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

Introduction

Package Leaflet: Information for the User

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

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 get 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 pack

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

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

Emtricitabine/Tenofovir Disoproxil Mylan contains two active substances, emtricitabineand tenofovir disoproxil. Both active substances are antiretroviral medicinesused to treat HIV infection. Emtricitabine is a nucleoside analogue reverse transcriptase inhibitorand tenofovir is a nucleotide analogue reverse transcriptase inhibitor. They are usually called NRTIs and work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce.

• Emtricitabine/Tenofovir Disoproxil Mylan is used to treat HIV-1 infection in adults.
• It is also used to treat HIV-1 infection in adolescents from 12 to less than 18 years of age with a body weight of at least 35 kgwho have already been treated with other HIV medicines that are no longer effective or have caused side effects.
• • Emtricitabine/Tenofovir Disoproxil Mylan must always be used in combination with other medicines to treat HIV infection.
  • Emtricitabine/Tenofovir Disoproxil Mylan can be taken instead of emtricitabine and tenofovir disoproxil taken separately at the same doses.

People with HIV infection should not take this medicine to reduce the risk of passing HIV to others, while taking this medicine, even if they are on effective antiretroviral therapy. Consult your doctor about the precautions needed to avoid infecting other people.

This medicine is not a cure for HIV infection. While you are taking Emtricitabine/Tenofovir Disoproxil Mylan, you may still develop infections or other illnesses associated with HIV.

• Emtricitabine/Tenofovir Disoproxil Mylan is also used to reduce the risk of getting HIV-1 infection in adultsand adolescents from 12 to less than 18 years of age with a body 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.

2. What you need to know before you take Emtricitabine/Tenofovir Disoproxil Mylan

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

If this happens, contact your doctor immediately.

Before taking Emtricitabine/Tenofovir Disoproxil Mylan to reduce the risk of getting HIV:

Emtricitabine/Tenofovir Disoproxil Mylan can only help reduce the risk of getting HIV beforeyou are infected.

• You must not be infected with HIV before you start taking Emtricitabine/Tenofovir Disoproxil Mylan to reduce the risk of getting HIV.You will need to have an HIV test to make sure you are not already infected with HIV. Do not take Emtricitabine/Tenofovir Disoproxil Mylan to reduce the risk of getting HIV unless you have been confirmed to be HIV-negative. People with HIV should take Emtricitabine/Tenofovir Disoproxil Mylan in combination with other medicines.

• Many HIV tests can miss a recent infection.If you get a flu-like illness, it could mean that you have recently been infected with HIV. These can be signs of HIV infection:

• Fatigue
• Fever
• Joint or muscle pain
• Headache
• Vomiting or diarrhea
• Rash
• Night sweats
• Swollen lymph nodes in the neck or groin

Tell your doctor about any flu-like illness, either in the month before starting Emtricitabine/Tenofovir Disoproxil Mylan or at any time while taking it.

Warnings and precautions

When taking Emtricitabine/Tenofovir Disoproxil Mylan to reduce the risk of getting HIV:

• Take Emtricitabine/Tenofovir Disoproxil Mylan every dayto reduce your risk, not just when you think you have been at risk of getting HIV.Do not miss any doses of Emtricitabine/Tenofovir Disoproxil Mylan or stop taking it. Missed doses can increase the risk of getting HIV.
• You should have regular HIV testing.
• If you think you have been infected with HIV, contact your doctor immediately. They may want to do more tests to make sure you are still not infected with HIV.
• Using Emtricitabine/Tenofovir Disoproxil Mylan on its own may not prevent you from getting HIV.

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

Talk to your doctor if you have any questions about how to prevent getting HIV or passing it to others.

When taking Emtricitabine/Tenofovir Disoproxil Mylan to treat HIV or reduce the risk of getting HIV:

• Emtricitabine/Tenofovir Disoproxil Mylan can affect your kidneys.Before and during treatment, your doctor may do blood tests to check your kidney function. If you have had kidney disease or if the tests show 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 Emtricitabine/Tenofovir Disoproxil Mylan or, if you already have HIV, take Emtricitabine/Tenofovir Disoproxil Mylan less often. Emtricitabine/Tenofovir Disoproxil Mylanis not recommended if you have severe kidney disease or are on dialysis.
• Bone problems(bone pain that does not go away or gets worse, and sometimes results in fractures) can occur due to damage to kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.

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

Generally, the effects of tenofovir disoproxil on long-term bone health and the risk of future fractures in adult and pediatric patients are not known.

Tell your doctor if you know you have osteoporosis. Patients with osteoporosis are at a greater risk of fractures.

