Leaflet: information for the user

Emtricitabine/Tenofovir disoproxil Aurovitas 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do 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 is Emtricitabine/Tenofovir disoproxil Aurovitas and what it is used for

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

3.How to take Emtricitabine/Tenofovir disoproxil Aurovitas

4.Possible side effects

5.Storage of Emtricitabine/Tenofovir disoproxil Aurovitas

6.Contents of the pack and additional information

Emtricitabina/Tenofovir disoproxilo Aurovitas contains two active principles,emtricitabinaytenofovir disoproxilo. Both active principles are antiretroviral drugs used to treat HIV infection. Emtricitabina is anucleoside reverse transcriptase inhibitorand tenofovir is anucleotide reverse transcriptase inhibitor. They are commonly known as ITIAN and act by interfering with the normal functioning of an enzyme (reverse transcriptase) essential for the virus to reproduce.

•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 kg who have already been treated with other HIV medications that are no longer effective or have caused adverse effects.

-Emtricitabina/tenofovir disoproxilo must always be used in combination with other medications to treat HIV infection.

-Emtricitabina/tenofovir disoproxilo can be administered in place of emtricitabina and tenofovir disoproxilo used separately at the same doses.

This medication is not a cure for HIV infection.While you are taking emtricitabina/tenofovir disoproxilo, you may still experience 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 kg when used as a daily treatment, in combination with safer sex practices:

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

Do not take emtricitabine/tenofovir disoproxil to treat HIV or reduce the risk of getting HIV if you are allergicto 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 taking emtricitabine/tenofovir disoproxil to reduce the risk of getting HIV:

Emtricitabine/tenofovir disoproxil can only help reduce the risk of getting HIVbeforeyou are infected.

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

•Many HIV tests may not detect a recent infection.If you get 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 disoproxil or at any time while taking emtricitabine/tenofovir disoproxil.

Warnings and precautions

When taking emtricitabine/tenofovir disoproxil to reduce the risk of getting HIV:

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

•You should have regular HIV detection tests.

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

•Using emtricitabine/tenofovir disoproxil alone may not prevent you from getting 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 razors.

-Do not share or reuse needles or other injections or medications.

-You should have tests for other sexually transmitted infections such as syphilis or gonorrhea. These infections make it easier for you to get HIV.

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

When taking emtricitabine/tenofovir disoproxil to treat HIV or reduce the risk of getting HIV:

•Emtricitabine/tenofovir disoproxil may affect your kidneys.Before and during treatment, your doctor may ask you to have blood tests to measure the function of your kidneys. If you have had kidney disease, or if the tests have shown kidney problems, tell your doctor. Emtricitabine/tenofovir disoproxil 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 disoproxil or, if you already have HIV, to take emtricitabine/tenofovir disoproxil less frequently. Emtricitabine/tenofovir disoproxil is not recommended if you have a 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 that sometimes ends in fractures) may also occur due to renal tubular cell damage (see section 4, Possible side effects).

Tenofovir disoproxil can also cause bone loss. The most pronounced bone loss was observed in clinical studies when patients received HIV treatment 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.

•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 disoproxil. If you have HBV, there is a serious risk of developing liver problems when you stop taking emtricitabine/tenofovir disoproxil, regardless of whether you also have HIV. It is essential not to stop taking emtricitabine/tenofovir disoproxil without consulting your doctor: see section 3, Do not stop taking emtricitabine/tenofovir disoproxil.

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

•Consult your doctor if you are lactose intolerant(see “Emtricitabine/Tenofovir disoproxil Aurovitas contains lactose” later in this section).

Children and adolescents

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

Other medications and Emtricitabine/Tenofovir disoproxil Aurovitas

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

Taking emtricitabine/tenofovir disoproxil with other medications that may harm your kidneys:it is especially important to tell your doctor if you are taking any of these medications, 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).

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

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

You should also inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir for treating hepatitis C infection.

Taking emtricitabine/tenofovir disoproxil with other medications that contain didanosine (for HIV treatment):

Taking emtricitabine/tenofovir disoproxil with other antiviral medications that contain didanosine may increase didanosine levels in your blood and 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.

Taking Emtricitabine/Tenofovir disoproxil Aurovitas with food and drinks

•When possible, emtricitabine/tenofovir disoproxil 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 taken emtricitabine/tenofovir disoproxil during your pregnancy, your doctor may ask you to have periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took ITIs during pregnancy, the benefit of HIV protection outweighed the risk of side effects.

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

•It is not recommended that women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.

•If you are breastfeeding or plan to breastfeed, you shouldconsult your doctor as soon as possible.

Driving and operating machines

Emtricitabine/tenofovir disoproxil may cause dizziness. If you experience dizziness during treatment with emtricitabine/tenofovir disoproxil,do not driveor operate tools or machines.

Emtricitabine/Tenofovir disoproxil Aurovitas contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Emtricitabine/Tenofovir disoproxil Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it 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 of emtricitabine/tenofovir disoproxil for treating HIV is:

•Adults: one tablet per day, preferably with food.

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

The recommended dose of emtricitabine/tenofovir disoproxil for reducing the risk of contracting HIV is:

•Adults: one tablet per day, preferably with food.

