EFAVIRENZ 600 mg/200 mg /245 Mg Film-Coated Tablets

Зміст інструкції

1. What is Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva and what it is used for
2. What you need to know before taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
3. How to take Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
4. Possible side effects
5. How to store Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
6. Package contents and other information

Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
600 mg/200 mg/245 mg film-coated tablets
efavirenz/emtricitabina/tenofovir disoproxil

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva and what it is used for

Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva contains three active ingredientsused in the
treatment of human immunodeficiency virus (HIV) infection:

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

Each of these active ingredients, also known as antiretroviral medicines, works by interfering with
the normal activity of an enzyme (reverse transcriptase) which is essential for the virus to
reproduce.

Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva is a treatment for human
immunodeficiency virus(HIV) infection in adults aged 18 years and over
previously treated with other antiretroviral medicines and with HIV-1 infection under control
for at least three months. Patients must not have experienced failure of a previous anti-HIV
therapy.

2. What you need to know before taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva

Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva

• if you are allergicto efavirenz, emtricitabina, 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 calledprolonged QT interval which puts you at risk of serious heart rhythm problems (torsades de pointes).
• if any member of your family (parents, grandparents, brothers or sisters) has suddenly died from heart problems or was born with heart problems.
• if your doctor has told you that you have low or high levels of electrolytes such as potassium or magnesium in your blood.
• if you are currently takingany of the following medicines (see also “Other medicines and Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva”):
• astemizole or terfenadine(used to treat hay fever or other allergies)
• bepridil(used to treat heart disease)
• cisapride(used to treat heartburn)
• elbasvir/grazoprevir(used to treat hepatitis C)
• ergot alkaloids(e.g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) (used to treat migraine and cluster headache)
• midazolam or triazolam(used to help you sleep)
• pimozide, imipramine, amitriptyline or clomipramine(used to treat certain mental conditions)
• St. John's Wort( Hypericum perforatum) (a herbal remedy for depression and anxiety)
• voriconazole(used to treat fungal infections)
• flecainide, metoprolol(used to treat irregular heartbeat)
• some antibiotics(macrolides, fluoroquinolones, imidazole)
• triazole antifungals
• some antimalarial agents
• methadone(used to treat opioid dependence)

Tell your doctor immediately if you are taking any of these medicines.Taking
these medicines together with Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva may cause
serious or potentially life-threatening side effects, or may prevent these medicines from
working properly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Efavirenz/Emtricitabina/Tenofovir disoproxil
Zentiva.

• This medicine is not a cure for HIV infection. While you are taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva you may still develop infections or other diseases associated with HIV infection.
• While you are taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva you must remain under your doctor's supervision.
• Tell your doctor:
• if you are taking other medicinescontaining efavirenz, emtricitabina, tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil. Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva should not be taken together with these medicines.
• if you have or have had kidney disease,or if tests have shown you have kidney problems. Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva is not recommended in case of moderate to severe kidney disease.

Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva may have effects on the
kidneys. Before starting treatment, your doctor may prescribe blood tests
to assess your kidney function. Your doctor may also prescribe blood tests during
treatment to monitor your kidneys.
Generally Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva is not taken
with other medicines that can damage the kidneys (see Other medicines and

Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva). If this is unavoidable, your
doctor will monitor your kidney function once a week.

• if you suffer from a heart condition, such as an abnormal electrical signal calledprolonged QT interval.
• if you have had mental health problems in the past,including depression, or if you have abused certain substances or alcohol. Tell your doctor immediately if you feel depressed, have suicidal thoughts or strange thoughts (see section 4, Possible side effects).
• if you have had seizures in the pastor if you are being treated with anticonvulsants such as carbamazepine, phenobarbital and phenytoin. If you are taking any of these medicines, your doctor may need to check the level of the anticonvulsant medicine in your blood, to make sure there are no problems during treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva. Your doctor may also give you a different anticonvulsant.
• if you have had liver problems in the past, including chronic active hepatitis.Patients with liver problems, including chronic hepatitis B or C, treated with combination antiretrovirals, have a higher risk of serious and potentially life-threatening liver complications. Your doctor may require blood tests to carefully monitor your liver function or may prescribe you another medicine. If you have severe liver disease, do not takeEfavirenz/Emtricitabina/Tenofovir disoproxil Zentiva(see above, section 2, Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva).

