Emtricitabina/tenofovir disoproxilo teva 200 mg/245 mg comprimidos recubiertos con pelicula efg

Package Leaflet: Information for the User

Emtricitabina/Tenofovir disoproxilo Teva 200 mg/245 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1.What is Emtricitabina/Tenofovir disoproxilo Teva and what it is used for

2.What you need to know before you start taking Emtricitabina/Tenofovir disoproxilo Teva

3.How to take Emtricitabina/Tenofovir disoproxilo Teva

4.Possible side effects

1. Storage of Emtricitabina/Tenofovir disoproxilo Teva

6.Contents of the pack and additional information

Emtricitabina/Tenofovir disoproxilo Teva contains two active principles, emtricitabine and tenofovir disoproxil.Both active principles are antiretroviral drugsthat are used to treat HIV infection. Emtricitabine is anucleoside reverse transcriptase inhibitor analogueand tenofovir is anucleotide reverse transcriptase inhibitor analogue. They are commonly known as ITIAN and act by interfering with the normal functioning of an enzyme (reverse transcriptase) that is essential for the virus to replicate.

• Emtricitabina/Tenofovir disoproxilo Teva is used to treat Human Immunodeficiency Virus Type 1 (HIV-1) infection in adults.in adults.
• It is also used to treat HIV in adolescents aged 12 to less than 18 years with a weight of at least 35 kgwho have already been treated with other HIV medications that are no longer effective or have caused adverse effects.

• Emtricitabina/Tenofovir disoproxilo Teva should always be used in combination with other medications to treat HIV infection.
• Emtricitabina/Tenofovir disoproxilo Teva can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.

This medication is not a cure for HIV infection. While you are taking Emtricitabina/Tenofovir disoproxilo Teva, you may still experience infections or other diseases associated with HIV infection.

Emtricitabina/Tenofovir disoproxilo Teva is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 to less than 18 years with a weight of at least 35 kgwhen used as a daily treatment, in combination with safer sex practices: See section 2 for a list of precautions to be taken against HIV infection.

Do not take Emtricitabina/Tenofovir disoproxilo Teva to treat HIV or reduce the risk of getting HIV if you are allergicto

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

?If this happens, call your doctor IMMEDIATELY.

Before taking Emtricitabina/Tenofovir disoproxilo Teva to reduce the risk of getting HIV:

Emtricitabina/Tenofovir disoproxilo Teva can only help reduce the risk of getting HIVifyou are not already infected.

• You should not be infected with HIV before starting to take Emtricitabina/Tenofovir disoproxilo Teva to reduce the risk of getting HIV.. You should have a test to ensure that you are not infected with HIV. Do not take Emtricitabina/Tenofovir disoproxilo Teva to reduce the risk unless you have been confirmed not to be infected with HIV. People with HIV should take Emtricitabina/Tenofovir disoproxilo in combination with other medicines.

• Many HIV tests may not detect a recent infection.. If you get a recent illness similar to the flu, it could mean that you have recently become infected with HIV.

These may be signs of HIV infection:

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

??Inform your doctor about any illness similar to the flu, either in the month before starting treatment with Emtricitabina/Tenofovir disoproxilo Teva or at any time while taking Emtricitabina/Tenofovir disoproxilo Teva.

Advertencias and precautions

When taking Emtricitabina/Tenofovir disoproxilo Teva to reduce the risk of getting HIV:

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

• You should have regular HIV detection tests.

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

• Using Emtricitabina/Tenofovir disoproxilo Teva alone may not prevent you from getting HIV.

• Always practice safe sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.

• Do not share personal items that may contain blood or bodily fluids, such as toothbrushes and razors.

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

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

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

When taking Emtricitabina/Tenofovir disoproxilo Teva to treat HIV or reduce the risk of getting HIV:

• Emtricitabina/Tenofovir disoproxilo Teva may affect your kidneys.Your doctor may ask you to have blood tests before and during treatment to check how well your kidneys are working. Emtricitabina/Tenofovir disoproxilo Teva should not be given to adolescents with existing kidney problems. If you have had kidney disease, or if blood tests have shown kidney problems, tell your doctor. If you have kidney problems, your doctor may advise you to stop taking Emtricitabina/Tenofovir disoproxilo Teva or, if you already have HIV, take Emtricitabina/Tenofovir disoproxilo Teva less often. Emtricitabina/Tenofovir disoproxilo Teva is not recommended if you have a serious kidney disease or are on dialysis.

