Leaflet: information for the user

Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets EFG

emtricitabine/tenofovir disoproxil

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Emtricitabina/Tenofovir disoproxilo Mylan contains two active principles,emtricitabinaandtenofovir disoproxilo. Both active principles are antiretroviral drugsthat are used to treat HIV infection. Emtricitabina is anucleoside reverse transcriptase inhibitor analogueand tenofovir is anucleotide reverse transcriptase inhibitor analogue. They are generally known as ITIAN and act by interfering with the normal functioning of an enzyme (reverse transcriptase) that is essential for the virus to replicate.

• Emtricitabina/Tenofovir disoproxilo Mylan is used to treat Human Immunodeficiency Virus type 1 (HIV-1) infection in adults.
• It is also used to treat HIV in adolescents aged 12 to less than 18 years with a weight of at least 35 kgwho have already been treated with other HIV medications that are no longer effective or have caused adverse effects.
• • Emtricitabina/Tenofovir disoproxilo Mylan should always be used in combination with other medications to treat HIV infection.
  • Emtricitabina/Tenofovir disoproxilo Mylan can be administered in place of emtricitabina and tenofovir used separately at the same doses.

People infected with HIV can still transmit HIV to others while taking this medication, although effective antiretroviral treatment reduces the risk. Consult your doctor about the necessary precautions to avoid infecting others.

This medication is not a cure for HIV infection. While you are taking Emtricitabina/Tenofovir disoproxilo Mylan, you may still experience infections or other diseases associated with HIV infection.

• Emtricitabina/Tenofovir disoproxilo Mylan is also used to reduce the risk of acquiring HIV-1 infection in adultsand adolescents aged 12 to less than 18 years with a weight of at least 35 kg, when used as a daily treatment, in combination with safer sex practices: See section 2 for a list of precautions to take against HIV infection.

Do not take Emtricitabina/Tenofovir disoproxilo Mylan to treat HIV or reduce the risk of getting HIV if you are allergicto emtricitabine, tenofovir, tenofovir disoproxil or to any of the other components of this medication (listed in section 6).

If this happens, call your doctor immediately.

Before taking Emtricitabina/Tenofovir disoproxilo Mylan to reduce the risk of getting HIV:

Emtricitabina/Tenofovir disoproxilo Mylan can only help reduce the risk of getting HIVbeforeyou are infected.

• You should not be infected with HIV before starting to take Emtricitabina/Tenofovir disoproxilo Mylan to reduce the risk of getting HIV.You should have a test to ensure that you are not infected with HIV. Do not take Emtricitabina/Tenofovir disoproxilo Mylan to reduce the risk unless it has been confirmed that you are not infected with HIV. People who have HIV should take Emtricitabina/Tenofovir disoproxilo Mylan in combination with other medications.

• Many HIV tests may not detect a recent infection.If you get a similar illness to the flu, it could mean that you have recently become infected with HIV. These may be signs of HIV infection:

• Fatigue
• Fever
• Muscle or joint pain
• Headache
• Vomiting or diarrhea
• Rash
• Nocturnal sweating
• Enlargement of the lymph nodes in the neck or groin

Inform your doctor about any flu-like illness, either in the month before starting treatment with Emtricitabina/Tenofovir disoproxilo Mylan or at any time while you are taking it.

Warnings and precautions

When taking Emtricitabina/Tenofovir disoproxilo Mylan to reduce the risk of getting HIV:

• Take Emtricitabina/Tenofovir disoproxilo Mylan every dayto reduce your risk, not just when you think you have been at risk of getting HIV infection.Do not forget any dose of Emtricitabina/Tenofovir disoproxilo Mylan or stop taking it. Missed doses can increase the risk of HIV infection.
• You should have regular HIV detection tests.
• If you think you have become infected with HIV, see your doctor immediately. They may want to do more tests to make sure you are still not infected with HIV.
• Using Emtricitabina/Tenofovir disoproxilo Mylan alone may not prevent you from getting HIV.

• Always practice safe sex. Use condoms to reduce contact with semen, vaginal fluids or blood.
• Do not share personal items that may contain blood or bodily fluids, such as toothbrushes and razors.
• Do not share or reuse needles or other injections or medications.
• You should have regular detection tests for other sexually transmitted infections such as syphilis or gonorrhea. These infections make it easier for you to get HIV.

Consult your doctor if you have any questions about how to prevent HIV transmission or transmission to others.