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

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 Emtricitabine/Tenofovir Disoproxil Mylan. If you have HBV, there is a high risk of liver problems when you stop taking Emtricitabine/Tenofovir Disoproxil Mylan, regardless of whether you also have HIV. It is important not to stop taking Emtricitabine/Tenofovir Disoproxil Mylan without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir Disoproxil Mylan.
• If you are over 65 years of age, tell your doctor.Emtricitabine/Tenofovir Disoproxil Mylan has not been studied in patients over 65 years of age.
• Talk to your doctor if you are lactose intolerant(see Emtricitabine/Tenofovir Disoproxil Mylan contains lactose later in this section).

Children and adolescents

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

Other medicines and Emtricitabine/Tenofovir Disoproxil Mylan

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

Taking Emtricitabine/Tenofovir Disoproxil Mylan with other medicines that can harm your kidneys: it is especially important that you tell your doctor if you are taking any of these medicines, 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 (for cancer treatment)
• cidofovir (for viral infection)
• non-steroidal anti-inflammatory drugs (NSAIDs, for pain relief or to reduce inflammation)

If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may do blood tests to closely monitor your kidney function.

It is also important to tell your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

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

Tell your doctorif you are taking any of these medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Emtricitabine/Tenofovir Disoproxil Mylan with food and drink

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

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.

If you have taken Emtricitabine/Tenofovir Disoproxil Mylan during your pregnancy, your doctor may do regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit of protecting them against HIV outweighed the risk of side effects.

• Do not breastfeed your child while taking Emtricitabine/Tenofovir Disoproxil Mylan.

This is because the active substances of this medicine pass into breast milk.

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

Driving and using machines

Emtricitabine/Tenofovir Disoproxil Mylan can cause dizziness. If you feel dizzy, do not driveor use tools or machines.

Emtricitabine/Tenofovir Disoproxil Mylan contains lactose.

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Emtricitabine/Tenofovir Disoproxil Mylan

• Always take this medicine exactly as your doctor has told you.If you are not sure, check with your doctor.

The recommended dose of Emtricitabine/Tenofovir Disoproxil Mylan for treating HIV is:

• Adults:one tablet once daily, when possible with food.
• Adolescents from 12 to less than 18 years of age with a body weight of at least 35 kg:one tablet once daily, when possible with food.

The recommended dose of Emtricitabine/Tenofovir Disoproxil Mylan for reducing the risk of getting HIV is:

• Adults:one tablet once daily, when possible with food.
• Adolescents from 12 to less than 18 years of age with a body weight of at least 35 kg:one tablet once daily, when possible with food.

If you have trouble 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 juice, or grape juice, and drink it immediately.

• Always take the dose recommended by your doctor.This is to make sure your medicine is fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.

• If you are taking Emtricitabine/Tenofovir Disoproxil Mylan for HIV treatment, your doctor will prescribe Emtricitabine/Tenofovir Disoproxil Mylan with other antiretroviral medicines. Check the package leaflets of the other antiretrovirals to find out how to take them.

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

Talk to your doctor if you have any questions about how to prevent getting HIV or passing it to others.

If you take more Emtricitabine/Tenofovir Disoproxil Mylan than you should

If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir Disoproxil Mylan, talk to your doctor or go to the nearest emergency room. Take the pack or container with you so that you can easily describe what you have taken.

If you forget to take Emtricitabine/Tenofovir Disoproxil Mylan

It is important that you do not miss a dose of Emtricitabine/Tenofovir Disoproxil Mylan.

• If you realize within 12 hoursof the time you usually take Emtricitabine/Tenofovir Disoproxil Mylan, take the tablet as soon as possible, preferably with food, and then take the next dose at the usual time.
• If more than 12 hours have passedsince the time you usually take Emtricitabine/Tenofovir Disoproxil Mylan, do not take the missed dose. Wait and take the next dose at the usual time, preferably with food.

If you vomit less than 1 hour after taking Emtricitabine/Tenofovir Disoproxil Mylan, take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking this medicine.

Do not stop taking Emtricitabine/Tenofovir Disoproxil Mylan

• If you are taking Emtricitabine/Tenofovir Disoproxil Mylan for HIV treatment, stopping treatment may reduce the effectiveness of the recommended HIV treatment.
• If you are taking Emtricitabine/Tenofovir Disoproxil Mylan to reduce the risk of getting HIV, do not stop taking it or miss any doses. If you stop using this medicine or miss doses, you may increase the risk of getting HIV.

Do not stop taking Emtricitabine/Tenofovir Disoproxil Mylan without talking to your doctor.