Bone problems

You may also experience bone problems (manifesting as persistent bone pain or worsening, and sometimes leading to fractures) due to damage to renal tubular cells (see section 4, Possible side effects).

Tenofovir disoproxil may also cause bone loss. The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a protease inhibitor.

The long-term effects of tenofovir disoproxil on bone health and the future risk of fractures in adult and pediatric patients are imprecise.

Inform your doctor if you know you have osteoporosis. Patients with osteoporosis have a higher risk of fractures.

• Talk to your doctor if you have a history of liver disease, including hepatitis.Patients infected with HIV who also have liver disease (including chronic hepatitis B or C) treated with antiretrovirals have a higher risk of severe and potentially fatal liver complications. If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.

• Know your hepatitis B virus (HBV) statusbefore starting to take Emtricitabina/Tenofovir disoproxilo Teva. If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabina/Tenofovir disoproxilo Teva, regardless of whether you also have HIV. It is essential not to stop taking Emtricitabina/Tenofovir disoproxilo Teva without consulting your doctor: see section 3, Do not stop taking Emtricitabina/Tenofovir disoproxilo Teva.

If you are over 65 years old, tell your doctor.The combination of emtricitabine and tenofovir disoproxil has not been studied in patients over 65 years old.

Children and adolescents

Emtricitabina/tenofovir disoproxil is not for use in children under 12 years old.

Taking Emtricitabina/Tenofovir disoproxilo Teva with other medicines

Do not take Emtricitabina/Tenofovir disoproxilo Tevaif you are already taking other medicines that contain the components of this medicine, emtricitabine and tenofovir disoproxil, or any other antiviral medicine that contains tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

• Taking Emtricitabina/Tenofovir disoproxilo Teva with other medicines that may damage your kidneys:it is especially important to tell your doctor if you are taking any of these medicines. Includes:

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

Also, inform your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Emtricitabina/Tenofovir disoproxilo Teva with other medicines that contain didanosine (for HIV treatment):When taking Emtricitabina/Tenofovir Disoproxilo Teva with other antiviral medicines that contain didanosine, the levels of didanosine in your blood may increase and the CD4 cell count may decrease. When taken together, medicines that contain tenofovir disoproxil and didanosine have been associated with rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) in some cases, which can be fatal. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

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

Taking Emtricitabina/Tenofovir disoproxilo Teva withfood and drinks

• When possible, Emtricitabina/Tenofovir disoproxilo Teva should be taken with food.

Emtricitabina/Tenofovir disoproxilo Teva contains sodium

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

• Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Emtricitabina/Tenofovir disoproxilo Teva for treating HIV is:

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

The recommended dose of Emtricitabina/Tenofovir disoproxilo Teva for reducing the risk of contracting HIV is:

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

tablet per day, preferably with food.

If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then, mix the powder with approximately 100 ml of water (half a glass), orange or grapefruit juice, and drink it immediately.

• Always take the recommended dose prescribed by your doctor. This is to ensure that your medication is completely effective, and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.

• If you are receiving treatment for HIV infection,your doctor will prescribe Emtricitabina/Tenofovir disoproxilo Teva with other antiretroviral medications. Consult the prospectuses of the other antiretrovirals to know how to take these medications.

• If you are an adult taking Emtricitabina/Tenofovir disoproxilo Teva to reduce the risk of contracting HIV,take Emtricitabina/Tenofovir disoproxilo Teva every day, not just when you think you have been at risk of contracting HIV.

Consult your doctor if you have any questions about how to prevent the transmission of HIV or prevent transmission to other people.

