests to monitor liver function (see section 3, Stopping Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas).
  • Regardless of previous liver disease, your doctor may consider regular blood tests to monitor liver function.
  • If you are over 65 years of age. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas has not been studied in a sufficient number of patients over 65 years of age. Your doctor will monitor patients over 65 years of age carefully.

• Patients starting Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should be aware of:

  • Dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or unusual dreams. These side effects may occur during the first or first two days of treatment and usually resolve after the first 2–4 weeks.
  • Any signs of skin rash. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may cause skin rash. If you notice signs of a severe rash with blisters and fever, stop taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and tell your doctor. If you previously had a rash with another NNRTI, you are more likely to develop a rash while taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas.
  • Any signs of inflammation or infection. In patients with advanced HIV infection (AIDS) and a history of opportunistic infections, symptoms of inflammation related to past infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from a strengthened immune system beginning to fight the previously undetected infection. If you notice any signs of infection, contact your doctor immediately. In addition to opportunistic infections, autoimmune diseases (conditions where the immune system attacks healthy body tissues) may also occur after starting treatment for HIV infection. Autoimmune diseases may occur many months after starting treatment. If you experience symptoms of infection or other symptoms such as muscle weakness, numbness or tingling starting in the hands and feet and progressing towards the trunk, palpitations, tremors, or hyperactivity, contact your doctor immediately to begin necessary treatment.
  • Bone disorders (manifesting as persistent or worsening bone pain and sometimes leading to fractures) may also occur due to damage to renal tubular cells (see section 4, Possible side effects). Inform your doctor if you experience bone pain or fractures.
  • Tenofovir disoproxil may also cause loss of bone mass. The most pronounced bone loss was observed in clinical trials when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor. Overall, the long-term effect of tenofovir disoproxil on bone health and future fracture risk in adult and pediatric patients is uncertain.
  • Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood flow to the bone). Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index may be among the many risk factors for developing this condition. Symptoms of osteonecrosis include joint stiffness, pain (especially in the hips, knees, and shoulders), and difficulty moving. If you experience any of these symptoms, inform your doctor.
  • If you have osteoporosis, have previously had a bone fracture, or have bone problems, inform your doctor.

Children and adolescents

• Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas must not be given to children and adolescents under 18 years of age. The use of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas in children and adolescents has not been studied.

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and other medicines

Do not take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas together with certain medicines. A list of these medicines is provided at the beginning of section 2, Do not take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas. It includes several commonly used medicines and herbal preparations (including St John’s wort), which may cause serious interactions.
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas with other medicines containing efavirenz (unless prescribed by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil.
Tell your doctor if you are taking other medicines that may cause kidney damage, including:

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

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. This may alter the blood levels of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas or other medicines. This could result in loss of effectiveness of the medicines used or increased side effects. In some cases, your doctor may adjust the dose or order blood tests. It is important that you inform your doctor or pharmacist if you are taking any of the following medicines:

