EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL MYLAN 600 mg/200 mg/245 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan 600 mg/200 mg/245 mg Film-Coated Tablets EFG

efavirenz/emtricitabine/tenofovir disoproxil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan and what is it used for
2. What you need to know before you take Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan
3. How to take Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan
4. Possible side effects
5. Storage of Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan
6. Package Contents and Further Information

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

Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan contains three active substancesused to treat 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.

Each of these active substances, also known as antiretroviral medicines, works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to multiply.

Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan is a treatment for human immunodeficiency virus(HIV) infection in adults aged 18 years or older who have previously received treatment with other antiretroviral medicines and have controlled HIV-1 infection for at least three months. Patients should not have experienced failure of a previous HIV treatment.

2. What you need to know before starting to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

• If you are allergicto efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other components 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 QT interval prolongation that puts you at high risk of serious heart rhythm problems (Torsade de Pointes).
• If any of your family members (parents, grandparents, brothers, or sisters) have died suddenly due to a heart problem or were born with heart problems.
• If your doctor has told you that you have high or low 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/Emtricitabine/Tenofovir disoproxil Mylan"):
• • astemizole or terfenadine(used to treat hay fever or other allergies)
  • bepridil(used to treat heart disease)
  • cisapride(used to treat stomach upset)
  • elbasvir/grazoprevir(used to treat hepatitis C)
  • ergot alkaloids(e.g., ergotamine, dihydroergotamine, ergonovine, and methylergonovine), (used to treat migraines and histamine headaches)
  • midazolam or triazolam(used to help with sleep)
  • pimozide, imipramine, amitriptyline, or clomipramine(used to treat certain mental problems)
  • St. John's Wort(Hypericum perforatum) (a herbal medicine used to treat depression and anxiety)
  • voriconazole(used to treat fungal infections)
  • flecainide, metoprolol(used to treat irregular heartbeats)
  • certain antibiotics(macrolides, fluoroquinolones, imidazoles)
  • antifungal triazoles
  • certain antimalarials
  • methadone(used to treat opioid addiction).

If you are taking any of these medicines, tell your doctor immediately.Taking these medicines with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan could cause serious or potentially life-threatening side effects or could make these medicines stop working properly.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.

• While taking this medicine you can still transmit HIV to others, even if effective antiretroviral therapy reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. This medicine is not a cure for HIV infection. While taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, you may still experience infections or other diseases associated with HIV infection.
• While taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, you must remain under the supervision of your doctor.

• Tell your doctor:
• • If you are taking other medicinesthat contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. You must not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan with any of these medicines.

• If you have or have had kidney disease,or if tests have shown problems with your kidneys. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is not recommended if you have moderate to severe kidney disease.

• Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may affect your kidneys. Before starting treatment, your doctor may ask you to have blood tests to check your kidney function. Your doctor may also ask you to have blood tests during treatment to monitor your kidneys.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is not usually taken with other medicines that can harm your 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 QT interval prolongation.

• If you have a history of mental illness,including depression, or drug or alcohol addiction. Tell your doctor immediately if you feel depressed, have thoughts of suicide, or have abnormal thoughts (see section 4, Possible side effects).

• If you have a history of seizures (fits or attacks)or are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital, and phenytoin. If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant in your blood to ensure that it is not affected while you are taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan. Your doctor may prescribe a different anticonvulsant.

• If you have a history of liver disease, including chronic active hepatitis.Patients with liver disease, including chronic hepatitis B or C, treated with combination antiretrovirals, have a greater risk of serious and potentially life-threatening liver complications. Your doctor may perform blood tests to monitor your liver or change you to another medicine. If you have severe liver disease, do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan(see above, in section 2, Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan).

If you have a hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. Tenofovir disoproxil and emtricitabine, two of the active ingredients in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, show some activity against the hepatitis B virus, although emtricitabine is not approved for the treatment of hepatitis B infection. The symptoms of your hepatitis may worsen after stopping treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan. Your doctor may perform blood tests at regular intervals to monitor your liver (see section 3, If you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan).

• Regardless of whether you have a history of liver disease, your doctor will consider regular blood tests to monitor your liver.

• If you are over 65 years old.The number of patients over 65 years old who have been studied is limited. If you are over 65 years old and have been prescribed Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, your doctor will monitor you carefully.

• 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 start in the first 1 or 2 days of treatment and usually disappear after the first 2 to 4 weeks.

• Any sign of skin rash.Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may cause skin rashes. If you notice any sign of a severe skin rash with blisters or fever, stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan and tell your doctor immediately. If you have had a skin rash while taking another NNRTI, you may be at greater risk of having a skin rash 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 of previous infections may appear soon after starting anti-HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight infections that were present without any apparent symptoms. If you notice any symptoms of infection, please tell your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves towards the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

• Bone problems.Some patients who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. The symptoms of osteonecrosis are: stiffness in the joints, pain, and discomfort, especially in the hip, knee, and shoulder, and difficulty moving. If you notice any of these symptoms, tell your doctor.

Bone problems (which manifest as persistent or worsening bone pain and sometimes end in fractures) due to damage to the renal tubule cells (see section 4, Possible side effects) may also occur. Tell your doctor if you have bone pain or fractures.

Tenofovir disoproxil can also cause bone mass loss. The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

In general, the effects of tenofovir disoproxil on long-term bone health and the risk of future fractures in adult and pediatric patients are uncertain.

Tell your doctor if you know you have osteoporosis. Patients with osteoporosis have a higher risk of fractures.

Children and adolescents

• Do not give Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan to children and adolescentsunder 18 years of age. The use of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan in children and adolescents has not been studied sufficiently.

Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

You must not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan with certain medicines.These are listed in Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, at the beginning of section 2. These include some commonly used medicines and some herbal medicines (including St. John's Wort) that can cause serious interactions.

Tell your doctoror pharmacist if you are taking, have recently taken, or might take any other medicines.

In addition, you must not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan with any other medicine that contains efavirenz (unless your doctor recommends it), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Tell your doctorif you are taking other medicines that can harm your kidneys. Some examples include:

• 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, for pain relief or to reduce inflammation).

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may interact with other medicines, including herbal medicines such as Ginkgo biloba extracts. This may result in the amounts of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan or other medicines in your blood being affected. This can prevent the medicines from working properly or can increase the risk of side effects. In some cases, your doctor may need to adjust your dose or check the levels in your blood. It is important that you tell your doctor or pharmacist if you are taking any of the following:

• Medicines that contain didanosine (for HIV infection):taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan with other antiviral medicines that contain didanosine may increase the levels of didanosine in your blood and reduce the CD4 cell count. When medicines that contain tenofovir disoproxil and didanosine are taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, sometimes fatally. Your doctor will carefully consider whether to treat you with medicines that contain tenofovir and didanosine.

• Other medicines used for HIV infection:the following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or atazanavir boosted by ritonavir or saquinavir. Your doctor may consider prescribing a different medicine or changing the dose of the protease inhibitors. Also, tell your doctor if you are taking maraviroc.

• Medicines used for the treatment of hepatitis C infection:elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.

• Medicines used to lower the amount of fat in the blood (also called statins):atorvastatin, pravastatin, simvastatin. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and consider changing the dose of the statin if necessary.

• Medicines used for the treatment of seizures/attacks (anticonvulsants):carbamazepine, phenytoin, phenobarbital. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may reduce the amount of anticonvulsant in your blood. Carbamazepine may reduce the amount of efavirenz, one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, in your blood. Your doctor may need to consider prescribing a different anticonvulsant.

• Medicines used for the treatment of bacterial infections,including tuberculosis and Mycobacterium avium complex related to AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may need to consider changing the dose or prescribing an alternative antibiotic. Additionally, your doctor may consider prescribing an additional dose of efavirenz to treat your HIV infection.

• Medicines used to treat fungal infections (antimycotics):itraconazole or posaconazole. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may reduce the amount of itraconazole or posaconazole in your blood. Your doctor may need to consider prescribing a different antimycotic.

• 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 your 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 should also use a reliable barrier method of contraception (see Pregnancy and breastfeeding). Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may affect the way hormonal contraceptives work. There have been reports of pregnancies in women taking efavirenz, a component of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, while using a contraceptive implant, although it has not been established that treatment with efavirenz was the cause of the contraceptive failure.

• Sertraline, a medicine used to treat depression, as 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 you stop smoking, as your doctor may need to adjust the dose of bupropion.

• Diltiazem or similar medicines (called calcium channel blockers):when you start treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, your doctor will need to adjust the dose of the calcium channel blocker.

• Medicines used to prevent organ rejection after transplantation (also called immunosuppressants)such as cyclosporin, sirolimus, or tacrolimus. Both when you start and when you stop treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, your doctor will carefully monitor your immunosuppressant levels and may need to adjust the dose you receive.

• 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 medicine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Follow your doctor's or pharmacist's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

One tablet per day, orally. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan should be taken on an empty stomach (usually defined as one hour before or two hours after a meal) and preferably at bedtime. This may make some of the adverse effects (e.g., dizziness, drowsiness) less problematic. Swallow Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan whole with a glass of water.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan should be taken daily.

If your doctor decides to discontinue one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, they may give you efavirenz, emtricitabine, or tenofovir disoproxil separately or with other medications for the treatment of HIV infection.

If you take more Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan than you should

If you accidentally take too many Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan tablets, you may be at a higher risk of experiencing possible adverse effects with this medication (see section 4, Possible adverse effects). Consult your doctor or it is advised that you go to the nearest emergency service. Bring the bottle of tablets with you so that you can easily describe what you have taken.

If you forget to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

It is essential that you do not forget to take a dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.

If you forget a dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan within 12 hours of when you normally take it, take it as soon as you can and then take your next dose at your usual time.

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

If you vomit the tablet (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 do not need to take another tablet if you vomit more than 1 hour after taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.

If you stop treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Do not stop treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan without first talking to your doctor.Stopping treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan can severely affect your response to future treatments. If you stop treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, consult your doctor before restarting Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan tablets. Your doctor may consider administering the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan separately if you have problems or if your dose needs to be adjusted.

When your supply of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is running low,request more from your doctor or pharmacist. This is extremely important because the amount of virus will start to increase if you stop taking the medication, even if only for a short time. In this case, the virus may become more difficult to treat.

If you have both HIV and hepatitis B infection at the same time,it is especially important not to stop your treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan without first talking to your doctor. Some patients have undergone blood tests or had symptoms indicating that their hepatitis had worsened after stopping emtricitabine or tenofovir disoproxil (two of the three components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan). If you stop treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, your doctor may recommend that you resume hepatitis B treatment. You may need blood tests to check liver function for four months after stopping treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment as this can lead to worsening of hepatitis, which can be life-threatening.

Talk to your doctor immediately about new or unusual symptoms after stopping your treatment, particularly symptoms that you associate with hepatitis B virus infection.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible adverse effects

During HIV treatment, there may be an increase in weight and glucose and lipid levels in the blood. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can cause adverse effects, although not all people experience them.

Severe adverse effects: inform your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare but severe adverse effect (it can affect up to 1 in 1,000 patients) that can be fatal. The following adverse effects may be signs of lactic acidosis:
• • deep and rapid breathing
  • drowsiness
  • nausea, vomiting, and stomach pain

If you think you may have lactic acidosis, contact your doctor immediately.