If you take more Emtricitabina/Tenofovir disoproxilo Teva than you should

If you accidentally take more than the recommended dose of Emtricitabina/Tenofovir disoproxilo Teva, consult your doctor or go to the nearest emergency service. Bring the tablet container with you so that you can easily describe what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget a dose

It is essential not to forget a dose of this medication.

• If you realize within 12 hourssince you normally take Emtricitabina/Tenofovir disoproxilo Teva, take the tablet as soon as possible, preferably with food, and then take the next dose at your usual time.

• If more than 12 hours have passedsince you normally take Emtricitabina/Tenofovir disoproxilo Teva, do not take the missed dose. Wait and take the next dose, preferably with food, at your usual time.

If you vomit within 1 hour of taking Emtricitabina/Tenofovir disoproxilo Teva, take another tablet. You do not need to take another tablet if you vomited more than an hour after taking Emtricitabina/Tenofovir disoproxilo Teva.

Do not interrupt treatment with Emtricitabina/Tenofovir disoproxilo Teva

• If you take Emtricitabina/Tenofovir disoproxilo Teva for HIV treatment,suspending treatment may reduce the effectiveness of the recommended HIV therapy by your doctor.

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

?Do not interrupt treatment with Emtricitabina/Tenofovir disoproxilo Teva without consulting your doctor.

• If you have hepatitis B,it is especially important not to suspend your treatment with Emtricitabina/Tenofovir disoproxilo Teva without first talking to your doctor. You may need to have blood tests for several months after suspending treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to suspend treatment as this may cause a worsening of your hepatitis, which may be potentially fatal.

?Speak to your doctorIMMEDIATELYabout new or unusual symptoms after suspending treatment, particularly symptoms associated with hepatitis B infection.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Possible serious side effects:

• Lactic acidosis (excess lactic acid in the blood)is a rare but potentially fatal side effect. Lactic acidosis is more common in women, especially if they are overweight, and in people with liver disease. The following side effects may be signs of lactic acidosis:

• deep and rapid breathing
• drowsiness
• nausea, vomiting
• abdominal pain

?If you think you may be experiencing lactic acidosis, seek medical attention immediately.

• Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of previous infections may appear shortly after starting HIV treatment. It is believed that these symptoms are due to the body's improved immune response, which allows the body to fight off infections that may be present without apparent symptoms.

• They may also appearautoimmune disorders, when the immune system attacks healthy body tissue, after starting to take medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms such as:
• muscle weakness
• weakness starting in the hands and feet and ascending to the body trunk
• palpitations, tremors, or hyperactivity

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

Possible side effects

Frequent side effects

(can affect more than 1 in 10 people)

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

Tests may also show:

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

Common side effects

(can affect up to 1 in 10 people)

• dizziness, abdominal pain
• difficulty sleeping, abnormal dreams
• digestive problems with discomfort after meals, feeling bloated (gas), flatulence
• skin eruptions (including red patches or spots sometimes with blisters and swelling of the skin), 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

Tests may also show:

• low white blood cell count (a reduced white blood cell count may make you more prone to infections)
• increased triglycerides (fats), bile, or sugar in the blood
• problems with the liver and pancreas

Rare side effects

(can affect up to 1 in 100 people):

• abdominal pain (stomach) caused by pancreatitis inflammation
• swelling of the face, lips, tongue, or throat

• anemia (low red blood cell count)
• muscle rupture, muscle pain, or muscle weakness that may occur in cases of renal tubular cell damage

Tests may also show:

• decreased potassium levels in the blood
• increased creatinine
• changes in urine

Very rare side effects

(can affect up to 1 in 1,000 people):

• lactic acidosis (seePossible serious side effects)
• steatosis (fatty liver)
• yellowing of the skin or eyes, itching, or abdominal pain (stomach) caused by liver inflammation
• kidney inflammation, increased urine volume, and feeling thirsty, renal failure, renal tubular cell damage
• bone weakening (with bone pain and sometimes leading to fractures)

• back pain due to kidney problems

Renal tubular cell damage may be associated with muscle rupture, bone weakening (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood.

??If you notice any of these side effects or if any of the side effects worsen, speak with your doctor or pharmacist.

The frequency of the following side effects is unknown.

