EFAVIRENZ 600 mg/200 mg /245 Mg Фильм-Coated Таблетки

Содержание инструкции

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

Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets

efavirenz/emtricitabina/tenofovir disoproxil

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

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

Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan 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 disoproxil 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 Mylan is a treatment for human immunodeficiency virus
(HIV) infectionin adults aged 18 years and over who have previously
been 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 Mylan

Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan:

• if you are allergicto efavirenz, emtricitabine, tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.
• if you have a heart condition, such as an abnormal electrical signal 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 Mylan”):
• 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 an 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 Mylan 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
Mylan.

• This medicine is not a cure for HIV infection. While you are taking Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan you may still develop infections or other diseases associated with HIV infection.
• While you are taking Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan you must remain under your doctor’s supervision.
• Tell your doctor:
• if you are taking other medicinescontaining efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil. Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan should not be taken together with these medicines.
• if you have or have had kidney diseaseor if tests have shown you have kidney problems. Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan is not recommended in case of moderate to severe kidney disease.
• Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan may have effects on the kidneys. Before you start 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 Mylan is not taken with
other medicines that can damage the kidneys (see Other medicines and

Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan). 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 anti-convulsants such as carbamazepine, phenobarbital and phenytoin. If you are taking any of these medicines, your doctor may need to check the level of the anti-convulsant medicine in your blood, to make sure there are no problems during treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan. Your doctor may also give you a different anti-convulsant.
• 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 monitor your liver function closely or may prescribe you another medicine. If you have severeliver disease, do not take Efavirenz/Emtricitabina/Tenofovir disoproxilMylan(see above, section 2, Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan).

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

• 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 old.Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan has not been studied in a sufficient number of patients over 65 years of age. If you are over 65 years old and have been prescribed Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan, your doctor will monitor you closely.
• Once you start taking Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan, becareful to:
• signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreams.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 Mylan can cause rashes. If you notice signs of a severe rash, with blisters or fever, stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan and tell your doctor immediately. If you have had a rash during treatment with another NNRTI, you may be at greater risk of developing a rash with Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan.
• any sign of inflammation or infection.In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of previous infections may appear shortly after starting anti-HIV treatment. These symptoms are thought to be due to an improvement in the body's immune response, allowing 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 medicines to treat 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 torso, palpitations, tremor
or hyperactivity, tell your doctor immediately for the necessary treatment.

• bone problems.Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (bone tissue death caused by a lack of blood supply to the bone). Some of the many risk factors for developing this disease may be the duration of use of combination antiretrovirals, the use of corticosteroids, alcohol consumption, severe immunosuppression, a high body mass index. Signs of osteonecrosis are joint stiffness, pain and discomfort (especially in the hip, knee and shoulder) 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) can also occur as a result of damage to
the cells of the renal tubules (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.
Tell 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 Mylan to children andadolescentsunder the age of 18 years. The use of Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan in children and adolescents has not yet been studied.

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

disoproxil Mylan, at the beginning of section 2. They include some common medicines and
some herbal remedies (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 Mylan should not be taken with other
medicines that contain efavirenz (unless advised by your doctor), emtricitabine,
tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil.

Tell 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 Mylan can interact with other medicines, including
herbal preparations such as Ginkgo biloba extracts. As a result, the amounts of
Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan or other medicines in the blood may
be altered. This could prevent the medicines from working correctly or could worsen
side effects. In some cases, your doctor may need to adjust the dose or check the levels
of medicines in your blood. It is important that you tell 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 Mylan with other antiviral medicines that contain didanosine may increase the level of didanosine in the blood and may reduce the CD4 cell count. When medicines containing tenofovir disoproxil and didanosine have been taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, which sometimes has been fatal. 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 you a different medicine or adjust the dose of the protease inhibitor. Also tell your doctor if you are taking maraviroc.
• Medicines used for the treatment of hepatitis C virus-related infections: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 Mylan may reduce the amount of statin in the blood. Your doctor will check your cholesterol levels and, if necessary, adjust the dose of statin.
• Medicines used to treat seizures/convulsions (anticonvulsants):carbamazepine, phenytoin, phenobarbital. Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan 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 Mylan, in the
blood. Your doctor may prescribe you a different anticonvulsant.

• Medicines used to treat bacterial infections,including tuberculosis and Mycobacterium avium complex infection related to AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may need to adjust the dose or prescribe you an alternative antibiotic. In addition, your doctor may prescribe you a higher dose of efavirenz to treat HIV infection.
• Medicines used to treat fungal infections (antifungals):itraconazole or posaconazole. Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan may reduce the amount 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 Mylan may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in the blood.
• Praziquantel, a medicine used to treat worm infections.
• Hormonal contraceptives, such as the birth control pill, a contraceptive injection (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 Mylan may reduce the activity of hormonal contraceptives. Cases of pregnancy have occurred in women taking efavirenz, a component of Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan, 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 adjust the dose of sertraline.
• Metamizole,a medicine used to treat pain and fever.
• Bupropion, a medicine used to treat depression or to stop smoking, because your doctor may need to adjust the dose of bupropion.
• Diltiazem or similar medicines (called calcium channel blockers):when you start taking Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan, your doctor may need to adjust the dose of calcium channel blocker.
• Medicines used to prevent organ transplant rejection (also called immunosuppressants)such as ciclosporin, sirolimus or tacrolimus. When you start or stop taking Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan, your doctor will need to carefully monitor your blood levels of the immunosuppressant and may need to adjust your dose.
• Warfarin or acenocoumarol(medicines used to reduce blood clotting): your doctor may need to adjust your dose of warfarin or acenocoumarol.
• Ginkgo biloba extracts(a herbal preparation).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant 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 Mylan 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 Mylan.

