Emtricitabine + tenofovir disoproxil aurovitas: detailed information

Package leaflet: Information for the patient

Emtricitabine + Tenofovir disoproxil Aurovitas, 200 mg + 245 mg, film-coated tablets
Emtricitabinum + Tenofovirum disoproxilum
Read the entire leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Emtricitabine + Tenofovir disoproxil Aurovitas is and what it is used for
Important information before taking Emtricitabine + Tenofovir disoproxil Aurovitas
How to take Emtricitabine + Tenofovir disoproxil Aurovitas
Possible side effects
How to store Emtricitabine + Tenofovir disoproxil Aurovitas
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 of these active substances are
antiretroviral medicines used in the treatment of HIV infections. Emtricitabine is a nucleoside
reverse transcriptase inhibitor, and tenofovir is a nucleotide reverse transcriptase inhibitor.
However, both substances are generally referred to as NRTIs and work by interfering with the normal function of an enzyme (reverse transcriptase), which is crucial for viral replication.

Emtricitabine + Tenofovir disoproxil Aurovitas is used to treat HIV-1 infection in adults.
It is also used to treat HIV in adolescents aged 12 to under 18 years, weighing at least 35 kg,
who have previously received other anti-HIV medicines that are no longer effective or caused adverse reactions.
- Emtricitabine + Tenofovir disoproxil Aurovitas must always be used in combination with other antiretroviral medicines in the treatment of HIV infection.
- Emtricitabine + Tenofovir disoproxil Aurovitas may be administered instead of separate emtricitabine and tenofovir disoproxil taken at the same doses.

This medicine will not cure HIV infection. While taking Emtricitabine + Tenofovir disoproxil Aurovitas, HIV-related infections or other diseases may still develop.

Emtricitabine + Tenofovir disoproxil Aurovitas is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 to under 18 years weighing at least 35 kg,
when taken daily in combination with safe sex practices:
See section 2 for a list of precautions to take to help protect against HIV infection.

2. Important information before taking Emtricitabine + Tenofovir disoproxil Aurovitas

Aurovitas
Do not take Emtricitabine + Tenofovir disoproxil Aurovitas for the treatment
of HIV infection or to reduce the risk of HIV infection if the patient is allergic to
emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this
medicine (listed in section 6).

The patient concerned should immediately inform the doctor.

Before using Emtricitabine + Tenofovir disoproxil Aurovitas to reduce the risk of HIV infection:
Emtricitabine + Tenofovir disoproxil Aurovitas may only help reduce the risk of
HIV infection before the patient becomes infected.

Before starting Emtricitabine + Tenofovir disoproxil Aurovitas, the patient must be HIV-negative to reduce the risk of HIV infection. The patient must undergo testing to confirm that they are not already infected with HIV. Do not take Emtricitabine + Tenofovir disoproxil Aurovitas to reduce the risk of HIV infection unless it has been confirmed that the patient is HIV-negative. People infected with HIV must take Emtricitabine + Tenofovir disoproxil Aurovitas in combination with other medicines.
Many HIV tests may not detect recent infection. If the patient experiences flu-like symptoms, these may indicate a recent HIV infection. Possible symptoms of HIV infection:
- fatigue
- fever
- joint or muscle pain
- headache
- nausea or diarrhoea
- rash
- night sweats
- swollen lymph nodes in the neck or groin

Inform the doctor about any flu-like illness – either within one month before
starting Emtricitabine + Tenofovir disoproxil Aurovitas, or at any time during
treatment with Emtricitabine + Tenofovir disoproxil Aurovitas.
Warnings and precautions
While taking Emtricitabine + Tenofovir disoproxil Aurovitas to reduce the risk of HIV infection:

Emtricitabine + Tenofovir disoproxil Aurovitas should be taken every day, to reduce the risk, not only when the patient believes they may have been exposed to HIV. Do not skip any dose of Emtricitabine + Tenofovir disoproxil Aurovitas
or interrupt treatment. Skipping doses may increase the risk of HIV infection.
Regularly perform HIV tests.
If the patient suspects they have been infected with HIV, they should immediately inform their doctor. The doctor may recommend further testing to rule out HIV infection.
Taking Emtricitabine + Tenofovir disoproxil Aurovitas may not prevent HIV infection.
- Always follow safe sex practices. Use condoms to reduce contact with semen, vaginal fluid, or blood.
- Do not share personal items that may have blood or body fluids on them, such as toothbrushes and razors.
- Do not share or reuse needles or other injecting or medication administration equipment.
- Perform regular testing for sexually transmitted infections, such as syphilis and gonorrhoea. Such infections can make it easier to become infected with HIV.

Contact the doctor for further questions about methods of preventing
HIV infection or transmitting HIV to other people.
Taking Emtricitabine + Tenofovir disoproxil Aurovitas for the treatment of HIV infection or to reduce the risk of HIV infection:

Emtricitabine + Tenofovir disoproxil Aurovitas may harm the kidneys. Before starting and during treatment, the doctor may order blood tests to assess kidney function. Inform the doctor if there is a history of kidney disease or if tests indicate kidney problems. Emtricitabine + Tenofovir disoproxil Aurovitas should not be given to adolescents with kidney disease. In case of kidney disease, the doctor may recommend discontinuing Emtricitabine + Tenofovir disoproxil Aurovitas or, if the patient is infected with HIV, taking Emtricitabine + Tenofovir disoproxil Aurovitas less frequently. Emtricitabine + Tenofovir disoproxil Aurovitas is not recommended if the patient has severe kidney disease or is undergoing dialysis.
If the patient has osteoporosis, a history of bone fractures, or bone problems, inform the doctor.
Bone disorders (manifesting as persistent or worsening bone pain), sometimes leading to fractures, may also occur due to damage to renal tubular cells (see section 4, Possible side effects). Inform the doctor about bone pain or fractures.

Tenofovir disoproxil may also cause loss of bone mineral density. The most pronounced
bone loss was observed in clinical trials when patients were treated for HIV with
tenofovir disoproxil in combination with a boosted protease inhibitor.
Overall, the long-term impact of tenofovir disoproxil on bone health and future fracture risk in adult patients, as well as in children and adolescents, is uncertain.

Patients with a history of liver disease, including hepatitis, should consult their doctor. HIV-infected patients with concurrent liver disease (including chronic viral hepatitis B or C) who are taking antiretroviral medicines are at increased risk of severe and potentially fatal liver-related adverse reactions. For patients with hepatitis B or C, the doctor will determine the most appropriate treatment regimen.
The hepatitis B virus (HBV) infection status should be known before starting Emtricitabine + Tenofovir disoproxil Aurovitas. If the patient has HBV, there is a significant risk of liver disease occurring after stopping Emtricitabine + Tenofovir disoproxil Aurovitas, regardless of whether the patient is infected with HIV. It is important not to discontinue Emtricitabine + Tenofovir disoproxil Aurovitas without consulting a doctor: see section 3, Do not stop taking Emtricitabine + Tenofovir disoproxil Aurovitas.
Patients over 65 years of age should consult their doctor. Studies on the use of Emtricitabine + Tenofovir disoproxil Aurovitas in patients over 65 years of age have not been conducted.
Patients with lactose intolerance should inform their doctor (further information in the leaflet indicates that Emtricitabine + Tenofovir disoproxil Aurovitas contains lactose).

Children and adolescents
Emtricitabine + Tenofovir disoproxil Aurovitas is not intended for use in children under 12 years of age.
Emtricitabine + Tenofovir disoproxil Aurovitas and other medicines
Do not take Emtricitabine + Tenofovir disoproxil Aurovitas if you are already taking other medicines containing the components of Emtricitabine + Tenofovir disoproxil Aurovitas (emtricitabine and tenofovir disoproxil) or any other antiviral medicines containing tenofovir alafenamide, lamivudine, or adefovir dipivoxil.
Taking Emtricitabine + Tenofovir disoproxil Aurovitas with other medicines that may harm the kidneys: it is particularly important to inform the doctor if taking medicines such as:

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

If taking another antiviral medicine called a protease inhibitor used in HIV treatment, the doctor may recommend blood tests to closely monitor kidney function.
Also inform the doctor if taking ledipasvir with sofosbuvir, sofosbuvir with velpatasvir, or sofosbuvir with velpatasvir and voxilaprevir, used in the treatment of hepatitis C virus infection.
Taking Emtricitabine + Tenofovir disoproxil Aurovitas with other medicines containing didanosine (used in the treatment of HIV infection): concomitant use of Emtricitabine + Tenofovir disoproxil Aurovitas and other antiviral medicines containing didanosine may increase didanosine blood levels and may also reduce CD4 cell count. Rarely, pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes leading to death, have been observed with concomitant use of tenofovir disoproxil and didanosine-containing medicines. The treating doctor will carefully consider whether tenofovir can be used together with didanosine.
Inform the doctor if taking any of these medicines. Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking Emtricitabine + Tenofovir disoproxil Aurovitas with food and drink
If possible, Emtricitabine + Tenofovir disoproxil Aurovitas should be taken with food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
If the patient took Emtricitabine + Tenofovir disoproxil Aurovitas during pregnancy, the doctor may recommend regular blood tests and other diagnostic tests to monitor the child's development. In children whose mothers took NRTIs during pregnancy, the benefit of reduced risk of HIV transmission outweighs the risk of adverse effects.

While taking Emtricitabine + Tenofovir disoproxil Aurovitas, do not breastfeed, as the active substances of this medicine pass into human milk.
Breastfeeding is not recommended for women infected with HIV, as HIV can be transmitted to the child through breast milk.
If the patient is breastfeeding or considering breastfeeding, she should consult a doctor as soon as possible.

Driving and operating machinery
Emtricitabine + Tenofovir disoproxil Aurovitas may cause dizziness. If dizziness occurs while taking Emtricitabine + Tenofovir disoproxil Aurovitas, do not drive, do not use any tools, or operate any machinery.
Emtricitabine + Tenofovir disoproxil Aurovitas contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
Emtricitabine + Tenofovir disoproxil Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Emtricitabine + Tenofovir disoproxil Aurovitas

This medicine should always be taken exactly as prescribed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
The recommended dose of Emtricitabine + Tenofovir disoproxil Aurovitas for the treatment of
HIV infection is:

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

The recommended dose of Emtricitabine + Tenofovir disoproxil Aurovitas for reducing the
risk of HIV infection is:

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

If you have difficulty swallowing, the tablet may be crushed with the back of a spoon. The
resulting powder should then be mixed with approximately 100 ml (half a glass) of water,
orange juice, or grape juice and taken immediately.

Always take the dose prescribed by your doctor. This is essential to ensure full effectiveness of the medicine and to reduce the risk of developing resistance to the drug. Do not change the dose unless instructed by your doctor.
When treating HIV infection, your doctor will prescribe Emtricitabine + Tenofovir disoproxil Aurovitas to be used in combination with other antiretroviral medicines. Please read the patient information leaflets of the respective antiretroviral medicines to learn about their proper use.
When taking Emtricitabine + Tenofovir disoproxil Aurovitas to reduce the risk of HIV infection, the medicine must be taken daily, not only on days when the patient believes they may have been exposed to HIV.

Contact your doctor if you have further questions about methods of preventing HIV infection or preventing transmission of HIV to others.
Taking more than the recommended dose of Emtricitabine + Tenofovir disoproxil Aurovitas
If you accidentally take more Emtricitabine + Tenofovir disoproxil Aurovitas than prescribed, contact your doctor or the nearest hospital emergency department for advice. Bring the medicine packaging with you so that the healthcare professionals can see which medicine you have taken.
Missed dose
It is important not to miss any dose of Emtricitabine + Tenofovir disoproxil Aurovitas.

If you realize within 12 hours of the usual time for taking Emtricitabine + Tenofovir disoproxil Aurovitas, take the tablet as soon as possible, preferably with food. Take the next dose at the usual time.
If you realize more than 12 hours after the usual time for taking Emtricitabine + Tenofovir disoproxil Aurovitas, do not take the missed dose. Wait and take the next dose at the usual time, preferably with food.

If vomiting occurs within 1 hour after taking Emtricitabine + Tenofovir disoproxil
Aurovitas, take another tablet. There is no need to take another tablet if vomiting occurs more than 1 hour after taking the medicine.
Do not stop taking Emtricitabine + Tenofovir disoproxil Aurovitas

When taking Emtricitabine + Tenofovir disoproxil Aurovitas for the treatment of HIV infection, stopping the tablets may reduce the effectiveness of the HIV treatment prescribed by your doctor.
If you are taking Emtricitabine + Tenofovir disoproxil Aurovitas to

reduce the risk of HIV infection, do not stop taking Emtricitabine + Tenofovir disoproxil Aurovitas and do not miss any doses. Stopping or missing doses of Emtricitabine + Tenofovir disoproxil Aurovitas may increase the risk of acquiring HIV infection.
Do not stop taking Emtricitabine + Tenofovir disoproxil Aurovitas without consulting your doctor.
It is especially important that patients with hepatitis B virus infection do not stop taking
Emtricitabine + Tenofovir disoproxil Aurovitas without first consulting their doctor. Blood tests may be required for several months after stopping the medicine. In some patients with advanced liver disease or cirrhosis, stopping the medicine is not recommended, as it may lead to a worsening of hepatitis B, which could be life-threatening.
Contact your doctor immediately if you experience any new or unusual symptoms after stopping treatment, particularly symptoms typically associated with hepatitis B virus infection.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
Possible serious adverse reactions:

Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening adverse reaction. Lactic acidosis occurs more frequently in women, especially those who are overweight, and in people with liver disease. Symptoms which may indicate lactic acidosis include:
- deep, rapid breathing;
- drowsiness;
- nausea, vomiting;
- abdominal pain.

If the patient suspects that lactic acidosis has occurred, they should seek
immediate medical help.

Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections occurring in people with weakened immune systems), symptoms and signs of inflammatory conditions related to previous infections may appear shortly after starting treatment for HIV infection. These symptoms are believed to be due to improved immune response, enabling the body to fight infections that may have been present but asymptomatic.
Autoimmune disorders, in which the immune system attacks healthy body tissues, may also occur after starting treatment with medicines used for HIV infection. Autoimmune disorders may occur many months after starting treatment. The patient should monitor their health for any signs of infection or other symptoms such as:
- muscle weakness;
weakness starting in the hands and feet and progressing upward through the body;
palpitations, tremor, or hyperactivity.

If these or any other signs of inflammatory or infectious conditions occur,
immediate medical help should be sought.
Possible adverse reactions:
Very common adverse reactions (may affect more than 1 in 10 people)

diarrhoea, vomiting, nausea;
dizziness, headache;
rash;
feeling of weakness.

Tests may also show:

decreased blood phosphate levels;
increased creatine kinase activity.

Common adverse reactions (may affect up to 1 in 10 people)

pain, abdominal pain;
difficulty sleeping, unusual dreams;
digestive problems leading to discomfort after meals, bloating, flatulence;
rashes (including red spots or patches, sometimes with blistering and skin swelling), which may be allergic reactions, itching, skin discoloration, including dark spots on the skin;
other allergic reactions such as wheezing, swelling, or feeling of emptiness in the head;
loss of bone mass.

Tests may also show:

decreased white blood cell count (reduced white blood cell count may increase susceptibility to infections);
increased levels of triglycerides (fatty acids), bile, or blood sugar;
impaired liver and pancreas function.

Uncommon adverse reactions (may affect up to 1 in 100 people)

abdominal pain caused by pancreatitis;
facial, lip, tongue or throat swelling;
anaemia (reduced number of red blood cells);
muscle cell breakdown, muscle pain or muscle weakness, which may occur due to damage to renal tubular cells.

Tests may also show:

decreased blood potassium levels;
increased blood creatinine levels;
changes in urine test results.

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

lactic acidosis (see Possible serious adverse reactions);
fatty liver;
yellowing of the skin or eyes, itching or abdominal pain caused by hepatitis;
kidney inflammation, excessive urination and thirst, kidney failure, damage to renal tubular cells;
softening of bones (manifested by bone pain and sometimes leading to fractures);
back pain caused by kidney dysfunction.

Damage to renal tubular cells may lead to muscle cell breakdown, softening
of bones (manifested by bone pain and sometimes leading to fractures), muscle pain, muscle
weakness, and decreased blood potassium or phosphate levels.
If any of the adverse reactions listed above occur, or if any of these
reactions worsen, the patient should inform their doctor or pharmacist.
The frequency of the following adverse reactions is unknown.

Bone disorders. In some patients taking combination antiretroviral medicines such as emtricitabine with tenofovir disoproxil, a bone disease called avascular necrosis (death of bone tissue due to lack of blood supply to the bone) may develop. Long-term use of such medicines, corticosteroid use, alcohol consumption, weakened immune system, and being overweight may be among the many risk factors for this condition. Symptoms of avascular necrosis include:
- joint stiffness;
- joint pain (especially in the hip, knee, or shoulder);
- difficulty moving.

The patient should contact their doctor if any of these symptoms occur.
During HIV treatment, increases in body weight and blood lipid and glucose levels may occur. This is partly related to improved health and lifestyle, and in the case of blood lipid levels, sometimes to the use of HIV medicines themselves. The doctor will order tests to detect these changes.
Other reactions in children

Skin pigmentation changes occurred very commonly in children receiving emtricitabine,
- including dark spots on the skin.
Anaemia (low red blood cell count) occurred commonly in children,
- which may cause fatigue or shortness of breath in the child.

If any of these symptoms occur, the patient should contact their doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store 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 label, carton, and bottle
after: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the pack and other information

What Emtricitabine + Tenofovir disoproxil Aurovitas contains
The active substances are emtricitabine and tenofovir disoproxil.
The other ingredients are:
Tablet core: microcrystalline cellulose, sodium croscarmellose, mannitol, pregelatinized starch,
corn starch, sodium stearyl fumarate.
Tablet coating – White colour: hypromellose 2910 (6 cPs), triacetin, titanium dioxide (E 171),
lactose.

What Emtricitabine + Tenofovir disoproxil Aurovitas looks like and contents of the pack
Film-coated tablet.
White or almost white, capsule-shaped film-coated tablets, embossed with "EMT" on one side and smooth on the other. Size: 19.1 x 8.6 mm.
Emtricitabine + Tenofovir disoproxil Aurovitas tablets are packed in blisters or HDPE containers, placed in cardboard boxes.
Pack sizes:
Blisters: 30, 50 and 90 film-coated tablets.
HDPE containers: 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area under the following names:
Belgium: Emtricitabin/Tenofovir disoproxil AB 200/245 mg filmomhulde tabletten
Germany: Emtricitabin/Tenofovirdisoproxil PUREN 200 mg/245 mg Filmtabletten
Italy: Emtricitabina e Tenofovir disoproxil Aurobindo
Netherlands: Emtricitabine/Tenofovir disoproxil Aurobindo 200 mg/245 mg, filmomhulde tabletten
Poland: Emtricitabine + Tenofovir disoproxil Aurovitas
Portugal: Emtricitabina + Tenofovir Generis
Spain: Emtricitabina/Tenofovir disoproxilo Aurovitas 200 mg/245 mg comprimidos recubiertos con película EFG