Label:information for the patient

Tenofovir disoproxil Aurovitas 245 mg film-coated tablets EFG

Read this label carefully before starting to take this medicine,because it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribedonlyto you, and you should not give it to other people even iftheyhavethe same symptomsas you,as it may harm them.

-If you experience any side effects,consult your doctor or pharmacist,eveniftheyare not listed in this label. See section 4.

1.What isTenofovir disoproxil Aurovitasand what is it used for

2.What you need to knowbeforestarting totakeTenofovir disoproxil Aurovitas

3.How to takeTenofovir disoproxil Aurovitas

4.Possible side effects

5.Storage ofTenofovir disoproxil Aurovitas

6.Contents of the pack and additional information

If tenofovir has been prescribed to your child, note that all the information in this labelis directed at your child (in this case, read “your child” instead of “you”).

Tenofovir contains the active ingredienttenofovir disoproxil. This active ingredient is anantiretroviralor antiviral medicationused to treat HIV infection, or HBV infection, or both.Tenofovir isanucleotide reverse transcriptase inhibitor analogue,commonly knownasITIAN and acts by interfering with the normal function of certain enzymes (in the case of HIV, thereverse transcriptaseandin HBV, theDNA polymerase) essential for viral replication. Forthe treatment of HIV infection, tenofovir must be used in combination withother medications.

Tenofovir is a medication used to treat HIV(Human Immunodeficiency Virus) infection. The tablets are suitablefor:

-adults..

-adolescents between 12 and less than 18 years who have already been treatedwithothermedications against HIV that are no longer fully effective due to the developmentofresistances, or that have caused adverseeffects.

Tenofovir is also used to treat chronic hepatitis B, ainfectioncaused by the HBV(hepatitis B virus). The tablets are suitablefor:

-adults..

-adolescents between 12 and less than 18 years..

No HIV infection is required to be treated with tenofovir for HBV.

This medication is not a cure for HIV infection. While taking tenofovir, you maystillbe able to contract infections or other diseases associated with HIV infection. You may alsocontinue to transmit HBV to others. Therefore, it is essential to take precautionstoavoid infecting others.

Do not takeTenofovir disoproxil Aurovitas

-If you are allergicto tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).

If this is the case,inform your doctor immediately and do not taketenofovir.

Warnings and precautions

Tenofovir disoproxil does not reduce the risk of transmission of HBV by sexual contact or blood contamination. You should continue to take precautions to avoid it.

Consult your doctor or pharmacist before starting to takeTenofovir disoproxil Aurovitas.

-If you have kidney disease or if your blood tests have shown kidney problems.Tenofovir should not be administered to adolescents with existing kidney problems. Before starting treatment, your doctor may request that you have some blood tests to evaluate the function of your kidneys. Tenofovir may affect your kidneys during treatment. Your doctor may request that you have some blood tests during treatment to control the function of your kidneys. If you are an adult, your doctor may advise you to take the tablets less frequently.Do not reduce the prescribed dose, unless your doctor has told you to.

Tenofovir is usually not taken with other medicines that may damage yourkidneys(seeOther medicines and Tenofovir disoproxil Aurovitas). If this is unavoidable, your doctor will monitor the function of your kidneys once aweek.

-If you have osteoporosis, a history of bone fractures, or bone problems.

You may also experiencebone problems(which manifest as persistent bone pain or worsening, and sometimes leading to fractures) due to damage to renal tubular cells (see section 4,Undesirable effects). Inform your doctor if you have bone pain or fractures.

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 boosted protease inhibitor.

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

Some adult patients with HIV who receive antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by a lack of blood supply to the bone). Among the numerous risk factors for developing this disease are the duration of antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and a high body mass index. The symptoms of osteonecrosis are: joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, inform your doctor.

-Speak to your doctor if you have a history of liver disease, includinghepatitis.

Patients with 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 infection, your doctor will carefully consider the best treatment for you. If you have a history of liver disease or chronic hepatitis B infection, your doctor may request blood tests to monitor your liver function.

-Infections.If you have advanced HIV infection (AIDS) and present another type ofinfection,you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection, when you start treatment with tenofovir. These symptoms may indicate that your improved immune system is fighting the infection. Be vigilant for the appearance of signs of inflammation or infection shortly after starting to take tenofovir. If you notice signs of inflammation or infection, inform your doctorimmediately.

