Emtricitabine and tenofovir alafenamide Zentiva

Patient Information Leaflet: Information for the User

Emtricitabine and Tenofovir alafenamide Zentiva 200 mg/10 mg film-coated tablets

Generic medicine
Please read all of this 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 other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Emtricitabine and Tenofovir alafenamide Zentiva is and what it is used for

This medicinal product contains two active substances:

• emtricitabine, an antiretroviral medicine belonging to the class of nucleoside reverse transcriptase inhibitors (NRTIs)
• tenofovir alafenamide, an antiretroviral medicine belonging to the class of nucleotide reverse transcriptase inhibitors (NtRTIs)

This medicine blocks the action of the reverse transcriptase enzyme, which is essential for the virus to replicate. Therefore, this medicine reduces the amount of HIV in your body.
Emtricitabine and Tenofovir alafenamide Zentiva, in combination with other medicines, is used for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with body weight of at least 35 kg.

2. What you need to know before taking Emtricitabine and Tenofovir alafenamide Zentiva

Do not take Emtricitabine and Tenofovir alafenamide Zentiva

• If you are allergic to emtricitabine, tenofovir alafenamide, or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

Warnings and precautions
While taking this medicine, you must continue to be monitored by your doctor.
This medicine does not cure HIV infection. While taking it, you may still develop infections or other illnesses associated with HIV infection.
Talk to your doctor before taking Emtricitabine and Tenofovir alafenamide Zentiva:

• If you have or have had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of developing severe liver complications that may be fatal. If you have hepatitis B, your doctor will carefully evaluate the most appropriate treatment regimen for you.
• If you have hepatitis B, liver problems may worsen when you stop treatment with this medicine. Do not stop treatment with Emtricitabine and Tenofovir alafenamide Zentiva without speaking to your doctor: see section 3, Do not stop treatment with Emtricitabine and Tenofovir alafenamide Zentiva.
• Your doctor may decide not to prescribe this medicine if the virus has a specific resistance mutation, as this medicine may not effectively reduce the amount of HIV in your body.
• If you have kidney disease or if tests have shown kidney problems. Your doctor may require blood tests to monitor how well your kidneys are functioning at the beginning and during treatment with this medicine.

While taking Emtricitabine and Tenofovir alafenamide Zentiva
When you start taking this medicine, be alert for:

• signs of inflammation or infection
• joint pain, stiffness, or bone problems

→ If you notice any of these symptoms, inform your doctor immediately. For more information, see section 4, Possible side effects.
Kidney problems may occur during long-term use of this medicine (see Warnings and precautions).

Children and adolescents
Do not give this medicine to children aged 11 years or younger or weighing less than 35 kg. The use of this medicine in children aged 11 years or younger has not yet been studied.

Other medicines and Emtricitabine and Tenofovir alafenamide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine. This medicine can interact with other medicines. As a result, the levels of this or other medicines in your blood may change. This could prevent the medicines from working properly or worsen their side effects. In some cases, your doctor may need to adjust the dose or monitor blood levels.

Medicines used to treat hepatitis B:
You must not take this medicine together with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil

→ Tell your doctor if you are taking any of these medicines.

Other types of medicines:
Talk to your doctor if you are taking:

• antibiotics used to treat bacterial infections, including tuberculosis, containing:
  • rifabutin, rifampicin, and rifapentine
• antiviral medicines used to treat HIV:
  • emtricitabine and tipranavir
• anticonvulsants, used to treat epilepsy, such as:
  • carbamazepine, oxcarbazepine, phenobarbital, and phenytoin
• herbal remedies used to treat depression and anxiety containing:
  • St. John’s wort (Hypericum perforatum)

→ Tell your doctor if you are taking these or any other medicines. Do not stop treatment without contacting your doctor.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
• If you become pregnant, inform your doctor immediately and discuss the potential benefits and risks of antiretroviral therapy for you and your baby.

If you have taken this medicine during pregnancy, your doctor may regularly perform blood tests and other diagnostic examinations to monitor your baby’s development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
Do not breastfeed while taking this medicine. This is because one of the active substances in this medicine is excreted in breast milk.
Breastfeeding is not recommended for HIV-positive women because HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
This medicine may cause dizziness. If dizziness occurs while taking this medicine, do not drive or operate tools or machinery.