• If you have hepatitis B, it is especially important not to stop your treatment with Emtricitabine/Tenofovir Disoproxil 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 worsening of your hepatitis, which can be life-threatening.

Talk to your doctor immediatelyabout any new or unusual symptoms after stopping treatment, especially symptoms that you think may be related to hepatitis B infection.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Possible Serious Adverse Effects:

• Lactic Acidosis(excess of lactic acid in the blood) is a rare but potentially fatal adverse effect. Lactic acidosis is more frequent 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
• stomach 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 weak immune system), signs and symptoms of inflammation of previous infections may appear soon 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 infections that may be present without any apparent symptoms.

• Autoimmune disorders may also appear,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. Pay attention to any symptoms of infection or other symptoms such as:

• muscle weakness
• weakness that starts in the hands and feet and ascends to the trunk of the body
• palpitations, tremors, or hyperactivity

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

Possible Adverse Effects:

Very Common Adverse Effects

(may affect more than 1 in 10 people)

• diarrhea, vomiting, nausea
• dizziness, headache
• rash
• feeling of weakness

Lab tests may also show:

• decrease in blood phosphate levels
• increase in creatine kinase

Common Adverse Effects

(may affect up to 1 in 10 people)

• pain, stomach pain
• difficulty sleeping, abnormal dreams
• digestive problems with discomfort after meals, feeling bloated (gas), flatulence
• rash (including red spots or pimples, 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 number of white blood cells can make you more prone to infections)
• increase in triglycerides (fatty acids), bile, or blood sugar
• problems with the liver and pancreas

Uncommon Adverse Effects

(may affect up to 1 in 100 people)

• abdominal pain (caused by pancreas inflammation)
• swelling of the face, lips, tongue, or throat
• anemia (low red blood cell count)
• muscle rupture, muscle pain, or muscle weakness that may appear in case of damage to the renal tubule cells

Lab tests may also show:

• decrease in blood potassium levels
• increase in blood creatinine
• changes in urine

Rare Adverse Effects

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

• lactic acidosis (see Possible Serious Adverse Effects)
• fatty liver
• yellow skin or eyes, itching, or abdominal pain (caused by liver inflammation)
• kidney inflammation, increased urine volume, and feeling of thirst, kidney failure, damage to the renal tubule cells
• weakening of the bones (with bone pain and which sometimes ends in fractures)
• back pain due to kidney problems

Damage to the renal tubule cells can be associated with muscle rupture, weakening of the bones (with bone pain and which sometimes ends in fractures), muscle pain, muscle weakness, and decrease in blood potassium or phosphate levels.

If you notice any of the above adverse effects or if any of the adverse effects worsen, talk to your doctor or pharmacist.

The frequency of the following adverse effects is unknown.

• Bone problems.Some patients taking combined antiretroviral medications like emtricitabine/tenofovir disoproxil may develop a bone disease called osteonecrosis(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 weak immune system, and being overweight can 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, talk to your doctor.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. 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.

Other Effects in Children

• Children who receive emtricitabine often suffer from changes in skin color, including

• dark spots on the skin
  • Children frequently present with a low number of red blood cells (anemia)

• this can cause fatigue or shortness of breath

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is 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 contribute to providing more information on the safety of this medicine.

5. Storage of Emtricitabine/Tenofovir Disoproxil Mylan

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

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

Bottle pack: use within 90 days of initial opening.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Emtricitabine/Tenofovir Disoproxil Mylan

• The active ingredients areemtricitabine and tenofovir disoproxil. Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
• The other ingredients aremicrocrystalline cellulose, hypromellose, red iron oxide (E172), colloidal anhydrous silica, lactose monohydrate (see section 2: "Emtricitabine/Tenofovir Disoproxil Mylan contains lactose"), magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, brilliant blue FCF aluminum lacquer (E133), yellow iron oxide (E172).

Appearance of Emtricitabine/Tenofovir Disoproxil Mylan and Package Contents

Emtricitabine/Tenofovir Disoproxil Mylan tablets are light green, film-coated, capsule-shaped, biconvex, 19.8 x 9.00 mm in size, marked with an "M" on one side and "ETD" on the other side.

This medicine 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, which include 3 bottles, each containing 30 film-coated tablets, or in blister packs with an embedded desiccant containing 30, 30 x 1, 90 x 1, 100 x 1 film-coated tablets and blister packs containing 30, 30 x 1, 90 x 1, 100 x 1 film-coated 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, H-2900 Komárom,

Hungary

McDermott Laboratories Limited under the trade name of Gerard Laboratories and Gerard Laboratories under the trade 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet: November 2021

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