Tenofovir disoproxil Aurovitas 245 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tenofovir disoproxil Aurovitas 245 mg film-coated tablets EFG

Read the entire 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

If tenofovir has been prescribed for your child, please note that all information in this leaflet refers to your child (in this case, read "your child" instead of "you").

1. What Tenofovir disoproxil Aurovitas is and what it is used for

Tenofovir 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, 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 must always be used in combination with other medicines.

Tenofovir is 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 anti-HIV medicines that are no longer fully effective due to the development of resistance, or that have caused adverse effects.

Tenofovir is 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 infection to be treated with tenofovir for HBV.

This medicine is not a cure for HIV infection. While taking tenofovir, you may still develop infections or other illnesses associated with HIV infection. You may also continue to transmit HBV to others. Therefore, it is important that you take precautions to avoid infecting other people.

2. What you need to know before taking Tenofovir disoproxil Aurovitas

Do not take Tenofovir disoproxil Aurovitas

• 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, inform your doctor immediately and do not take tenofovir.

Warnings and precautions

Tenofovir disoproxil does not reduce the risk of transmission of HBV through sexual contact or blood contamination. You must continue to take precautions to prevent transmission.

Consult your doctor or pharmacist before starting to take Tenofovir disoproxil Aurovitas.

• If you have had kidney disease or if your blood tests have shown kidney problems. Tenofovir must not be administered to adolescents with pre-existing kidney problems. Before starting treatment, your doctor may request blood tests to assess how well your kidneys are working. Tenofovir may affect your kidneys during treatment. Your doctor may request regular blood tests during treatment to monitor kidney function. 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 instructed you to do so.

Tenofovir is generally not taken together with other medicines that may harm your kidneys (see Other medicines and Tenofovir disoproxil Aurovitas). 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 if you experience bone pain or fractures.

Tenofovir disoproxil may also cause loss of bone mineral density. The most 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 uncertain.

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, and discomfort (particularly in the hip, knee, and 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. These symptoms may indicate that your improved immune system is fighting the infection. Watch for signs of inflammation or infection shortly after starting tenofovir. If you notice signs of inflammation or infection, inform 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 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, weakness beginning in the hands and feet and moving up toward the 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 has not been studied in patients over 65 years of age. If you are older than this and have been prescribed tenofovir, your doctor will monitor you closely.

Children and adolescents

Tenofovir is suitable for:

• Adolescents infected with HIV-1 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.
• Adolescents infected with HBV aged 12 to less than 18 years who weigh at least 35 kg.

Tenofovir is not suitable for the following groups:

• Not for children infected with HIV-1 under 12 years of age.
• Not for children infected with HBV under 12 years of age.

For dosage information, see section 3, How to take Tenofovir disoproxil Aurovitas.

Other medicines and Tenofovir disoproxil Aurovitas

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 tenofovir treatment if you have both HBV and HIV.

• Do not take tenofovir if you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take tenofovir 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 produce immunosuppression).

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

• Other medicines containing didanosine (for HIV infection): Taking tenofovir with other antiviral medicines containing didanosine may increase levels of didanosine in the 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 medicines containing 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 to treat hepatitis C virus infection.

Taking Tenofovir disoproxil Aurovitas with food and drink

Take tenofovir with food (for example, 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 taken tenofovir during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took TDF during pregnancy, the benefit of protection against HIV outweighed the risk of adverse effects.
• If you are a mother with HBV infection, and your baby has been treated to prevent transmission of hepatitis B at birth, you may be able to breastfeed, but discuss this with your doctor first to get more information.
• 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 should consult your doctor as soon as possible.

Driving and using machines

Tenofovir may cause dizziness. If you feel dizzy during treatment with tenofovir, do not drive or ride a bicycle or operate tools or machinery.

Tenofovir disoproxil Aurovitas contains lactose

This medicine contains lactose monohydrate. If your doctor has informed 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 unit; this is essentially “sodium-free”.

3. How to take Tenofovir Disoproxil Aurovitas

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

Recommended dose:

• Adults: 1 tablet daily, with food (for example, a meal or a snack).
• Adolescents aged 12 to less than 18 years 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 recommended 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 and have kidney problems, your doctor may advise you to take tenofovir 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 Aurovitas than you should

If you accidentally take too many tenofovir tablets, you may have an 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

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

If you forget to take Tenofovir Disoproxil Aurovitas

It is important not to miss a dose of tenofovir. 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 the missed dose 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 missed doses.

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

If you stop taking Tenofovir Disoproxil Aurovitas

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

If you have hepatitis B, or HIV and hepatitis B (coinfection), it is very important not to stop your treatment with tenofovir without first speaking to your doctor. After stopping treatment with tenofovir, 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, stopping treatment is not recommended, as this may lead to a worsening of hepatitis.

• Talk to your doctor before stopping tenofovir 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 tablets.

If you have any further questions about 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 in blood glucose and lipid levels. This may be partly related to improved health, lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Possible serious adverse effects: inform your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare adverse effect (may affect up to 1 in 1,000 patients) but serious, and can be life-threatening. The following adverse 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 adverse effects

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

• abdominal pain caused by inflammation of the pancreas.
• damage to renal tubule cells.

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

• kidney inflammation, increased urine volume, and sensation of thirst.
• changes in your urine and back pain due to kidney problems, including kidney failure.
• bone weakening (with bone pain and sometimes resulting in fractures), which may occur due to damage to renal tubule cells.
• fatty liver.

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

More common adverse effects

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

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

Blood tests may also show:

• decreased blood phosphate levels.

Other possible adverse effects

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

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

Blood tests may also show:

• liver problems.

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

• muscle rupture, muscle pain, or muscle weakness.

Blood tests may also show:

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

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

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

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

Reporting of adverse effects

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

5. Storage of Tenofovir Disoproxil Aurovitas

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

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

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tenofovir Disoproxil Aurovitas

• The active substance is tenofovir disoproxil. Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).
• The other components are:

Tablet core: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, and magnesium stearate.

Tablet coating: hypromellose 2910, lactose monohydrate, titanium dioxide (E171), triacetin, FD&C Blue No. 2 aluminium lake (3-5%) EHD (E132), and FD&C Blue No. 2 aluminium lake (3-5%) SEN (E132).

Appearance of the product and contents of the pack

Film-coated blue, oval, biconvex tablets, marked “300” on one side and “T” on the other.

Tenofovir Disoproxil Aurovitas film-coated tablets are available in blister packs and HDPE bottles.

Pack sizes:

Blister packs: 30 film-coated tablets.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19, Venda Nova

2700-487 Amadora

Portugal

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

Germany:	Tenofovirdisoproxil PUREN 245 mg Film tablets
Spain:	Tenofovir disoproxil Aurovitas 245 mg film-coated tablets EFG
France:	TENOFOVIR DISOPROXIL ARROW 245 mg, film-coated tablet
Italy:	Tenofovir disoproxil Aurobindo
Netherlands:	Tenofovirdisoproxil Aurobindo 245mg, film-coated tablets
Poland:	Tenofovir disoproxil Aurovitas
Portugal:	Tenofovir Aurobindo

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

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