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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Emtricitabine/Tenofovir disoproxil Aurovitas 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. 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 pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Emtricitabine/Tenofovir disoproxil Aurovitas is and what it is used for

Emtricitabine/Tenofovir disoproxil Aurovitas 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.

• Emtricitabine/tenofovir disoproxil 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 weighing at least 35 kg who have previously been treated with other HIV medicines that are no longer effective or have caused adverse effects.
  • Emtricitabine/tenofovir disoproxil should always be used in combination with other medicines to treat HIV infection.
  • Emtricitabine/tenofovir disoproxil may be administered instead of emtricitabine and tenofovir disoproxil given separately at the same doses.

This medicine is not a cure for HIV infection. While you are taking emtricitabine/tenofovir disoproxil, you may still develop infections or other illnesses associated with HIV infection.

• Emtricitabine/tenofovir disoproxil is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 to less than 18 years weighing at least 35 kg, when used as a daily treatment, in combination with safer sexual practices:

See section 2 for a list of precautions to consider for protection against HIV infection.

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

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

?If any of the following occurs, contact 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 HIV before you become infected.

• You must not be infected with HIV before starting emtricitabine/tenofovir disoproxil to reduce the risk of acquiring HIV. You must be tested to ensure you are not infected with HIV. Do not take emtricitabine/tenofovir disoproxil for risk reduction 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 flu-like illness, it could mean you have recently become infected with HIV.

These may be signs of HIV infection:

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

?Inform your doctor about any flu-like illness, whether occurring in the month prior to 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 day to reduce your risk, not only when you think you have been exposed to HIV infection. Do not miss any doses of emtricitabine/tenofovir disoproxil or stop taking it. Missed doses may increase the risk of acquiring HIV infection.
• You should undergo regular HIV testing.
• If you think you have become infected with HIV, consult your doctor immediately. Additional tests may be needed to confirm you remain uninfected with HIV.
• Using emtricitabine/tenofovir disoproxil alone may not prevent you from getting HIV.
  • Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
  • Do not share personal items that may contain blood or body fluids, such as toothbrushes and razors.
  • Do not share or reuse needles or other injecting equipment.
  • You should be tested for other sexually transmitted infections such as syphilis or gonorrhea. These infections make it easier for you to acquire HIV.

Consult your doctor if you have further questions about preventing HIV infection or transmission to others.

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

• Emtricitabine/tenofovir disoproxil may affect your kidneys. Before and during treatment, your doctor may request blood tests to monitor your kidney function. If you have had kidney disease, or if blood tests have shown kidney problems, inform your doctor. Emtricitabine/tenofovir disoproxil should not be given 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 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, sometimes leading to fractures) may also occur due to damage to renal tubule 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 received tenofovir disoproxil in combination with a boosted protease inhibitor for HIV treatment.

Overall, the long-term effects of tenofovir disoproxil on bone health and future fracture risk 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) treated with antiretrovirals have an increased risk of serious and potentially fatal liver complications. If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.

• Know your hepatitis B virus (HBV) status before starting emtricitabine/tenofovir disoproxil. If you have HBV, there is a serious risk of liver problems when you stop taking emtricitabine/tenofovir disoproxil, regardless of whether you also have HIV. It is important 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, inform 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 given to children under 12 years of age.

Other medicines and Emtricitabine/Tenofovir disoproxil Aurovitas

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

Taking emtricitabine/tenofovir disoproxil with other medicines that may harm your kidneys: it is especially important that you tell your doctor if you are taking any of the following medicines, including:

• aminoglycosides (for bacterial infection).
• amphotericin B (for fungal infection).
• foscarnet (for viral infection).
• ganciclovir (for viral infection).
• pentamidine (for infections).
• vancomycin (for bacterial infection).
• interleukin-2 (for cancer treatment).
• cidofovir (for viral infection).
• non-steroidal anti-inflammatory drugs (NSAIDs, for relief of bone or muscle pain).

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

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

Taking emtricitabine/tenofovir disoproxil with other medicines containing didanosine (for treatment of HIV infection):

Taking emtricitabine/tenofovir disoproxil with other antiviral medicines containing didanosine may increase levels of didanosine in your blood and may reduce 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), including fatal cases, have been reported. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

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

Taking Emtricitabine/Tenofovir disoproxil Aurovitas with food and drink

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

Pregnancy and breastfeeding

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

If you have taken emtricitabine/tenofovir 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 in 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 should consult your doctor as soon as possible.

