Tenofovir disoproxil Teva 245 mg film-coated tablets EFG

Patient Information Leaflet

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, 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

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

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

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

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

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

• adults
• adolescents aged 12 to less than 18 years who have previously been treated with other HIV medicines 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, an infection caused by HBV (hepatitis B virus). The tablets are suitable for:

• adults
• adolescents aged 12 to 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 taking Tenofovir Disoproxil Teva, you may still develop infections or other illnesses associated with HIV infection.

You may also continue to transmit HIV or HBV to others. Therefore, it is important that you take precautions to avoid infecting other people.

2. What you need to know before starting 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, contact your doctor immediately and do not take Tenofovir Disoproxil Teva.

Warnings and precautions

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

Talk to your doctor or pharmacist before starting to take Tenofovir Disoproxil Teva

• If you have had kidney disease or if your laboratory tests have shown kidney problems, consult your doctor or pharmacist. Tenofovir Disoproxil Teva should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may request blood tests to assess how well your kidneys are working. Tenofovir Disoproxil Teva may affect your kidneys during treatment. Your doctor may request periodic blood tests during treatment to monitor kidney function. If you are an adult, your doctor may advise taking the tablets less frequently. Do not reduce the prescribed dose unless your doctor has instructed you to do so.

Tenofovir Disoproxil Teva is generally not taken together with other medicines that may harm your kidneys (see Taking 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.

Bone problems (manifesting as persistent or worsening bone pain, and sometimes leading to fractures) may also occur due to damage to renal tubule cells (see section 4, Possible side effects). Inform your doctor or the child's doctor if you or the child experience bone pain or fractures.

Tenofovir disoproxil may also cause loss of bone mineral density. More pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

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

• Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Numerous risk factors for developing this condition include duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include joint stiffness, pain, discomfort (especially in the hip, knee, or shoulder), and difficulty moving. If you notice any of these symptoms, inform 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, treated with antiretrovirals, have an increased risk of serious 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 perform blood tests to monitor your liver function.

• Infections. If you have advanced HIV infection (AIDS) and have another type of infection, you may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when you start treatment with Tenofovir Disoproxil Teva. These symptoms may indicate that your improved immune system is fighting the infection. Be aware of any signs of inflammation or infection after starting Tenofovir Disoproxil Teva. If you notice signs of inflammation or infection, contact your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you have started taking medicines for your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, ascending weakness starting in the hands and feet and moving toward the trunk, palpitations, tremors, or hyperactivity, contact your doctor immediately for appropriate treatment.

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

Children and adolescents

Tenofovir Disoproxil Teva is suitable for:

• HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have previously been treated with other HIV medicines that are no longer fully effective due to resistance development, or that have caused adverse effects.
• Hepatitis B infected adolescents aged 12 to less than 18 years who weigh at least 35 kg.

Tenofovir Disoproxil Teva is not suitable for the following groups:

• not for HIV-1 infected children under 12 years of age.
• not for hepatitis B infected children under 12 years of age.

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

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

• Do not stop taking any anti-HIV medicines prescribed by your doctor when starting treatment with Tenofovir Disoproxil Teva if you have both HBV and HIV.
• Do not take Tenofovir Disoproxil Teva if you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Disoproxil Teva together with medicines containing 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 harm 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),

• adefovir dipivoxil (used to treat HBV infection),

• tacrolimus (used to induce immune suppression),

• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

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

• It is also important that you inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir for the treatment of hepatitis C virus infection.

Taking Tenofovir Disoproxil Teva with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• If you have been taking Tenofovir Disoproxil Teva during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV outweighed 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, breastfeeding may be possible, but first speak with your doctor for further advice.

• Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

For adolescent/pediatric patients:

• If the girl has HBV and her baby has been treated to prevent transmission of hepatitis B at birth, she may be able to breastfeed, but first speak with the girl's doctor for further advice.

• Breastfeeding is not recommended for mothers living with HIV because HIV infection can be transmitted to the baby through breast milk. If your daughter is breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

Tenofovir Disoproxil Teva may cause dizziness. If you experience dizziness during treatment with Tenofovir Disoproxil Teva, do not drive or ride a bicycle or operate tools or machinery.

Tenofovir Disoproxil Teva contains lactose and sodium

If your doctor has informed 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”.

3. How to take Tenofovir Disoproxil Teva

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults: 1 tablet daily with food (for example, a meal or a snack).
• Adolescents between 12 and under 18 years of age weighing at least 35 kg: 1 tablet daily with food (for example, a meal or a snack).

?If you have particular difficulty swallowing, you may 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 immediately.

• Always take the dose prescribed by your doctor. This is to ensure that your medicine is fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless your doctor tells you to do so.

• If you are an adult with kidney problems, your doctor may advise you to take Tenofovir Disoproxil Teva less frequently.

• If you have HBV, your doctor may offer you an HIV test to determine whether you have both HBV and HIV.

Refer to the package leaflets of other antiretrovirals for instructions on how to take those medicines.

If you take more Tenofovir Disoproxil Teva than you should

?If you accidentally took too many Tenofovir Disoproxil Teva tablets, you may be at increased risk of experiencing possible adverse effects with this medicine (see section 4, Possible adverse effects). Contact your doctor or go to the nearest emergency department. Bring the bottle, blister pack, or carton with you so you can clearly describe what you have taken.

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

If you forget to take Tenofovir Disoproxil Teva

It is important not to miss a dose of Tenofovir Disoproxil Teva. If you forget a dose, determine how long it has been since you were supposed to take it.

• If it is less than 12 hours since you normally take it, take it as soon as possible, then take your next dose at the usual time.

• If it is more than 12 hours since 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 a missed dose.

If you vomit within 1 hour after 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 your doctor's instruction. Stopping treatment with Tenofovir Disoproxil Teva may reduce the effectiveness of the treatment prescribed by your doctor.

If you have hepatitis B, or HIV and hepatitis B (coinfection), it is very important that you do not stop treatment with Tenofovir Disoproxil Teva without first talking to your doctor. After stopping treatment with Tenofovir Disoproxil Teva, some patients have had blood test results 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, stopping treatment is not recommended, as this may lead to a worsening of hepatitis.

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

• Contact your doctor immediately if you experience any new or unusual symptoms after stopping treatment, particularly symptoms related to hepatitis B virus infection.

• Contact your doctor before restarting Tenofovir Disoproxil Teva tablets.

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

4. Possible side effects

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious possible side effects: tell your doctor immediately

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

• deep, rapid breathing

• drowsiness

• nausea, vomiting, and stomach pain

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

Other possible serious side effects

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

• abdominal pain (stomach pain) caused by inflammation of the pancreas
• damage to renal tubule cells

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

• inflammation of the kidney, increased urine volume and feeling thirsty
• changes in your urine and back pain due to kidney problems, including kidney failure
• weakening of the bones (with bone pain, sometimes leading to fractures), which may occur due to damage to renal tubule cells
• fatty liver

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

More common side effects

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

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

Blood tests may also show:

• decreased blood phosphate levels

Other possible side effects

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

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

Blood tests may also show:

• liver problems

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

• muscle rupture, muscle pain or weakness

Blood tests may also show:

• decreased blood potassium levels
• increased blood creatinine
• pancreas problems

Muscle rupture, weakening of the bones (with bone pain, sometimes leading to fractures), muscle pain, muscle weakness, and decreased blood potassium or phosphate levels may occur due to damage to renal tubule cells.

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

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

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tenofovir Disoproxil Teva

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

Do not use this medicine after the expiry date stated on the blister or bottle and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tenofovir Disoproxil Teva

• The active substance is tenofovir. Each tablet contains 245 mg of tenofovir disoproxil (as phosphate).

• The other components are:

• Tablet core: microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, hydrogenated vegetable oil and sodium lauryl sulfate

• Film coating: polyvinyl alcohol, partially hydrolysed (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), indigo carmine aluminium lake (indigo carmine) (E132) and carminic acid (E120)

See section 2 “Tenofovir Disoproxil Teva contains lactose”

Appearance of the product and contents of the pack

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

Tenofovir Disoproxil Teva is available in blister packs containing 30 or 90 tablets, unit dose packs containing 30x1 or 90x1 tablets, clinical packs containing 10x1 tablets, and bottles containing 30 or 90 (3x30) tablets.

The bottles contain one or two silica gel desiccant cartridges. Please do not swallow.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 Operations Poland Sp. z o.o.

Ul. Mogilska 80

31-546 Kraków

Poland

This medicine is authorised 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 Disoproxilo Teva 245 mg film-coated tablets EFG

France: Tenofovir disoproxil Teva 245 mg, comprimé pelliculé

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 mg apvalkotas tabletes

Netherlands: Tenofovirdisoproxil Teva 245 mg, filmomhulde tabletten

Portugal: Tenofovir Teva, 245 mg Comprimidos revestidos por película

Sweden: Tenofovir disoproxil Teva

Date of the most recent revision of this leaflet: April 2024

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