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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

emtricitabine/tenofovir disoproxil

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Emtricitabina/Tenofovir disoproxilo Mylan contains two active substances, emtricitabine and tenofovir disoproxil. Both active substances are antiretroviral drugs used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor, and tenofovir is a nucleotide reverse transcriptase inhibitor. They are commonly known as NRTIs and work by interfering with the normal function of an enzyme (reverse transcriptase) essential for viral replication.

• Emtricitabina/Tenofovir disoproxilo Mylan is used to treat infection with Human Immunodeficiency Virus type 1 (HIV-1) in adults.
• It is also used to treat HIV in adolescents aged 12 to less than 18 years weighing at least 35 kg who have previously been treated with other antiretroviral medicines that are no longer effective or have caused adverse effects.
  • Emtricitabina/Tenofovir disoproxilo Mylan must always be used in combination with other antiretroviral medicines to treat HIV infection.
  • Emtricitabina/Tenofovir disoproxilo Mylan may be administered as a substitute for separate emtricitabine and tenofovir disoproxil taken at the same doses.

People infected with HIV can still transmit the virus to others while taking this medicine, although effective antiretroviral therapy reduces the risk. Consult your doctor about the precautions needed to avoid infecting others.

This medicine is not a cure for HIV infection. While you are taking Emtricitabina/Tenofovir disoproxilo Mylan, you may continue to experience infections or other illnesses associated with HIV infection.

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

2. What you need to know before taking Emtricitabina/Tenofovir disoproxilo Mylan

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

If any of the following apply to you, 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 HIV before you become infected.

• You must not be infected with HIV before starting Emtricitabina/Tenofovir disoproxilo Mylan to reduce the risk of getting HIV. You must be tested to ensure 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 must take Emtricitabina/Tenofovir disoproxilo Mylan in combination with other medicines.

• Many HIV tests may not detect a recent infection. If you develop flu-like illness, it could mean you have recently become infected with HIV. These may be signs of HIV infection:

• Fatigue

• Fever

• Joint or muscle pain

• Headache

• Nausea or diarrhea

• Rash

• Night sweats

• Swelling of lymph nodes in the neck or groin

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

Warnings and precautions

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

• Take Emtricitabina/Tenofovir disoproxilo Mylan every day to reduce your risk, not only when you think you may have been exposed to HIV infection. Do not miss any doses of Emtricitabina/Tenofovir disoproxilo Mylan or stop taking it. Missed doses may increase the risk of acquiring HIV infection.

• You must have regular HIV screening tests.

• If you think you have become infected with HIV, consult your doctor immediately. They may want to perform further tests to confirm you remain uninfected with HIV.

• Using Emtricitabina/Tenofovir disoproxilo Mylan alone 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 may contain blood or body fluids, such as toothbrushes and razors.

• Do not share or reuse needles or other injecting equipment.

• You should be tested for other sexually transmitted infections such as syphilis or gonorrhea. These infections make it easier for you to acquire HIV.

Consult your doctor if you have further questions about how to prevent getting or transmitting HIV.

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

• Emtricitabine/tenofovir disoproxilum can affect your kidneys. Before and during treatment, your doctor may request blood tests to monitor your kidney function. If you have had kidney disease, or if blood tests have shown kidney problems, inform 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, to take Emtricitabina/Tenofovir disoproxilo Mylan less frequently. Emtricitabine/tenofovir disoproxilum is not recommended if you have severe kidney disease or are on dialysis.
• Bone problems (bone issues may also occur, manifesting as persistent or worsening bone pain and, sometimes, leading to fractures) due to damage to renal tubular cells (see section 4, Possible side effects). Inform your doctor if you experience bone pain or fractures.

Tenofovir disoproxilum may also cause loss of bone mineral density. The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxilum in combination with a boosted protease inhibitor.

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

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. HIV-infected patients who also have liver disease (including chronic hepatitis B or C), treated with antiretrovirals, have an increased 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) status before starting emtricitabine/tenofovir disoproxilum. If you have HBV, there is a high risk of developing liver problems when you stop taking emtricitabine/tenofovir disoproxilum, regardless of whether you also have HIV. It is important not to stop taking emtricitabine/tenofovir disoproxilum without consulting your doctor: see section 3, Do not stop taking emtricitabine/tenofovir disoproxilum Mylan.
• If you are over 65 years old, inform your doctor. Emtricitabine/tenofovir disoproxilum has not been studied in patients over 65 years of age.
• Consult your doctor if you are lactose intolerant (see Emtricitabine/Tenofovir disoproxilum Mylan contains lactose later in this section).

Children and adolescents

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

Other medicines and Emtricitabine/Tenofovir disoproxilum Mylan

Do not take Emtricitabine/Tenofovir disoproxilum Mylan if you are already taking other medicines containing the components of this medicine (emtricitabine and tenofovir disoproxilum) or any other antiviral medicine containing tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Taking Emtricitabine/Tenofovir disoproxilum Mylan with other medicines that may 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 relieving bone or muscle pain)

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

It is also important to inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

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

Inform your doctor if you are taking any of these medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Taking Emtricitabine/Tenofovir disoproxilum Mylan with food and drink

• Emtricitabine/Tenofovir disoproxilum Mylan should be taken with food whenever possible.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

• Do not breastfeed while being treated with Emtricitabine/Tenofovir disoproxilum Mylan.

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

• Women infected with HIV are advised not to breastfeed, to avoid transmitting the virus to the child through breast milk.

Driving and using machines

Emtricitabine/tenofovir disoproxilum may cause dizziness. If you experience dizziness during treatment with this medicine, do not drive or operate tools or machinery.