Other possible severe adverse effects

The following adverse effects are uncommon(they can affect up to 1 in 100 patients):

• allergic reaction (hypersensitivity) that can cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
• swelling of the face, lips, tongue, or throat
• aggression, suicidal thoughts, abnormal thoughts, paranoia, inability to think clearly, mood changes, vision or hearing things that are not really there (hallucinations), suicide attempts, personality changes (psychosis), catatonia (a condition in which the patient remains immobile and unable to speak for a period of time)
• abdominal pain (stomach) caused by pancreatitis
• forgetfulness, confusion, seizures (convulsions), incoherent speech, tremors (shaking)
• yellowing of the skin or eyes, itching, or abdominal pain (stomach) caused by liver inflammation
• kidney tubule damage

Psychiatric adverse effects, in addition to those mentioned above, include delusions (false beliefs), neurosis. Some patients have committed suicide. These problems tend to occur more often in those with a history of mental illness. Always inform your doctor immediately if you experience these symptoms.

Adverse effects on the liver: If you are also infected with the hepatitis B virus, you may experience a worsening of hepatitis after stopping treatment (see section 3).

The following adverse effects are rare(they can affect up to 1 in 1,000 patients):

• liver failure, which in some cases leads to death or liver transplantation. Most cases occurred in patients who already had liver disease, but there have been some reports in patients without existing liver disease
• kidney inflammation, increased urine volume, and feeling of thirst
• back pain due to kidney problems, including kidney failure. Your doctor may perform blood tests to see if your kidneys are working properly
• weakening of the bones (with bone pain and which sometimes ends in fractures) that can occur due to damage to the kidney tubule cells
• fatty liver

If you think you may have any of these severe adverse effects, talk to your doctor.

More frequent adverse effects

The following adverse effects are very common(they can affect more than 1 in 10 patients):

• dizziness, headache, diarrhea, feeling of discomfort (nausea), vomiting
• rash (including red spots or bumps, sometimes with blisters and swelling of the skin), which can be allergic reactions
• weakness

Lab tests may also show:

• decreased phosphate levels in the blood
• increased creatine kinase levels in the blood, which can cause muscle pain and weakness

Other possible adverse effects

The following adverse effects are common(they can affect up to 1 in 10 patients):

• allergic reactions
• balance and coordination disorders
• feeling of worry or depression
• difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
• pain, stomach pain
• digestive problems with discomfort after meals, feeling bloated (gases), gas (flatulence)
• loss of appetite
• fatigue
• itching
• changes in skin color, such as darkening of the skin in patches, often starting on the hands and soles of the feet

Lab tests may also show:

• low white blood cell count (a reduced number of white blood cells can make you more prone to infections)
• liver and pancreas problems
• increased fatty acids (triglycerides), bilirubin, or blood sugar levels

The following adverse effects are uncommon(they can affect up to 1 in 100 patients):

• muscle rupture, muscle pain, muscle weakness
• anemia (low red blood cell count)
• feeling of spinning or moving sideways (vertigo), ringing, buzzing, or other persistent noises in the ears
• blurred vision
• chills
• enlargement of the breasts in men
• loss of sexual desire
• flushing
• dry mouth
• increased appetite

Lab tests may also show:

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

In the case of damage to the kidney tubule cells, muscle rupture, weakening of the bones (with bone pain and which sometimes ends in fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur.

The following adverse effects are rare(they can affect up to 1 in 1,000 patients):

• skin rash with itching, caused by a reaction to sunlight

Reporting adverse effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medication.

5. Storage of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the bottle and carton after "EXP".

The expiration date is the last day of the month indicated.

Bottles of 30 tablets:Write the date you opened the bottle on the label or packaging in the space provided. After opening the packaging for the first time, the product should be used within 60 days.

Do not store above 25 °C. Store in the original packaging to protect from light.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Content of Efavirenz/Emtricitabine/Tenofovir Disoproxil Mylan

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

Appearance and Container Content of the Product

The Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan film-coated tablets are pink, capsule-shaped tablets, marked with an "M" on one side and "TME" on the other side.

This medicine is available in plastic bottles with a desiccant labeled with the phrase "DO NOT EAT" containing 30 or 90 film-coated tablets and in multi-packs of 90 film-coated tablets, which include 3 bottles, each containing 30 film-coated tablets.

Only certain 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:

Date of the Last Revision of this Leaflet:

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