EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA 200 MG/245 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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 is Emtricitabine/Tenofovir Disoproxil Teva and what is it used for
2. What you need to know before you take Emtricitabine/Tenofovir Disoproxil Teva
3. How to take Emtricitabine/Tenofovir Disoproxil Teva
4. Possible side effects
   1. Storage of Emtricitabine/Tenofovir Disoproxil Teva

1. Contents of the pack and other information

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

Emtricitabine/Tenofovir Disoproxil Teva contains two active substances, emtricitabine and tenofovir disoproxil.Both active substances are antiretroviral medicines used to treat HIV infection.Emtricitabine is a nucleoside analogue reverse transcriptase inhibitorand tenofovir is a nucleotide analogue reverse transcriptase inhibitor. They are generally known as 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 Teva 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, weighing at least 35 kg, who have already been treated with other HIV medicines that are no longer effective or have caused side effects.

• Emtricitabine/Tenofovir Disoproxil Teva must always be used in combination with other medicines to treat HIV infection.
• Emtricitabine/Tenofovir Disoproxil Teva can be taken instead of emtricitabine and tenofovir disoproxil taken separately at the same doses.

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

Emtricitabine/Tenofovir Disoproxil Teva is also used to reduce the risk of getting HIV-1 infection in adults and adolescents from 12 to less than 18 years of age, weighing 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 Teva

Do not take Emtricitabine/Tenofovir Disoproxil Teva to treat or reduce the risk of HIV infection if you are allergicto

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

If this happens, call your doctor IMMEDIATELY.

Before taking Emtricitabine/Tenofovir Disoproxil Teva to reduce the risk of HIV infection:

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

• You must not be infected with HIV before starting Emtricitabine/Tenofovir Disoproxil Teva 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 Teva to reduce the risk of getting HIV unless you have been confirmed to be HIV-negative. People with HIV should take Emtricitabine/Tenofovir Disoproxil Teva 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
• enlarged lymph nodes in the neck or groin

Tell your doctor about any flu-like illness, either in the month before starting 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 just when you think you have been at risk of getting HIV.Do not miss any doses of Emtricitabine/Tenofovir Disoproxil Teva or stop taking it. Missed doses can increase the risk of getting HIV.

• You will need to have regular HIV tests.

• If you think you have been 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 Emtricitabine/Tenofovir Disoproxil Teva 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 may contain blood or bodily fluids, such as toothbrushes or razor blades.

• Do not share or reuse needles or other injections or medicines.

• You will need to have tests for other sexually transmitted infections, such as syphilis or gonorrhea. These infections can 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 Teva to treat HIV infection or 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 check your kidney function. Emtricitabine/Tenofovir Disoproxil Teva should not be given to adolescents with existing kidney problems. If you have had kidney disease, or if your 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, take Emtricitabine/Tenofovir Disoproxil Teva less often. 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 (which show up as persistent or worsening bone pain and sometimes result in fractures) may also 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 most pronounced bone loss was seen in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

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

• Talk to 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 higher risk of serious and potentially life-threatening liver problems. 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 Teva. If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Tenofovir Disoproxil Teva, whether you also have HIV or not. It is important not to stop taking Emtricitabine/Tenofovir Disoproxil Teva without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir Disoproxil Teva.

If you are over 65 years of age, 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 Teva is not for use in children under 12 years of age.

Taking Emtricitabine/Tenofovir Disoproxil Teva with other medicines

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

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

• Taking Emtricitabine/Tenofovir Disoproxil Teva 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. 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 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 ask you to have 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 Teva with other medicines that contain didanosine (for HIV treatment):Taking Emtricitabine/Tenofovir Disoproxil Teva 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 Teva with food and drink

• Whenever possible, Emtricitabine/Tenofovir Disoproxil Teva 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 been taking emtricitabine/tenofovir disoproxil during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefits of protection against HIV outweighed the risks of side effects.

• Do not breastfeed your child during treatment with emtricitabine/tenofovir disoproxil.This is because the active ingredients of this medicine pass into breast milk.
• It is recommended that women with HIV do not breastfeed their babies because HIV can be passed to the baby through breast milk.
• If you are breastfeeding or thinking of breastfeeding, talk to your doctor as soon as possible.

Driving and using machines

The combination of emtricitabine and tenofovir disoproxil may cause dizziness. If you feel dizzy while taking this medicine, do not driveor operate tools or machines.

Emtricitabine/Tenofovir Disoproxil Teva contains sodium

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

3. How to take Emtricitabine/Tenofovir disoproxil Teva

• Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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

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

The recommended dose of Emtricitabine/Tenofovir disoproxil Teva for reducing the risk of getting HIV is:

• Adults: one tablet a day, preferably with food.
• Adolescents from 12 to less than 18 years of age with a weight of at least 35 kg: one tablet a day, preferably 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 juice, or grape juice, and drink it immediately.

