TENOFOVIR DISOPROXIL AUROVITAS 245 mg FILM-COATED TABLETS

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 is the case, tell 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 avoid this.

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 should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may ask you to have blood tests to assess your kidney function. Tenofovir can affect your kidneys during treatment. Your doctor may ask you to have blood tests during treatment to monitor your 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 tells you to.

Tenofovir is not usually taken with other medicines that can 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 (which manifest as persistent or worsening bone pain and sometimes result in fractures) can also occur due to damage to the renal tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.

Tenofovir disoproxil can also cause bone mass loss. The most significant bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a protease inhibitor.

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

Some adult patients with HIV who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by 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 hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, tell your doctor.

• Tell 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 serious 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 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 the symptoms of an existing infection when you start treatment with tenofovir. These symptoms may indicate that your immune system is improving and fighting the infection. Watch for signs of inflammation or infection soon after starting to take tenofovir. 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) can also occur after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders can occur many months after starting treatment. If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves up to the torso, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

• If you are over 65 years old, tell your doctor or pharmacist. Tenofovir has not been studied in patients over 65 years old. If you are over this age and have been prescribed tenofovir, your doctor will monitor you closely.

Children and adolescents

Tenofovir is suitable for:

• adolescents infected with HIV-1 between 12 and less than 18 years who weigh at least 35 kg and have already been treated with 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 is not suitable for the following groups:

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

To know the dose, see section 3, How to take Tenofovir disoproxil Aurovitas.

Other medicines and Tenofovir disoproxil Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Do not stop taking any anti-HIV medicines prescribed by your doctor when you start treatment with tenofovir if you have 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 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 can 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 immune system suppression).
• non-steroidal 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 can increase the levels of didanosine in the 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 lactic acid in the blood) have been reported, 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 tell 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 drinks

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 been taking tenofovir during 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 NtRTIs 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, you may be able to breastfeed your infant, but first talk to your doctor for 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 thinking of breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

Tenofovir can cause dizziness. If you feel dizzy during treatment with tenofovir, do not drive or ride a bicycleor operate tools or machines.

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 them before taking this medicine.

Tenofovir disoproxil Aurovitas contains sodium

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

3. How to take Tenofovir disoproxil Aurovitas

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 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 juice, or grape juice, and drink it immediately.

• Always take the dose recommended by your doctor. This is to ensure that your medicine 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 HBV, your doctor may offer you an HIV test to see if you have HBV and HIV.

Consult the leaflets of the other antiretrovirals to know how to take these medicines.

If you take more Tenofovir disoproxil Aurovitas than you should

If you accidentally took too many tenofovir tablets, you may be at a higher risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Consult your doctor or go to the nearest emergency department.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

Bring the package with you so that you can easily describe what you have taken.

If you forget to take Tenofovir disoproxil Aurovitas

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

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

• If it is more than 12 hours since you should have taken 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 the missed doses.

If you vomit before 1 hour has passed 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 treatment with Tenofovir disoproxil Aurovitas

Do not stop taking tenofovir without your doctor telling you to. 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 (co-infection), it is crucial that you do not stop your treatment with tenofovir without first talking to your doctor. After stopping treatment with tenofovir, some patients have had blood tests or symptoms indicating that their hepatitis had 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 can lead to worsening of hepatitis.

• Talk to your doctor before stopping tenofovir for any reason, especially if you experience any side effects or have another illness.
• Talk to your doctor immediately if you experience any new or unusual symptoms after stopping your treatment, especially those symptoms that you relate to hepatitis B virus infection.
• Contact your doctor before restarting tenofovir tablets.

If you have any other 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 glucose and lipid levels 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 patients) 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 patients):

• 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 patients):

• kidney inflammation, increased urine volume, and feeling of thirst.
• changes in 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 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 patients):

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

Lab tests may alsoshow:

• decrease in 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, bone mass loss.

Lab tests may alsoshow:

• liver problems.

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

• muscle rupture, muscle pain or weakness.

Lab tests may alsoshow:

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

Muscle rupture, bone weakening (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 Medication Surveillance System for Human Use: 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 Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle, packaging, or blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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 of Tenofovir Disoproxil Aurovitas

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

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

Tablet coating: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 and Package Contents of the Product

Blue, oval, biconvex film-coated tablets with "300" marked on one side and "T" on the other.

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

Package sizes:

Blister pack:30 film-coated tablets.

HDPE bottles:30, 90, and 90 (3x30) film-coated tablets.

Not all package 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

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 medication is authorized in the member states of the European Economic Area under the following names:

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 Health Products (AEMPS) (http://www.aemps.gob.es/).