•Adolescents aged 12 to less than 18 years with a weight of at least 35 kg: one tablet per 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 (half a glass) of water, orange juice, 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 emtricitabine/tenofovir disoproxil with other antiretroviral medications. Consult the prospectuses of the other antiretrovirals to know how to take these medications.

•If you are taking emtricitabine/tenofovir disoproxil to reduce the risk of contracting HIV, take emtricitabine/tenofovir disoproxil 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 moreEmtricitabine/Tenofovir disoproxil Aurovitasthan you should

If you accidentally took more than the recommended dose of emtricitabine/tenofovir disoproxil, consult your doctor or go to the nearest emergency service. Bring the tablet container 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 forget to takeEmtricitabine/Tenofovir disoproxil Aurovitas

It is essential not to forget a dose of emtricitabine/tenofovir disoproxil.

If you forget a dose:

•If you realize within 12 hourssince the time you normally take emtricitabine/tenofovir disoproxil, 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 passedsince the time you normally take emtricitabine/tenofovir disoproxil, 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 emtricitabine/tenofovir disoproxil,take another tablet. You do not need to take another tablet if you vomited more than an hour after taking emtricitabine/tenofovir disoproxil.

Do not interrupt treatment withEmtricitabine/Tenofovir disoproxil Aurovitas

•If you are taking emtricitabine/tenofovir disoproxil for HIV treatment, stopping treatment may reduce the effectiveness of the recommended HIV therapy by your doctor.

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

?Do not stop taking emtricitabine/tenofovir disoproxil without consulting your doctor.

If you have hepatitis B,it is especially important not to stop your treatment with emtricitabine/tenofovir disoproxil 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, it is not recommended to stop treatment as this may cause a worsening of your hepatitis, which may be potentially fatal.

?Talk to your doctor immediatelyabout new or unusual symptoms after stopping treatment, particularly symptoms associated with hepatitis B infection.

If you have any other questions 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.

Possible serious side effects:

•Lactic acidosis(excess of lactic acid in the blood) is a side effect that is rare but potentially fatal. 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.

-stomach pain.

?If you think you may have lactic acidosis, contact your doctor 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 an improvement in the body's immune response, which allows the body to fight off infections that may be present without any apparent symptoms.

•Autoimmune disordersmay also 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 that starts in the hands and feet and ascends to the trunk of the body.

-palpitations, tremors, or hyperactivity.

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

Possible side effects:

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

•diarrhea, vomiting, nausea.

•dizziness, headache.

•eruption.

•feeling weak.

Lab tests may also show:

•decreased phosphates in the blood.

•increased 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.

•eruptions (including dark spots or red patches on the skin with blisters and swelling).

•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 white blood cell count can 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 1,000 people)

•pancreatitis (inflammation of the pancreas) causing abdominal pain.

•swelling of the face, lips, tongue, or throat.

•anemia (low red blood cell count).

•muscle rupture, muscle pain, or muscle weakness that may occur due to damage to the renal tubular cells.

Lab tests may also show:

•decreased potassium levels in the blood.

•increased creatinine in the blood.

•changes in urine.

Unknown frequency of the following side effects:

•Bone problems.Some patients taking combined antiretroviral medications such as emtricitabine/tenofovir disoproxil may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medication for a long time, taking corticosteroids, consuming alcohol, having a very weakened immune system, and being overweight may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:

-joint stiffness.

-joint pain or discomfort (especially in the hips, knees, and shoulders).

-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 sugar and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of lipid levels, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Other side effects in children:

•Children taking emtricitabine often experience changes in skin color, including:

-dark spots on the skin

•Children often 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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, carton or bottle after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

Composition of Emtricitabina/Tenofovir disoproxilo Aurovitas

• The active ingredients 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).
• The other components are:

Tablet core:microcrystalline cellulose, sodium croscarmellose, mannitol, pregelatinized maize starch, and stearate and sodium fumarate.

Film coating:white color: hypromellose 2910 (6 cps), triacetin, titanium dioxide (E171), and lactose.

Appearance of the product and contents of the package

White or off-white film-coated tablets, capsule-shaped, with the mark “EMT” on one face and smooth on the other. The size is 19.1 × 8.6 mm.

Emtricitabina/Tenofovir disoproxilo Aurovitas tablets are available inblister packs and HDPE bottles.

Packaging sizes:

Blister packs:30, 50, and 90 tablets.

HDPE bottles:30 and 90 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Emtricitabin/Tenofovirdisproxil PUREN 200 mg/245 mg Filmtabletten

Belgium:Emtricitabin/Tenofovir disoproxil AB 200/245 mg filmomhulde tabletten

Spain:Emtricitabina/Tenofovir disoproxilo Aurovitas 200 mg/245 mg comprimidos recubiertos con película EFG

Italy:Emtricitabina e Tenofovir disoproxil Aurobindo

Netherlands:Emtricitabine /Tenofovir disoproxil Aurobindo 200/245 mg, filmomhulde tabletten

Poland:Emtricitabine + Tenofovir disoproxil Aurovitas

Portugal:Emtricitabina + Tenofovir Generis

Last review date of this leaflet:May 2024

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