Leaflet: information for the user

Emtricitabine/tenofovir disoproxilAccordpharma 200 mg/245 mg film-coated tablets EFG

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

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

1. What isEmtricitabine/tenofovir disoproxilAccordpharmaand what it is used for

2. What you need to know before you start takingEmtricitabine/tenofovir disoproxilAccordpharma

3. How to takeEmtricitabine/tenofovir disoproxilAccordpharma

4. Possible side effects

5. Storage ofEmtricitabine/tenofovir disoproxilAccordpharma

6. Contents of the pack and additional information

Emtricitabina/tenofovir disoproxilo Accordpharmacontains two active principles,emtricitabinaandtenofovir disoproxilo. Both active principles are antiretroviral drugsthat are used to treat HIV infection.

Emtricitabina is anucleoside reverse transcriptase inhibitor analogueand tenofovir is anucleotide reverse transcriptase inhibitor analogue. They are generally known as ITIAN and act by interfering with the normal functioning of an enzyme (reverse transcriptase) that is essential for the virus to replicate.

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

This medication is not a cure for HIV infection. While you are taking Emtricitabina/tenofovir disoproxiloyou may still develop infections or other diseases associated with HIV infection.

• Emtricitabina/tenofovir disoproxilo is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 to less than 18 years with a weight of at least 35 kgwhen taken daily, in combination with safer sex practices:

See section 2 for a list of precautions to be taken against HIV infection.

Do not takeEmtricitabina/tenofovir disoproxiloAccordpharma to treat HIV or reduce the risk of contracting HIV

• if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other components of this medication (listed in section 6).

If this happens, call your doctor immediately.

Before takingEmtricitabina/tenofovir disoproxiloAccordpharma to reduce the risk of contracting HIV:

Emtricitabina/tenofovir disoproxilo can only help reduce the risk of contracting HIVbeforeyou are infected.

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

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

These may be signs of HIV infection:

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

Inform your doctor about any flu-like illness, either in the month before starting treatment with emtricitabine/tenofovir disoproxilo or at any time while taking emtricitabine/tenofovir disoproxilo.

Warnings and precautions

When takingEmtricitabina/tenofovir disoproxiloAccordpharma to reduce the risk of contracting HIV:

• Take emtricitabine/tenofovir disoproxilo every dayto reduce your risk, not just when you think you have been at risk of contracting HIV infection.Do not forget any dose of emtricitabine/tenofovir disoproxilo or stop taking it. Missed doses can increase the risk of HIV infection.

• You should have regular HIV detection tests.

• If you think you have become infected with HIV, consult your doctor immediately. They may want to do further tests to make sure you are still not infected with HIV.

• The use of emtricitabine/tenofovir disoproxilo alone may not prevent you from contracting HIV.

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

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

When takingEmtricitabina/tenofovir disoproxiloAccordpharma to treat HIV or reduce the risk of contracting HIV:

• Emtricitabine/tenofovir disoproxilo may affect your kidneys.Your doctor may ask you to have blood tests before and during treatment to measure your renal function. If you have had kidney disease, or if the tests have shown kidney problems, tell your doctor. Emtricitabine/tenofovir disoproxilo should not be administered to adolescents with existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking emtricitabine/tenofovir disoproxilo or, if you already have HIV, take emtricitabine/tenofovir disoproxilo less frequently. Emtricitabine/tenofovir disoproxilo is not recommended if you have severe kidney disease or are on dialysis.

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

• Bone problems(which manifest as persistent bone pain or that worsens and sometimes ends in fractures) due to damage to renal tubular cells (see section 4,Adverse reactions). Inform your doctor if you have bone pain or fractures.

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

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

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

• Know your hepatitis B virus (HBV) statusbefore starting to take emtricitabine/tenofovir disoproxilo. If you have HBV, there is a serious risk of liver problems when you stop taking emtricitabine/tenofovir disoproxilo, regardless of whether you also have HIV. It is essential not to stop taking emtricitabine/tenofovir disoproxilo without consulting your doctor: see section 3,Do not stop takingemtricitabine/tenofovir disoproxilo.

• If you are over 65 years old, tell your doctor.Emtricitabine/tenofovir disoproxilo has not been studied in patients over 65 years of age.

