Package Leaflet: Information for the Patient

Tenofovir Disoproxil Teva 245 mg Film-Coated Tablets EFG

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 the same symptoms as you, 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 Tenofovir Disoproxil Teva is and what it is used for

2.What you need to know before you start taking Tenofovir Disoproxil Teva

3.How to take Tenofovir Disoproxil Teva

4.Possible side effects

5.Storage of Tenofovir Disoproxil Teva

6.Contents of the pack and additional information

If Tenofovir Disoproxil Teva has been prescribed for your child, please note that all the information in this leaflet is directed at your child (in this case, read “your child” instead of “you”).

Teva Tenofovir Disoproxilcontains the active ingredienttenofovir disoproxil. This active ingredient is anantiretroviralor antiviral medication that is used to treat HIV infection, or HBV, or both. Tenofovir is anucleotide reverse transcriptase inhibitor,commonly known as NRTI, which acts by interfering with the normal function of certain enzymes (in the case of HIV thereverse transcriptaseand in hepatitis B theDNA polymerase) that are essential for the viruses to replicate. For the treatment of HIV infection,Teva Tenofovir Disoproxilmust be used always in combination with other medications.

Tenofovir Disoproxil Teva tablets are a medication used to treat HIV infection(human immunodeficiency virus). The tablets are suitable for:

• adults
• adolescents between 12 and less than 18 years who have already been treatedwith other HIV medications that are no longer fully effective due to the development of resistance, or that have caused adverse effects.

Tenofovir Disoproxil Teva tablets are also used to treat chronic hepatitis B, a HBV infection. The tablets are suitable for:

• adults
• adolescents between 12 and less than 18 years.

You do not need to have HIV to be treated withTenofovir Disoproxil Tevafor HBV.

This medication is not a cure for HIV infection. While takingTenofovir Disoproxil Tevayou may still get infections or other diseases associated with HIV infection.

You may also continue to transmit HIV or HBV to others. Therefore, it is essential to take precautions to avoid infecting others.

Do not take Tenofovir Disoproxil Teva

-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 Disoproxil Teva.

Warnings and precautions

• Tenofovir Disoproxil Tevadoes 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 take Tenofovir Disoproxil Teva

• If you have had kidney disease or if your tests have shown kidney problems, consult your doctor or pharmacist.Tenofovir Disoproxil Tevashould not be administeredto adolescents with existing kidney problems. Before starting treatment, your doctor may request that blood tests be done to evaluate the functioning of your kidneys.Tenofovir Disoproxil Tevamay affect your kidneys during treatment. Your doctor may request that blood tests be done during treatment to monitor the functioning 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 Disoproxil Tevais usually not taken with other medicines that may damage your kidneys (seeTaking Tenofovir Disoproxil Teva with other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.

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

You may also experience bone 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 or the child's doctor if you or the child has 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.

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 combined 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 combined antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and 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.

• Discuss with your doctor if you have a history of liver disease, including hepatitis.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 develop another type of infection, you may experience symptoms of infection and inflammation or worsening of existing infection symptoms when starting treatment withTenofovir Disoproxil Teva. These symptoms may indicate that your improved immune system is fighting the infection. Be aware if you develop signs of inflammation or infection after starting to takeTenofovir Disoproxil Teva. If you notice signs of inflammation or infection, inform your doctor immediately.

In addition to 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 HIV treatment. Autoimmune disorders may appear many months after starting 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 body trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

• If you are over 65 years old, inform your doctor or pharmacist.Tenofovir Disoproxil Tevahas not been studied in patients over 65 years old. If you are over this age and have been prescribedTenofovir Disoproxil Teva, your doctor will monitor you carefully.

Children and adolescents.

Tenofovir Disoproxil Tevaisappropriatefor:

• 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 caused side effects.
• adolescents infected with HBV between 12 and less than 18 years old who weigh at least 35 kg.

Tenofovir Disoproxil Tevais notappropriate for the following groups:

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

To know the dose, see section 3,How to take Tenofovir Disoproxil Teva.

Other medicines and Tenofovir Disoproxil TevaInform your doctor or pharmacist if you are taking,have takenrecentlyor may have to take any other medicine.

• Do not stop taking any HIV medicine prescribed by your doctor when starting treatment withTenofovir Disoproxil Tevaif you have HBV and HIV.
• Do not take Tenofovir Disoproxil Tevaif you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not takeTenofovir Disoproxil Tevawith medicines that contain dipivoxil of adefovir (a medicine used to treat chronic hepatitis B).
• It is very important that you tell your doctor if you are taking other medicines that may damage your kidneys.

These medicines include:

• 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 treat cancer),
• dipivoxil of adefovir (used to treat HBV infection),
• tacrolimus (used to produce immune suppression),
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

• Other medicines that contain didanosine (for HIV infection):TakingTenofovir Disoproxil Tevawith other antiviral medicines that contain didanosine may increase didanosine levels in your blood and reduce CD4 cell count. When taken together, medicines that contain tenofovir disoproxil and didanosine have been reported in rare cases to cause pancreatitis and lactic acidosis (excess lactic acid in the blood), in some cases fatal. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

• It is also important that you inform your doctorif you are taking ledipasvir/sofosbuvir,sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevirto treat hepatitis C virus infection.

Taking Tenofovir Disoproxil Teva with food and drinks

Take Tenofovir Disoproxil Teva with food(e.g. a meal or a snack).

Pregnancy and breastfeeding

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

.

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

For adult patients:

• If you are a mother with HBV and your baby has been treated to prevent 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

• Do not recommend that women living 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.

For adolescents/pediatric patients:

• If the girl has HBV and her baby has been treated to prevent transmission of hepatitis B at birth, it is possible that the girl may breastfeed her infant, but first speak with the girl's doctor to get more information.

• Do not recommend that mothers living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk. If your daughter is breastfeeding or plans to breastfeed, you mustconsult your doctor as soon as possible.

Driving and operating machines

Tenofovir Disoproxil Tevamay cause dizziness. If you experience dizziness during treatment withTenofovir Disoproxil Teva,do not drive or ride a bikeor operate tools or machines.

Tenofovir Disoproxil Teva containslactose and sodium

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

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

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

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 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 an adult and have kidney problems,your doctor may advise you to takeTenofovir Disoproxilo Tevaless 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 Teva than you should

?If you accidentally took too many tablets ofTenofovir Disoproxilo Teva, you may be at a higher risk of experiencing possible side effects with this medication (see section 4,Possible side effects). Consult your doctor or go to the nearest emergency service. Bring the bottle, blister pack or tablet container with you so that you can easily describe what you have taken.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Tenofovir Disoproxilo Teva

It is important not to forget a dose ofTenofovir Disoproxilo Teva. If you forget a dose, determine how long it has been since you should have taken it.

• If it is less than 12 hourssince when you take it normally, take it as soon as you can, and then take your next dose at your usual time.

• If it is more than 12 hourssince 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 before 1 hour after taking Tenofovir Disoproxilo Teva,take another tablet. You do not need to take another tablet if you vomited more than an hour after takingTenofovir Disoproxilo Teva.

If you interrupt the treatment with Tenofovir Disoproxilo Teva

Do not stop takingTenofovir Disoproxilo Tevawithout your doctor telling you to. Stopping treatment withTenofovir Disoproxilo Tevamay 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 withTenofovir Disoproxilo Tevawithout talking to your doctor first. After interrupting treatment withTenofovir Disoproxilo Teva, 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 takingTenofovir Disoproxilo Tevafor any reason, particularly if you experience any side effect or have another illness.

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

• Contact your doctor before restarting the tablets ofTenofovir Disoproxilo Teva.

If you have any other questions 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 health recovery and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication may produce side effects, although not all people will experience them.

Severe side effects: inform your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare but severe side effect that can be fatal. The following side effects may be signs of lactic acidosis:

• Deep and rapid breathing
• Drowsiness
• Nausea, vomiting, and stomach pain

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

Other possible severe side effects

The following side effects areinfrequent(may affect up to 1 in 100 people):

• Abdominal pain(abdominal cramps) caused by pancreatitis inflammation
• Damage to kidney cells.

The following side effects arerare(may affect up to 1 in 1,000 people):

• Renal inflammation,increased urine volume, and sensation of thirst
• Changes inyoururineandback paindue to kidney problems, including renal failure
• Weakness of the bones (withbone painand sometimes ending in fractures), which may occur due to damage to kidney cells.
• Fatty liver

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

More frequent side effects

The following side effects arevery frequent(may affect more than 1 in 10 people):

• Diarrhea, vomiting, nausea, dizziness, rash, feeling weak

Analyses may also show:

• Decreased level of phosphates in blood

Other possible side effects

The following side effects arecommon(may affect up to 1 in 10 people):

• Headache, stomach pain, feeling tired, feeling bloated, flatulence, bone loss

Analyses may also show:

• Liver problems

The following side effects areinfrequent(may affect up to 1 in 100 people):

• Muscle rupture, muscle pain or weakness

Analyses may also show:

• Decreased levels of potassium in blood
• Increased creatinine in blood
• Problems with the pancreas

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

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

• Abdominal pain (abdominal cramps) caused by liver inflammation
• Swelling of the face, lips, tongue, or throat

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 this prospectus.You can also report them directlythrough the Spanish System for Pharmacovigilance of human use medicines: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofTenofovir Disoproxil Teva

• The active ingredient istenofovir. Each tablet contains 245 mg of tenofovir disoproxil (as phosphate).
• The other excipients are:

• Tablet core:microcrystalline cellulose, lactose monohydrate, pregelatinized cornstarch, hydrogenated vegetable oil, and sodium lauryl sulfate
• Coating:partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), aluminum lake indigo carmine (E132), and carmine acid (E120)

See section 2 “Tenofovir Disoproxil Tevacontains lactose”

Appearance of the product and contents of the package

Tenofovir Disoproxil Tevaare film-coated tablets of a light blue to blue color, oval, 16.6 mm in length, and 8.9 mm in width, marked with “T” on one face, and the other face is flat.

Tenofovir DisoproxilTeva is available in blisters containing 30 or 90 tablets, single-dose packs containing 30x1 or 90x1 tablets, in a clinical pack of 10x1 tablets, and in bottles containing 30 or 90 (3x30) tablets.

The bottles contain one or two silica gel desiccants in the form of cartridges. Please do not swallow.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer

TEVA Gyógyszergyár Zrt. (Teva Pharmaceutical Works Private Limited Company)

Debrecen, Pallagi út 13,

H-4042, Hungary

or

Merckle GmbH

Ludwig-Merckle-Straße 3, Blaubeuren

89143, Germany

or

Teva Pharma B.V.

Swensweg 5, Haarlem

2031 GA, Netherlands

or

Teva Operations Poland Sp. z o.o.

Ul. Mogilska 80

31-546 Kraków

Poland

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

Austria:Tenofovir ratiopharm 245mg Filmtabletten

Germany:Tenofovirdisoproxil-ratiopharm 245 mg Filmtabletten

Denmark:Tenofovir disoproxil Teva

Spain:Tenofovir Disoproxil Teva 245 mg film-coated tablets

France:Tenofovir disoproxil Teva 245 mg, coated tablet

Ireland:Tenofovir Disoproxil Teva 245 mg Film-coated Tablets

Italy:Tenofovir Disoproxil Teva 245 mg compresse rivestite con film

Luxembourg:Tenofovirdisoproxil-ratiopharm 245 mg Filmtabletten

Latvia:Tenofovir Disoproxil Teva 245 mgfilm-coated tablets

Netherlands:Tenofovirdisoproxil Teva 245 mg, filmomhulde tabletten

Portugal:Tenofovir Teva, 245 mg Comprimidos revestidos por película

Sweden:Tenofovir disoproxil Teva

Date of the last review of this leaflet: April 2024

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