If you have hepatitis B, your doctor will carefully assess the best treatment regimen
for you. Tenofovir disoproxil and emtricitabina, two of the active ingredients of
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva, have some activity
against the hepatitis B virus, although emtricitabina is not authorized for the
treatment of hepatitis B infection. Symptoms of hepatitis may worsen after
stopping treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil
Zentiva. Your doctor may require blood tests at regular intervals to
carefully monitor your liver function (see section 3, If you stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva).

Regardless of past liver problems, your doctor may require blood tests at regular intervals to check your liver function.

• if you are over 65 years of age.Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva has not been studied in a sufficient number of patients over 65 years of age. If you are over 65 years of age and have been prescribed Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva, your doctor will monitor you carefully.
• Once you start taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva, becareful to:
• signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating orabnormal dreams.These side effects may appear in the first 1-2 days of treatment and usually disappear after the first 2-4 weeks.
• any sign of rash.Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva can cause rashes. If you notice signs of a severe rash, with blisters or fever, stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva and tell your doctor immediately. If you have had a rash during

treatment with another NNRTI, you may be at greater risk of
developing rashes with Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva.

• any sign of inflammation or infection.In some patients with advanced HIV infection (AIDS) and with a history of opportunistic infection, signs and symptoms of previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to be due to an improvement in the body's immune response, which allows the body to fight infections that may have been present without clear symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks
the body's healthy tissue) may also occur after you start taking medicines for
treating HIV infection. Autoimmune disorders can occur many
months after starting treatment. If you notice any symptoms of infection or other
symptoms such as muscle weakness, initial weakness in hands and feet that rises towards
the trunk of the body, palpitations, tremors or hyperactivity, tell your doctor immediately to request the necessary treatment.

• bone problems.(which manifest as persistent or worsening bone pain and sometimes fractures) may also occur as a result of damage to the renal tubular cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.

Tenofovir disoproxil can also cause loss of bone mass. The most pronounced loss of bone mass was observed in clinical studies in which patients were
treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the long-term effects of tenofovir disoproxil on bone health and the risk of future fractures in adult and pediatric patients are uncertain.
Some adult HIV patients taking combination antiretroviral therapy
may develop a bone disease called osteonecrosis (death of bone tissue caused by a lack of blood flow to the bone). The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, a higher body mass index, among others,
may be some of the numerous risk factors for the development of this disease.
Signs of osteonecrosis are joint stiffness, discomfort and pain (especially
in the hips, knees and shoulders) and difficulty moving. See your doctor,
if you notice the appearance of any of these symptoms.

Tell your doctor if you suffer from osteoporosis, have a history of bone fractures or if youhave bone problems.

Children and adolescents

• Do not give Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva to children andadolescentsunder 18 years of age. The use of Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva in children and adolescents has not yet been studied.

Other medicines and Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva together with certain
medicines.These medicines are listed in Do not take Efavirenz/Emtricitabina/Tenofovir

disoproxil Zentiva, at the beginning of section 2. They include some commonly used medicines and
some herbal preparations (including St. John's Wort), which can cause serious interactions.

Tell your doctoror pharmacist if you are taking, have recently taken or might take
any other medicines.
Also Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva should not be taken together with
other medicines that contain efavirenz (unless advised by your doctor),
emtricitabina, tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil.

Inform your doctorif you are taking other medicines that can damage the kidneys. These include
for example:

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

Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva can interact with other medicines, including
herbal preparations such as Ginkgo biloba extracts. As a result, the amounts of
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva or other medicines in the blood may
be altered. This could prevent medicines from working correctly or could worsen
side effects. In some cases, your doctor will need to change the dose or check the levels of
medicines in your blood. It is important that you inform your doctor or pharmacist if you are taking any
of the following medicines:

