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

Зміст інструкції

1. Efavirenz/Emtricitabina/Tenofovir disoproxil Krka 600 mg/200 mg/245 mg coated tablets
2. efavirenz/emtricitabina/tenofovir disoproxil
   1. What is Efavirenz/Emtricitabina/Tenofovir disoproxil Krka and what it is used for
   2. What you need to know before taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka
3. Efavirenz/Emtricitabina/Tenofovir disoproxil Krka ). If this is unavoidable, your doctor
   1. How to take Efavirenz/Emtricitabina/Tenofovir disoproxil Krka
   2. Possible side effects
   3. How to store Efavirenz/Emtricitabina/Tenofovir disoproxil Krka
   4. Content of the pack and other information

Efavirenz/Emtricitabina/Tenofovir disoproxil Krka 600 mg/200 mg/245 mg coated tablets

with film coating

efavirenz/emtricitabina/tenofovir disoproxil

Read this leaflet carefully before 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Efavirenz/Emtricitabina/Tenofovir disoproxil Krka is and what it is used for
• 2. What you need to know before you take Efavirenz/Emtricitabina/Tenofovir disoproxil Krka
• 3. How to take Efavirenz/Emtricitabina/Tenofovir disoproxil Krka
• 4. Possible side effects
• 5. How to store Efavirenz/Emtricitabina/Tenofovir disoproxil Krka
• 6. Contents of the pack and other information

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

Efavirenz/Emtricitabina/Tenofovir disoproxil Krka contains three active substancesused 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 substances, 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 Krka is a treatment for human
immunodeficiency virus(HIV) infection in adults aged 18 years and over who have previously
been treated with other antiretroviral medicines and whose HIV-1 infection has been controlled 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 Krka

Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Krka

• 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 Krka”):
• 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 with Efavirenz/Emtricitabina/Tenofovir disoproxil Krka may cause serious or potentially life-threatening side effects, or may prevent these medicines from working properly. Warnings and precautionsTalk to your doctor or pharmacist before taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka.
• This medicine is not a cure for HIV infection. While you are taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka you may still develop infections or other diseases associated with HIV infection.
• While you are taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka 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 Krka must not be taken with these medicines.
• if you have or have had kidney disease,or if tests have shown you have kidney problems. Efavirenz/Emtricitabina/Tenofovir disoproxil Krka is not recommended in case of moderate to severe kidney disease. Efavirenz/Emtricitabina/Tenofovir disoproxil Krka can have effects on the kidneys. Before starting treatment, your doctor may prescribe blood tests to assess your

renal function. Your doctor may also prescribe blood tests during treatment
to monitor your kidneys.
Generally Efavirenz/Emtricitabina/Tenofovir disoproxil Krka is not taken with other
medicines that can damage the kidneys (see Other medicines and

Efavirenz/Emtricitabina/Tenofovir disoproxil Krka ). 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 calledQT interval prolongation.
• if you have had mental health problems in the past,including depression, or if you have abused certain substances or alcohol. Immediately inform your doctor if you feel depressed, have suicidal thoughts or strange thoughts (see paragraph 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 medications, your doctor may need to check the level of the anticonvulsant medication in your blood to ensure there are no problems during treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Krka. Your doctor may also give you a different anticonvulsant.
• if you have had liver problems in the past, including active chronic hepatitis.Patients with liver problems, including chronic hepatitis B or C, treated with combination antiretrovirals, have a higher risk of severe and potentially fatal liver complications. Your doctor may request blood tests to carefully monitor liver function or may prescribe you another medication. If you have severe liver disease, do not takeEfavirenz/Emtricitabina/Tenofovir disoproxil Krka(see above, paragraph 2, Do nottake Efavirenz/Emtricitabina/Tenofovir disoproxil Krka). If you have hepatitis B, your doctor will carefully evaluate the best therapeutic regimen for you. Tenofovir disoproxil and emtricitabine, two of the active ingredients of Efavirenz/Emtricitabina/Tenofovir disoproxil Krka, possess some activity against the hepatitis B virus, although emtricitabine is not authorized for the treatment of hepatitis B infection. Hepatitis symptoms may worsen after discontinuation of treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Krka. Your doctor may request blood tests at regular intervals to carefully monitor liver function (see paragraph 3, If you stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka).
• Regardless of past liver problems, your doctor may request blood tests at regular intervals to check liver function.
• if you are over 65 years of age.Efavirenz/Emtricitabina/Tenofovir disoproxil Krka 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 Krka, your doctor will monitor you carefully.
• Once you start taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka, becareful to:
• signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormaldreams.These side effects may appear in the first 1-2 days of treatment and generally disappear after the first 2-4 weeks.
• any sign of rash.Efavirenz/Emtricitabina/Tenofovir disoproxil Krka can cause rashes. If you notice signs of a severe rash, with blistering or fever, stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka and
  immediately inform your doctor. If you have experienced a rash during treatment with another NNRTI,
  you may be at greater risk of developing rashes with
  Efavirenz/Emtricitabina/Tenofovir disoproxil Krka.

any sign of inflammation or infection.In some patients with advanced HIV infection (AIDS) and with a history of opportunistic infection, shortly after starting anti-HIV treatment, inflammatory signs and symptoms of previous infections may occur. 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 healthy tissue in the body) may also occur after you have started taking medications to treat HIV infection. Autoimmune disorders can occur many months after the start of 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 torso, palpitations, tremor or hyperactivity, inform your doctor immediately for the necessary treatment.

• bone problems.Some 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 any of these symptoms. Bone problems (which manifest as persistent or worsening bone pain and sometimes resulting in fractures) may also occur as a result of damage to the renal tubular cells (see paragraph 4, Possible side effects). Inform your doctor if you have bone pain or fractures. Tenofovir disoproxil can also cause bone mass loss. The most pronounced bone mass loss was observed in clinical studies in which patients were treated for HIV with tenofovir disoproxil in association with a boosted protease inhibitor. In general, the long-term effects of tenofovir disoproxil on bone health and the future risk of fractures in adult and pediatric patients are uncertain. Inform your doctor if you suffer from osteoporosis. Patients with osteoporosis are at higher risk of fractures. Children and adolescents
• Do not give Efavirenz/Emtricitabina/Tenofovir disoproxil Krka to children andadolescentsunder 18 years of age. The use of Efavirenz/Emtricitabina/Tenofovir disoproxil Krka in children and adolescents has not been studied. Other medications and Efavirenz/Emtricitabina/Tenofovir disoproxil KrkaYou must not take Efavirenz/Emtricitabina/Tenofovir disoproxil Krka with some medications. These medications are listed in Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Krka,

at the beginning of paragraph 2. They include some commonly used medications and some herbal preparations (including St. John's wort), which can cause serious interactions.

Inform yourdoctor or pharmacist if you are taking, have recently taken or may take
any other medication.
In addition, Efavirenz/Emtricitabina/Tenofovir disoproxil Krka must not be taken with other
medications containing efavirenz (unless advised by your doctor), emtricitabine,
tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil.

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

• aminoglycosides, vancomycin (medications for bacterial infections)
• foscarnet, ganciclovir, cidofovir (medications for viral infections)
• amphotericin B, pentamidine (medications 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 Krka can interact with other medications, including
herbal preparations such as Ginkgo biloba extracts. Consequently, the amounts of
Efavirenz/Emtricitabina/Tenofovir disoproxil Krka or other medications in the blood may
be altered.
This may prevent medications from working properly or may worsen side effects. In
some cases, your doctor will need to adjust the dose or check the levels of medications in your blood. It is
important that you inform your doctor or pharmacist if you are taking any of the following medications:

• Medications containing didanosine (for HIV infection):taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka with other antiviral medications containing didanosine may increase the level of didanosine in the blood and may reduce the CD4 cell count. Rarely, cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported when medications containing tenofovir disoproxil and didanosine have been taken together, sometimes causing death. Your doctor will need to carefully consider whether to treat you with medications containing tenofovir and didanosine
• Other medications used for HIV infection:The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir or ritonavir boosted, atazanavir or saquinavir. Your doctor may prescribe you a different medication or adjust the dose of the protease inhibitor. Also tell your doctor if you are taking maraviroc.
• Medications used to treat hepatitis C virus infections:elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
• Cholesterol-lowering medications (also known as statins):atorvastatin, pravastatin or simvastatin. Efavirenz/Emtricitabina/Tenofovir disoproxil Krka may reduce the amount of statin in the blood. Your doctor will check your cholesterol levels and, if necessary, adjust the dose of statin.
• Medications used to treat seizures/convulsions (anticonvulsants):carbamazepine, phenytoin, phenobarbital. Efavirenz/Emtricitabina/Tenofovir disoproxil Krka 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 Krka, in the blood. Your doctor may prescribe you a different anticonvulsant.
• Medications used to treat bacterial infections,including tuberculosis and mycobacterium avium complex infection associated with AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may decide to adjust the dose or prescribe you an alternative antibiotic. In addition, your doctor may prescribe you a higher dose of efavirenz for the treatment of HIV infection.
• Medications used to treat fungal infections (antifungals):itraconazole or posaconazole. Efavirenz/Emtricitabina/Tenofovir disoproxil Krka may reduce the levels of

itraconazole or posaconazole in the blood. Your doctor may consider
treating you with a different antifungal.

