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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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 you should not give it to other people, even if they have the same symptoms as you, because it may 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 Teva is and what it is used for

2. What you need to know before taking Emtricitabine/Tenofovir disoproxil Teva

3. How to take Emtricitabine/Tenofovir disoproxil Teva

4. Possible adverse effects

   1. Storage of Emtricitabine/Tenofovir disoproxil Teva

5. Contents of the pack and other information

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

Emtricitabina/Tenofovir disoproxilo Teva 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) that is essential for the virus to replicate.

• Emtricitabina/Tenofovir disoproxilo Teva 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 under 18 years with a body weight of at least 35 kg who have previously been treated with other HIV medicines that are no longer effective or have caused adverse effects.

• Emtricitabina/Tenofovir disoproxilo Teva must always be used in combination with other medicines for the treatment of HIV infection.

• Emtricitabina/Tenofovir disoproxilo Teva may be administered instead of separate emtricitabine and tenofovir disoproxil taken at the same doses.

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

Emtricitabina/Tenofovir disoproxilo Teva is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 to under 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 take to prevent HIV infection.

2. What you need to know before taking Emtricitabine/Tenofovir disoproxil Teva

Do not take Emtricitabine/Tenofovir disoproxil Teva to treat HIV or to reduce the risk of getting HIV if you are allergic to

• emtricitabine, tenofovir, tenofovir disoproxil fumarate, or any of the other ingredients of this medicine (listed in section 6).

?If this applies to you, call your doctor IMMEDIATELY.

Before taking Emtricitabine/Tenofovir disoproxil Teva to reduce the risk of getting HIV:

Emtricitabine/Tenofovir disoproxil Teva can only help reduce the risk of getting HIV before you become infected.

• You must not be infected with HIV before starting Emtricitabine/Tenofovir disoproxil Teva to reduce the risk of getting HIV. You must be tested to ensure that you are not infected with HIV. Do not take Emtricitabine/Tenofovir disoproxil Teva to reduce the risk unless it has been confirmed that you are not infected with HIV. People who have HIV should take Emtricitabine/Tenofovir disoproxil in combination with other medicines.

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

These may be signs of HIV infection:

• fatigue
• fever
• joint or muscle pain
• headache
• vomiting or diarrhea
• rash
• night sweats
• enlarged lymph nodes in the neck or groin

??Tell your doctor about any flu-like illness, whether occurring in the month before starting treatment with Emtricitabine/Tenofovir disoproxil Teva or at any time while taking Emtricitabine/Tenofovir disoproxil Teva.

Warnings and precautions

When taking Emtricitabine/Tenofovir disoproxil Teva to reduce the risk of getting HIV:

• Take Emtricitabine/Tenofovir disoproxil Teva 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 Emtricitabine/Tenofovir disoproxil Teva or stop taking it. Missed doses may increase the risk of acquiring HIV infection.

• You should have regular HIV testing.

• If you think you may have become infected with HIV, consult your doctor immediately. Additional tests may be needed to confirm that you remain uninfected with HIV.

• Using Emtricitabine/Tenofovir disoproxil Teva 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 injection equipment or medications.

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

Talk to your doctor if you have further questions about how to prevent getting or spreading HIV.

When taking Emtricitabine/Tenofovir disoproxil Teva to treat HIV or to reduce the risk of getting HIV:

• Emtricitabine/Tenofovir disoproxil Teva can affect your kidneys. Before and during treatment, your doctor may ask you to have blood tests to monitor kidney function. Emtricitabine/Tenofovir disoproxil Teva should not be given to adolescents with existing kidney problems. If you have had kidney disease or if blood tests have shown kidney problems, tell your doctor. If you have kidney problems, your doctor may advise you to stop taking Emtricitabine/Tenofovir disoproxil Teva or, if you already have HIV, to take Emtricitabine/Tenofovir disoproxil Teva less frequently. Emtricitabine/Tenofovir disoproxil Teva is not recommended if you have severe kidney disease or are on dialysis.

• Talk to your doctor if you have osteoporosis, a history of bone fractures, or bone problems.

Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures) may also occur due to damage to renal tubular cells (see section 4, Possible side effects). Inform your doctor if you experience bone pain or fractures.

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

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

• 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) and are treated with antiretrovirals have a higher 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) infection status before starting Emtricitabine/Tenofovir disoproxil Teva. If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Tenofovir disoproxil Teva, regardless of whether you also have HIV. It is important not to stop taking Emtricitabine/Tenofovir disoproxil Teva without consulting your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir disoproxil Teva.

If you are over 65 years old, tell your doctor. The combination of emtricitabine and tenofovir disoproxil has not been studied in patients over 65 years of age.

Children and adolescents

Emtricitabine/tenofovir disoproxil is not intended for use in children under 12 years of age.

Taking Emtricitabine/Tenofovir disoproxil Teva with other medicines

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

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

• Taking Emtricitabine/Tenofovir disoproxil Teva 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. These include:

• 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 treating cancer)

• 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 that you inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

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

? Tell 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 disoproxil Teva with food and drinks

• Emtricitabine/Tenofovir disoproxil Teva should be taken with food whenever possible.

Pregnancy and breastfeeding

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

If you have taken emtricitabine/tenofovir disoproxil 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 disoproxil. This is because the active substances of this medicine pass into breast milk.
• Women living with HIV are not recommended to breastfeed because HIV infection can be transmitted to the baby through breast milk.
• If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

The combination of emtricitabine and tenofovir disoproxil may cause dizziness. If you experience dizziness during treatment with this medicine, do not drive or operate tools or machinery.

Emtricitabine/Tenofovir disoproxil Teva contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free.”

3. How to take Emtricitabine/Tenofovir disoproxil Teva

• Always follow your doctor's instructions on how to take this medicine exactly. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Emtricitabine/Tenofovir disoproxil Teva 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 Teva to reduce 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 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 immediately.

• Always take the dose prescribed by your doctor. This is to ensure that your medication 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 Teva 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 Teva to reduce the risk of acquiring HIV, take Emtricitabine/Tenofovir disoproxil Teva every day, not only when you believe you may have been exposed to HIV.

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 Teva than you should

If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir disoproxil Teva, contact your doctor or go to the nearest emergency department. Take the medicine container with you so you can clearly describe what you have taken.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget a dose

It is important not to miss a dose of this medicine.

• If you remember within 12 hours of your usual time for taking Emtricitabine/Tenofovir disoproxil Teva, take the tablet as soon as possible, preferably with food, and then take your next dose at the usual time.

• If more than 12 hours have passed since your usual time for taking Emtricitabine/Tenofovir disoproxil Teva, do not take the missed dose. Wait and take the next dose at your usual time, preferably with food.

If you vomit within 1 hour after taking Emtricitabine/Tenofovir disoproxil Teva, take another tablet. You do not need to take another tablet if you vomited more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Teva.

Do not stop taking Emtricitabine/Tenofovir disoproxil Teva

• If you are taking Emtricitabine/Tenofovir disoproxil Teva for the treatment of HIV infection, stopping treatment may reduce the effectiveness of the antiretroviral therapy prescribed by your doctor.

• If you are taking Emtricitabine/Tenofovir disoproxil Teva to reduce the risk of acquiring HIV, do not stop taking Emtricitabine/Tenofovir disoproxil Teva or miss any doses. Stopping treatment or missing doses may increase your risk of acquiring HIV infection.

?Do not stop taking Emtricitabine/Tenofovir disoproxil Teva without consulting your doctor.

• If you have hepatitis B, it is especially important not to stop treatment with Emtricitabine/Tenofovir disoproxil Teva without first talking to your doctor. You may need 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 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 adverse effects

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

Possible serious adverse effects:

• Lactic acidosis (excess lactic acid in the blood) is a rare but potentially fatal adverse effect. Lactic acidosis occurs more frequently in women, especially those who are overweight, and in people with liver disease. The following adverse effects 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 occurring 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 result from an improved immune response, allowing the body to fight infections that may have been present without apparent symptoms.

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

• muscle weakness

• weakness beginning in the hands and feet and moving upward toward the trunk

• palpitations, tremor, 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

Blood tests may also show:

• decreased phosphate levels in blood
• elevated creatine kinase

Common adverse 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 color such as darkening of the skin in patches
• other allergic reactions, such as difficulty breathing, swelling, or feeling slightly dizzy
• Loss of bone mass

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 adverse effects
(may affect up to 1 in 100 people)

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

Blood tests may also show:

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

Rare adverse effects
(may affect up to 1 in 1,000 people)

• lactic acidosis (see Possible serious adverse effects)
• fatty liver
• yellowing of the skin or eyes, itching, or abdominal pain caused by liver inflammation
• kidney inflammation, increased urine volume and sensation of 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 notice any of the adverse effects listed above, or if any of the adverse effects worsen, speak with your doctor or pharmacist.

The frequency of the following adverse effects is unknown.

• Bone problems. Some patients taking combined antiretroviral medicines such as Emtricitabine/Tenofovir disoproxil Teva may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Long-term use of such medicines, use of 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, speak with your doctor.

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

Other effects in children

• Children receiving emtricitabine very commonly experience changes in skin pigmentation, including
  • dark spots on the skin
• Children frequently develop a low number of red blood cells (anemia)
  • which may cause fatigue or dyspnea

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Emtricitabine/Tenofovir disoproxil Teva

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, after EXP. The expiry date refers to the last day of the month indicated.

Blister packs: Do not store above 30 °C. Keep in the original blister packaging to protect from moisture.

HDPE bottles:

• Store in the original bottle to protect from moisture. Keep the bottle tightly closed.
• The product has been shown to remain stable for up to 60 days after first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Emtricitabine/Tenofovir disoproxil Teva

• The active substances are emtricitabine and tenofovir disoproxil. Each film-coated tablet of Emtricitabine/Tenofovir disoproxil Teva contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291.22 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
• The other components are mannitol, sodium stearyl fumarate, microcrystalline cellulose (E460), low-substituted hydroxypropylcellulose (E463), and hypromellose (E464).

The other components in the coating are partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), and indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

The film-coated tablets of Emtricitabine/Tenofovir disoproxil Teva are green to light green in colour, oval-shaped, approximately 18 mm x 10 mm in size, printed with "E T" on one side and plain on the other.

Each bottle contains a desiccant which should remain in the bottle to help protect your tablets. The desiccant is contained in a separate sachet or compartment and must not be swallowed.

The following pack sizes are available:

Blister packs: Pack sizes of 30, 30x1, and 90 film-coated tablets.

Bottles: Pack sizes of 30, 90 (3 bottles of 30), and multi-packs including 3 packs, each containing 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Manufacturer

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

Zagreb 10000

Croatia

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

Krakow 31-546

Poland

or

Merckle GmbH

Ludwig-Merckle-Straße 3

Blaubeuren 89143

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

AT Emtricitabin/Tenofovir disoproxil ratiopharm 200 mg/245 mg Filmtabletten

CZ Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg

DE Emtricitabin/Tenofovirdisoproxil ratiopharm 200 mg/245 mg Filmtabletten

DK Emtricitabine/Tenofovir disoproxil Teva

EE Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg

ES Emtricitabina/Tenofovir disoproxilo Teva 200 mg/245 mg comprimidos recubiertos con película EFG

FI Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg tabletti, kalvopäällysteinen

FR Emtricitabine/Tenofovir disoproxil Teva 200mg/245mg, comprimé pelliculé

HR Emtricitabin/Tenofovirdizoproksil Pliva 200 mg/245 mg filmom obložene tablete

HU Emtricitabine/Tenofovir-disoproxil Teva 200 mg/ 245 mg filmtabletta

IE Emtricitabine/Tenofovir disoproxil Teva 200mg/245mg Film-coated Tablets

IS Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg filmuhúðaðar töflur

IT Emtricitabina e Tenofovir disoproxil Teva LV Emtricitabine/Tenofovir disoproxil Teva 200mg/245mg apvalkotas tabletes

NL Emtricitabine/Tenofovirdisoproxil Teva 200/245 mg, filmomhulde tabletten

PT Emtricitabina +Tenofovir disoproxil Teva

RO EMTRICITABINA/TENOFOVIR DISOPROXIL TEVA 200mg/245mg comprimate filmate

SE Emtricitabine/Tenofovir disoproxil Teva

SI Emtricitabin/dizoproksiltenofovirat Teva 200 mg/245 mg filmsko obložene tablete

UK Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets

Date of latest revision of the leaflet: February 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).