• Medicines that contain didanosine (for HIV infection):taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva with other antiviral medicines that contain didanosine may increase the level of didanosine in the blood and may reduce the count of CD4 cells. When medicines containing tenofovir disoproxil and didanosine have been taken together, rare cases of inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood) have been reported, which sometimes caused death. Your doctor will need to consider very carefully 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 boosted ritonavir, atazanavir or saquinavir. Your doctor may prescribe a different medicine or change the dose of the protease inhibitor. Also tell your doctor if you are taking maraviroc.
• Medicines used for the treatment of infections related to the hepatitis C virus:elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
• Medicines that lower cholesterol (also known as statins):atorvastatin, pravastatin or simvastatin. Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva may reduce the amount of statin in the blood. Your doctor will check your cholesterol levels and, if necessary, change the dose of statin.
• Medicines used to treat seizures/convulsions (anticonvulsants):carbamazepine, phenytoin, phenobarbital. Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva may reduce the amount of anticonvulsant in the blood.
• Carbamazepine may reduce the amount of efavirenz, one of the components of Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva, in the blood. Your doctor may prescribe a different anticonvulsant.
• Medicines used to treat bacterial infections,including tuberculosis and infection with Mycobacterium avium complexassociated with AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may decide to change the dose or prescribe you another

antibiotic. In addition, your doctor may prescribe a higher dose of
efavirenz to treat HIV infection.

• Medicines used to treat fungal infections (antifungals):itraconazole or posaconazole. Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva may reduce the levels of itraconazole or posaconazole in the blood. Your doctor may consider treating you with a different antifungal.
• Medicines used to treat malaria:atovaquone/proguanil or artemether/lumefantrine. Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva may reduce the levels of atovaquone/proguanil or artemether/lumefantrine in the blood.
• Hormonal contraceptives, such as the birth control pill, an injectable contraceptive (for example, Depo-Provera), or a contraceptiveimplant (for example, Implanon):you must also use a reliable barrier contraceptive (see Pregnancyand breastfeeding). Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva may reduce the activity of hormonal contraceptives. Cases of pregnancy have occurred in women taking efavirenz, a component of Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva, while using a contraceptive implant, although it has not been established that efavirenz therapy causes contraceptive failure.
• Sertraline, a medicine used to treat depression, because your doctor may need to change the dose of sertraline.
• Bupropion, a medicine used to treat depression or to quit smoking, because your doctor may need to change the dose of bupropion.
• Diltiazem or similar medicines (called calcium channel blockers):when you start taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva, your doctor may need to change the dose of calcium channel blocker.
• Medicines used to prevent organ transplant rejection (also calledimmunosuppressants)such as ciclosporin, sirolimus or tacrolimus. When you start or stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva your doctor will need to carefully monitor the levels of immunosuppressant in your blood and may adjust your dose.
• Warfarin or acenocoumarol(medicines used to reduce blood clotting): your doctor may need to adjust the dose of warfarin or acenocoumarol.
• Ginkgo biloba extracts(a herbal preparation).
• Metamizole, a medicine used to treat pain and fever.
• Praziquantel, a medicine used to treat certain parasitic infections.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Women must not become pregnant during treatment with
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva and for 12 weeks after
treatment. Your doctor may decide to perform a pregnancy test to make sure you
are not pregnant before starting treatment with
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva.

If there is a possibility of becoming pregnant during treatment with
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva,you must use a reliable barrier contraceptive
(e.g. a condom) with other contraceptive methods including oral (pill) or other
hormonal contraceptives (e.g. subcutaneous implant, injection). Efavirenz, one of the active ingredients of
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva, can remain in the blood for a certain period
of time after the end of treatment. Therefore, you must continue to use contraceptive methods, as
described above, for 12 weeks after the end of treatment with
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva.

Tell your doctor immediately if you are pregnant or intend to become
pregnant.If you are pregnant, you should take Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
only if you decide, with your doctor's advice, that it is absolutely necessary.
Serious birth defects have been observed in animals and in newborns of women treated
with efavirenz during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
If you have already taken Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva during pregnancy,
your doctor may request periodic blood tests and other diagnostic tests to monitor
the development of the baby. In children whose mothers took NRTIs during pregnancy,
the benefit of protection against HIV outweighed the risk of side effects.

Do not breastfeed during treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil
Zentiva.Both HIV and the components of Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
can pass into breast milk and cause serious harm to the baby.
Breastfeeding is not recommended for HIV-positive women as HIV infection can be
transmitted to the baby through breast milk.
If you are breastfeeding or are thinking about breastfeeding you should talk toyour doctor as soon as possible.
Driving and using machines
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva can cause dizziness, decreased
concentration and drowsiness.If you experience these effects, do not drive and do not use tools or
machinery.

Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva contains sodium
This medicine contains less than 1 mmol (23mg) of sodium per tablet, i.e. essentially
“sodium-free”.

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

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:
One tablet a day, to be taken by mouth. Efavirenz/Emtricitabina/Tenofovir disoproxil
Zentiva should be taken on an empty stomach (generally understood as 1 hour before or 2 hours after
a meal), preferably before going to bed. This may make some side effects (e.g.
dizziness, drowsiness) less bothersome. Swallow the Efavirenz/Emtricitabina/Tenofovir
disoproxil Zentiva tablet whole with water.
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva must be taken every day.
If your doctor decides to stop one of the components of Efavirenz/Emtricitabina/Tenofovir
disoproxil Zentiva, you may be given efavirenz, emtricitabina and/or tenofovir disoproxil
separately or with other medicines for the treatment of HIV infection.

Remove the child-resistant closure
Open the bottles by pressing down on the child-resistant closure and turning it counterclockwise.

If you take more Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva than you should
If you accidentally take too many tablets of Efavirenz/Emtricitabina/Tenofovir disoproxil
Zentiva, it may increase the risk of possible side effects related to this
medicine (see section 4, Possible side effects). Contact your doctor or the nearest
emergency center. Bring the tablet bottle with you so you can easily describe
what you have taken.

If you forget to take Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
It is important that you do not forget to take any dose of Efavirenz/Emtricitabina/Tenofovir
disoproxil Zentiva.

If you forget a dose of Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva within 12 hours
of the usual time of taking it, take it as soon as possible and then take the next
dose at the scheduled time.

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

In case of vomiting within 1 hour after taking Efavirenz/Emtricitabina/Tenofovir
disoproxil Zentiva,you should take another tablet. Do not wait until the time of the
next dose. You should not take another tablet if you have vomited more than one hour after taking
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva.

If you stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
Do not stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
without first contacting your doctor.Stopping Efavirenz/Emtricitabina/Tenofovir
disoproxil Zentiva may seriously compromise the response to future treatment. If
treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva is stopped, talk to your
doctor before starting to take Efavirenz/Emtricitabina/Tenofovir
disoproxil Zentiva tablets again. If problems occur, or if a dose adjustment is necessary, your
doctor may decide to give you the components of Efavirenz/Emtricitabina/Tenofovir
disoproxil Zentiva separately.

When your supply of Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva begins to
run low,ask your doctor or pharmacist to give you more. This is very important
because if you stop taking the medicine even for a short time, the virus may begin to
multiply and, in this case, it may become more difficult to fight it.

If you have both HIV infection and hepatitis B,it is particularly important not to stop
taking Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva without first contacting
your doctor. Some patients have experienced a worsening of their hepatitis after
stopping taking emtricitabina or tenofovir disoproxil (two of the three components of
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva), as indicated by symptoms or blood tests.
If therapy with Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva is
interrupted, your doctor may recommend that you resume treatment for hepatitis B. Blood tests may be
necessary for 4 months after stopping treatment, in order to
check liver function. In some patients with advanced liver disease or cirrhosis, it is
not recommended to stop treatment as this may lead to a worsening
of hepatitis that may be life-threatening.
Immediately inform your doctor of any new or unusual symptoms observed after stopping
treatment, especially symptoms that are normally associated with hepatitis B infection.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur. This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check these changes.
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious possible side effects: tell your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare(may affect up to 1 in 1,000 people) but serious side effect that can be fatal. The following side effects may be signs of lactic acidosis:
• frequent and deep breathing
• fatigue
• feeling sick (nausea), vomiting and stomach pain.

If you think you have lactic acidosis, contact your doctor immediately.
Other possible serious side effects
The following side effects are uncommon(may affect up to 1 in 100 people):

• allergic reaction (hypersensitivity) that can cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
• swelling of the face, lips, tongue or throat
• aggressive behavior, suicidal thoughts, strange thoughts, paranoia, difficulty thinking clearly, mood disorders, feeling like you are seeing or hearing things that are not there (hallucinations), attempted suicide, personality change (psychosis), catatonia (a condition in which patients remain immobile and mute for a certain period of time)
• abdominal pain (in the stomach area) caused by inflammation of the pancreas
• forgetfulness, confusion, seizures, incoherent speech, tremor (shaking)
• yellowing of the skin and eyes, itching or abdominal pain (in the stomach area) caused by inflammation of the liver
• damage to the kidney tubules