When taking Emtricitabina/Tenofovir disoproxilo Mylan to treat HIV or reduce the risk of getting HIV:

• Emtricitabina/tenofovir disoproxilo may affect your kidneys.Your doctor may ask you to have blood tests to measure your kidney function before and during treatment. If you have had kidney disease, or if the tests have shown kidney problems, tell your doctor. This medicine should not be given to adolescents with existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabina/Tenofovir disoproxilo Mylan or, if you already have HIV, take Emtricitabina/Tenofovir disoproxilo Mylan less frequently.Emtricitabine/tenofovir disoproxilois not recommended if you have a severe kidney disease or are on dialysis.
• Bone problems(bone problems can also occur, which manifest as persistent or worsening bone pain, and sometimes end in fractures) due to damage to renal tubular cells (see section 4,Adverse reactions). Inform your doctor if you have bone pain or fractures.

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

The effects of tenofovir disoproxil on long-term bone health and the future risk of fractures in adult and pediatric patients are imprecise.

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

• Talk to your doctor if you have a history of liver disease, including hepatitis.Patients infected with HIV, who also have liver disease (including chronic hepatitis B or C), treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.

grave. If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.

• Know your hepatitis B virus (HBV) statusbefore starting to take emtricitabine/tenofovir disoproxil. If you have HBV, there is a great risk of developing liver problems when you stop taking emtricitabine/tenofovir disoproxil, regardless of whether you also have HIV. It is important not to stop taking emtricitabine/tenofovir disoproxil without consulting your doctor: see section 3,Do not stop taking emtricitabine/tenofovir disoproxilo Mylan.
• If you are over 65 years old, tell your doctor.Emtricitabine/tenofovir disoproxil has not been studied in patients over 65 years of age.
• Talk to your doctor if you are lactose intolerant(see Emtricitabine/Tenofovir disoproxilo Mylan contains lactose later in this section).

Children and adolescents

Emtricitabine/Tenofovir disoproxilo Mylan should not be given to children under 12 years of age.

Other medications and Emtricitabine/Tenofovir disoproxilo Mylan

Do not take Emtricitabine/Tenofovir disoproxilo Mylanif you are already taking other medications that contain the components of this medication (emtricitabine and tenofovir disoproxil) or any other antiviral medication that contains tenofovir alafenamide, lamivudine or adefovir dipivoxil.

Taking Emtricitabine/Tenofovir disoproxilo Mylan with other medications that may damage your kidneys: it is especially important to tell your doctor if you are taking any of these medications, including:

• Aminoglycosides (for bacterial infection)
• Amphotericin B (for fungal infection)
• Foscarnet (for viral infection)
• Ganciclovir (for viral infection)
• Pentamidine (for infections)
• Vancomycin (for bacterial infection)
• Interleukin-2 (to treat cancer)
• Cidofovir (for viral infection)
• Nonsteroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain)

If you are taking another antiviral medication called a protease inhibitor to treat HIV, your doctor may ask you to have blood tests to closely monitor your renal function.

Also, it is important to inform your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Emtricitabine/Tenofovir disoproxilo Mylan with other medications that contain didanosine (for HIV treatment):Taking emtricitabine/tenofovir disoproxil with other antiviral medications that contain didanosine may increase didanosine levels in your blood and reduce CD4 cell count. When taken together, medications that contain tenofovir disoproxil and didanosine have been reported in rare cases to cause pancreatitis and lactic acidosis (excess lactic acid in the blood) in some cases fatal. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

Inform your doctorif you are taking any of these medications. Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Taking Emtricitabine/Tenofovir disoproxilo Mylan with food and drinks

• When possible, Emtricitabine/Tenofovir disoproxilo Mylan should be taken with food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

If you have taken Emtricitabine/Tenofovir disoproxilo Mylan during your pregnancy, your doctor may ask you to have periodic blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took ITNs during pregnancy, the benefit of HIV protection outweighed the risk of side effects.

• Do not breastfeed your child during treatment with Emtricitabine/Tenofovir disoproxilo Mylan.

This is because the active principles of this medication pass into breast milk.

• If you are a woman with HIV infection, it is recommended that you do not breastfeed, to avoid passing the virus to the child through breast milk.

Driving and operating machines

Emtricitabine/tenofovir disoproxil may cause dizziness. If you notice dizziness during treatment with this medication,do not driveor operate tools or machines.

