TENOFOVIR DISOPROXIL TEVA 245 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tenofovir Disoproxil Teva 245 mg Film-Coated Tablets EFG

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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tenofovir Disoproxil Teva and what is it used for
2. What you need to know before you take 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 other information

If Tenofovir Disoproxil Teva has been prescribed to your child, please note that all the information in this leaflet that refers to ‘you’ also applies to your child (in this case, read ‘your child’ instead of ‘you’).

1. What is Tenofovir Disoproxil Teva and what is it used for

Tenofovir Disoproxil Teva contains the active substance tenofovir disoproxil. This active substance is an antiretroviralor antiviral medicine used to treat HIV infection, or HBV, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, also known as NtRTI, which works by interfering with the normal functioning of enzymes (in the case of HIV, reverse transcriptase, and in hepatitis B, DNA polymerase) that are essential for the viruses to reproduce. For the treatment of HIV infection, Tenofovir Disoproxil Teva must always be used in combination with other medicines.

Tenofovir Disoproxil Teva tablets are a medicine 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 medicines that are no longer fully effective due to the development of resistance, or that have caused side effects.

Tenofovir Disoproxil Teva tablets are also used to treat chronic hepatitis B, an infection caused by the HBV(hepatitis B virus). The tablets are suitable for:

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

You do not need to have HIV to be treated with Tenofovir Disoproxil Teva for HBV.

This medicine is not a cure for HIV infection. While you are taking Tenofovir Disoproxil Teva, you may still develop infections or other illnesses associated with HIV.

You can also still pass on HIV or HBV to others when taking this medicine. It is therefore very important that you use precautions to avoid infecting others.

2. What you need to know before you take Tenofovir Disoproxil Teva

Do not take Tenofovir Disoproxil Teva

• if you are allergic to tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6.

If this applies to you, tell your doctor immediately and do not take Tenofovir Disoproxil Teva.

Warnings and precautions

• Tenofovir Disoproxil Teva does not reduce the risk of transmission of HBV through sexual contact or blood contamination. You must continue to take precautions to avoid this.

Talk to your doctor or pharmacist before you start taking Tenofovir Disoproxil Teva

• If you have had kidney disease or if your blood tests have shown kidney problems, talk to your doctor or pharmacist.Tenofovir Disoproxil Teva should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may ask you to have blood tests to check that your kidneys are working properly. Tenofovir Disoproxil Teva can affect your kidneys during treatment. Your doctor may ask you to have blood tests during treatment to check that your kidneys are working properly. If you are an adult, your doctor may advise you to take the tablets less often. Do not reduce the dose yourself, unless your doctor has told you to.

Tenofovir Disoproxil Teva is not normally taken with other medicines that can damage your kidneys (see Taking Tenofovir Disoproxil Teva with other medicines). If this is unavoidable, your doctor will check your kidney function once a week.

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

Problems in the bones (which show up as persistent or worsening bone pain and sometimes result in fractures) may also occur due to damage to the kidney tubule cells (see section 4, Possible side effects). Tell your doctor or your child’s doctor if you or your child have bone pain or fractures.

Tenofovir disoproxil can also cause bone loss. The greatest bone loss was seen in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

Generally, the effects of tenofovir disoproxil on long-term bone health and the risk of future fractures in adult and pediatric patients are not known.

• Some adult patients with HIV who are taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone).Among the many risk factors for developing this disease are the duration of combination 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 hips, knees, and shoulders), and difficulty moving. If you notice any of these symptoms, tell your doctor.

• Talk to your doctor if you have a history of liver disease, including hepatitis.Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretrovirals have a higher risk of severe and potentially life-threatening 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 perform blood tests to check your liver function.

• Infections.If you have advanced HIV infection (AIDS) and you have an infection, you may develop symptoms of infection or inflammation, or worsening of the symptoms of an existing infection when you start taking Tenofovir Disoproxil Teva. These symptoms may indicate that your immune system is improving and starting to fight the infection. Be aware of these signs of inflammation or infection when you start taking Tenofovir Disoproxil Teva. If you notice signs of inflammation or infection, tell your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders can occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves up towards the trunk of the body, palpitations, tremors, or hyperactivity, tell your doctor immediatelyto receive the necessary treatment.

• If you are over 65 years of age, tell your doctor or pharmacist.Tenofovir Disoproxil Teva has not been studied in patients over 65 years of age. If you are over 65 and have been prescribed Tenofovir Disoproxil Teva, your doctor will monitor you carefully.

Children and adolescents.

Tenofovir Disoproxil Teva is suitablefor:

• adolescents infected with HIV-1 between 12 and less than 18 years 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 who weigh at least 35 kg.

Tenofovir Disoproxil Teva is notsuitable for the following groups:

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

For dosage information, see section 3, How to take Tenofovir Disoproxil Teva.

Other medicines and Tenofovir Disoproxil TevaTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Do not stop taking any anti-HIV medicinesprescribed by your doctor when you start taking Tenofovir Disoproxil Teva if you have HBV and HIV.
• Do not take Tenofovir Disoproxil Tevaif you are already taking medicines that contain tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Disoproxil Teva with medicines that contain adefovir dipivoxil (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 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),
• adefovir dipivoxil (used to treat HBV infection),
• tacrolimus (used to produce immune system suppression),
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).

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

• It is also important that you tell your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Tenofovir Disoproxil Teva with food and drink

Take Tenofovir Disoproxil Teva with food(for example, a meal or a snack).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

.

• If you have been taking Tenofovir Disoproxil Tevaduring your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests 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 side effects.

For adult patients:

• If you are a mother with HBV and your baby has been treated to prevent hepatitis B transmission at birth,you may be able to breast-feed your baby, but first talk to your doctor for more information.

• It is not recommended that women with HIV breast-feed their babiesbecause HIV can be passed on to the baby through breast milk. If you are breast-feeding or thinking of breast-feeding, talk to your doctor as soon as possible.

For adolescents/pediatric patients:

• If the girl has HBV and her baby has been treated to prevent hepatitis B transmission at birth,she may be able to breast-feed her baby, but first talk to her doctor for more information.

• It is not recommended that mothers with HIV breast-feed their babiesbecause HIV can be passed on to the baby through breast milk. If your daughter is breast-feeding or thinking of breast-feeding, she should talk to her doctor as soon as possible.

Driving and using machines

Tenofovir Disoproxil Teva may cause dizziness. If you feel dizzy when taking Tenofovir Disoproxil Teva, do not drive or ride a bicycleor use tools or machines.

Tenofovir Disoproxil Teva containslactose and sodium

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

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

3. How to take Tenofovir Disoproxil Teva

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

The recommended dose is:

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

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 juice, or grape juice, and drink it immediately.

• Always take the dose recommended by your doctor.This is to ensure that your medicine is fully 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 Disoproxil Teva less often.

• If you have HBV, your doctor may offer you an HIV test to see if you have HBV and HIV.

Talk to your doctor or pharmacist if you have any questions about how to take your other antiretroviral medicines.

If you take more Tenofovir Disoproxil Teva than you should

If you accidentally take too many Tenofovir Disoproxil Teva tablets, you may be at a higher risk of experiencing side effects with this medicine (see section 4, Possible side effects). Talk to your doctor or go to the nearest emergency department. Take the bottle, blister, or box of tablets with you so that you can easily describe what you have taken.

In case of overdose or accidental ingestion, contact your doctor immediately or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Tenofovir Disoproxil Teva

It is important that you do not miss a dose of Tenofovir Disoproxil Teva. If you miss a dose, determine how long ago you should have taken it.

• If it is less than 12 hourssince you were supposed to take it, take it as soon as you can, and then take your next dose at the usual time.

• If it is more than 12 hourssince you were supposed to take it, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for missed doses.

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

If you stop taking Tenofovir Disoproxil Teva

Do not stop taking Tenofovir Disoproxil Teva without talking to your doctor first. Stopping treatment with Tenofovir Disoproxil Teva may reduce the effectiveness of the treatment recommended by your doctor.

If you have hepatitis B, or HIV and hepatitis B (co-infection),it is very important that you do not stop taking Tenofovir Disoproxil Teva without first talking to your doctor. After stopping treatment with Tenofovir Disoproxil Teva, some patients have had blood tests or symptoms indicating that their hepatitis has worsened. You may need to have blood tests for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment as this may lead to worsening of hepatitis.

• Talk to your doctor before stopping Tenofovir Disoproxil Teva for any reason, especially if you experience any side effects or if you have another illness.

• Talk to your doctor immediately if you experience any new or unusual symptoms after stopping treatment, especially those symptoms that you think may be related to hepatitis B infection.

• Contact your doctor before restarting Tenofovir Disoproxil Teva tablets.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

During HIV treatment, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly related to the recovery of health 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 adverse effects, although not all people suffer from them.

Possible Serious Adverse Effects: Inform Your Doctor Immediately

• Lactic Acidosis(excess lactic acid in the blood) is a rare(may affect up to 1 in 1,000 people) but serious adverse effect that can be fatal. The following adverse effects may be signs of lactic acidosis:

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

If you think you may have lactic acidosis, contact your doctor immediately.

Other Possible Serious Adverse Effects

The following adverse effects are uncommon(may affect up to 1 in 100 people):

• abdominal pain(stomach pain) caused by pancreas inflammation
• damage to renal tubular cells.

The following adverse effects are rare(may affect up to 1 in 1,000 people):

• kidney inflammation, increased urine volume, and feeling of thirst
• changes inyour urineand back paindue to kidney problems, including kidney failure
• weakening of bones (with bone painand sometimes resulting in fractures), which may occur due to damage to renal tubular cells.
• fatty liver

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

More Frequent Adverse Effects

The following adverse effects are very common(may affect more than 1 in 10 people):

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

Lab tests may also show:

• decrease in blood phosphate levels

Other Possible Adverse Effects

The following adverse effects are common(may affect up to 1 in 10 people):

• headache, stomach pain, feeling tired, feeling bloated, flatulence, bone mass loss

Lab tests may also show:

• liver problems

The following adverse effects are uncommon(may affect up to 1 in 100 people):

• muscle rupture, muscle pain or weakness

Lab tests may also show:

• decrease in blood potassium levels
• increase in blood creatinine
• pancreas problems

Muscle rupture, weakening of bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness, and decrease in blood potassium or phosphate levels may occur due to damage to renal tubular cells.

The following adverse effects are rare(may affect up to 1 in 1,000 patients):

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tenofovir Disoproxil Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofTenofovir Disoproxil Teva

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

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

See section 2 "Tenofovir Disoproxil Teva contains lactose"

Appearance of the Product and Package Contents

Tenofovir Disoproxil Teva are film-coated tablets of light blue to blue color, oval, 16.6 mm long and 8.9 mm wide, marked on one side with "T" and the other side flat.

Tenofovir Disoproxil Teva is available in blisters containing 30 or 90 tablets, single-dose containers containing 30x1 or 90x1 tablets, in a clinical package 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 a cartridge. 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, 1ª planta,

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 medication is authorized in the Member States of the European Economic Area under 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, film-coated tablets

Ireland: Tenofovir Disoproxil Teva 245 mg Film-coated Tablets

Italy: Tenofovir Disoproxil Teva 245 mg film-coated tablets

Luxembourg: Tenofovirdisoproxil-ratiopharm 245 mg Filmtabletten

Latvia: Tenofovir Disoproxil Teva 245 mg film-coated tablets

Netherlands: Tenofovirdisoproxil Teva 245 mg, film-coated tablets

Portugal: Tenofovir Teva, 245 mg film-coated tablets

Sweden: Tenofovir disoproxil Teva

Date of the Last Revision of this Leaflet:April 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS)http://www.aemps.gob.es/