Emtricitabine and Tenofovir alafenamide Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Emtricitabine and Tenofovir alafenamide Zentiva

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose is:
Adults: One tablet daily, taken with or without food.
Adolescents aged 12 years and older, with a body weight of at least 35 kg: One tablet daily, taken with or without food.
Due to its bitter taste, it is recommended not to chew or crush the tablet.
Always take the dose recommended by your doctor. This is important to ensure that your medicine remains fully effective and to reduce the risk of developing treatment resistance. Do not change your dose unless your doctor tells you to do so.
If you are undergoing dialysis, take your daily dose of this medicine after completion of dialysis.
If you take more Emtricitabine and Tenofovir alafenamide Zentiva than you should
If you take more of this medicine than recommended, you may have a higher risk of side effects (see section 4, Possible side effects).
Contact your doctor or the nearest emergency department immediately. Bring the medicine container with you so you can show what you have taken.
If you forget to take Emtricitabine and Tenofovir alafenamide Zentiva
It is important that you do not miss any doses of this medicine.
If you forget a dose:

• If you remember within 18 hours of your usual dosing time, take the tablet as soon as possible. Then take your next dose at the usual time.
• If you remember 18 hours or more after your usual dosing time, do not take the missed dose. Wait and take your next dose at the usual time.

If you vomit within 1 hour after taking Emtricitabine and Tenofovir alafenamide Zentiva, take another tablet.
Do not stop treatment with Emtricitabine and Tenofovir alafenamide Zentiva
Do not stop taking this medicine without talking to your doctor. Stopping treatment may seriously affect the effectiveness of future treatment. If treatment with this medicine is stopped for any reason, discuss with your doctor before restarting.
When your supply of Emtricitabine and Tenofovir alafenamide Zentiva starts to run out, get a new supply from your doctor or pharmacist. This is very important because the amount of virus in your body may start to increase if you stop taking the medicine, even for a few days. The disease may become more difficult to treat.
If you have both HIV infection and hepatitis B, it is very important not to stop treatment with this medicine without first talking to your doctor. Blood tests may need to be repeated for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which can potentially be fatal.
→ Contact your doctor immediately if you notice any new or unusual symptoms after stopping treatment, especially symptoms normally associated with hepatitis B infection.
If you have any 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 everyone will experience them.
Serious possible side effects: inform your doctor immediately

• Signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) who have previously had opportunistic infections (infections occurring in people with weakened immune systems), signs and symptoms of inflammation from prior infections may occur shortly after starting antiretroviral therapy. These symptoms are believed to result from an improved immune response, allowing the body to fight infections that may have been present without obvious symptoms.
• Autoimmune diseases (the immune system attacks healthy body tissues) may also occur when you start taking medicines for HIV infection. Autoimmune diseases may appear many months after starting treatment. Be alert for any signs of infection or other symptoms such as:
  • muscle weakness
  • weakness starting in the hands and feet and progressing towards the trunk
  • palpitations, tremor, or hyperactivity → If you experience any of the side effects described above, inform your doctor immediately.

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

• feeling unwell (nausea)

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

• abnormal dreams
• headache
• dizziness
• diarrhoea
• vomiting
• stomach ache
• intestinal gas (flatulence)
• rash
• tiredness (fatigue)

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

• low red blood cell count (anaemia)
• digestive problems causing discomfort after meals (dyspepsia)
• swelling of the face, lips, tongue, or throat (angioedema)
• itching
• hives (urticaria)
• joint pain (arthralgia)

→ If any of these side effects worsen, inform your doctor.
Other possible side effects observed during HIV treatment
The frequency of the following side effects is unknown (cannot be estimated from the available data).

• Bone problems. Some patients taking combination antiretroviral medicines like this one may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Prolonged use of this type of medicine, use of corticosteroids, alcohol consumption, having a weakened immune system, and being overweight may be among the many risk factors for developing this condition. Signs of osteonecrosis include:
  • joint stiffness
• discomfort and pain in joints (especially hips, knees, and shoulders)
• difficulty moving → If you notice any of these symptoms, inform your doctor.