Aside from opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders may appear many months after the start of treatment. If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

-If you are over 65 years old, inform your doctor or pharmacist.

Tenofovir has not been studiedinpatients over 65 years old. If you are over this age and have been prescribed tenofovir, your doctor will monitor you carefully.

Children and adolescents

Tenofovir isappropriatefor:

-adolescents infected with HIV-1 between 12 and less than 18 years old who weigh at least 35 kg and who have already been treatedwith other HIV medicines that are no longer fully effective due to the development of resistance, or that have causedside effects.

-adolescents infected with HBV between 12 and less than 18 years old who weigh at least 35kg.

Tenofoviris notappropriate for the followinggroups:

-not for children infected with HIV-1under 12years old.

-not for children infected with HBVunder 12years old.

See section 3,How to take Tenofovir disoproxil Aurovitasto know the dose.

Other medicines and Tenofovir disoproxil Aurovitas

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

-Do not stop taking any HIV medicine prescribed by your doctor when you start treatment with tenofovir if you have HBV andVIH.

-Do not take tenofovirif you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take tenofovir with medicines that containadefovirdipivoxil (a medicine used to treat chronic hepatitis B).

-It is very important that you tell your doctor if you are taking other medicinesthatmay damage yourkidneys.

Among these medicines are:

-aminoglycosides, pentamidine, or vancomycin (used to treat bacterial infections).

-amphotericin B (used to treat fungal infections).

-foscarnet, ganciclovir, or cidofovir (used to treat viral infections).

-interleukin-2 (used to treatcancer).

-adefovir dipivoxil (used to treat HBV infection).

-tacrolimus (used to produce immune suppression).

-nonsteroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

-Other medicines that contain didanosine (for HIV infection):Taking tenofovir with other antiviral medicines that contain didanosine may increase the levels of didanosine in the blood and may reduce the CD4 cell count. When taken together, medicines that contain tenofovir disoproxil and didanosine have been associated in rare cases with inflammation of the pancreas and lactic acidosis (excess of lactic acid in the blood), in some cases fatal. Your doctor will carefully consider whether to treat you with combinations of tenofovir anddidanosine.

-You should also inform your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasviror sofosbuvir/velpatasvir/voxilaprevirto treat hepatitis C infection.

Taking Tenofovir disoproxil Aurovitas with food and drinks

Take tenofovir with food(for example, a meal or anappetizer).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using thismedicine.

-If you have been taking tenofovirduring your pregnancy, your doctor may request that you have periodic blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took ITIAN during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects.

-If you are a mother and have HBV infection, and your baby has been treated to prevent the transmission of hepatitis B at birth, it is possible that you may breastfeed your infant, but first speak with your doctor to get more information.

-It is not recommended that women with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or plan to breastfeed, you mustconsult your doctor as soon as possible.

Driving and operating machines

Tenofovir may cause dizziness. If you notice dizziness during treatment with tenofovir,do not drive orride a bikeor operatemachines.

Tenofovir disoproxil Aurovitas contains lactose

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Tenofovir disoproxil Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.Your doctor or pharmacist.Consult your doctor or pharmacist again in case of doubt.

The recommended dose is:

-Adults:1 tablet per day, with food (for example, a meal or an appetizer).

-Adolescents between 12 and less than 18 years who weigh at least 35 kg:1 tablet per day, with food (for example, a meal or an appetizer).

If you have special 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 grape juice and drink it immediately.

-Always take the dose recommended 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 an adult and have kidney problems, your doctor may advise you to take tenofovir less frequently.

-If you have VHB, your doctor may offer you to undergo a HIV test to see if you have VHB and HIV.

Consult the prospectuses of other antiretrovirals to know how to take these medications.

If you take more Tenofovir disoproxilo Aurovitas than you should:

If you accidentally took too many tablets of tenofovir, you may be at greater risk of experiencing possible adverse effects with this medication (see section 4, Possible Adverse Effects). Consult your doctor or go to the nearest emergency service.

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.

Carry the packaging with you so that you can easily describe what you have taken.

If you forgot to take Tenofovir disoproxilo Aurovitas:

It is essential not to forget a dose of tenofovir. If you forget a dose, determine how long it has been since you should have taken it.

-If it has been less than 12 hours since you normally take it, take it as soon as possible, and then take your next dose at your usual time.

-If it has been more than 12 hours since you should have taken it, do not take the missed dose. Wait and take the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

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

If you interrupt the treatment with Tenofovir disoproxilo Aurovitas:

Do not stop taking tenofovir without your doctor's permission. Stopping treatment with tenofovir may reduce the effectiveness of the recommended treatment by your doctor.

If you have hepatitis B, or HIV and hepatitis B (coinfection),it is very important that you do not interrupt your treatment with tenofovir without first talking to your doctor. After interrupting treatment with tenofovir, some patients have presented blood test results or symptoms indicating that their hepatitis had worsened. You may need to have blood tests for several months after interrupting treatment. In patients with advanced liver disease or cirrhosis, it is not recommended to interrupt treatment as this may lead to worsening of their hepatitis.

-Talk to your doctor before stopping tenofovir for any reason, particularly if you experience any side effects or have another disease.

-Talk to your doctor immediately if you experience any new or unusual symptoms after interrupting your treatment, particularly those symptoms related to hepatitis B virus infection.

-Contact your doctor before restarting the tablets of tenofovir.

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

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.andlactateacidosisis a rare but serious side effect (can affect up to 1 in 1,000 patients) that can be fatal. The following side effects may be signs of lactate acidosis:

-Deep and rapid breathing.

-Somnolence.

-Nausea, vomiting, and stomach pain.

If you think you may havelactate acidosis, contact your doctor immediately.

Other possible serious side effects

The following side effects areinfrequent(can affect up to 1 in 100 patients):

-Abdominal pain(due to pancreatitis inflammation).

-Kidney cell damage.

The following side effects arerare(can affect up to 1 in 1,000 patients):

-Kidney inflammation,increased urine volume, and sensation ofthirst.

-Changes inyoururineandback paindue to kidney problems, including renal failure.

-Debilitation of bones (withbone painand sometimes ending in fractures),whichmay occur due to kidney cell damage.

-Fatty liver.

If you think you may have any of these serious side effects, consult your doctor.

More frequent side effects

The following side effects arevery frequent(can affect more than 1 in 10 patients):

-Diarrhea, vomiting, nausea, dizziness, rash, feelingweak.

The tests may also show:

-Decreased level of phosphates in blood.

Other possible side effects

The following side effects arecommon(can affect up to 1 in 10 patients):

-Headache, stomach pain, feeling tired, feeling bloated, flatulence, bone loss.

The tests may also show:

-Liver problems.

The following side effects areinfrequent(can affect up to 1 in 100 patients):

-Muscle rupture, muscle pain or weakness.

The tests may also show:

-Decreased levels of potassium in blood.

-Increased creatinine in blood.

-Kidney problems.

Muscle rupture, debilitation of bones (with bone pain and sometimes ending in fractures), muscle pain, muscle weakness, and decreased levels of potassium or phosphates in blood, may occur due to kidney cell damage.

The following side effects arerare(can affect up to 1 in 1,000 patients):

-Abdominal pain (due to liver inflammation).

-Swelling of the face, lips, tongue, orthroat.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe bottle, carton or blister packafter CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of your pharmacy.Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Tenofovir disoproxil Aurovitas

-The active ingredient is tenofovir disoproxil. Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).

-The other components are:

Core of the tablet:sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch and magnesium stearate.

Coating of the tablet:hypromellose 2910, lactose monohydrate, titanium dioxide (E171), triacetin, aluminum lake blue FD&C 2 (3-5%) EHD (E132) and aluminum lake blue FD&C 2 (3-5%) SEN (E132).

Appearance of the product and contents of the package

Film-coated tablets of blue color, oval, biconvex, with the mark “300” on one face and “T” on the other.

Tenofovir disoproxil Aurovitas film-coated tablets are available inblister packs and in HDPE bottles.

Package sizes:

Blister packs:30 film-coated tablets.

HDPE bottles:30, 90 and 90 (3×30) film-coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

O

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 with the following names:

Last review date of this leaflet: April 2024

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/).