Psychiatric side effects, in addition to those already mentioned, include delirium (false beliefs),
neurosis. Some patients have committed suicide. These problems tend to occur more often in those
who have had mental illness. In all cases, if you experience these symptoms, tell your doctor
immediately.
Liver side effects: if you are also infected with hepatitis B, you may experience a
worsening of hepatitis after stopping treatment (see section 3).
The following side effects are rare(may affect up to 1 in 1,000 people):

• liver failure, which in some cases has been fatal or has required a liver transplant. Most cases have occurred in patients already suffering from a liver disease, but some cases have been reported in patients without any pre-existing liver disease
• inflammation of the kidneys, abundant urine and feeling thirsty
• back pain caused by kidney problems, including kidney failure. Your doctor may perform blood tests to check your kidney function
• softening of the bones (with bone pain and sometimes fractures), which may be a consequence of damage to the kidney tubule cells and fatty liver

If you think you have any of these serious side effects, tell your doctor.
More frequent side effects
The following side effects are very common(may affect more than 1 in 10 people):

• dizziness, headache, diarrhea, feeling unwell (nausea), feeling sick (vomiting)
• skin rashes (including red spots or pustules sometimes with blisters and swelling of the skin) which may be an allergic reaction
• feeling weak

Tests may also show:

• decreases in blood phosphate levels
• increased levels of creatine kinase in the blood, resulting in pain and muscle weakness

Other possible side effects
The following side effects are common(may affect up to 1 in 10 people):

• allergic reactions
• coordination disorders and balance problems
• worry or depression
• difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
• pain, stomach pain
• digestive problems with discomfort after meals, feeling full, excessive intestinal gas (flatulence)
• loss of appetite
• fatigue
• itching
• change in skin color with the appearance of dark patches, often starting on the hands and soles of the feet
• loss of bone mass

Tests may also show:

• decreased white blood cell count (this may make you more susceptible to infection)
• problems with the liver and pancreas
• increased levels of fatty acids (triglycerides), bilirubin or glucose in the blood

The following side effects are uncommon(may affect up to 1 in 100 people):

• muscle weakness, muscle pain or muscle weakness
• anemia (low red blood cell count)
• feeling of spinning (vertigo), ringing, buzzing or other persistent noise in the ear
• blurred vision
• chills
• increased breast volume in men
• decreased sexual desire
• flushing
• dry mouth
• increased appetite

Tests may also show:

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

Muscle weakness, softening of the bones (with bone pain and sometimes fractures), muscle pain, muscle weakness and decreased potassium or phosphate in the blood may occur
due to damage to the kidney tubule cells and fatty liver.
The following side effects are rare(may affect up to 1 in 1,000 people):

• itchy skin rashes due to sunlight

Reporting side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the pack after
“Exp.”. The expiry date refers to the last day of that month.
Use within 30 days of first opening. This medicine does not require any particular storage
temperature. Store in the original packaging to protect the medicine
from humidity. Keep the bottle tightly closed.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva contains

• The active ingredients are efavirenz, emtricitabine and tenofovir disoproxil. Each film-coated tablet of Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva contains 600 mg of efavirenz, 200 mg of emtricitabine and tenofovir disoproxil phosphate equivalent to 245 mg of tenofovir disoproxil.
• The other ingredients contained in the tablet are microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica, talc.
• The other ingredients contained in the film coating of the tablet are polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva and package contents
The film-coated tablets of Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva are pink in color,
oval, biconvex and available in bottles of 30 tablets (with a sachet of silica gel desiccant
which must remain in the bottle to protect the tablets). The silica gel desiccant is
contained in a separate jar and must not be swallowed.
The following packs are available:
Outer packaging containing 1 bottle of 30 film-coated tablets and outer packaging
containing 3 bottles of 30 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
S.C. Zentiva S.A.
Bvd. Theodor Pallady, nr. 50
Sector 3
032266 Bucharest
Romania
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
[email protected]

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: + 35924417136
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf.: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2034 1796
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva, Denmark ApS
Tlf: +45 787 68 400
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS
Sími: +354 539 5025
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39 800081631
[email protected]

Suomi/Finland
Zentiva, Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu .