Emtricitabine + Tenofovir disoproxil Aurovitas

Leaflet attached to the packaging: patient information

Emtricitabine + Tenofovir disoproxil Aurovitas, 200 mg + 245 mg, film-coated tablets

Emtricitabine + Tenofovir disoproxil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Emtricitabine + Tenofovir disoproxil Aurovitas and what is it used for
• 2. Important information 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 packaging and other information

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

used for

Emtricitabine + Tenofovir disoproxil Aurovitas contains two active substances:

emtricitabineand tenofovir disoproxil. Both of these active substances are antiretroviral
medicinesused to treat HIV infections. Emtricitabine is a nucleoside
reverse transcriptase inhibitor, and tenofovir is a nucleotide
reverse transcriptase inhibitor, but both substances are generally referred to as NRTI and work by
interfering with the normal functioning of an enzyme (reverse transcriptase) that is essential for the
replication of the virus.

• Emtricitabine + Tenofovir disoproxil Aurovitas is used to treat adults infected with human immunodeficiency virus type 1 (HIV-1).
• It is also used to treat HIV in adolescents aged 12 to less than 18 years, with a body weight of at least 35 kg,who have already taken other HIV medicines that are no longer effective or have caused side effects.
• In the treatment of HIV infection, Emtricitabine + Tenofovir disoproxil Aurovitas should always be used in combination with other medicines.
• Emtricitabine + Tenofovir disoproxil Aurovitas can be given instead of emtricitabine and tenofovir disoproxil taken separately at the same doses.

This medicine will not cure HIV infection.While taking Emtricitabine + Tenofovir disoproxil
Aurovitas, you may still develop infections or other illnesses related to your HIV infection.

• -Emtricitabine + Tenofovir disoproxil Aurovitas is also used to reduce the risk of HIV-1 infection in adults and adolescents aged 12 to less than 18 years, with a body weight of at least 35 kg, if taken daily, in addition to practicing safe sex:
  See section 2, which lists precautions to take to protect yourself from HIV infection.

Take Emtricitabine + Tenofovir disoproxil Aurovitas every day, as prescribed by your doctor, to reduce the risk of HIV infection.If you think you have been exposed to HIV,
tell your doctor immediately. Your doctor may recommend additional tests to rule out HIV infection.

2. Important information before taking Emtricitabine + Tenofovir disoproxil Aurovitas

Aurovitas

Do not take Emtricitabine + Tenofovir disoproxil Aurovitas to treat or reduce the risk of HIV infection if you are allergic to

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

• -If this applies to you, tell your doctor immediately.

Before taking Emtricitabine + Tenofovir disoproxil Aurovitas to reduce the risk of HIV infection:

Emtricitabine + Tenofovir disoproxil Aurovitas can only help reduce the risk of HIV infection beforeyou become infected.

• -Before starting Emtricitabine + Tenofovir disoproxil Aurovitas, you must be HIV-negative to reduce the risk of HIV infection.You must have tests to confirm that you are not already infected with HIV. Do not take Emtricitabine + Tenofovir disoproxil Aurovitas to reduce the risk of HIV infection if you have not confirmed that you are 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 you have flu-like symptoms, they may be a sign of recent HIV infection. Possible symptoms of HIV infection:
• fatigue
• fever
• joint or muscle pain
• headache
• nausea or vomiting
• rash
• night sweats
• enlarged lymph nodes in the neck or armpit

Tell your doctor about any flu-like illness- either in the month before starting Emtricitabine + Tenofovir disoproxil Aurovitas or at any time while taking 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, and not just when you think you have been exposed to HIV.Do not miss any dose of Emtricitabine + Tenofovir disoproxil Aurovitas or stop taking it. If you miss a dose, the risk of HIV infection may be higher.

Regularly have HIV tests.

• If you think you have been infected with HIV, tell your doctor immediately. Your doctor may recommend additional tests to rule out HIV infection.
• -Taking Emtricitabine + Tenofovir disoproxil Aurovitas may not prevent HIV infection.
• Always practice safe sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
• Do not share personal items that may have blood or bodily fluids on them, such as toothbrushes and razors.
• Do not share or reuse needles or equipment for injecting or administering medicines.
• Have tests for sexually transmitted infections, such as syphilis and gonorrhea. These infections can increase the risk of HIV infection.

Tell your doctor if you have any further questions about methods to prevent HIV infection or prevent passing HIV infection to others.

While taking Emtricitabine + Tenofovir disoproxil Aurovitas to treat HIV infection or reduce the risk of HIV infection:

• Emtricitabine + Tenofovir disoproxil Aurovitas may harm your kidneys.Before and during treatment, your doctor may order blood tests to assess your kidney function. Tell your doctor if you have had kidney problems or if your tests show kidney problems. Emtricitabine + Tenofovir disoproxil Aurovitas should not be given to adolescents with kidney problems. If you have kidney problems, your doctor may recommend stopping Emtricitabine + Tenofovir disoproxil Aurovitas or taking it less often. It is not recommended to take Emtricitabine + Tenofovir disoproxil Aurovitas if you have severe kidney problems or are on dialysis.
• If you have osteoporosis, have had bone fractures, or have bone problems, tell your doctor.
• Bone problems(persistent or worsening bone pain) that can lead to fractures may also occur due to kidney damage (see section 4, Possible side effects). Tell your doctor about bone pain or fractures.

Tenofovir disoproxil can also cause bone loss. The most significant bone loss was observed in clinical trials when patients were treated for HIV with tenofovir disoproxil in combination with a boosted protease inhibitor.
The long-term effect of tenofovir disoproxil on bone health and future fracture risk in adults and in children and adolescents is not known.

• Patient with a history of liver disease, including hepatitis, should consult their doctor.Patients with HIV and liver disease (including chronic viral hepatitis B or C) taking antiretroviral medicines are at a higher risk of severe and potentially life-threatening side effects from the liver. For patients with hepatitis B or C, the doctor will determine the most suitable treatment regimen.
• Know your hepatitis B virus (HBV) status before taking Emtricitabine + Tenofovir disoproxil Aurovitas.If you have HBV, there is a high risk of liver disease after stopping Emtricitabine + Tenofovir disoproxil Aurovitas, regardless of whether you are HIV-infected. It is essential not to stop taking Emtricitabine + Tenofovir disoproxil Aurovitas without consulting your doctor: see section 3, Do not stop taking Emtricitabine + Tenofovir disoproxil Aurovitas.
• Patient over 65 years of age should consult their doctor.There have been no studies on the use of Emtricitabine + Tenofovir disoproxil Aurovitas in patients over 65 years of age.
• Patient with lactose intolerance should inform their doctor(see also section 6, which states 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 Aurovitasif you are already taking other medicines that contain the active ingredients of Emtricitabine + Tenofovir disoproxil Aurovitas (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Taking Emtricitabine + Tenofovir disoproxil Aurovitas with other medicines that

can harm your kidneys: it is particularly important to tell your doctor if you are 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, to reduce bone or muscle pain).

If you are taking another antiviral medicine called a protease inhibitor used to treat HIV, your doctor may recommend blood tests to closely monitor your kidney function.
Also, tell your doctorif you are taking ledipasvir with sofosbuvir, sofosbuvir with velpatasvir, or sofosbuvir with velpatasvir and voxilaprevir used to treat hepatitis C virus infection.

Taking Emtricitabine + Tenofovir disoproxil Aurovitas with other medicines

containing didanosine (used to treat HIV):taking Emtricitabine + Tenofovir disoproxil Aurovitas and other antiviral medicines that contain didanosine at the same time may increase the level of didanosine in your blood and may also decrease the number of CD4 cells. Rarely, pancreatitis and lactic acidosis (excessive lactic acid in the blood) have been reported when tenofovir disoproxil and didanosine were taken together, sometimes leading to death. Your doctor will carefully consider whether you can take tenofovir with didanosine.
Tell your doctorif you are taking any of these medicines. Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.

Taking Emtricitabine + Tenofovir disoproxil Aurovitas with food and drink

Where possible, take Emtricitabine + Tenofovir disoproxil Aurovitas with
food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you have taken Emtricitabine + Tenofovir disoproxil Aurovitas during pregnancy, your doctor may recommend regular blood tests and other diagnostic tests to monitor the development of your baby. In children whose mothers took NRTI during pregnancy, the benefit of reducing the risk of HIV infection outweighs the risk of side effects.

• -Do not breastfeed while taking Emtricitabine + Tenofovir disoproxil Aurovitas,as the active substances of this medicine pass into human milk.
• Women with HIV should not breastfeed their babies to avoid passing on the virus through breast milk.
• If you are breastfeeding or thinking of breastfeeding, consult your doctor as soon as possible.

Driving and using machines

Emtricitabine + Tenofovir disoproxil Aurovitas may cause dizziness. If you experience dizziness while taking Emtricitabine + Tenofovir disoproxil Aurovitas, do not drive,
do not use tools or operate machinery.

Emtricitabine + Tenofovir disoproxil Aurovitas contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Emtricitabine + Tenofovir disoproxil Aurovitas contains sodium

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

3. How to take Emtricitabine + Tenofovir disoproxil Aurovitas

Always take this medicine exactly as your doctor has told you.If you are not sure, ask your doctor or pharmacist.

Recommended dose of Emtricitabine + Tenofovir disoproxil Aurovitas for the treatment of HIV infection is:

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

Recommended dose of Emtricitabine + Tenofovir disoproxil Aurovitas to reduce the risk of HIV infection is:

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

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

• Always take the dose recommended by your doctor.This will help ensure the full effectiveness of the medicine and reduce the development of resistance to the medicine. Do not change the dose of the medicine unless your doctor recommends it.
• For the treatment of HIV infection, your doctor will prescribe Emtricitabine + Tenofovir disoproxil Aurovitas to be taken with other antiretroviral medicines. Read the patient information leaflets for the other antiretroviral medicines to learn how to take them.
• For reducing the risk of HIV infection, take Emtricitabine + Tenofovir disoproxil Aurovitas every day, and not just when you think you have been exposed to HIV.

Tell your doctor if you have any further questions about methods to prevent HIV infection or prevent passing HIV infection to others.

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

If you have taken more Emtricitabine + Tenofovir disoproxil Aurovitas than you should, contact your doctor or the nearest hospital emergency department for advice. Bring the package leaflet and any remaining tablets with you.

Missed dose

It is important not to miss any dose of Emtricitabine + Tenofovir disoproxil Aurovitas.

• If you realize within 12 hoursof the normal time you take 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 after at least 12 hoursof the normal time you take Emtricitabine + Tenofovir disoproxil Aurovitas, do not take the missed dose. Wait and take the next dose at the usual time, preferably with food.

If you vomit within 1 hour of taking Emtricitabine + Tenofovir disoproxil Aurovitas

take another tablet.You do not need to take another tablet if you vomit more than 1 hour after taking the medicine.

Do not stop taking Emtricitabine + Tenofovir disoproxil Aurovitas

• For the treatment of HIV infection, stopping Emtricitabine + Tenofovir disoproxil Aurovitas may reduce the effectiveness of your HIV treatment as recommended 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 or miss any dose. Stopping Emtricitabine + Tenofovir disoproxil Aurovitas or missing doses may increase the risk of HIV infection.

Do not stop taking Emtricitabine + Tenofovir disoproxil Aurovitas without consulting your doctor.

It is particularly important that patients with hepatitis B do not stop taking Emtricitabine + Tenofovir disoproxil Aurovitas without consulting their doctor.For several months after stopping treatment, it may be necessary to have blood tests. In some patients with advanced liver disease or cirrhosis, it is not recommended to stop taking Emtricitabine + Tenofovir disoproxil Aurovitas, as this may lead to a life-threatening flare-up of hepatitis.
Tell your doctor immediatelyabout any new or unusual symptoms you notice after stopping treatment, especially those that are typically associated with hepatitis B.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible serious side effects:

• Lactic acidosis(excessive lactic acid in the blood) is a rare but potentially life-threatening side effect. Lactic acidosis occurs more often in women, especially if they are overweight, and in people with liver disease. Symptoms that may be signs of lactic acidosis are:
• deep, rapid breathing;
• drowsiness;
• nausea, vomiting;
• abdominal pain.

If you think you have lactic acidosis, seek medical help immediately.

• Any sign of inflammation or infection.In some patients with advanced HIV disease (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 occur when HIV treatment is started. It is believed that these symptoms are due to the improvement in the body's immune response, enabling it to fight infections that may have been present but not causing symptoms.
• Autoimmune disorders, in which the immune system attacks healthy tissues, may also occur after starting HIV treatment. Autoimmune disorders may occur many months after starting treatment. You should be aware of any symptoms of infection or other symptoms such as:
• muscle weakness;
• weakness starting in the hands and feet and moving up towards the trunk of the body;
• heart rhythm disturbances, tremors, or excessive activity.

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

Possible side effects:

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

• diarrhea, vomiting, nausea;
• dizziness, headache;
• rash;
• feeling weak.

Tests may also show:

• decreased phosphate levels in the blood;
• increased creatine kinase activity.

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

• pain, abdominal pain;
• difficulty sleeping, unusual dreams;
• digestive problems leading to a feeling of being unwell after eating, bloating, gas;
• rash (including red spots or patches, sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin color, including darker skin patches;
• other allergic reactions, such as wheezing, swelling, or a feeling of emptiness in the head;
• bone loss.

Tests may also show:

• decreased white blood cell count (decreased white blood cell count may increase the risk of infections);
• increased levels of triglycerides (fatty acids), bile, or sugar in the blood;
• liver or pancreas problems.

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

• abdominal pain caused by pancreatitis;
• swelling of the face, lips, tongue, or throat;
• anemia (reduced red blood cell count);
• breakdown of muscle cells, muscle pain, or muscle weakness, which can occur due to kidney damage.

Tests may also show:

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

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

• lactic acidosis (see Possible serious side effects);
• fatty liver;
• yellowing of the skin or eyes, itching, or abdominal pain caused by liver inflammation;
• kidney inflammation, excessive urine production, and thirst, kidney failure, kidney damage;
• softening of the bones (causing bone pain and sometimes leading to fractures);
• back pain caused by kidney problems.

Kidney damage can cause muscle breakdown, softening of the bones (causing bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood.

If you experience any of the side effects listed above or if they get worse, tell your doctor or pharmacist.

The frequency of the following side effects is not known.

• Bone problems.In some patients taking combination antiretroviral therapies, including emtricitabine with tenofovir disoproxil, a bone disease called osteonecrosis(death of bone tissue due to lack of blood supply to the bone) has been reported. Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a weakened immune system, and being overweight may be some of the many risk factors for this disease. Symptoms of osteonecrosis are:
• joint stiffness;
• joint pain (especially in the hips, knees, and shoulders);
• difficulty moving.

Tell your doctor if you notice any of these symptoms.

During HIV treatment, you may experience an increase in weight and levels of lipids and glucose in the blood. This is partly due to the improvement in your health and lifestyle, and in the case of lipid levels, sometimes to the HIV treatment itself. Your doctor will order tests to detect these changes.

Other side effects in children

• Very common in children taking emtricitabine were changes in skin color,
• including darker skin patches.
• Common in children was a low red blood cell count (anemia)
• this may cause tiredness or shortness of breath in the child.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported to the Department of Drug Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the label, carton, and bottle after EXP. The expiry date refers to the last day of that month.
Store in a temperature not above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Emtricitabine + Tenofovir disoproxil Aurovitas contains

The active substances are emtricitabine and tenofovir disoproxil.
The other ingredients are:
Core:microcrystalline cellulose, sodium croscarmellose, mannitol, maize starch, sodium stearyl fumarate.
Coating:White color: hypromellose 2910 (6cPs), triacetin, titanium dioxide (E 171),
lactose.

What Emtricitabine + Tenofovir disoproxil Aurovitas looks like and contents of the pack

Tablet.
White or almost white film-coated tablets, capsule-shaped, with the inscription "EMT" on one side and smooth on the other. Size: 19.1 x 8.6 mm.
Emtricitabine + Tenofovir disoproxil Aurovitas tablets are packaged in blisters or HDPE containers, in cardboard boxes.
Pack sizes:
Blisters:30, 50, and 90 film-coated tablets.
HDPE container:30 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: medicalinformation@aurovitas.pl

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Emtricitabine/Tenofovir disoproxil AB 200/245 mg film-coated tablets
Germany:
Emtricitabine/Tenofovirdisoproxil PUREN 200 mg/245 mg Filmtabletten
Italy:
Emtricitabina e Tenofovir disoproxil Aurobindo
Netherlands:
Emtricitabine/Tenofovir disoproxil Aurobindo 200 mg/245 mg, film-coated tablets
Poland:
Emtricitabine + Tenofovir disoproxil Aurovitas
Portugal:
Emtricitabina + Tenofovir Generis
Spain:
Emtricitabina/Tenofovir disoproxilo Aurovitas 200 mg/245 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: 04/2024