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

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website [insert address].
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Emtricitabine and Tenofovir alafenamide Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
Store below 30 °C. Keep in the original packaging to protect the medicine from moisture.
After first opening, store below 25 °C and use the medicine within 30 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Emtricitabina e Tenofovir alafenamide Zentiva contains

• The active substances are emtricitabine and tenofovir alafenamide. Each film-coated tablet of Emtricitabina e Tenofovir alafenamide Zentiva contains 200 mg of emtricitabine and 10 mg of tenofovir alafenamide.
• The other components are:

Tablet core: microcrystalline cellulose, sodium croscarmellose, magnesium stearate,
hypromellose.
Tablet coating: a mixture containing polyvinyl alcohol, titanium dioxide (E 171),
macrogol, talc and iron oxide black (E 172).
Description of the appearance of Emtricitabina e Tenofovir alafenamide Zentiva and contents of the
package
Emtricitabina e Tenofovir alafenamide Zentiva 200 mg/10 mg film-coated tablets are
grey oval tablets. The tablet length is approximately 12.5 mm and the width is approximately 6.4 mm.
Emtricitabina e Tenofovir alafenamide Zentiva 200 mg/10 mg film-coated tablets are
available in white plastic bottles closed with a child-resistant screw cap made of plastic, with a desiccant attached to the cap.
The following pack sizes are available: 30, 60 or 90 tablets (the outer package contains a

package leaflet and one, two or three bottles of 30 tablets).

Not all pack sizes may be marketed.
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan
Italy
Manufacturer:
Zentiva k.s
U kabelovny 130
Prague 10, 102 37
Czech Republic
This medicinal product is authorized in the European Economic Area countries under the
following names:
Czech Republic, Denmark Emtricitabine/Tenofovir alafenamide Zentiva
France EMTRICITABINE/TENOFOVIR ALAFENAMIDE ZENTIVA
200 mg/10 mg, film-coated tablet
Germany Emtricitabin/Tenofoviralafenamid Zentiva 200 mg/10 mg
Filmtabletten
Iceland, Italy, Portugal Emtricitabine+Tenofovir alafenamide Zentiva
Netherlands Emtricitabine/Tenofovir alafenamide Zentiva 200 mg/10 mg
film-coated tablets
Spain Emtricitabina+Tenofovir alafenamida Zentiva 200 mg/10 mg
comprimidos recubiertos con película EFG
Norway/Sweden Emtricitabine/Tenofovir alafenamide Zentiva

Package leaflet: Information for the user

Emtricitabine and Tenofovir alafenamide Zentiva 200 mg/25 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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 give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Emtricitabine and Tenofovir alafenamide Zentiva is and what it is used for

This medicinal product contains two active substances:

• emtricitabine, an antiretroviral medicine belonging to the class of nucleoside reverse transcriptase inhibitors (NRTIs)
• tenofovir alafenamide, an antiretroviral medicine belonging to the class of nucleotide reverse transcriptase inhibitors (NtRTIs)

This medicine blocks the action of the reverse transcriptase enzyme, which is essential for the virus to replicate. Therefore, this medicine reduces the amount of HIV in your body.
Emtricitabine and Tenofovir alafenamide Zentiva, in combination with other medicines, is used for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with a body weight of at least 35 kg.

2. What you need to know before taking Emtricitabina e Tenofovir alafenamide Zentiva

Do not take Emtricitabina e Tenofovir alafenamide Zentiva

• If you are allergic to emtricitabine, tenofovir alafenamide, or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

Warnings and precautions
While taking this medicine, you must continue to be monitored by your doctor.
This medicine does not cure HIV infection. While taking it, you may still develop infections or other illnesses associated with HIV infection.
Talk to your doctor before taking Emtricitabina e Tenofovir alafenamide Zentiva:

• If you have or have had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of serious liver complications that may be fatal. If you have hepatitis B, your doctor will carefully evaluate the most appropriate treatment regimen for you.
• If you have hepatitis B, liver problems may worsen when you stop treatment with this medicine. Do not stop treatment with Emtricitabina e Tenofovir alafenamide Zentiva without discussing it with your doctor: see section 3, Do not stop treatment with Emtricitabina e Tenofovir alafenamide Zentiva.
• Your doctor may decide not to prescribe this medicine if the virus has a specific resistance mutation, as this medicine may not effectively reduce the amount of HIV in your body.
• If you have kidney disease or if tests have shown kidney problems. Your doctor may request blood tests to monitor how well your kidneys are functioning, both at the beginning and during treatment with this medicine.

While taking Emtricitabina e Tenofovir alafenamide Zentiva
When you start taking this medicine, be alert for:

• signs of inflammation or infection
• joint pain, stiffness, or bone problems

→ If you notice any of these symptoms, inform your doctor immediately. For more information, see section 4, Possible side effects.
Kidney problems may occur during long-term use of this medicine (see Warnings and precautions).

Children and adolescents
Do not give this medicine to children aged 11 years or younger or weighing less than 35 kg. The use of this medicine in children aged 11 years or younger has not yet been studied.

Other medicines and Emtricitabina e Tenofovir alafenamide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This medicine may interact with other medicines. As a result, the levels of this or other medicines in your blood may change. This could prevent the medicines from working properly or may worsen their side effects. In some cases, your doctor may need to adjust the dose or monitor blood levels.

Medicines used to treat hepatitis B:
You must not take this medicine together with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudina
• adefovir dipivoxil

→ Tell your doctor if you are taking any of these medicines.

Other types of medicines:
Talk to your doctor if you are taking:

• antibiotics used to treat bacterial infections, including tuberculosis, containing:
  • rifabutin, rifampicin, and rifapentine
• antiviral medicines used to treat HIV:
  • emtricitabine and tipranavir
• anticonvulsants, used to treat epilepsy, such as:
  • carbamazepine, oxcarbazepine, phenobarbital, and phenytoin
• herbal remedies used to treat depression and anxiety containing:
  • St. John’s wort (Hypericum perforatum)

→ Tell your doctor if you are taking these or any other medicines. Do not stop treatment without contacting your doctor.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
• If you become pregnant, inform your doctor immediately and discuss the potential benefits and risks of antiretroviral therapy for you and your baby.

If you have taken this medicine during pregnancy, your doctor may regularly request blood tests and other diagnostic examinations to monitor your baby’s development. In children whose mothers have taken NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
Do not breastfeed during treatment with this medicine. This is because one of the active substances in this medicine is excreted in breast milk.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
This medicine may cause dizziness. If dizziness occurs while taking this medicine, do not drive and do not operate tools or machinery.

Emtricitabina e Tenofovir alafenamide Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Emtricitabine and Tenofovir alafenamide Zentiva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults: One tablet daily, taken with or without food.
Adolescents aged 12 years and older, weighing at least 35 kg: One tablet daily, taken with or without food.

Due to its bitter taste, it is recommended not to chew or crush the tablet.
The score line on the tablet is not intended for breaking the tablet.

Always take the dose prescribed by your doctor. This is important to ensure that your medicine remains fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless instructed by your doctor.

If you are undergoing dialysis, take your daily dose of this medicine after completion of dialysis.

If you take more Emtricitabine and Tenofovir alafenamide Zentiva than you should
Taking more than the prescribed dose may increase your risk of experiencing side effects (see section 4, Possible side effects).
Contact your doctor or the nearest emergency department immediately. Bring the medicine container with you so you can show what you have taken.

If you forget to take Emtricitabine and Tenofovir alafenamide Zentiva
It is important not to miss any dose of this medicine.
If you miss a dose:

• If you remember within 18 hours of your usual dosing time, take the missed tablet as soon as possible. Then take your next dose at the usual time.
• If you remember more than 18 hours after your usual dosing time, do not take the missed dose. Wait and take your next dose at the usual time.

If you vomit within 1 hour after taking Emtricitabine and Tenofovir alafenamide Zentiva, take another tablet.

Do not stop treatment with Emtricitabine and Tenofovir alafenamide Zentiva
Do not stop taking this medicine without talking to your doctor. Stopping treatment may seriously affect the effectiveness of future treatment. If treatment with this medicine is stopped for any reason, discuss with your doctor before restarting.

When your supply of Emtricitabine and Tenofovir alafenamide Zentiva is running low, obtain a new supply from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is interrupted, even for a few days. The disease may become more difficult to treat.

If you have both HIV infection and hepatitis B, it is very important not to stop treatment with this medicine without first consulting your doctor. Blood tests may need to be repeated for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which can potentially be fatal.
→ Inform your doctor immediately about any new or unusual symptoms occurring after stopping treatment, especially symptoms typically associated with hepatitis B infection.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Possible serious side effects: inform your doctor immediately

• Signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) who have previously had opportunistic infections (infections occurring in people with weakened immune systems), signs and symptoms of inflammation from prior infections may occur shortly after starting antiretroviral therapy. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that may have been present without obvious symptoms.
• Autoimmune disorders (the immune system attacks healthy body tissues) may also occur when you start taking medicines for HIV infection. Autoimmune disorders may appear many months after treatment has begun. Be alert for any signs of infection or other symptoms such as:
  • muscle weakness
  • weakness starting in the hands and feet and progressing towards the trunk
  • palpitations, tremor, or hyperactivity
    → If you experience any of the above side effects, inform your doctor immediately.

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

• feeling unwell (nausea)

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

• abnormal dreams
• headache
• dizziness
• diarrhoea
• vomiting
• stomach ache
• intestinal gas (flatulence)
• rash
• tiredness (fatigue)

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

• low red blood cell count (anaemia)
• digestive problems causing discomfort after meals (dyspepsia)
• swelling of the face, lips, tongue, or throat (angioedema)
• itching
• hives (urticaria)
• joint pain (arthralgia)

→ If any of these side effects worsen, inform your doctor.

Other possible side effects observed during HIV treatment
The frequency of the following side effects is unknown (frequency cannot be estimated from the available data).

• Bone problems. Some patients taking combination antiretroviral medicines such as this one may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Prolonged use of this type of medicine, taking corticosteroids, alcohol consumption, having a weakened immune system, and being overweight may be among the many risk factors for developing this condition. Signs of osteonecrosis include:
  • joint stiffness
• discomfort and pain in the joints (especially hips, knees, and shoulders)
• difficulty moving
  → If you notice any of these symptoms, inform your doctor.

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Emtricitabine and Tenofovir alafenamide Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
Store below 30 °C. Keep in the original packaging to protect the medicine from moisture.
After first opening, store below 25 °C and use the medicine within 30 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Emtricitabine and Tenofovir alafenamide Zentiva contains

• The active substances are emtricitabine and tenofovir alafenamide. Each film-coated tablet of Emtricitabine and Tenofovir alafenamide Zentiva contains 200 mg of emtricitabine and 25 mg of tenofovir alafenamide.
• The other ingredients are:

Tablet core: microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
hypromellose.
Tablet coating: a mixture containing polyvinyl alcohol, titanium dioxide (E 171),
macrogol and talc.

Description of the appearance of Emtricitabine and Tenofovir alafenamide Zentiva and pack contents
Emtricitabine and Tenofovir alafenamide Zentiva 200 mg/25 mg film-coated tablets are
white, oval-shaped tablets with a decorative score line. The tablet is approximately
12.5 mm long and approximately 6.4 mm wide.
Emtricitabine and Tenofovir alafenamide Zentiva 200 mg/25 mg film-coated tablets are
available in white plastic bottles, closed with a child-resistant plastic screw cap with a
desiccant attached to the cap.
The following pack sizes are available: 30, 60 or 90 tablets (the outer package contains a

package leaflet and one, two or three bottles of 30 tablets each).

Not all pack sizes may be marketed.
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan
Italy
Manufacturer:
Zentiva k.s
U kabelovny 130
Prague 10, 102 37
Czech Republic
This medicinal product is authorized in the European Economic Area countries under the
following names:
Czech Republic, Denmark Emtricitabine/Tenofovir alafenamide Zentiva
France EMTRICITABINE/TENOFOVIR ALAFENAMIDE ZENTIVA
200 mg/25 mg, film-coated tablet
Germany Emtricitabin/Tenofoviralafenamid Zentiva 200 mg/25 mg
Filmtabletten
Iceland, Italy, Portugal Emtricitabine+Tenofovir alafenamide Zentiva
Netherlands Emtricitabine/Tenofovir alafenamide Zentiva 200 mg/25 mg
film-coated tablets
Spain Emtricitabina+Tenofovir alafenamida Zentiva 200 mg/25 mg
comprimidos recubiertos con película EFG
Norway/Sweden Emtricitabine/Tenofovir alafenamide Zentiva