• Medicines containing didanosine (for HIV infection): Taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas together with other antiviral medicines containing didanosine may increase the blood level of didanosine and may also reduce the number of CD4 cells. Pancreatitis and lactic acidosis (excess lactic acid in the blood) have been rarely observed when tenofovir disoproxil and didanosine are taken together, sometimes resulting in death. Your doctor will consider whether tenofovir can be used together with didanosine.
• Other medicines used for HIV infection: The following protease inhibitors: darunavir, indinavir, lopinavir with ritonavir, ritonavir, or ritonavir boosted with atazanavir or saquinavir. Your doctor will consider whether an alternative medicine can be used or whether the dose of the protease inhibitor should be changed. You should also inform your doctor if you are taking maraviroc.
• Medicines used to treat hepatitis C virus infection: elbasvir with grazoprevir, glecaprevir with pibrentasvir, sofosbuvir with velpatasvir, sofosbuvir with velpatasvir and voxilaprevir.
• Medicines that lower blood cholesterol (also called statins): atorvastatin, pravastatin, or simvastatin. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may reduce the blood levels of statins. Your doctor will check your cholesterol level and may consider changing the statin dose if necessary.
• Medicines used to prevent seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may reduce the blood levels of anticonvulsant medicines. Carbamazepine may reduce the blood level of efavirenz, one of the components of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas. Your doctor may consider changing the anticonvulsant medicine.
• Medicines used to treat bacterial infections, including tuberculosis and Mycobacterium avium complex infection associated with AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may consider changing the dose or using an alternative antibiotic. Additionally, your doctor may consider giving an additional dose of efavirenz for HIV treatment.
• Medicines used to treat fungal infections (antifungals): itraconazole or posaconazole. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may reduce the blood levels of itraconazole or posaconazole. Your doctor may consider changing the antifungal medicine.
• Medicines used to treat malaria: atovaquone with proguanil or artemether with lumefantrine. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may reduce the blood levels of atovaquone and proguanil or artemether and lumefantrine.
• Hormonal contraception, such as “the pill”, injections (e.g. Depo-Provera), or implants (e.g. Implanon): Always use effective barrier methods (see section Pregnancy and breast-feeding). Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may reduce the effectiveness of hormonal contraceptives. Pregnancies have occurred in women taking efavirenz, a component of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, while using a contraceptive implant, although it has not been shown that efavirenz treatment caused the contraceptive failure.
• Sertraline, a medicine used to treat depression; your doctor may change the dose.
• Bupropion, a medicine used to treat depression or as an aid to stop smoking; your doctor may change the dose.
• Diltiazem or similar medicines (called calcium channel blockers): After starting Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, your doctor may change the dose of the calcium channel blocker.
• Medicines used to prevent rejection of transplanted organs (also called immunosuppressants), such as cyclosporine, sirolimus, or tacrolimus. After starting or stopping Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, your doctor will closely monitor the blood level of the immunosuppressant and dose adjustment may be necessary.
• Warfarin or acenocoumarol (anticoagulants). Your doctor may decide to adjust the dose of warfarin or acenocoumarol.
• Ginkgo biloba extracts (herbal preparation).
• Metamizole, a medicine used to treat pain and fever.
• Praziquantel (a medicine used to treat parasitic infections).

Pregnancy and breast-feeding

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby, talk to your doctor or pharmacist before taking this medicine.
You must not become pregnant while taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and for 12 weeks after stopping treatment.
Before starting Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, your doctor may recommend a pregnancy test to confirm you are not pregnant.
If you could become pregnant while taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, you must use effective barrier methods (e.g. condoms) together with other contraceptive methods, including oral contraceptives (pills) or other hormonal contraception (e.g. implants, injections). Efavirenz, one of the active substances in Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, may remain in the blood for some time after stopping the medicine. Therefore, contraception should be continued for approximately 12 weeks after stopping Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas.
If you are pregnant or plan to become pregnant, inform your doctor immediately. A pregnant woman may take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas only if your doctor considers it absolutely necessary.
Serious developmental abnormalities have been observed in animal fetuses and in human newborns whose mothers were given efavirenz during pregnancy.
Talk to your doctor or pharmacist before taking any medicine.
If you took Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas during pregnancy, your doctor may order regular blood tests and other diagnostic tests to monitor the child's development. In children whose mothers took NRTIs during pregnancy, the benefit of reduced risk of HIV transmission outweighs the risk of side effects.
Do not breast-feed while taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas. Both HIV and the components of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas can pass into breast milk and may seriously harm the baby.

Driving and using machines

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may cause dizziness, difficulty concentrating, and drowsiness. If you experience these symptoms, do not drive, operate tools, or use any machinery.

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered “sodium-free”.

3. How to use Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:
One tablet taken once daily by mouth. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should be taken on an empty stomach (this usually means 1 hour before or 2 hours after a meal), preferably at bedtime. Taking the medicine this way may reduce certain side effects (such as dizziness, drowsiness), making them less bothersome. The tablet should be swallowed whole with water.

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas must be taken every day. If your doctor decides to discontinue one of the components of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, you may need to take efavirenz, emtricitabine and/or tenofovir disoproxil separately, or in combination with other medicines used to treat HIV infection.

Taking more than the recommended dose of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas
Accidentally taking too many tablets of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may increase the risk of side effects associated with this medicine (see section 4, Possible side effects). Contact your doctor or the emergency department of your nearest hospital immediately for advice. Take the medicine container with you so that the medicine taken can be identified.

Missed dose of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas
It is important not to miss any doses of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas.

If you missed a dose of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and less than 12 hours have passed since the usual time of intake, take the missed dose as soon as possible, then take the next dose at the usual time.

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

If vomiting occurs within 1 hour after taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, take another tablet. If vomiting occurs more than 1 hour after taking the medicine, do not take another tablet.

Stopping treatment with Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas
Do not stop taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas without consulting your doctor. Stopping treatment may seriously affect how your body responds to HIV therapy in the future. If you have stopped taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, contact your doctor before restarting the tablets.

If you experience any problems or need dose adjustments, your doctor may consider prescribing each component of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas separately.

When your supply of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas runs out, contact your doctor or pharmacist for a new supply. This is extremely important because interrupting treatment, even briefly, may allow the virus to multiply more rapidly, making it harder to treat.

If you are infected with HIV and also have hepatitis B virus infection, it is especially important not to stop taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas without first consulting your doctor. In some patients, discontinuation of emtricitabine or tenofovir disoproxil (two of the three components of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas) has led to worsening of hepatitis, as shown by blood test results or symptoms. If treatment with Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas is stopped, your doctor may recommend resuming treatment for hepatitis B. Liver function should be monitored with blood tests for up to 4 months after stopping the medicine. In some patients with advanced liver disease or cirrhosis, discontinuation of treatment is not recommended, as it may lead to life-threatening worsening of hepatitis.

Immediately inform your doctor about any new or unusual symptoms occurring after stopping treatment, particularly those typically associated with hepatitis B virus infection.

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

4. Possible side effects

During treatment for HIV infection, increases in body weight, as well as blood lipid and glucose levels, may occur. This is partly related to improved health and lifestyle, and in the case of blood lipid levels, sometimes to the use of antiretroviral medications themselves. Your doctor will monitor these changes.

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

Serious side effects: contact your doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (may occur in no more than 1 in 1,000 patients), but serious and potentially fatal side effect. The following symptoms may indicate lactic acidosis:

• deep, rapid breathing
• drowsiness
• nausea (feeling sick), vomiting, and abdominal pain.

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

Other possible serious side effects

The following side effects are uncommon (may occur in no more than 1 in 100 patients):

• allergic reactions (hypersensitivity), which may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
• swelling of the face, lips, tongue, or throat
• aggressive behaviour, suicidal thoughts, strange thoughts, paranoia, inability to think clearly, mood disturbances, seeing and hearing things that are not there (hallucinations), suicide attempts, personality changes (psychoses), catatonia (a state in which the patient remains motionless and mute for a period of time)
• abdominal (stomach) pain due to pancreatitis
• memory loss, disorientation, seizures (fits), slurred speech, tremor
• yellowing of the skin or eyes, itching, or abdominal (stomach) pain due to hepatitis
• kidney tubule damage.

Psychiatric side effects, in addition to those listed above, have included delusions (false beliefs) and anxiety. Some patients have committed suicide. These symptoms occur more frequently in patients with a history of psychiatric illness. If you experience any of the above symptoms, you should contact your doctor without delay.

Liver-related side effects: if you are co-infected with hepatitis B virus, liver inflammation may worsen after stopping treatment (see section 3).

The following side effects are rare (may occur in no more than 1 in 1,000 patients):

• liver failure, sometimes requiring liver transplantation or leading to death. Most cases have been reported in patients with pre-existing liver disease, although a few have occurred in patients without prior liver disease
• kidney inflammation, excessive urination, and increased thirst
• back pain due to kidney problems, including kidney failure. Your doctor may recommend blood tests to monitor kidney function
• bone softening (with bone pain, and sometimes fractures), which may occur as a result of kidney tubule cell damage
• fatty liver.

If you suspect you are experiencing any of these serious side effects, you should contact your doctor.

Most common side effects

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

• dizziness, headache, diarrhoea, nausea (feeling sick), vomiting
• skin rash (including red spots or patches, sometimes with blistering and skin swelling), which may be an allergic reaction
• feeling weak.

Blood tests may also show:

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

Other possible side effects

The following side effects are common (may occur in no more than 1 in 10 patients):

• allergic reactions
• movement coordination and balance disturbances
• anxiety or depression
• difficulty sleeping, unusual dreams, difficulty concentrating, drowsiness
• pain, abdominal pain
• digestive problems, leading to discomfort after meals, bloating, flatulence (passing gas)
• loss of appetite
• fatigue
• itching
• changes in skin pigmentation, including dark spots on the skin, often first appearing on the hands and soles of the feet
• loss of bone mass.

Blood tests may also show:

• reduced white blood cell count (reduced white blood cells may increase susceptibility to infections)
• liver and pancreas function abnormalities
• increased blood triglyceride (fatty acid), bilirubin, or glucose levels.

The following side effects are uncommon (may occur in no more than 1 in 100 patients):

• muscle breakdown, muscle pain, or muscle weakness
• anaemia (reduced number of red blood cells)
• sensation of spinning or tilting (dizziness), ringing, buzzing, or other persistent noises in the ears (tinnitus)
• blurred vision
• chills
• breast enlargement in men
• decreased sex drive
• hot flushes
• dry mouth
• increased appetite.

Blood tests may also show:

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

Muscle breakdown, bone softening (with bone pain, and sometimes fractures), muscle pain, muscle weakness, and decreased blood potassium or phosphate levels may also occur as a result of kidney tubule cell damage.

The following side effects are rare (may occur in no more than 1 in 1,000 patients):

• itchy rash caused by a skin reaction to sunlight.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Reporting side effects helps provide more information on the safety of this medicine.

Side effects can also be reported to the marketing authorisation holder.

5. How to store 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 after EXP. The expiry date refers to the last day of the stated month.
Cold-form triple laminated aluminium/aluminium blister: Store below 30°C.
Transparent PVC/PE/PVDC/aluminium blister: Store below 25°C.
HDPE bottle: Store below 30°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas contains
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 tenofovir disoproxil fumarate).
Other ingredients:
Tablet core: sodium croscarmellose, microcrystalline cellulose (type 101),
low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose (low viscosity), sodium
lauryl sulfate (see section 2 “Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas contains
sodium”), microcrystalline cellulose (type 102), hypromellose 2910, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172), iron oxide black (E 172).
What Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas looks like and contents of the
package
Film-coated tablet.
Pink, oval, biconvex film-coated tablets, embossed with the code “EET” on one side and plain on the other side.
Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas film-coated tablets are available in
blister packs and HDPE bottles, packed in a cardboard box.
Pack sizes:
Blister pack: 30 and 90 film-coated tablets.
HDPE bottle: 30 and 90 film-coated tablets with a desiccant.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua Joao De Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France
This medicinal product is authorised in the European Economic Area under the following
names:
Belgium: Efavirenz/Emtricitabine/Tenofovir disoproxil AB 600 mg-200 mg-245 mg
film-coated tablets
France: EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL Arrow 600mg/200
mg/245 mg, film-coated tablet
Germany: Efavirenz/Emtricitabin/Tenofovirdisoproxil PUREN 600 mg/200 mg/245 mg
film-coated tablets
Italy: Efavirenz e Emtricitabina e Tenofovir Disoproxil Aurobindo
Poland: Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas
Portugal: Efavirenz + Emtricitabina + Tenofovir Generis
Spain: Efavirenz/Emtricitabina/Tenofovir disoproxilo Aurovitas 600 mg/200 mg/245 mg
comprimidos recubiertos con película EFG
Netherlands: Efavirenz/Emtricitabine/Tenofovir disoproxil Aurobindo, 600 mg/200 mg/245 mg
film-coated tablets