• Bone problems. Some patients taking combined antiretroviral medications such as Emtricitabine/Tenofovir disoproxil Teva may develop a bone disease called osteonecrosis (bone tissue death caused by loss of blood supply to the bone). Taking this type of medication for a long time, taking corticosteroids, consuming alcohol, having a very weakened immune system, and being overweight may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
• joint stiffness
• joint pain or discomfort (especially in the hip, knee, and shoulder)
• difficulty moving

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

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

Other effects in children

• Children receiving emtricitabine often experience frequent changes in skin color, including:
• dark skin patches
• Children often present with a low red blood cell count (anemia)
• which may cause fatigue or shortness of breath

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

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in thisleaflet.You can also report them directlythrough the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the bottle and the carton after CAD. The expiration date is the last day of the month indicated.

Blister packs: Do not store above 30 °C. Store in the original blister pack to protect from moisture.

HDPE Bottles:

Medicines should not be disposed of through the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Emtricitabina/Tenofovir disoproxilo Teva

• The active ingredients are emtricitabina and tenofovir disoproxilo. Each film-coated tablet of Emtricitabina/Tenofovir disoproxilo Teva contains 200 mg of emtricitabina and 245 mg of tenofovir disoproxilo (equivalent to 291.22 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir)
• The other components are mannitol, sodium stearate fumarate, microcrystalline cellulose (E460), low-substituted hydroxypropylcellulose (E463), and hypromellose (E464).

The other components in the coating are partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), and indigo carmine lake (E132).

Appearance of the product and contents of the package

The film-coated tablets of Emtricitabina/Tenofovir disoproxilo Teva are green to light green in color, oval in shape, approximately 18mm x 10 mm in size, and engraved with “E T” on one face and flat on the other face.

Each bottle contains a silica gel desiccant that should be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or container and should not be swallowed.

The following package sizes are available:

Blister: Package sizes of 30, 30x1, and 90 film-coated tablets.

Bottle: Package sizes of 30, 90 (3 bottles of 30), and multi-pack including 3 packages, each containing 30 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Responsible for manufacturing

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

Zagreb 10000

Croatia

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

Krakow 31-546

Poland

or

Merckle GmbH

Ludwig-Merckle-Straße 3

Blaubeuren 89143

Germany

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

ATEmtricitabin/Tenofovir disoproxil ratiopharm 200 mg/245 mg Filmtabletten

CZEmtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg

DEEmtricitabin/Tenofovirdisoproxilratiopharm 200 mg/245 mg Filmtabletten

DKEmtricitabine/Tenofovir disoproxil Teva

EEEmtricitabine/Tenofovir disoproxilTeva 200 mg/245 mg

ESEmtricitabina/Tenofovir disoproxilo Teva 200 mg/245 mg comprimidos recubiertos conpelícula EFG

FIEmtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg tabletti, kalvopäällysteinen

FREmtricitabine/Tenofovir disoproxil Teva 200mg/245mg, comprimé pelliculé

HREmtricitabin/Tenofovirdizoproksil Pliva 200 mg/245 mg filmom obložene tablete

HUEmtricitabine/Tenofovir-disoproxil Teva 200 mg/ 245 mg filmtabletta

IEEmtricitabine/Tenofovir disoproxil Teva 200mg/245mg Film-coated Tablets

ISEmtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg filmuhúðaðar töflur

ITEmtricitabina e Tenofovir disoproxil Teva LVEmtricitabine/Tenofovir disoproxil Teva 200mg/245mg apvalkotas tabletes

NLEmtricitabine/Tenofovirdisoproxil Teva 200/245 mg, filmomhulde tabletten

PTEmtricitabina +Tenofovir disoproxil Teva

ROEMTRICITABINA/TENOFOVIR DISOPROXIL TEVA 200mg/245mg comprimate filmate

SEEmtricitabine/Tenofovir disoproxil Teva

SIEmtricitabin/dizoproksiltenofovirat Teva 200 mg/245 mg filmsko obložene tablete

UKEmtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets

Last review date of this leaflet:September 2023

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