Driving and use of machines

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

Emtricitabine/Tenofovir disoproxil Aurovitas contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Emtricitabine/Tenofovir disoproxil Aurovitas contains sodium

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

3. How to take Emtricitabine/Tenofovir disoproxil Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose of emtricitabine/tenofovir disoproxil for treating HIV is:

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

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

• Adults: one tablet daily, preferably with food.
• Adolescents aged 12 to less than 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 (half a glass) of water, orange juice, or grape juice, and drink immediately.

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

• If you are being treated for HIV infection, your doctor will prescribe emtricitabine/tenofovir disoproxil 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 taking emtricitabine/tenofovir disoproxil to reduce the risk of acquiring HIV, take emtricitabine/tenofovir disoproxil every day, not only when you think you may have been exposed to HIV infection.

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

If you take more Emtricitabine/Tenofovir disoproxil Aurovitas than you should

If you have accidentally taken more than the recommended dose of emtricitabine/tenofovir disoproxil, consult 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 the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Emtricitabine/Tenofovir disoproxil Aurovitas

It is important not to miss a dose of emtricitabine/tenofovir disoproxil.

If you miss a dose:

• If you remember within 12 hours of your usual dosing time, 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 since your usual dosing time, 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, take another tablet. You do not need to take another tablet if you vomited more than 1 hour after taking emtricitabine/tenofovir disoproxil.

Do not stop treatment with Emtricitabine/Tenofovir disoproxil Aurovitas

• If you are taking emtricitabine/tenofovir disoproxil for the treatment of HIV infection, stopping treatment may reduce the effectiveness of the HIV therapy recommended by your doctor.
• If you are taking emtricitabine/tenofovir disoproxil to reduce the risk of acquiring HIV, do not stop taking emtricitabine/tenofovir disoproxil or miss any doses. Stopping treatment or missing doses may increase your risk of acquiring 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 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, 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 experiences them.

Possible serious adverse effects:

• Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening adverse effect. Lactic acidosis occurs more frequently in women, especially those who are overweight, and in people with liver disease. The following may be signs of lactic acidosis:
  • deep, rapid breathing.
  • drowsiness.
  • nausea, vomiting.
  • stomach pain.

?If you think you may have lactic acidosis, 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 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 any apparent symptoms.

• Autoimmune disorders may also occur after starting medications to treat HIV infection, when the immune system attacks healthy body tissue. Autoimmune disorders can occur many months after starting treatment. Be alert 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, tremors, 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, feeling sick (nausea).
• dizziness, headache.
• rash.
• feeling of weakness.

Blood tests may also show:

• decreased phosphate levels in the 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 (stomach) pain caused by inflammation of the pancreas.
• swelling of the face, lips, tongue, or throat.
• anemia (low red blood cell count).
• 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 (stomach) pain caused by liver inflammation.
• kidney inflammation, increased urine volume and feeling thirsty, 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 to 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 may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Long-term use of these types of medicines, corticosteroid use, 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 to your doctor.

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

Other adverse effects in children

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

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

Reporting of adverse effects

If you experience any type of 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 Aurovitas

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

Do not use this medicine after the expiry date stated on the blister, packaging, or bottle after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Emtricitabine/Tenofovir Disoproxil Aurovitas

• The active substances are emtricitabine and tenofovir disoproxil. Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate).
• The other components are:

Tablet core: microcrystalline cellulose, sodium croscarmellose, mannitol, pregelatinized corn starch, and stearic acid and sodium fumarate.

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

Appearance of the product and contents of the pack

White or almost white, capsule-shaped film-coated tablets, marked with "EMT" on one side and smooth on the other. Size: 19.1 × 8.6 mm.

Emtricitabine/Tenofovir Disoproxil Aurovitas tablets are available in blister packs and HDPE bottles.

Pack sizes:

Blister packs: 30, 50, and 90 tablets.

HDPE bottles: 30 and 90 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 medicinal product is authorized in the European Economic Area member states under 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

Date of the most recent review of this leaflet: May 2024

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