• Medications used to treat malaria:atovaquone/proguanil or artemether/lumefantrine. Efavirenz/Emtricitabina/Tenofovir disoproxil Krka 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 contraceptive implant (for example,Implanon):you must also use a reliable barrier contraceptive (see Pregnancy andbreastfeeding). Efavirenz/Emtricitabina/Tenofovir disoproxil Krka may reduce the activity of hormonal contraceptives. Cases of pregnancy have occurred in women taking efavirenz, a component of Efavirenz/Emtricitabina/Tenofovir disoproxil Krka, while using a contraceptive implant, although it has not been established that efavirenz therapy causes contraceptive failure.
• Praziquantel,a medication used to treat parasitic worm infections.
• Sertraline, a medication used to treat depression, because your doctor may need to adjust the dose of sertraline.
• Metamizole,a medication used to treat pain and fever.
• Bupropion, a medication used to treat depression or to quit smoking, because your doctor may need to adjust the dose of bupropion.
• Diltiazem or similar medications (called calcium channel blockers):when you start taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka, your doctor may need to adjust the dose of calcium channel blocker.
• Medications used to prevent organ transplant rejection (also calledimmunosuppressants)such as cyclosporine, sirolimus or tacrolimus. When you start or stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Krka your doctor will need to monitor your levels of immunosuppressant in the blood carefully and may adjust your dose.
• Warfarin or acenocoumarol(medications used to reduce blood clotting): your doctor may need to adjust the dose of warfarin or acenocoumarol.
• Ginkgo biloba extracts(an herbal preparation).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

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

If there is a possibility of becoming pregnant during treatment with
Efavirenz/Emtricitabina/Tenofovir disoproxil Krka,you must use a reliable barrier contraceptive
method (e.g., a condom) with other contraceptive methods including oral ones (pill) or other
hormonal contraceptives (e.g., subcutaneous implant, injection). Efavirenz, one of the active ingredients of
Efavirenz/Emtricitabina/Tenofovir disoproxil Krka, may 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 stopping treatment with
Efavirenz/Emtricitabina/Tenofovir disoproxil Krka.

Tell your doctor immediately if you are pregnant or if you are planning to become
pregnant.If you are pregnant, you should take Efavirenz/Emtricitabina/Tenofovir disoproxil Krka only
if you and your doctor decide that it is absolutely necessary.
Serious birth defects have been observed in animals and in the 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 Krka during pregnancy, your doctor
may request periodic blood tests and other diagnostic tests to monitor the development of
the child. In children whose mothers have taken NRTIs during pregnancy, the benefit of
protection against HIV has outweighed the risk of side effects.

Do not breastfeed during treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Krka.Both
HIV and the components of Efavirenz/Emtricitabina/Tenofovir disoproxil Krka 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 to your doctor as soon as possible.

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

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

Take this medicine following exactly the instructions of your doctor or pharmacist. 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 Krka
should be taken on an empty stomach (usually 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
Krka tablet whole with water.
Efavirenz/Emtricitabina/Tenofovir disoproxil Krka must be taken every day.
If the doctor decides to stop one of the components of Efavirenz/Emtricitabina/Tenofovir
disoproxil Krka, you may be given efavirenz, emtricitabina and/or tenofovir disoproxil separately
or with other medicines for the treatment of HIV infection.

If you take more Efavirenz/Emtricitabina/Tenofovir disoproxil Krka than you should
If you accidentally take too many tablets of Efavirenz/Emtricitabina/Tenofovir disoproxil Krka,
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 Krka
It is important that you do not forget to take any dose of Efavirenz/Emtricitabina/Tenofovir
disoproxil Krka.

If you forget a dose of Efavirenz/Emtricitabina/Tenofovir disoproxil Krka 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 forgotten 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 the tablet (within 1 hour after taking
Efavirenz/Emtricitabina/Tenofovir disoproxil Krka),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 Krka.