Emtricitabine/Tenofovir disoproxilo Mylan contains lactose.

If your doctor has told you that you are intolerant to certain sugars, contact them before taking this medication.

• Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor again.

The recommended dose of Emtricitabina/Tenofovir disoproxilo Mylan for treating HIV is:

• Adults:one tablet a day, whenever possible with food.
• Adolescents aged 12 to less than 18 years with a weight of at least 35 kg:one tablet a day, whenever possible with food.

The recommended dose of Emtricitabina/Tenofovir disoproxilo Mylan for reducing the risk of contracting HIV is:

• Adults:one tablet a day, whenever possible with food.
• Adolescents aged 12 to less than 18 years with a weight of at least 35 kg:one tablet a day, whenever possible with food.

If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then, mix the powder with approximately 100 ml of water (half a glass), orange or grape juice, and drink it immediately.

• Always take the recommended dose prescribed by your doctor.This is to ensure that your medication is completely effective, and to reduce the risk of developing treatment resistance. Do not change the dose unless your doctor tells you to.

• If you are receiving treatment for HIV infection, your doctor will prescribe Emtricitabina/Tenofovir disoproxilo Mylan with other antiretroviral medications. Consult the prospectuses of the other antiretrovirals to know how to take those medications.

• If you are an adult and taking Emtricitabina/Tenofovir disoproxilo Mylan to reduce the risk of contracting HIV, take it every day, not just when you think you have been at risk of contracting HIV.

Consult your doctor if you have any questions about how to prevent the transmission of HIV or prevent its transmission to other people.

If you take more Emtricitabina/Tenofovir disoproxilo Mylan than you should

If you accidentally took more than the recommended dose of Emtricitabina/Tenofovir disoproxilo Mylan, consult your doctor or go to the nearest emergency service. Bring the tablet container or packaging with you so that you can easily describe what you have taken.

If you forget to take Emtricitabina/Tenofovir disoproxilo Mylan

It is essential that you do not forget a dose of Emtricitabina/Tenofovir disoproxilo Mylan.

• If you realize within 12 hoursfrom the time you normally take Emtricitabina/Tenofovir disoproxilo Mylan, take the tablet as soon as possible, preferably with food, and then take the next dose at your usual time.
• If more than 12 hourshave passed since the time you normally take Emtricitabina/Tenofovir disoproxilo Mylan, do not take the missed dose. Wait and take the next dose, preferably with food, at your usual time.

If you vomit within 1 hour of taking Emtricitabina/Tenofovir disoproxilo Mylan,take another tablet. You do not need to take another tablet if you vomited more than an hour after taking this medication.

Do not interrupt treatment with Emtricitabina/Tenofovir disoproxilo Mylan

• If you are taking Emtricitabina/Tenofovir disoproxilo Mylan for HIV treatment, stopping treatment may reduce the effectiveness of the recommended HIV therapy prescribed by your doctor.
• If you are taking Emtricitabina/Tenofovir disoproxilo Mylan to reduce the risk of contracting HIV, do not stop taking it or miss any doses. If you stop using this medication or miss a dose, you may increase the risk of contracting HIV.

Do not interrupt treatment with Emtricitabina/Tenofovir disoproxilo Mylan without consulting your doctor.

• If you have hepatitis B,it is especially important not to stop your treatment withEmtricitabina/Tenofovir disoproxilo Mylanwithout first talking to your doctor. You may need to have blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment as this may cause a worsening of your hepatitis, which can be potentially fatal.

Talk to your doctor immediatelyabout new or unusual symptoms after stopping treatment, particularly symptoms associated with hepatitis B infection.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Possible serious side effects:

• Lactic acidosis(excess of lactic acid in the blood) is a rare but potentially fatal side effect. Lactic acidosis is more common in women, especially if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:

• deep and rapid breathing
• drowsiness
• nausea, vomiting
• abdominal pain

If you think you may have lactic acidosis, seek medical attention immediately.

• Any sign of inflammation or infection.In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of previous infections may appear shortly after starting HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, allowing the body to fight off infections that may be present without apparent symptoms.

• Autoimmune disorders may also occur,when the immune system attacks healthy body tissue, after starting to take medications to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms such as:

• muscle weakness
• weakness starting in the hands and feet and ascending to the body trunk
• palpitations, tremors, or hyperactivity

If you notice these or any symptoms of inflammation or infection, seek medical attention immediately.

