Efavirenz / emtricitabine / tenofovir disoproxil Mylan: detailed information

Package leaflet: Information for the patient

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets
efavirenz/emtricitabine/tenofovir disoproxil
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any doubts, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is and what it is used for
What you need to know before taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Possible side effects
How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Contents of the pack and other information

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

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan contains three active substances used in
the treatment of human immunodeficiency virus (HIV) infection:

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
Tenofovir disoproxil 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) that is essential for the virus to replicate.
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a treatment for human immunodeficiency
virus (HIV) infection in adults aged 18 years and older who have previously been treated with other antiretroviral medicines and whose HIV-1 infection has been under control for at least three months. Patients must not have experienced prior anti-HIV therapy failure.

2. What you should know before taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan:

if you are allergic to 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 called prolongation of the QT interval that puts you at risk of serious heart rhythm problems (torsades de pointes).
if any member of your family (parents, grandparents, siblings) has died suddenly due to heart problems or was born with heart defects.
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 taking any of the following medicines (see also “Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan”):
astemizole or terfenadine (used to treat hay fever or other allergies)
bepridil (used to treat heart diseases)
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 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, imidazoles)
triazole antifungals
some antimalarial agents
methadone (used to treat opioid dependence)

Inform your doctor immediately if you are taking any of these medicines. Taking these
medicines together with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may cause serious or potentially fatal side effects, or may prevent these medicines from working properly.

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

This medicine is not a cure for HIV infection. While taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, you may still develop infections or other illnesses associated with HIV infection.
While taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, you must remain under medical supervision.
Inform your doctor:
if you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan must not be taken together with these medicines.
if you have or have had kidney disease or if blood tests have shown kidney problems. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is not recommended in cases of moderate to severe kidney disease.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may affect the kidneys.
Before starting treatment, your doctor may order blood tests to assess kidney function. Your doctor may also order blood tests during treatment to monitor kidney function.
Generally, Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan should not be taken with other medicines that may harm the kidneys (see Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan). If this is unavoidable, your doctor will monitor your kidney function once a week.

if you have a heart condition, such as an abnormal electrical signal called prolongation of the QT interval.
if you have previously had mental health problems, including depression, or if you have abused certain substances or alcohol. Inform your doctor immediately if you feel depressed, have suicidal thoughts or unusual thoughts (see section 4, Possible side effects).
if you have previously had seizures or if you are being treated with anticonvulsants such as carbamazepine, phenobarbital or 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 ensure there are no problems during treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan. Your doctor might also prescribe a different anticonvulsant.
if you have previously had liver problems, including active chronic hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with combination antiretroviral therapy, have a higher risk of serious and potentially fatal liver complications. Your doctor may request blood tests to closely monitor liver function or may prescribe another medicine. If you have severe liver disease, do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (see above, section 2, Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan).

If you have hepatitis B, your doctor will carefully evaluate the best treatment regimen for you. Tenofovir disoproxil and emtricitabine, two of the active substances in Efavirenz/Emtricitabine/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/Emtricitabine/Tenofovir disoproxil Mylan. Your doctor may request regular blood tests to closely monitor liver function (see section 3, If you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan).

Regardless of any previous liver problems, your doctor may request regular blood tests to monitor liver function.
if you are over 65 years of age. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan has not been studied in a sufficient number of patients over 65 years of age. If you are over 65 and have been prescribed Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, your doctor will monitor you closely.
Once you start taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, be aware of:
signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreams. These side effects may occur during the first 1-2 days of treatment and usually disappear after the first 2-4 weeks.
any sign of skin rash. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may cause skin rash. If you notice signs of a severe rash, with blistering or fever, stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan and inform your doctor immediately. If you have previously experienced a rash during treatment with another NNRTI, you may have an increased risk of developing rashes with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed 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, inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition where the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and feet progressing towards the trunk, palpitations, tremor or hyperactivity, inform your doctor immediately to receive necessary treatment.

Inform your doctor if you have osteoporosis, have had bone fractures in the past or have bone problems.
bone problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood flow to the bone). Some of the many risk factors for developing this disease may include duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. Signs of osteonecrosis include joint stiffness, pain and discomfort (especially in the hip, knee and shoulders) and difficulty moving. Consult your doctor if you notice any of these symptoms.

Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures) may also occur as a result of damage to renal tubule cells (see section 4, Possible side effects). Inform your doctor if you have bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mass. The most pronounced bone mass loss has been observed in clinical studies where 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 paediatric patients are uncertain.

Children and adolescents

Do not administer Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan to children and adolescents under 18 years of age. The use of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan in children and adolescents has not yet been studied.

Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
You must not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan together with certain
medicines. These medicines are listed in Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, at the beginning of section 2. They include some commonly used medicines and some herbal preparations (including St. John’s wort), which may cause serious interactions.
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
In addition, Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan must not be taken together with other medicines containing efavirenz (unless advised by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Inform your doctor if you are taking other medicines that may 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 (for cancer treatment)
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)

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

Medicines containing didanosine (for HIV infection): taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan with other antiviral medicines containing didanosine may increase the level of didanosine in the blood and may reduce 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, sometimes resulting in 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 adjust the dose of the protease inhibitor. Also inform your doctor if you are taking maraviroc.
Medicines used to treat hepatitis C virus-related infections: elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
Lipid-lowering medicines (also known as statins): atorvastatin, pravastatin or simvastatin. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may reduce the amount of statins in the blood. Your doctor will monitor your cholesterol levels and, if necessary, adjust the statin dose.
Medicines used to treat seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz/Emtricitabine/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/Emtricitabine/Tenofovir disoproxil Mylan, in
the blood. Your doctor may prescribe 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 an alternative antibiotic. In addition, your doctor may prescribe a higher dose of efavirenz for the treatment of HIV infection.
Medicines used to treat fungal infections (antifungals): itraconazole or posaconazole. Efavirenz/Emtricitabine/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/Emtricitabine/Tenofovir disoproxil Mylan may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in the blood.
Praziquantel, a medicine used to treat parasitic worm infections.
Hormonal contraceptives, such as birth control pills, an injectable contraceptive (e.g., Depo-Provera) or a contraceptive implant (e.g., Implanon): you must also use a reliable barrier method of contraception (see Pregnancy and breastfeeding). Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may reduce the effectiveness of hormonal contraceptives. Cases of pregnancy have occurred in women taking efavirenz, one of the components of Efavirenz/Emtricitabine/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 help 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/Emtricitabine/Tenofovir disoproxil Mylan, your doctor may need to adjust the dose of the calcium channel blocker.
Medicines used to prevent organ transplant rejection (also called immunosuppressants) such as cyclosporine, sirolimus or tacrolimus. When you start or stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, your doctor will need to closely 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, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Women must not become pregnant during treatment with
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan and for 12 weeks after
treatment. Your doctor may decide to perform a pregnancy test to confirm that you are not pregnant before starting treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
If there is a possibility of becoming pregnant during treatment with
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, you must use a reliable barrier method of contraception (e.g., a condom) in combination with other contraceptive methods, including oral contraceptives (the pill) or other hormonal contraceptives (e.g. subcutaneous implant, injection). Efavirenz, one of the active substances in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, may remain in the blood for some time after treatment ends. Therefore, you must continue using contraceptive methods as described above for 12 weeks after stopping treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Inform your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant, you should take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan only if, after consulting your doctor, it is decided that it is absolutely necessary.
Severe birth defects have been observed in unborn animals and in infants born to women treated with efavirenz during pregnancy.
Consult your doctor or pharmacist before taking any medicine.
If you have already taken Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor the baby's development. 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/Emtricitabine/Tenofovir disoproxil
Mylan. The components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may pass into breast milk and cause serious harm to the infant.
Breastfeeding is not recommended for HIV-positive women because HIV infection can be transmitted to the infant through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may cause dizziness, reduced
concentration and drowsiness. If you experience these effects, do not drive and do not operate tools or machinery.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan contains sodium and lactose
This medicine contains 7.5 mg of sodium metabisulfite per tablet, which may rarely cause severe hypersensitivity reactions and bronchospasm. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”. Each tablet also contains 105.5 mg of lactose per tablet. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

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

Take this medicine exactly as prescribed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is:
One tablet daily, taken by mouth. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
should be taken on an empty stomach (commonly understood as 1 hour before or 2 hours after a meal),
preferably at bedtime. This may make certain side effects (e.g. dizziness,
drowsiness) less bothersome. Swallow the Efavirenz/Emtricitabine/Tenofovir disoproxil
Mylan tablet whole with water.
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan must be taken every day.
If your doctor decides to discontinue one of the components of Efavirenz/Emtricitabine/Tenofovir
disoproxil Mylan, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil
separately or in combination with other medicines for the treatment of HIV infection.

If you take more Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan than you should
If you accidentally take too many tablets of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan,
you may increase the risk of experiencing possible side effects associated with this medicine
(see section 4, Possible side effects). Contact your doctor or the nearest emergency department.
Take the tablet packaging with you so that you can clearly describe what you have taken.

If you forget to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
It is important that you do not miss any doses of Efavirenz/Emtricitabine/Tenofovir
disoproxil Mylan.
If you miss a dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan within 12 hours
of your usual dosing time, take it as soon as possible, and then take your next dose at the
scheduled time.
If it is almost time (less than 12 hours) for your next dose, do not take the missed dose. Wait and
take your next dose at the regular time. Do not take a double dose to make up for a missed tablet.

If you vomit (within 1 hour after taking Efavirenz/Emtricitabine/Tenofovir disoproxil
Mylan), you should take another tablet. Do not wait until the time of your next dose. You
should not take another tablet if you vomit more than 1 hour after taking
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.

If you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Do not stop treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan without
first contacting your doctor. Stopping Efavirenz/Emtricitabine/Tenofovir disoproxil
Mylan may seriously compromise your response to future treatment. If treatment with
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is stopped, speak with your doctor before
resuming treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan tablets.
If problems arise, or if dose adjustment becomes necessary, your doctor may decide to prescribe the
components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan separately.

When your supply of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is running low,
obtain a new supply from your doctor or pharmacist. This is very important because if you stop taking
the medicine, even for a short time, the virus may begin to multiply, making it more difficult to control.

If you have both HIV and hepatitis B infection, it is especially important not to stop
treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan without first consulting your
doctor. Some patients have experienced worsening of their hepatitis after stopping
emtricitabine or tenofovir disoproxil (two of the three components of
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan), as shown by symptoms or blood tests. If
treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is stopped, your doctor may
recommend restarting treatment for hepatitis B. Blood tests may be required for 4 months after
stopping treatment to monitor liver function. In some patients with advanced liver disease or cirrhosis,
stopping treatment is not recommended, as it may lead to life-threatening worsening of hepatitis.

Inform your doctor immediately of any new or unusual symptoms occurring after stopping treatment,
particularly symptoms normally associated with hepatitis B infection.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

During HIV treatment, an increase in weight and in blood levels of lipids and glucose may occur.
This is partly related to the recovery of general health and lifestyle, and in the case of blood lipids,
sometimes also to the HIV medicines themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible serious 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, which can be fatal. The following side effects may be signs of lactic acidosis:
- rapid and deep breathing
- drowsiness
- feeling unwell (nausea), vomiting, and stomach ache.

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) which may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
swelling of the face, lips, tongue or throat
aggressive behaviour, suicidal thoughts, strange thoughts, paranoia, difficulty thinking clearly, mood disturbances, sensation of seeing or hearing things that are not there (hallucinations), suicide attempt, change in personality (psychosis), catatonia (a condition in which the patient remains motionless and mute for a 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 liver inflammation
kidney tubule damage

Psychiatric side effects, in addition to those already mentioned, include delirium (false beliefs),
neurosis. Some patients have died by suicide. These problems tend to occur more frequently in patients
who have had mental illnesses. In all cases, if you experience any of these symptoms, inform your
doctor immediately.
Liver-related side effects: if you also have hepatitis B, your hepatitis may worsen after stopping treatment (see section 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 required liver transplantation. Most cases occurred in patients already suffering from liver disease, but some cases have been reported in patients without pre-existing liver disease
kidney inflammation, excessive urination and feeling thirsty
back pain caused by kidney problems, including kidney failure. Your doctor may perform blood tests to monitor kidney function.
softening of the bones (with bone pain and sometimes fractures), which may be a consequence of damage to kidney tubule cells
fatty liver

If you think you may have any of these serious side effects, inform your doctor.

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

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

Blood tests may also show:

reduced levels of phosphate in the blood
increased levels of creatine kinase in the blood, leading to muscle pain and weakness

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

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

Blood tests may also show:

decrease in 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
anaemia (low red blood cell count)
sensation of dizziness (vertigo), ringing, buzzing or other persistent noise in the ear
blurred vision
chills
breast enlargement in men
decreased sex drive
redness
dry mouth
increased appetite

Blood tests may also show:

reduced potassium levels in the blood
increased creatinine levels in the blood
protein in the urine
increased cholesterol levels in the blood

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

itchy skin rash caused by sunlight

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

5. How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Bottle of 30 tablets: Note the date of opening the bottle in the designated space on the label and/or
on the box. Use within 60 days of first opening.
Do not store above 25 °C. Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan Contains

The active substances are efavirenz, emtricitabine and tenofovir disoproxil. Each film-coated tablet of Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate).
The other components of the film-coated tablet are croscarmellose sodium, hydroxypropylcellulose, low-substituted 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 tablet film coating are yellow iron oxide (E172), red iron oxide (E172), macrogol, poly(vinyl alcohol), talc, titanium dioxide (E171).

Description of the Appearance of Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan and Contents of the Pack
The film-coated tablets of Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan are pink, capsule-shaped, marked with the code 'M' on one side and 'TME' on the other side.
This medicine is available in plastic bottles containing a desiccant labelled "DO NOT EAT" and either 30 or 90 film-coated tablets, and in multipacks of 90 film-coated tablets containing 3 bottles, each with 30 film-coated tablets.
This medicine is also available in blisters containing 30 and 90 tablets, and in unit-dose divisible blisters containing 30 x 1 and 90 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 02 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 02 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: +356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 33 299 7080

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: +351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 326 04 910 / +421 917 206 274

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris OY
Tel: +39 (0) 2 612 46921 Puh/Tel: +358 9 46 60 03

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 1 8711600

More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.