Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

Leaflet accompanying the packaging: information for the user

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, 600 mg + 200 mg + 245 mg,

coated tablets
Efavirenz + Emtricitabine + Tenofovir disoproxil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• -You should keep this leaflet so that you can read it again if you need to.
• -If you have any doubts, you should consult a doctor or pharmacist.
• -This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• -If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and what is it used for
• 2. Important information 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. Package contents and other information

1. What is Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and what is it used for

what is it used for

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas contains three active substances,

used in the treatment of 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 drugs, works by disrupting the normal functioning of an enzyme (reverse transcriptase) that is essential for the replication of the virus.
Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas is used in the treatment of HIV-infected adult patients aged 18 years and older who have previously been treated with other antiretroviral drugs and whose HIV-1 infection has been controlled for at least three months. The drug should be used in patients who have not failed previous HIV treatment.

2. Important information before taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

disoproxil Aurovitas

When not to take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

if the patient is allergicto efavirenz, emtricitabine, tenofovir disoproxil or any of the other ingredients of this medicine (listed in section 6).
if the patient has severe liver disease.
if the patient has heart rhythm disorders, such as abnormal electrical signal conduction
known as QT interval prolongation, which is associated with a high risk of
developing a serious heart rhythm disorder (torsades de pointes).
if any family member of the patient (parents, grandparents, siblings) has died suddenly due to heart disease or was born with heart disease.
if the doctor has found that the patient has low or high levels of certain electrolytes (such as potassium or magnesium) in the blood.
if the patient is currently takingthe following medications (see also "Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and other medications"): astemizole or terfenadine(used to treat hay fever or other allergic symptoms),
bepridil(used to treat heart disease),
cisapride(used to treat heartburn),
elbasvir/grazoprevir(used to treat hepatitis C),
ergot alkaloids(such as ergotamine, dihydroergotamine, ergonovine, and methylergonovine, used to treat migraines or cluster headaches),
midazolam or triazolam(used to help with sleep),
pimozide, imipramine, amitriptyline, or clomipramine(used to treat certain mental disorders),
St. John's Wort(Hypericum perforatum) (a herbal preparation used for depression and anxiety),
voriconazole(used to treat fungal infections),
flecainide, metoprolol(used to treat irregular heartbeat),
certain antibiotics(macrolide antibiotics, fluoroquinolones, imidazole antifungals),
triazole antifungals,
certain antimalarial drugs,
methadone(used to treat opioid addiction).

If the patient is taking any of these medications, they should immediately tell their

doctor.Taking these medications with Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may cause serious, potentially life-threatening side effects or may reduce the effectiveness of the medications being taken.

Warnings and precautions

Before starting to take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, the patient should discuss with their doctor or pharmacist if:

• -The patient may still be able to transmit HIVwhile taking this medicine, despite the fact that effective antiretroviral therapy reduces this risk. The patient should discuss with their doctor the precautions necessary to avoid infecting others. This medicine does not cure HIV infection. While taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, infections and other diseases associated with HIV may occur.
• -While taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, the patient should remain under constant medical supervision.
• -The patient should tell their doctor:If they are taking other medications containing efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should not be taken with any of these medications. If the patient has or has had kidney diseaseor 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, the doctor may order blood tests to assess kidney function. Also, during treatment, the doctor may order blood tests to monitor kidney function.

and control kidney function.
The patient should inform their doctor if they have any of the following conditions:
bone disease (such as osteoporosis),
if they have had a bone fracture or have bone problems.
If the patient has a history of heart rhythm disorders, such as abnormal electrical signal conduction.

If the patient has a history of mental illness

including depression or addiction to substances or alcohol.The patient should immediately inform their doctor about depression or suicidal thoughts or other unusual thoughts (see section 4, Possible side effects).
If the patient has a history of seizures(epilepsy or seizure disorders) or if they are being treated with antiepileptic medications, such as carbamazepine, phenobarbital, and phenytoin. If the patient is taking any of these medications, the doctor may order a test to check the level of the antiepileptic medication in the blood to ensure that it has not changed while taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas. The doctor may prescribe a different antiepileptic medication.
If the patient has a history of liver disease, including chronic active hepatitis. Patients with liver disease, including those with chronic viral hepatitis B or C, who are taking antiretroviral medications are at increased risk of severe and potentially life-threatening liver side effects. The doctor may order blood tests to monitor liver function or change the medication being taken.

Patient with severe liver disease should not take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

(see section 2, When not to take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas).
If the patient has hepatitis B, the treating doctor will carefully consider the choice of treatment. Tenofovir disoproxil and emtricitabine, two of the active substances in Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, have some activity against hepatitis B virus, although emtricitabine has not been approved for the treatment of hepatitis B. Symptoms of hepatitis may worsen after discontinuation of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas. The doctor may regularly perform blood tests to monitor liver function (see section 3, Discontinuation of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas).
Regardless of previous liver disease, the treating doctor will consider regular blood tests to monitor liver function.
If the patient is over 65 years old. There have been no studies of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas in a sufficient number of patients over 65 years old. The doctor will carefully monitor patients over 65 years old who are prescribed Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas.

• -Patients who start taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should be aware of:

Dizziness, difficulty sleeping, drowsiness, concentration problems or

unusual dreams.These side effects may occur in 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 a rash. If symptoms of a severe rash with blisters and fever occur, the patient should stop taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and inform their doctor. If a rash occurred when taking another NNRTI, there is a high probability of a rash occurring when taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas.
Any symptoms of inflammation or infection.In patients with advanced HIV disease (AIDS) and a history of opportunistic infections, symptoms of inflammation related to previous infections may appear soon after starting HIV treatment. It is believed that these symptoms may indicate that the immune system is recovering and starting to fight the infection that was previously hidden. If symptoms of infection are noticed, the patient should immediately inform their doctor.
In addition to opportunistic infections, autoimmune diseases (diseases that occur when the immune system attacks healthy tissues) may also occur after starting antiretroviral treatment. Autoimmune diseases can occur months after starting treatment. If symptoms of infection or other symptoms such as muscle weakness, weakness starting from the hands and feet and progressing towards the torso, heart palpitations, tremors, or hyperactivity occur, the patient should immediately contact their doctor.

• Bone disorders(characterized by persistent or worsening bone pain and sometimes leading to fractures) can also occur due to damage to the renal tubules (see section 4, Possible side effects). The patient should inform their doctor if they experience bone pain or fractures.

Tenofovir disoproxil may also cause bone mass loss. The most significant bone mass loss was observed in clinical trials when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor. In general, the effect of tenofovir disoproxil on long-term bone health and future fracture risk in adult and pediatric patients is uncertain.
In some adult patients taking combination antiretroviral therapy, including those with a history of AIDS, osteonecrosis (death of bone tissue due to lack of blood supply) may develop. The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and increased body mass index may be some of the many risk factors for developing osteonecrosis. Symptoms of osteonecrosis include joint stiffness, pain (especially in the hip, knee, and shoulder), and difficulty moving. If the patient experiences any of these symptoms, they should inform their doctor.

If the patient has osteoporosis, has had a bone fracture, or has bone problems, they should inform their doctor.

Children and adolescents

• -Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should not be given to children and adolescentsunder 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 medications

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should not be taken with certain medications.

at the same time. The list of these medications is provided at the beginning of section 2, When not to take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas. It includes several commonly used medications and several herbal preparations (including St. John's Wort), which can cause serious interactions.
The patient should tell their doctoror pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should not be taken with other medications containing efavirenz (unless prescribed by a doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil.
The patient should tell their doctorabout taking other medications that may harm the kidneys. These include aminoglycosides, vancomycin (medications used to treat bacterial infections), foscarnet, ganciclovir, cidofovir (medications used to treat viral infections), amphotericin B, pentamidine (medications used to treat fungal infections), interleukin-2 (used to treat cancer), and non-steroidal anti-inflammatory drugs (NSAIDs, used to reduce bone or muscle pain).
Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may interact with other medications, including herbal preparations such as Ginkgo biloba extract. As a result, the level of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas or other medications in the blood may change. This may lead to a loss of therapeutic effect of the medications being taken or may increase side effects. In some cases, the doctor may adjust the dose or order a blood test. It is essential for the patient to inform their doctor or pharmacist about taking any of the following medications:

• -Medications containing didanosine (for HIV):Taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and other antiviral medications containing didanosine may increase the level of didanosine in the blood and may decrease the number of CD4 cells. Rarely, pancreatitis and lactic acidosis (excessive lactic acid in the blood) have been observed in patients taking tenofovir disoproxil and didanosine. The treating doctor will consider whether to use tenofovir with didanosine.
• -Other medications used to treat HIV:The following protease inhibitors: darunavir, indinavir, lopinavir with ritonavir, ritonavir, or ritonavir boosted with atazanavir or saquinavir. The treating doctor will consider whether to use an alternative medication or change the dose of the protease inhibitor. The patient should also inform their doctor about taking maraviroc.
• -Medications used to treat hepatitis C:elbasvir with grazoprevir, glecaprevir with pibrentasvir, sofosbuvir with velpatasvir, sofosbuvir with velpatasvir and voxilaprevir.
• -Medications used to lower cholesterol levels in the blood (statins):atorvastatin, pravastatin, or simvastatin. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may decrease the level of statins in the blood. The doctor will check the cholesterol level and consider changing the dose of statins if necessary.
• -Medications used to prevent seizures (antiepileptics):carbamazepine, phenytoin, phenobarbital. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may decrease the level of antiepileptic medications in the blood. Carbamazepine may decrease the level of efavirenz, one of the components of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, in the blood. The treating doctor may consider changing the antiepileptic medication.
• -Medications used to treat bacterial infections, including tuberculosis and AIDS-related Mycobacterium avium complex: clarithromycin, rifabutin, rifampicin. The treating doctor may consider changing the dose or using an alternative antibiotic. Additionally, the doctor may consider administering an additional dose of efavirenz to treat HIV infection.
• -Medications used to treat fungal infections(antifungals): itraconazole or posaconazole. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may decrease the level of itraconazole or posaconazole in the blood. The treating doctor may consider changing the antifungal medication.

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may also decrease the level of atovaquone and proguanil or artemether and lumefantrine in the blood.

• -Medications used to treat malaria:atovaquone with proguanil or artemether with lumefantrine.
• -Hormonal contraception, such as "the pill," injections (e.g., Depo-Provera), or implants (e.g., Implanon):The patient should always use effective mechanical contraception (see section Pregnancy and breastfeeding). Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may reduce the effectiveness of hormonal contraception. In women taking efavirenz, a component of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, there have been cases of pregnancy while using a contraceptive implant, although it has not been shown that efavirenz treatment was the cause of the contraceptive failure.
• -Sertraline, a medication used to treat depression, the doctor may change the dose.
• -Bupropion, a medication used to treat depression or as an aid to quit smoking, the doctor may change the dose.
• -Diltiazem or similar medications (calcium channel blockers):After starting Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, the doctor may change the dose of the calcium channel blocker.
• -Medications used to prevent rejection of transplanted organs (also known as immunosuppressants), such as cyclosporine, sirolimus, or tacrolimus. After starting or stopping Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, the doctor will closely monitor the level of the immunosuppressant in the blood and may need to adjust the dose.
• -Warfarin or acenocoumarol(blood thinners). The doctor may decide to adjust the dose of warfarin or acenocoumarol.
• -Ginkgo biloba extract(a herbal preparation).
• -Metamizole, a medication used to treat pain and fever.
• -Praziquantel, a medication used to treat parasitic infections.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medication.

The patient should not become pregnant while taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and for 12 weeks after stopping treatment

.Before starting Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, the doctor may order a pregnancy test to check if the patient is pregnant.
While taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, the patient should use effective mechanical contraception (e.g., condoms) in addition to other contraceptive methods, including oral contraception (birth control 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 medication. Therefore, the patient should use contraception for approximately 12 weeks after stopping Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas.
If the patient becomes pregnant while taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, they should immediately inform their doctor.
A woman who is pregnant may take Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas only if the doctor considers it absolutely necessary.
Severe developmental disorders have been observed in animal fetuses and newborns of women who took efavirenz during pregnancy.
Before taking any medication, the patient should consult their doctor or pharmacist.
If the patient took Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas during pregnancy, the doctor may order regular blood tests and other diagnostic tests to monitor the development of the child. In children whose mothers took NRTIs during pregnancy, the benefit of reducing the risk of HIV transmission outweighs the risk of adverse reactions.

While taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, the patient should not breastfeed

.Both HIV and the components of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas can pass into breast milk and seriously harm the baby.

Driving and using machines

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may cause dizziness, difficulty concentrating, and drowsiness

.If the patient experiences these symptoms, they should not drive vehicles, operate tools, or operate machinery.
Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

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

Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Recommended dose:

One tablet taken orally once a day. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should be taken on an empty stomach (which usually means 1 hour before a meal or 2 hours after a meal), preferably before bedtime. This way, some side effects (such as dizziness, drowsiness) are less bothersome. Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should be swallowed whole with water.
Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas should be taken every day.
If the doctor decides to discontinue one of the components of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, it is possible that the patient will take efavirenz, emtricitabine, and/or tenofovir disoproxil separately or with other medications used to treat HIV.

Taking more than the recommended dose of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

If the patient accidentally takes too many Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas tablets, they may be at increased risk of side effects of this medicine (see section 4, Possible side effects). The patient should contact their doctor or the emergency department of the nearest hospital for advice. The patient should take the package of tablets with them so that they can show the doctor which medication they have taken.
It is essential not to miss any dose of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas.

If the patient misses a dose of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas and

it has been less than 12 hours since the usual time of taking the dose, the patient should take it as soon as possible, and then take the next dose at the usual time.
If it is almost time for the next dose (less than 12 hours until the next dose), the patient should not take the missed dose. The patient should wait and take the next dose at the usual time. The patient should not take a double dose to make up for the missed tablet.

If the patient vomits (within 1 hour) after taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

,the patient should take another tablet. The patient does not need to take another tablet if vomiting occurs more than 1 hour after taking the medication.

Discontinuation of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

The patient should not stop taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas without consulting their doctor

.Stopping Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas may seriously affect the body's response to future treatment. If the patient stops taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, they should consult their doctor before resuming treatment with Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas tablets.
In case of problems or the need to modify the dose, the doctor may consider prescribing each component of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas separately.
If the supply of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas runs out, the patient should contact their doctor or pharmacist for a new prescription. This is extremely important because stopping treatment, even for a short time, may cause the virus to become more difficult to treat.

If the patient is infected with HIV and also has hepatitis B

,it is particularly important not to stop taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas without consulting their doctor. In some patients, after discontinuation of emtricitabine or tenofovir disoproxil (two of the three components of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas), blood test results or symptoms indicated worsening liver disease. If the patient stops taking Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas, the treating doctor may recommend returning to hepatitis B treatment. For 4 months after stopping the medication, it may be necessary to perform blood tests to monitor liver function. In patients with advanced liver disease or liver cirrhosis, it is not recommended to stop treatment, as this may lead to life-threatening worsening of liver disease.
The patient should immediately inform their doctor about any new or unusual symptoms noticed after stopping treatment, especially those that are typically associated with hepatitis B.
If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to improved health and lifestyle, and in the case of lipid levels in the blood, sometimes to the antiretroviral medications themselves. The doctor will check for these changes.
Like all medications, Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas can cause side effects, although not everyone will experience them.

Possible serious side effects: inform your doctor immediately

Lactic acidosis(excessive lactic acid in the blood) is a rare(may occur in less than 1 in 1,000 patients) but serious side effect that can be fatal. The following side effects may be symptoms of lactic acidosis:

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

If the patient thinks they may have lactic acidosis, they should immediately contact their doctor

Other possible serious side effects

The following side effects are uncommon(may occur in less than 1 in 100 patients):
allergic reactions (hypersensitivity), which 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, strange thoughts, paranoia, inability to think clearly, mood changes, hallucinations (seeing or hearing things that are not there), suicide attempts, personality changes (psychosis), catatonia (a state in which the patient remains immobile and silent for a period of time)
abdominal pain (stomach pain) caused by pancreatitis
jaundice (yellowing of the skin or eyes) or itching or liver pain (liver damage) caused by hepatitis
kidney damage.
Psychiatric side effects, in addition to those listed above, included delusions (false beliefs), anxiety. Some patients committed suicide. These symptoms occur more frequently in patients who have previously had mental health problems. If the patient experiences any of the above symptoms, they should immediately inform their doctor.
Liver-related side effects: if the patient is also infected with hepatitis B, liver disease may worsen after stopping treatment (see section 3).
The following side effects are rare(may occur in less than 1 in 1,000 patients):

• -liver failure, which can lead to liver transplantation or death. Most cases were observed in patients with pre-existing liver disease, although some were observed in patients without pre-existing liver disease
• -kidney inflammation, excessive urine production, and increased thirst
• -back pain caused by kidney problems, including kidney failure. The treating doctor may order a blood test to check kidney function.
• -bone softening (with bone pain, and sometimes with fractures), which can occur due to damage to the renal tubules
• -fatty liver.

If the patient thinks they are experiencing any of these serious side effects, they should contact their doctor

Most common side effects

The following side effects are very common(may occur in more than 1 in 10 patients):
dizziness, headache, diarrhea, nausea (nausea), vomiting
rash (including red spots or patches, sometimes with blistering and swelling of the skin), which may be an allergic reaction
feeling weak.
Tests may also show:
decreased phosphate levels in the blood,
increased creatine kinase levels in the blood, which may be indicated by muscle pain and weakness.

Other possible side effects

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

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

Tests may also show:

• -decreased white blood cell count (decreased white blood cell count may increase the risk of infections)
• -liver or pancreas disorders
• -increased levels of triglycerides (fatty acids), bilirubin, or glucose in the blood.

The following side effects are uncommon(may occur in less than 1 in 100 patients):
muscle breakdown, muscle pain or weakness
anemia (decreased red blood cell count)
dizziness or feeling of spinning or tilting (vertigo), ringing or other persistent noises in the ears (tinnitus)
blurred vision
chills
breast enlargement in men
decreased sex drive
hot flashes
dry mouth
increased appetite.
Tests may also show:
decreased potassium levels in the blood
increased creatinine levels in the blood
protein in the urine
increased cholesterol levels in the blood.
Muscle breakdown, bone softening (with bone pain, and sometimes with fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may also occur due to damage to the renal tubules.
The following side effects are rare(may occur in less than 1 in 1,000 patients):

• -itchy rash caused by a skin reaction to sunlight.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
By reporting side effects, more information can be collected on the safety of the medication.
Side effects can also be reported to the marketing authorization holder.

5. How to store Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the month stated.
Triply laminated cold-formed blister pack with aluminum/aluminum foil:Store at a temperature below 30°C.
Transparent blister pack with PVC/PE/PVDC/aluminum foil:Store at a temperature below 25°C.
HDPE bottle:Store at a temperature below 30°C. Store in the original packaging to protect from moisture.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What contains the drug Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas

The active substances of the drug are efavirenz, emtricitabine, and tenofovir disoproxil.
Each coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine, and 245 mg of tenofovir disoproxil (in the form of tenofovir disoproxil fumarate).

Other ingredients:

Tablet core:sodium croscarmellose, microcrystalline cellulose (type 101),
hydroxypropyl cellulose low substituted, hydroxypropyl cellulose (low viscosity), sodium lauryl sulfate (see section 2 "The drug 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 does the drug Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas look like and what does the packaging contain

Coated tablet.
Pink, oval, biconvex coated tablets, with the inscription "EET" on one side and smooth on the other side.
The coated tablets of Efavirenz + Emtricitabine + Tenofovir disoproxil Aurovitas are available in blisters and HDPE bottles, in a cardboard box.

Packaging sizes:

Blister: 30 and 90 coated tablets.
HDPE bottle: 30 and 90 coated tablets with a desiccant.
Not all packaging sizes may be on the market.

Responsible entity and manufacturer/importer

Responsible entity:

Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

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 authorized in the Member States of the European Economic Area under the following names:

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 and Emtricitabine and 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
film-coated tablets EFG
Netherlands:
Efavirenz/ Emtricitabine/ Tenofovir disoproxil Aurobindo, 600 mg/200 mg/245 mg
film-coated tablets

Date of last update of the leaflet: 04/2025