• Consult your doctor if you are lactose intolerant(see emtricitabine/tenofovir disoproxilo contains lactose later in this section).

Children and adolescents

Emtricitabine/tenofovir disoproxilo should not be administered to children under 12 years of age.

Other medications andEmtricitabina/tenofovir disoproxiloAccordpharma

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

Taking Emtricitabine/tenofovir disoproxilo with other medications that may damage your kidneys:it is especially important to tell your doctor if you are taking any of these medications. This includes:

• 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)
• nonsteroidal anti-inflammatory drugs (NSAIDs, for relieving bone or muscle pain)

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

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

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

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

TakingEmtricitabina/tenofovir disoproxiloAccordpharma with food and drinks

• When possible, emtricitabine/tenofovir disoproxilo should be taken with food.

Pregnancy and breastfeeding

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

If you have been taking emtricitabine/tenofovir disoproxilo during your pregnancy, your doctor may ask you to have periodic blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took ITIs during pregnancy, the benefit of protection against HIV outweighed the risk of side effects.

• Do not breastfeed your child during treatment with emtricitabine/tenofovir disoproxilo.This is because the active ingredients of this medication pass into breast milk.

• It is not recommended that women with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.
• If you are breastfeeding or plan to breastfeed,you should consult with your doctor as soon as possible.

Driving and operating machinery

Emtricitabine/tenofovir disoproxilo may cause dizziness. If you experience dizziness during treatment with emtricitabine/tenofovir disoproxilo,do not driveor operate machinery.

This medication contains lactose

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

This medication contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

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

The recommended dose ofemtricitabina/tenofovir disoproxilofor treating HIV is:

• Adults:one tablet a day. When possible, emtricitabina/tenofovir disoproxilo should be taken with food.
• Adolescents aged 12 to less than 18 years with a weight of at least 35 kg: one tablet a day, when possible with food.

The recommended dose of emtricitabina/tenofovir disoproxilo for reducing the risk of contracting HIV is:

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

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

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

If you are receiving treatment for HIV infection,your doctor will prescribe emtricitabina/tenofovir disoproxilo with other antiretroviral medications. Consult the prospectuses of the other antiretrovirals to know how to take these medications.

If you are taking emtricitabina/tenofovir disoproxilo to reduce the risk of contracting HIV, take emtricitabina/tenofovir disoproxilo every day, not just when you think you have been at risk of contracting HIV.

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

If you take moreEmtricitabina/tenofovir disoproxilo Accordpharma than you should

If you accidentally took more than the recommended dose of emtricitabina/tenofovir disoproxilo, consult your doctor or go to the nearest emergency service. Bring the packaging of the tablets with you so that they can easily describe what you have taken.

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

If you forgot a dose

It is essential not to forget a dose of emtricitabina/tenofovir disoproxilo.

If you realize within 12 hoursfrom the time you take emtricitabina/tenofovir disoproxilo habitually, take the tablet as soon as possible, preferably with food, and then take the next dose at your usual time.

If more than 12 hours have passed sincethe time you take emtricitabina/tenofovir disoproxilo habitually, do not take the missed dose. Wait and take the next dose, preferably with food, at your usual time.

If you vomit within 1 hour after taking emtricitabina/tenofovir disoproxilo,take another tablet. You do not need to take another tablet if you vomited more than an hour after taking emtricitabina/tenofovir disoproxilo.

Do not interrupt treatment withemtricitabina/tenofovir disoproxilo.

If you are taking emtricitabina/tenofovir disoproxilo for HIV treatment,suspending treatment may reduce the effectiveness of the recommended HIV therapy by your doctor.

If you are taking emtricitabina/tenofovir disoproxilo to reduce the risk of contracting HIV,do not stop taking emtricitabina/tenofovir disoproxilo or miss any doses. Stopping treatment with emtricitabina/tenofovir disoproxilo, or missing doses, may increase the risk of contracting HIV infection.

Do not interrupt treatment with this medication without consulting your doctor.

If you have hepatitis B,it is especially important not to suspend your treatment withemtricitabina/tenofovir disoproxilowithout first talking to your doctor. You may need to have blood tests for several months after suspending treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to suspend treatment as this may cause a worsening of your hepatitis, which may be potentially fatal.

Talk to your doctorimmediatelyabout new or unusual symptoms after suspending treatment, particularly symptoms associated with hepatitis B infection.

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

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

Severe possible 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 and rapid breathing
• Drowsiness
• Nausea, vomiting
• Abdominal pain

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

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

• Also, autoimmune disorders may occur, when the immune system attacks healthy body tissue, after starting treatment for HIV infection. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms such as:
• Muscle weakness
• Weakness starting in the hands and feet and ascending to the body trunk
• Palpitations, tremors, or hyperactivity

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

Possible side effects:

Very common side effects(may affect more than 1 in 10 people)

• Diarrhea, vomiting, nausea
• Dizziness, headache

• Rash
• Sensation of weakness

The following may also be shown by analysis:

• Decreased phosphate levels in the blood
• Elevated creatine kinase

Common side effects(may affect up to 1 in 10 people)

• Pain, abdominal pain
• Difficulty sleeping, abnormal dreams
• Digestive problems with discomfort after meals, feeling bloated (gas), flatulence
• Rashes (including red patches or spots 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

Bone lossThe following may also be shown by analysis:

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

Rare side effects(may affect up to 1 in 100 people)

• Abdominal pain caused by pancreatitis inflammation
• Swelling of the face, lips, tongue, or throat
• Anemia (low red blood cell count)
• Muscle rupture, muscle pain, or muscle weakness that may occur in cases of renal tubular cell damage

The following may also be shown by analysis:

• Decreased potassium levels in the blood
• Increased creatinine in the blood
• Changes in urine

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

• Lactic acidosis (see Severe possible side effects)
• Fatty liver
• Yellow skin or eyes, itching, or abdominal pain caused by liver inflammation
• Renal inflammation, increased urine volume, and sensation of thirst, renal failure, renal tubular cell damage
• Weakening of bones (with bone pain and sometimes leading to fractures)
• Back pain due to kidney problems

Renal tubular cell damage may be associated with muscle rupture, bone weakening (with bone pain and sometimes leading to 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 combined antiretroviral medications such as emtricitabine/tenofovir disoproxil may develop a bone disease calledosteonecrosis(bone tissue death caused by loss of blood supply to the bone). Taking this type of medication for a long time, taking corticosteroids, consuming alcohol, having a very weakened immune system, and being overweight may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
• Joint stiffness
• Pain or joint 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 blood glucose and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Other side effects in children

• Children receiving emtricitabine often experience frequent changes in skin color, including dark patches on the skin
• Children often have a low red blood cell count (anemia), which may cause fatigue or shortness of breath.

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

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this prospectus.You can also report them directlythrough the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaRAM.es.

By reporting side effects, you can contribute toproviding more information on the safety of this medicine.

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

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

OPA-Alu-PVC/Alu Blister:Store below 30°C.

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

Composition of Emtricitabina/tenofovir disoproxilo Accordpharma

• The active principles are emtricitabina and tenofovir disoproxilo . Each film-coated tablet contains 200 mg of emtricitabina and 245 mg of tenofovir disoproxilo (equivalent to 300 mg of tenofovir disoproxilo fumarate or 136 mg of tenofovir).

• The other components are:

Tablet core: croscarmelosa sódica, lactosa monohidrato, celulosa microcristalina, estearato de magnesio, almidón pregelatinizado (de maíz).

Film coating of the tablet: hipromelosa, lactosa monohidrato, dióxido de titanio (E171), triacetina, laca de aluminio índigo carmín (E132).

Appearance of the product and content of the container

The film-coated tablets of Emtricitabina/tenofovir disoproxilo Accordpharma are blue tablets, in capsule shape, marked on one face with “H” and on the other with “E44”.

Packs of 30x1 tablets in OPA-Alu-PVC/Alu single-dose perforated blisters.

Only some pack sizes may be marketed.

Holder of the marketing authorization:

Accord Healthcare SLU

World Trade Center,

Moll de Barcelona s/n,

Efici Est 6ª planta

08039 Barcelona

Responsible for manufacturing:

Pharmadox healthcare Ltd

KW20A Kordin Industrial Park, Paola

PLA 3000

Malta

O

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

08040, Barcelona

Spain

Last review date of this leaflet: August 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es