Possible side effects:

Very common side effects

(may affect more than 1 in 10 people)

• diarrhea, vomiting, nausea
• dizziness, headache
• skin rash
• feeling weak

Lab tests may also show:

• decreased phosphate levels in the blood
• increased creatine kinase

Common side effects

(may affect up to 1 in 10 people)

• pain, abdominal pain
• difficulty sleeping, abnormal dreams
• digestive problems with discomfort after meals, feeling bloated (gas), flatulence
• skin eruptions (including red patches or spots sometimes with blisters and swelling of the skin), which may be allergic reactions, itching, changes in skin color such as darkening of the skin in patches
• other allergic reactions, such as difficulty breathing, swelling, or feeling slightly dizzy

Lab tests may also show:

• low white blood cell count (a reduced white blood cell count may make you more prone to infections)
• increased triglycerides (fats), bile, or sugar in the blood
• problems with the liver and pancreas

Rare side effects

(may affect up to 1 in 1,000 people)

• lactic acidosis (seePossible serious side effects)
• steatosis (fatty liver)
• yellowing of the skin or eyes, itching, or abdominal pain (stomach) caused by liver inflammation
• kidney inflammation, increased urine volume, and feeling thirsty, renal failure, damage to kidney tubule cells
• bone weakening (with bone pain and sometimes leading to fractures)
• back pain due to kidney problems

The damage to kidney tubule cells may be associated with muscle rupture, bone weakening (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased levels of potassium or phosphate in the blood.

If you notice any of the above side effects or if any of the side effects worsen, speak with your doctor or pharmacist.

The frequency of the following side effects is unknown.

• Bone problems.Some patients taking combined antiretroviral medications such as emtricitabine/tenofovir disoproxil may develop a bone disease calledosteonecrosis(death of bone tissue caused by loss of blood supply to the bone). Taking this type of medication for a long time, taking corticosteroids, consuming alcohol, having a very weakened immune system, and being overweight may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:

• joint stiffness
• joint pain or discomfort (especially in the hip, knee, and shoulder)
• difficulty moving

If you notice any of these symptoms, speak with your doctor.

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

Other effects in children

• Children receiving emtricitabine often experience frequent changes in skin color, including:

-dark patches on the skin

• Children often have a low number of red blood cells (anemia)

-this may cause fatigue or shortness of breath

If you notice any of these symptoms, inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and carton after CAD or EXP. The expiration date is the last day of the month indicated.

Bottle packaging: use within 90 days after initial opening.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Emtricitabina/Tenofovir disoproxilo Mylan

• The active ingredients areemtricitabina and tenofovir disoproxilo. Each film-coated tablet contains 200 mg of emtricitabina and 245 mg of tenofovir disoproxilo (equivalent to 300 mg of tenofovir disoproxilo maleate).
• The other components aremicrocrystalline cellulose, hydroxypropyl cellulose, low-substituted, red iron oxide (E172), anhydrous colloidal silica, lactose monohydrate (see section 2: “Emtricitabina/Tenofovir disoproxilo Mylan contains lactose”), magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, brilliant blue aluminum lake FCF (E133), yellow iron oxide (E172).

Appearance of Emtricitabina/Tenofovir disoproxilo Mylan and contents of the pack

The tablets of Emtricitabina/Tenofovir disoproxilo Mylan are light green, film-coated, capsule-shaped, biconvex, 19.8 x 9.00 mm in size, marked with an “M” on one face and with “ETD” on the other face.

This medicinal product is available in plastic bottles with a desiccant (DO NOT INGEST THE DESICCANT) containing 30 film-coated tablets and in multiple packs of 90 film-coated tablets that include 3 bottles, each containing 30 film-coated tablets or in blister packs with a desiccant incorporated that contain 30, 30 x 1, 90 x 1, 100 x 1 film-coated tablets and blister packs that contain 30, 30 x 1, 90 x 1, 100 x 1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan Pharmaceuticals Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

DUBLIN

Ireland

Responsible for manufacturing:

Mylan Hungary Kft

Mylan utca 1, H-2900 Komárom,

Hungary

McDermott Laboratories Limited under the commercial name of Gerard Laboratories and Gerard Laboratories under the commercial name of Mylan Dublin

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Medis International a.s

vyrobani zavod Bolatice, Prumyslova, -961/16, Bolatice

747 23, Czech Republic

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352,

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet: November 2021

Further detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.