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

• If you are receiving treatment for HIV infection,your doctor will prescribe Emtricitabine/Tenofovir disoproxil Teva with other antiretroviral medications. Consult the package inserts of the other antiretrovirals to learn how to take these medications.

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

Consult your doctor if you have any questions about how to prevent HIV transmission or prevent its 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, consult your doctor or go to the nearest emergency room. Bring the bottle of tablets with you so that you can easily describe what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you miss a dose

It is essential that you do not miss a dose of this medication.

• If you realize within 12 hoursfrom the time you usually take Emtricitabine/Tenofovir disoproxil Teva, take the tablet as soon as possible, preferably with food, and then take the next dose at your usual time.

• If it has been 12 hours or moresince the time you usually take Emtricitabine/Tenofovir disoproxil Teva, do not take the missed dose. Wait and take the next dose, preferably with food, at your usual time.

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

Do not interrupt treatment with 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 recommended HIV therapy by your doctor.

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

Do not interrupt treatment with Emtricitabine/Tenofovir disoproxil Teva without consulting your doctor.

• If you have hepatitis B,it is especially important not to stop your treatment with Emtricitabine/Tenofovir disoproxil Teva without first talking to your doctor. You may need to have blood tests done for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment as this can cause worsening of hepatitis, which can be potentially fatal.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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 side effects 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, which allows the body to fight infections that may be present without any apparent symptoms.

• Also, autoimmune disordersmay appear when the immune system attacks healthy body tissue after starting 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 moves up to the torso
• 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,
• rash.
• feeling of weakness

Lab tests may also show:

• decreased phosphate levels in the blood.
• elevated creatine kinase

Common side 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 can 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
• Bone loss

Lab tests may also show:

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

Uncommon side effects

(may affect up to 1 in 100 people):

• stomach pain (abdominal pain) caused by pancreatitis
• swelling of the face, lips, tongue, or throat

• anemia (low red blood cell count)
• muscle breakdown, muscle pain, or muscle weakness that can occur in case of damage to the renal tubular cells

Lab tests may also show:

• decreased potassium levels in the blood
• increased creatinine in the 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 stomach pain caused by liver inflammation
• kidney inflammation, increased urine volume, and feeling of thirst, kidney failure, damage to the renal tubular cells
• weakening of the bones (with bone pain and sometimes resulting in fractures)

• back pain due to kidney problems

The damage to the renal tubular cells can be associated with muscle breakdown, weakening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood.

If you notice any of the above side effects 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 combination antiretroviral medications like Emtricitabine/Tenofovir disoproxil Teva 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 glucose and lipid levels in the blood. This may be partly related to the recovery of health and lifestyle, and in the case of lipids in the blood, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Other effects in children

• Children who receive emtricitabine often experience changes in skin color, including
• • dark spots on the skin
• Children frequently have a low red blood cell count (anemia)
• • this can cause fatigue or shortness of breath

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package insert. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Emtricitabine/Tenofovir disoproxil Teva

Keep this medication out of sight and reach of children.

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

Blisters: Do not store above 30 °C. Store in the original blister pack 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 be stable for up to 60 days after the first opening of the bottle.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Emtricitabine/Tenofovir disoproxil Teva

• The active ingredients 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 phosphate or 136 mg of tenofovir)
• The other ingredients are mannitol, sodium stearyl fumarate, microcrystalline cellulose (E460), low-substituted hydroxypropylcellulose (E463), and hypromellose (E464).

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

Appearance of the product and package contents

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

Each bottle contains a desiccant that should be kept in the bottle to help protect the tablets. The desiccant is contained in a separate pouch or container and should not be swallowed.

The following package sizes are available:

Blister: Package size of 30, 30x1, and 90 film-coated tablets.

Bottle: Package size 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, 1ª planta

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 medication is authorized in the member states of the European Economic Area under the following names:

AT Emtricitabine/Tenofovir disoproxil ratiopharm 200 mg/245 mg film-coated tablets

CZ Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg

DE Emtricitabine/Tenofovir disoproxil ratiopharm 200 mg/245 mg film-coated tablets

DK Emtricitabine/Tenofovir disoproxil Teva

EE Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg

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

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

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

HR Emtricitabine/Tenofovir disoproxil Pliva 200 mg/245 mg film-coated tablets

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

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

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

IT Emtricitabine and Tenofovir disoproxil Teva

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

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

PT Emtricitabine + Tenofovir disoproxil Teva

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

SE Emtricitabine/Tenofovir disoproxil Teva

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

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

Date of the last revision of this package insert:February 2025

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