Emtricitabine/Tenofovir disoproxilum Mylan contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Emtricitabine/Tenofovir disoproxil Mylan

• Follow exactly your doctor's instructions for taking this medicine. If in doubt, consult your doctor again.

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

• Adults: one tablet daily, preferably with food.
• Adolescents aged 12 to under 18 years weighing at least 35 kg: one tablet daily, preferably with food.

The recommended dose of Emtricitabine/Tenofovir disoproxil Mylan for reducing the risk of acquiring HIV is:

• Adults: one tablet daily, preferably with food.
• Adolescents aged 12 to under 18 years weighing at least 35 kg: one tablet daily, preferably with food.

If you have difficulty swallowing, you may use the back 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 immediately.

• Always take the dose prescribed by your doctor. This is to ensure that your medicine is fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless your doctor tells you to do so.

• If you are being treated for HIV infection, your doctor will prescribe Emtricitabine/Tenofovir disoproxil Mylan together with other antiretroviral medicines. Please refer to the package leaflets of the other antiretrovirals for instructions on how to take them.

• If you are an adult taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of acquiring HIV, take it every day, not only when you think you may have been exposed to HIV infection.

Consult your doctor if you have any questions about how to prevent HIV infection or prevent transmission 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, contact your doctor or go to the nearest emergency department. Take the bottle of tablets or the packaging with you so you can clearly describe what you have taken.

If you forget to take Emtricitabine/Tenofovir disoproxil Mylan

It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Mylan.

• If you realize within 12 hours of your usual dosing time, take the tablet as soon as possible, preferably with food, and then take your next dose at the usual time.
• If 12 hours or more have passed since your usual dosing time, do not take the missed dose. Wait and take your next dose at the usual time, preferably with food.

If you vomit within 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 treatment with Emtricitabine/Tenofovir disoproxil Mylan

• If you are taking Emtricitabine/Tenofovir disoproxil Mylan for treatment of HIV infection, stopping treatment may reduce the effectiveness of your prescribed HIV therapy.
• If you are taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of acquiring HIV infection, do not stop taking it or miss any doses. Stopping this medicine or missing doses may increase your risk of acquiring HIV infection.

Do not stop treatment with Emtricitabine/Tenofovir disoproxil Mylan without consulting your doctor.

• If you have hepatitis B, it is especially important not to stop treatment with Emtricitabine/Tenofovir disoproxil Mylan without 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, stopping treatment is not recommended, as this may lead to a worsening of hepatitis, which could be potentially fatal.

Contact your doctor immediately if you experience any new or unusual symptoms after stopping treatment, particularly symptoms you associate with hepatitis B virus infection.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible serious side effects:

• Lactic acidosis (excess 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, 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 weakened immune system), signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to be due to an improved immune response, allowing the body to fight infections that may have been present without any apparent symptoms.

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

• muscle weakness

• weakness starting in the hands and feet and moving up toward the trunk of the body

• palpitations, tremor, 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)

• diarrhoea, vomiting, feeling sick (nausea)
• dizziness, headache
• rash
• feeling weak

Blood tests may also show:

• decreased phosphate levels in blood
• elevated creatine kinase

Common side effects

(may affect up to 1 in 10 people)

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

Blood tests may also show:

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

Uncommon side effects

(may affect up to 1 in 100 people)

• abdominal pain (stomach ache) caused by inflammation of the pancreas
• swelling of the face, lips, tongue, or throat
• anaemia (low red blood cell count)
• muscle rupture, muscle pain, or muscle weakness, which may occur if there is damage to renal tubule cells

Blood tests may also show:

• decreased potassium levels in blood
• increased creatinine in blood
• changes in your urine

Rare side effects

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

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

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

If you experience any of the side effects listed above, or if any of the side effects worsen, talk to your doctor or pharmacist.

The frequency of the following side effects is unknown.

• Bone problems. Some patients taking combined antiretroviral medicines such as emtricitabine/tenofovir disoproxil may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Long-term use of these medicines, taking corticosteroids, alcohol consumption, having a very weak immune system, and being overweight may be among the many risk factors for developing this condition. Signs of osteonecrosis include:

• joint stiffness

• joint discomfort or pain (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 in blood glucose and lipid levels. This may be partly due to improved health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Other effects in children

• Children receiving emtricitabine very commonly experience changes in skin colour, including

• dark spots on the skin

  • Children frequently have a low number of red blood cells (anaemia)

• this may cause tiredness or shortness of breath

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting side effects, you can help provide 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 expiry date stated on the bottle and carton following CAD or EXP. The expiry date refers to the last day of the month indicated.

Bottle container: use within 90 days after first opening.

Do not store above 25°C. Keep in the original container to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Emtricitabine/Tenofovir Disoproxil Mylan

• The active substances are emtricitabine 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 components are microcrystalline cellulose, low-substituted hydroxypropylcellulose, red iron oxide (E172), colloidal anhydrous silica, monohydrate lactose (see section 2: “Emtricitabine/Tenofovir Disoproxil Mylan contains lactose”), magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, aluminium lake of brilliant blue FCF (E133), yellow iron oxide (E172).

Appearance of Emtricitabine/Tenofovir Disoproxil Mylan and contents of the pack

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

This medicine is available in plastic bottles with a desiccant (DO NOT INGEST THE DESICCANT) containing 30 film-coated tablets, in multiple packs of 90 film-coated tablets consisting of 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

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

Manufacturer(s):

Mylan Hungary Kft
Mylan utca 1, H-2900 Komárom,
Hungary

McDermott Laboratories Limited trading as Gerard Laboratories and Gerard Laboratories trading as 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

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

Date of the most recent review of this leaflet: November 2021

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