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

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

If you have both HIV and hepatitis B infection,it is particularly important not to stop
treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Krka 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 Krka). If therapy with
Efavirenz/Emtricitabina/Tenofovir disoproxil Krka is stopped, 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, particularly symptoms that are normally associated with hepatitis B infection.
If you have any further questions on 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. Your doctor will check these
changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Possible serious 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 patients), but serious, side effect that can be fatal. The following side effects may be signs of lactic acidosis:
• frequent and deep breathing
• fatigue
• feeling of 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 patients):

• allergic reaction (hypersensitivity) that can cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see paragraph 2)
• swelling of the face, lips, tongue, or throat
• aggressive behavior, suicidal thoughts, strange thoughts, paranoia, difficulty thinking clearly, mood disorders, feeling of seeing or hearing things that are not there (hallucinations), attempted suicide, personality change (psychosis), catatonia (a condition in which the patient remains immobile and silent 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
• kidney tubule damage

Psychiatric side effects, in addition to those already mentioned, include delusions (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, always inform your doctor.
Liver side effects: if you are also infected with hepatitis B, you may experience a
worsening of hepatitis after stopping treatment (see paragraph 3).
The following side effects are rare (may affect up to 1 in 1,000 patients):

• 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 of thirst
• 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 cells of the kidney tubules
• fatty liver

→ If you believe 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 patients):

• 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 of weakness 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 patients):

• 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 of fullness, 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 Tests may also show:
• decreased white blood cell count (this may make you more susceptible to infection)
• problems with 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 patients):

• muscle weakness, muscle pain, or muscle weakness
• anemia (low red blood cell count)
• feeling of dizziness (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.
The following side effects are rare (may affect up to 1 in 1,000 patients):

• itchy skin rashes due to sunlight

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please 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 Krka

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 packaging after EXP. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30  C.
Keep the bottle tightly closed to protect the medicine from moisture.
The shelf life after first opening is 2 months, if not stored above 25  C.
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. Content of the pack and other information

What contains Efavirenz/Emtricitabina/Tenofovir disoproxil Krka

• The active ingredients are efavirenz, emtricitabine and tenofovir disoproxil. Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate).
• Other ingredients are: Tablet core:microcrystalline cellulose, hydroxypropylcellulose, sodium lauryl sulfate, sodium croscarmellose, red iron oxide (E172), magnesium stearate, sodium stearyl fumarate. Film coating:poly(vinyl alcohol), macrogol 3350, titanium dioxide (E171), talc, red iron oxide (E172), yellow iron oxide (E172). See section 2 “Efavirenz/Emtricitabina/Tenofovir disoproxil Krka contains sodium”.

Description of the appearance of Efavirenz/Emtricitabina/Tenofovir disoproxil Krka and pack content
Efavirenz/Emtricitabina/Tenofovir disoproxil Krka film-coated tablets (tablets) are
light pink, oval, biconvex, film-coated tablets with beveled edges.
Tablet dimensions: 20 x 11 mm.
Efavirenz/Emtricitabina/Tenofovir disoproxil Krka is available in bottles of 30 tablets, with a
child-resistant polypropylene closure with a silica gel desiccant, which helps to
protect the tablets from moisture.
The following pack sizes are available: cartons containing one bottle of 30 film-coated tablets (1x30) or 90 (3 bottles of 30) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta

• E. J. Busuttil Ltd. Tel: + 356 21 445 885 DeutschlandTAD Pharma GmbH Tel: + 49 (0) 4721 606-0 NederlandKRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) EestiKRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658 NorgeKRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) ΕλλάδαKRKA ΕΛΛΑΣ ΕΠΕ Τηλ: + 30 2100101613 ÖsterreichKRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300 EspañaKRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80 PolskaKRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500 FranceKRKA France Eurl Tél: + 33 (0)1 57 40 82 25 PortugalKRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650 HrvatskaKRKA - FARMA d.o.o. Tel: + 385 1 6312 100 RomâniaKRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05 IrelandKRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710 SlovenijaKRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100 ÍslandLYFIS ehf. Sími: + 354 534 3500 Slovenská republikaKRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 501 ItaliaKRKA Farmaceutici Milano S.r.l. Suomi/FinlandKRKA Finland Oy

Tel: + 39 02 3300 8841 Puh/Tel: + 358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .