Tenofovir disoproxil Aurovitas

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tenofovir disoproxil Aurovitas (Tenofovirdisoproxil Aurobindo), 245 mg, film-coated tablets

Tenofovir disoproxil
Tenofovir disoproxil Aurovitas and Tenofovirdisoproxil Aurobindo are different trade names for the same medicine.

The patient should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Tenofovir disoproxil Aurovitas and what is it used for
• 2. Important information 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 packaging and other information

If Tenofovir disoproxil Aurovitas is prescribed to a child, all the information in this leaflet is addressed to the child (in this case, "child" should be read instead of "adult patient").

1.

What is Tenofovir disoproxil Aurovitas and what is it used for

Tenofovir disoproxil Aurovitas contains the active substance tenofovir disoproxil. This active substance is an antiretroviral medicine, i.e., an antiviral medicine used to treat HIV or HBV infection or both. Tenofovir is a nucleotide reverse transcriptase inhibitor. This substance is generally referred to as NRTI and works by disrupting the normal functioning of enzymes (in HIV, reverse transcriptase, in hepatitis B virus - DNA polymerase), which are crucial for the replication of viruses. In the case of HIV, Tenofovir disoproxil Aurovitas should always be used in combination with other medicines for the treatment of HIV infection.

Tenofovir disoproxil Aurovitas 245 mg tablets are intended for the treatment of HIV infection

(human immunodeficiency virus). The tablets are suitable for:

• •adults
• •adolescents from 12 to less than 18 years of age, previously treatedwith other HIV medicines that are no longer fully effective due to the development of resistance or have caused side effects.

Tenofovir disoproxil Aurovitas 245 mg tablets are also intended for the treatment of

chronic hepatitis B, an infection caused by HBV(hepatitis B virus). The tablets are suitable for:

• •adults
• •adolescents from 12 to less than 18 years of age.The patient does not need to have HIV to be treated with Tenofovir disoproxil Aurovitas for hepatitis B. Page 1 9

This medicine will not cure HIV infection. People taking Tenofovir disoproxil Aurovitas may still develop infections or other diseases related to HIV infection. It is also possible to transmit HBV to others, so it is essential to take precautions to avoid infecting others.

2. Important information before taking Tenofovir disoproxil Aurovitas

When not to take Tenofovir disoproxil Aurovitas

• If the patient is allergicto tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine, listed in section 6.

The patient should immediately inform their doctor and not take
Tenofovir disoproxil Aurovitas.

Warnings and precautions

Tenofovir disoproxil Aurovitas does not reduce the risk of transmitting HBV to others through sexual contact or contaminated blood. Precautions should still be taken to prevent this. Before starting treatment with Tenofovir disoproxil Aurovitas, the patient should discuss this with their doctor or pharmacist.

• If the patient has had kidney disease or if tests indicate kidney disease. Tenofovir disoproxil Aurovitas should not be given to adolescents with kidney disease. Before starting treatment, the doctor may order blood tests to assess kidney function. Tenofovir disoproxil Aurovitas may harm the kidneys during treatment. During treatment, the doctor may order blood tests to monitor kidney function. If the patient is an adult, the doctor may recommend taking the tablets less frequently. The prescribed dose should not be reduced unless the doctor recommends it.

Tenofovir disoproxil Aurovitas is not usually taken with other medicines that may harm the kidneys (see Tenofovir disoproxil Aurovitas and other medicines). If this cannot be avoided, the doctor will check kidney function every week.

• If the patient has osteoporosis, has had a bone fracture, or has bone problems.

Bone disorders(manifested as persistent or worsening bone pain, and sometimes leading to fractures) may also occur due to damage to the kidney tubule cells (see section 4, Possible side effects). If the patient experiences bone pain or fractures, they should inform their doctor.
Tenofovir disoproxil may also cause a decrease in bone mass. The most significant bone loss was observed in clinical trials where patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
Generally, the long-term effect of tenofovir disoproxil on bone health and the risk of fractures in the future in adult patients, as well as in children and adolescents, is not clear.
In some adult HIV patients taking combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone) may develop. The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and increased body mass index may be some of the risk factors for the development of the disease. Symptoms of osteonecrosis are: joint stiffness, pain (especially in the hip, knees, and shoulders), and difficulty moving. If the patient experiences any of these symptoms, they should inform their doctor.
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• If the patient has had liver disease in the past, including hepatitis, they should consult their doctor. Patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral medicines, are at increased risk of severe and potentially life-threatening side effects related to the liver. In patients with hepatitis B, the doctor will determine the most appropriate treatment. If the patient has had liver disease in the past or chronic hepatitis B, the doctor may recommend blood tests to monitor liver function.
• Protection against infections is necessary. In patients with advanced HIV infection (AIDS), when they become infected, after starting treatment with Tenofovir disoproxil Aurovitas, symptoms of infection and inflammation or worsening of existing infection symptoms may occur. These symptoms may indicate that the immune system has strengthened and is fighting the infection. Soon after starting Tenofovir disoproxil Aurovitas, the patient should be aware of symptoms of inflammation or infection. If symptoms of inflammation or infection are noticed, the doctor should be informed immediately.

In addition to opportunistic infections, autoimmune diseases (diseases that occur when the immune system attacks healthy tissues) may also occur after starting antiretroviral therapy. Autoimmune diseases may occur several months after starting treatment. If the patient notices symptoms of infection or other symptoms, such as muscle weakness, weakness starting from the hands and feet and progressing towards the torso, heart palpitations, tremors, or hyperactivity, they should contact their doctor as soon as possible to start necessary treatment.

• Patient over 65 years of age should consult their doctor or pharmacist. No studies have been conducted on Tenofovir disoproxil Aurovitas in patients over 65 years of age. Patients over this age who are prescribed Tenofovir disoproxil Aurovitas will be under medical supervision.

Children and adolescents

Tenofovir disoproxil Aurovitas 245 mg tablets are suitable for:

• HIV-1 infected adolescents from 12 to less than 18 years of age, with a body weight of at least 35 kg and previously treatedwith other HIV medicines that are no longer fully effective due to the development of resistance or have caused side effects.
• HBV infected adolescents from 12 to less than 18 years of age, with a body weight of at least 35 kg.Tenofovir disoproxil Aurovitas 245 mg tablets are not suitable for the following groups:
• not for HIV-1 infected childrenunder 12 years of age.
• not for HBV infected childrenunder 12 years of age.

Dosing, see section 3, How to take Tenofovir disoproxil Aurovitas.

Tenofovir disoproxil Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Do not stop taking HIV medicinesprescribed by the doctor when starting Tenofovir disoproxil Aurovitas, if the patient has both HBV and HIV.
• Do not take Tenofovir disoproxil Aurovitasat the same time as any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Aurovitas at the same time as medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).

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• It is very important to inform the doctor about taking other medicines that may harm the kidneys, such as:
• 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 suppress the immune system),
• non-steroidal anti-inflammatory drugs (NSAIDs, used to reduce bone or muscle pain).
• Other medicines containing didanosine (against HIV):taking Tenofovir disoproxil Aurovitas and other antiviral medicines that contain didanosine may increase the level of didanosine in the blood and may also decrease the number of CD4 cells. When taking medicines containing tenofovir disoproxil and didanosine, pancreatitis and lactic acidosis (excessive amount of lactic acid in the blood) have been rarely observed, sometimes leading to death. The doctor will carefully consider whether to use tenofovir with didanosine in the patient.
• The patient should also inform the doctorabout taking ledipasvir with sofosbuvir, sofosbuvir with velpatasvir, or sofosbuvir with velpatasvir and voxilaprevir to treat hepatitis C virus infection.

Tenofovir disoproxil Aurovitas with food and drink

Tenofovir disoproxil Aurovitas should be taken with food(e.g., with a meal or snack).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

• Tenofovir disoproxil Aurovitas should not be taken during pregnancywithout a detailed discussion with the doctor. Although there are limited clinical data on the use of Tenofovir disoproxil Aurovitas in pregnant women, it is not usually used unless absolutely necessary.
• If the patient is pregnantor plans to become pregnant, they must contact their doctor to discuss the possible benefits and risks for them and their child from the antiretroviral therapy.
• If the patient took Tenofovir disoproxil Aurovitasduring pregnancy, the doctor may order regular blood tests and other diagnostic tests to monitor the development of the child. In children whose mothers took NRTI during pregnancy, the benefit of reducing the possibility of HIV infection outweighs the risk of side effects.
• If the mother has HBV and her child has been given medicines to prevent the transmission of hepatitis B virus during birth, the patient may be able to breastfeed, but they should first discuss this with their doctor to get detailed information.
• Breastfeeding is not recommended for mothers with HIV, as HIV can be transmitted to the child through breast milk. If the patient is breastfeeding or considering breastfeeding, they should contact their doctor as soon as possible.

Driving and using machines

Tenofovir disoproxil may cause dizziness. If the patient experiences dizziness while taking Tenofovir disoproxil Aurovitas, they should not drive vehicles or ride a bicycleand should not operate any tools or machines.

Tenofovir disoproxil Aurovitas contains lactose monohydrate

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Before taking Tenofovir disoproxil Aurovitas, the patient should talk to their doctor. If the doctor has previously informed the patient about intolerance to certain sugars, they should contact their doctor before taking this medicine.

Tenofovir disoproxil Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Tenofovir disoproxil Aurovitas

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dose:

• adults:1 tablet taken once a day with food (e.g., with a meal or snack).
• adolescents from 12 to less than 18 years of age, with a body weight of at least 35 kg:1 tablet taken once a day with food (e.g., with a meal or snack).

In case of significant swallowing difficulties, the tablet can be crushed with the tip of a spoon. Then, the powder should be mixed with approximately 100 ml (half a glass) of water, orange juice, or grape juice and taken immediately.

• The patient should always take the dose prescribed by their doctor.This is to ensure the full effectiveness of the medicine and to limit the development of resistance to the medicine. The patient should not change the dose of the medicine unless their doctor recommends it.
• If the patient is an adult and has kidney problems, the doctor may recommend taking Tenofovir disoproxil Aurovitas less frequently.
• If the patient is infected with HBV, the doctor may offer an HIV test to check if the patient also has HIV and HBV infection.

The patient should read the patient information leaflets for the respective antiretroviral medicines to learn about their use.

Taking a higher dose of Tenofovir disoproxil Aurovitas than recommended

Accidental ingestion of too many Tenofovir disoproxil Aurovitas tablets may lead to an increased risk of side effects of this medicine (see section 4, Possible side effects). The patient should contact their doctor or the emergency department of the nearest hospital for advice. The patient should take the packaging of the tablets with them so that they can show the medicine they have taken.

Missing a dose of Tenofovir disoproxil Aurovitas

It is essential not to miss any dose of Tenofovir disoproxil Aurovitas. If the patient misses a dose, they should calculate how much time has passed since they were supposed to take it.

• If it has been less than 12 hours since the usual time of taking the dose, the patient should take it as soon as possible, and then take the next dose at the usual time.
• If it has been more than 12 hours since the time the patient was supposed to take the dose, they should not take the missed dose. The patient should wait and take the next dose at the usual time. The patient should not take a double dose to make up for the missed tablet.

If the patient vomits within 1 hour of taking Tenofovir disoproxil Aurovitas

they should take another tablet. The patient does not need to take another tablet if vomiting occurs later than 1 hour after taking Tenofovir disoproxil Aurovitas.

Stopping treatment with Tenofovir disoproxil Aurovitas

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The patient should not stop taking Tenofovir disoproxil Aurovitas without consulting their doctor. Stopping treatment with Tenofovir disoproxil Aurovitas may lead to a decrease in the effectiveness of the treatment prescribed by the doctor.
It is very important that patients with hepatitis B virus infection or both HIV and hepatitis B virus infectiondo not stop taking Tenofovir disoproxil Aurovitas without first consulting their doctor. In some patients, after stopping Tenofovir disoproxil Aurovitas, blood test results or symptoms indicated a worsening of hepatitis. For several months after stopping the medicine, it may be necessary to perform blood tests. In patients with advanced liver disease or liver cirrhosis, it is not recommended to stop treatment, as it may lead to a worsening of hepatitis.

• Before stopping Tenofovir disoproxil Aurovitas for any reason, the patient should consult their doctor, especially if they have experienced any side effects or have another illness.
• The patient should immediately inform their doctor about any new or unusual symptoms noticed after stopping treatment, especially those that are usually associated with hepatitis B virus infection.
• Before restarting Tenofovir disoproxil Aurovitas tablets, the patient should contact their doctor.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

During treatment for HIV infection, an increase in body weight and levels of lipids and glucose in the blood may occur. This is partly related to the improvement in health and lifestyle, and in the case of lipid levels in the blood, sometimes to the use of HIV medicines themselves. The doctor will monitor these changes.
Like all medicines, Tenofovir disoproxil Aurovitas can cause side effects, although not everybody gets them.

Possible serious side effects: the patient should immediately inform their doctor

• Lactic acidosis (excessive amount of lactic acid in the blood) is a rare (may occur in less than 1 in 1,000 patients) but serious side effect that can be fatal. Symptoms that may be signs of lactic acidosis are:
• deep, rapid breathing
• drowsiness
• nausea, vomiting, and abdominal pain.

If the patient thinks they have lactic acidosis, they should immediately contact their doctor.

Other possible serious side effects

The following side effects are uncommon (may occur in less than 1 in 100 patients):

• abdominal paincaused by pancreatitis
• kidney tubule cell damage.

The following side effects are rare (may occur in less than 1 in 1,000 patients):

• kidney inflammation, excessive urination, and thirst
• changes in urine test resultsand back paincaused by kidney function disorders, including kidney failure
• bone softening (manifested as bone painand sometimes leading to fractures), which may occur due to damage to the kidney tubule cells
• fatty liver.

If the patient thinks they have any of the above serious side effects, they should contact their doctor.

Very common side effects

The following side effects are very common (may occur in more than 10 in 100 patients):

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

Tests may also show:

• decreased phosphate levels in the blood.

Other possible side effects

The following side effects are common (may occur in less than 10 in 100 patients):

• headache, stomach pain, feeling tired, feeling bloated, bloating, weight loss.

Tests may also show:

• liver function disorders.

The following side effects are uncommon (may occur in less than 1 in 100 patients):

• muscle breakdown, muscle pain, or muscle weakness.

Tests may also show:

• decreased potassium levels in the blood
• increased creatinine levels in the blood
• pancreas function disorders.

Muscle breakdown, bone softening (manifested as bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur due to damage to the kidney tubule cells.
The following side effects are rare (may occur in less than 1 in 1,000 patients):

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tenofovir disoproxil Aurovitas

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Store in a temperature below 30°C.
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Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tenofovir disoproxil Aurovitas contains

• The active substance of the medicine is tenofovir disoproxil. Each film-coated tablet contains 245 mg of tenofovir disoproxil (in the form of tenofovir disoproxil fumarate).
• Other ingredients are: tablet core: lactose monohydrate, sodium croscarmellose, microcrystalline cellulose, maize starch, magnesium stearate. tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin, aluminum lake FD&C Blue 2 (3-5%) EHD (E 132), aluminum lake FD&C Blue 2 (3-5%) SEN (E 132).

What Tenofovir disoproxil Aurovitas looks like and contents of the pack

Film-coated tablet.
Blue, oval, biconvex film-coated tablets with dimensions of 18 mm x 8.6 mm, with the inscription "300" on one side and "T" on the other side.
Tenofovir disoproxil Aurovitas film-coated tablets are available in blisters.

Pack sizes:

Blisters: 30 film-coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Aurobindo Pharma B.V., Baarnsche Dijk 1, 3741 LN Baarn, Netherlands

Manufacturer:

APL Swift Services (Malta) Limited (Aurobindo), HF26, Hal Far Industrial Estate, BBG 3000 Birzebbugia, Malta
Arrow Generiques, 26 avenue Tony Garnier, 69007 Lyon, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

This medicine is authorized in the Member States of the European Economic Area under the following names:

France:

TENOFOVIR DISOPROXIL ARROW 245 mg, film-coated tablet

Germany:

Tenofovirdisoproxil PUREN 245 mg film-coated tablets

Italy:

Tenofovir disoproxil Aurobindo

Netherlands:

Tenofovirdisoproxil Aurobindo

Poland:

Tenofovir disoproxil Aurovitas

Portugal:

Tenofovir Aurobindo

Spain:

Tenofovir disoproxilo Aurovitas 245 mg film-coated tablets EFG

Marketing authorization number in the Netherlands, the country of export: RVG 119096

Parallel import authorization number: 420/24

Date of approval of the leaflet: 27.11.2024

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[Information about the trademark]
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