If there is a possibility of becoming pregnant during treatment with
Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan,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 Mylan, can remain in the blood for a certain period of
time after treatment has stopped. Therefore, you must continue to use contraceptive methods, as
described above, for 12 weeks after stopping treatment with
Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan.

Tell your doctor immediately if you are pregnant or are planning to become
pregnant.If you are pregnant, you should take Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan
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 Mylan 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 has outweighed the risk of side effects.

Do not breastfeed during treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil
Mylan.The components of Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan can pass into
breast milk and cause serious harm to the baby.
Breastfeeding is not recommendedfor HIV-positive women as HIV infection can be
transmitted to the baby through breast milk.
If you are breastfeeding or are planning to breastfeed you should talk to your doctor as soon as possible.

Driving and using machines
Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan can cause dizziness, decreased
concentration and drowsiness.If you experience these effects, do not drive and do not use tools or machines.

Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan contains sodium and lactose
This medicine contains 7.5 mg of sodium metabisulfite per tablet, which rarely may
cause severe hypersensitivity reactions and bronchospasm. This medicine contains less than 1 mmol
(23 mg) of sodium per dose, that is to say essentially “sodium-free”. Each tablet also contains
105.5 mg of lactose per tablet. If you have been diagnosed by your doctor as having intolerance to some
sugars, contact your doctor before taking this medicine.

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

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 Mylan
should be taken on an empty stomach (commonly 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 tablet of Efavirenz/Emtricitabina/Tenofovir disoproxil
Mylan whole with water.
Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan must be taken every day.
If your doctor decides to stop one of the components of Efavirenz/Emtricitabina/Tenofovir
disoproxil Mylan, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil
separately or with other medicines to treat HIV infection.

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

If you forget a dose of Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan 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 (within 1 hour after taking Efavirenz/Emtricitabina/Tenofovir disoproxil
Mylan),you should take another tablet. Do not wait until the time of the next dose. Do not
take another tablet if you have vomited more than 1 hour after taking
Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan.

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

When your supply of Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan 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 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 that you do not stop the
treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan without first contacting your
doctor. Some patients have experienced a worsening of their hepatitis after stopping
taking emtricitabine or tenofovir disoproxil (two of the three components of
Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan), as indicated by symptoms or blood tests. If the therapy with Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan
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 can 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 questions 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 for these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious possible side effects: inform 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
• drowsiness
• feeling unwell (nausea), feeling sick (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 like you are seeing or hearing things that are not there (hallucinations), attempted suicide, personality changes (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 (convulsions), 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 delirium (false beliefs),
neurosis. Some patients have committed suicide. These problems tend to occur more often in those
who have had mental health problems. In all cases, if you experience these symptoms, inform 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 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 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 cells of the kidney tubules
• fatty liver

If you believe you have any of these serious side effects, inform your doctor.
More common 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 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 patients):

• allergic reactions
• coordination disorders and balance problems
• anxiety 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

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 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 cells of the kidney tubules.
The following side effects are rare(may affect up to 1 in 1,000 patients)

• itchy skin rashes due to sunlight

Reporting side effects
If you experience any side effects, including 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 Mylan

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 carton after
“Exp.”.
The expiry date refers to the last day of that month.

Bottle of 30 tablets: Note the date of opening of the bottle in the designated space on the label and/or
on the carton. Use within 60 days of first opening.
Do not store at a temperature above 25 °C. Store in the original packaging to protect
the medicine from light.
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 Mylan contains

• The active ingredients are efavirenz, emtricitabine and tenofovir disoproxil. Each film-coated tablet of Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as maleate).
• The other components of the film-coated tablet are sodium croscarmellose, hydroxypropylcellulose, low substitution hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica, sodium metabisulfite (E223), lactose monohydrate and red iron oxide (E172).
• This medicine contains sodium metabisulfite (E223) and lactose. See section 2.
• The other components contained in the film coating of the tablets are yellow iron oxide (E172), red iron oxide (E172), macrogol, poly(vinyl alcohol), talc, titanium dioxide (E171).

Description of the appearance of Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan and package contents
The film-coated tablets of Efavirenz/Emtricitabina/Tenofovir disoproxil Mylan are
pink in colour, capsule-shaped, imprinted with the inscription 'M' on one side and 'TME' on the other side.
This medicine is supplied in plastic bottles containing a desiccant labelled "DO
NOT INGEST" and 30 or 90 film-coated tablets and in multipacks of 90 film-coated tablets
containing 3 bottles, each of which contains 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Mylan Hungary Kft
Mylan utca 1, Komárom, 2900,
Hungary
McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe,
Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352,
Germany
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Mylan bvba/sprl
Tél/Tel: + 32 02 658 61 00

Lietuva
BGP Products UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Mylan bvba/sprl
Tél/Tel: + 32 02 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Mylan EPD Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: + 31 33 299 7080

Eesti
BGP Products Switzerland GmbH Eesti filiaal
Tel: +372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Generics Pharma Hellas ΕΠΕ
Τηλ: +30 210 993 6410

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

España
Viatris Pharmaceuticals, S.L.U.
Tel: + 34 900 102 712

Polska
Mylan Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel.: + 351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: + 40 372 579 000

Ireland
Mylan Ireland Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 326 04 910 / +421 917 206 274

Italia
Mylan Italia S.r.l.
Tel: + 39 02 612 46921

Suomi/Finland
Viatris OY
Puh/Tel: + 358 9­46 60 03

Κύπρος
Varnavas Hadjipanayis Ltd
Τηλ: +357 2220 7700

Sverige
Viatris AB
Tel: + 46 (0)8 630 19 00

Latvija
Mylan Healthcare SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .