Tenofovir disoproxil aurovitas

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is 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.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Tenofovir disoproxil Aurovitas is and what it is 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 pack and other information

If Tenofovir disoproxil Aurovitas is prescribed for a child, please note that all information in this
leaflet applies to the child (in such cases, read “child” instead of “adult patient”).
1. What Tenofovir disoproxil Aurovitas is and what it is used for
Tenofovir disoproxil Aurovitas contains the active substance tenofovir disoproxil. This active
substance is an antiretroviral, i.e. an antiviral medicine used in the treatment of HIV or HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor. This substance is generally referred to as an NRTI and works by interfering with the normal function of certain enzymes (in HIV, reverse transcriptase; in hepatitis B virus – DNA polymerase), which are crucial for viral replication. In the case of HIV, Tenofovir disoproxil Aurovitas must 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 aged 12 to less than 18 years who have previously been treated with other HIV medicines that are no longer fully effective due to resistance development or have caused adverse 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 aged 12 to less than 18 years. The patient does not need to have HIV to be treated with Tenofovir disoproxil Aurovitas for hepatitis B virus infection. Page 1 of 9

This medicine does not cure HIV infection. In people taking Tenofovir disoproxil Aurovitas, infections or other diseases related to HIV infection may still develop. It is also possible to transmit HBV to others, so it is important to take preventive measures to avoid infecting other people.

2. Important information before taking Tenofovir disoproxil Aurovitas

When not to take Tenofovir disoproxil Aurovitas

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

The patient concerned should immediately inform their doctor and must 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 infected blood. Preventive measures should still be taken to avoid transmission.
Before starting Tenofovir disoproxil Aurovitas, discuss this with your 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 have harmful effects on the kidneys during treatment. During treatment, the doctor may order regular blood tests to monitor kidney function. If the patient is an adult, the doctor may recommend less frequent dosing. Do not reduce the prescribed dose unless instructed by the doctor.

Tenofovir disoproxil Aurovitas is generally not used together with other medicines that may
harm the kidneys (see Tenofovir disoproxil Aurovitas and other medicines ). If this cannot be avoided, the doctor will monitor kidney function weekly.

• If the patient has osteoporosis , has had bone fractures in the past, or has bone problems.

Bone disorders (manifesting as persistent or worsening bone pain, and sometimes leading to fractures) may also occur due to damage to renal tubular 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 mineral density. 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 impact of tenofovir disoproxil on bone health and the risk of future fractures in adult patients, as well as in children and adolescents, is not fully understood.
In some adult HIV patients receiving 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, use of corticosteroids, alcohol consumption, severe immunosuppression, and increased body mass index may be among the many risk factors for developing this condition. Symptoms of osteonecrosis include: joint stiffness, pain (especially in the hips, 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 disorders in the past, including hepatitis, consult your doctor . Patients with liver diseases, including chronic hepatitis B or C, treated with antiretroviral medicines, are at increased risk of severe and potentially fatal liver-related adverse reactions. For patients with hepatitis B, the doctor will determine the most appropriate treatment. If the patient has had liver disease or chronic hepatitis B in the past, the doctor may recommend regular blood tests to monitor liver function.
• Protect yourself from infections . In patients with advanced HIV infection (AIDS), after starting treatment with Tenofovir disoproxil Aurovitas, symptoms of infection and inflammatory conditions may develop, or symptoms of an existing infection may worsen. These symptoms may indicate that the immune system has become stronger and is now fighting the infection. Immediately after starting Tenofovir disoproxil Aurovitas, be alert for signs of inflammation or infection. If symptoms of inflammation or infection occur, contact your doctor immediately .

In addition to opportunistic infections, autoimmune diseases (diseases that occur when the
immune system attacks healthy body tissues) may also occur after starting antiretroviral
treatment for HIV infection. Autoimmune diseases may appear several months after starting
treatment. If you notice symptoms of infection or other symptoms such as muscle weakness,
weakness starting in the hands and feet and progressing towards the trunk, palpitations, tremors or
hyperexcitability, contact your doctor as soon as possible to begin necessary treatment.

• Patients aged 65 years and older should consult their doctor or pharmacist . Studies on Tenofovir disoproxil Aurovitas have not been conducted in patients aged 65 years and older. Patients in this age group prescribed Tenofovir disoproxil Aurovitas will remain under medical supervision.

Children and adolescents
Tenofovir disoproxil Aurovitas 245 mg tablets are suitable for:

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

Dosage, see section 3, How to take Tenofovir disoproxil Aurovitas .
Tenofovir disoproxil Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

• Do not stop taking HIV medicines prescribed by your doctor when starting Tenofovir disoproxil Aurovitas, if you have both HBV and HIV.
• Do not take Tenofovir disoproxil Aurovitas together with any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Aurovitas together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).

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• It is very important to inform your doctor if you are taking other medicines that may damage 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 immune system function),
• non-steroidal anti-inflammatory drugs (NSAIDs, used to reduce bone or muscle pain).
• Other medicines containing didanosine (for HIV infection): concomitant use of Tenofovir disoproxil Aurovitas and other antiviral medicines containing didanosine may increase didanosine blood levels and may also reduce CD4 cell count. Pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal, have been rarely observed during concomitant use of medicines containing tenofovir disoproxil and didanosine. The treating doctor will carefully consider whether tenofovir can be used together with didanosine.
• You should also inform your doctor if you are taking ledipasvir with sofosbuvir, sofosbuvir with velpatasvir, or sofosbuvir with velpatasvir with voxilaprevir for the treatment of 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, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

• Tenofovir disoproxil Aurovitas should not be used during pregnancy without thoroughly discussing this issue with the doctor. Although there are limited clinical data on the use of Tenofovir disoproxil Aurovitas in pregnant women, it is generally not used unless absolutely necessary.
• If the patient is pregnant or plans to become pregnant, she must contact her doctor to discuss the potential benefits and risks to her and her child associated with antiretroviral therapy.
• If the patient took Tenofovir disoproxil Aurovitas during pregnancy, the doctor may order regular blood tests and other diagnostic tests to monitor the child's development. In children whose mothers took NRTIs during pregnancy, the benefit of reduced risk of HIV transmission outweighs the risk of adverse effects.
• If the mother has HBV and the baby has received medicines to prevent transmission of hepatitis B virus during childbirth, the patient may be able to breastfeed, but she should first talk to her doctor to obtain detailed information.
• Breastfeeding is not recommended for mothers infected with HIV, as HIV can be transmitted to the child through breast milk. If the patient is breastfeeding or considering breastfeeding, she should speak to her doctor as soon as possible .

Driving and operating machinery
Tenofovir disoproxil may cause dizziness. If you experience dizziness while taking Tenofovir disoproxil
Aurovitas, do not drive or ride a bicycle and do not use any tools or operate any machinery.
Tenofovir disoproxil Aurovitas contains lactose monohydrate
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Before taking Tenofovir disoproxil Aurovitas, talk to your doctor . If your doctor has previously informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.
Tenofovir disoproxil Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Tenofovir disoproxil Aurovitas

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Recommended dose:

• Adults: 1 tablet taken once daily with food (for example, with a meal or a snack).
• Adolescents aged 12 to less than 18 years, weighing at least 35 kg: 1 tablet taken once daily with food (for example, with a meal or a snack).

If you have significant difficulty swallowing, the tablet may be crushed with the back of a spoon.
The resulting powder should then be mixed with approximately 100 ml (half a glass) of water,
orange juice, or grape juice and drunk immediately.

• Always take the dose prescribed by your doctor. This is important to ensure full effectiveness of the medicine and to reduce the risk of developing resistance to the medicine. Do not change the dose unless instructed by your doctor.
• If you are an adult and have kidney problems, your doctor may recommend taking Tenofovir disoproxil Aurovitas less frequently.
• If you are infected with HBV, your doctor may suggest testing for HIV to check whether you are co-infected with both HBV and HIV.

Please read the patient information leaflets of the appropriate antiretroviral medicines to learn
about their proper use.
Accidentally taking more Tenofovir disoproxil Aurovitas than prescribed
Accidentally taking too many tablets of Tenofovir disoproxil Aurovitas may increase the risk of
experiencing side effects of this medicine (see section 4, Possible side effects). Contact your doctor
or the emergency department of your nearest hospital for advice. Take the tablet packaging with
you so that you can show which medicine was taken.
Missing a dose of Tenofovir disoproxil Aurovitas
It is important not to miss any dose of Tenofovir disoproxil Aurovitas. If you miss a dose, calculate
how much time has passed since it should have been taken.

• If less than 12 hours have passed since the usual time of taking the dose, take it as soon as possible, then take the next dose at the usual time.
• If more than 12 hours have passed since the time you should have taken the dose, 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 tablet.

If vomiting occurs within 1 hour after taking Tenofovir disoproxil Aurovitas,
take another tablet. There is no need to take another tablet if vomiting occurs more than 1 hour
after taking Tenofovir disoproxil Aurovitas.
Stopping treatment with Tenofovir disoproxil Aurovitas
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Do not stop taking Tenofovir disoproxil Aurovitas without consulting your doctor.
Stopping treatment with Tenofovir disoproxil Aurovitas may reduce the effectiveness of the
treatment prescribed by your doctor.
It is very important that patients with chronic hepatitis B or those co-infected with HIV and
hepatitis B do not stop taking Tenofovir disoproxil Aurovitas without first discussing it with
their doctor. In some patients, blood test results or symptoms have indicated a worsening of
hepatitis after stopping Tenofovir disoproxil Aurovitas. Blood tests may be necessary for several
months after stopping the medicine. Discontinuation of treatment is not recommended in patients
with advanced liver disease or cirrhosis, as this may lead to worsening of hepatitis in some
patients.

• Before stopping Tenofovir disoproxil Aurovitas for any reason, consult your doctor, especially if you experience any side effects or develop another illness.
• Inform your doctor immediately about any new or unusual symptoms noticed after stopping treatment, particularly those usually associated with hepatitis B virus infection.
• Before restarting Tenofovir disoproxil Aurovitas tablets, contact your doctor.

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

4. Possible adverse reactions

During treatment for HIV infection, an increase in body weight as well as blood lipid and glucose levels may occur. This is partly related to improved health and lifestyle, and in the case of blood lipid levels, sometimes to the antiretroviral therapy itself. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.

Possible serious adverse reactions: contact 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 and potentially fatal adverse reaction. Symptoms that may indicate lactic acidosis include:
  • deep, rapid breathing
  • drowsiness
  • nausea, vomiting, and abdominal pain.

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

Other possible serious adverse reactions

The following adverse reactions occur uncommonly (may affect up to 1 in 100 patients):

• abdominal pain due to inflammation of the pancreas (pancreatitis)
• kidney tubule cell damage.

The following adverse reactions occur rarely (may affect up to 1 in 1,000 patients):

• kidney inflammation, passing large amounts of urine and feeling thirsty
• changes in urine test results and back pain due to kidney dysfunction, including kidney failure
• softening of the bones (manifesting as bone pain and sometimes leading to fractures), which may occur due to kidney tubule cell damage (Page 6 of 9)
• fatty liver.

If you suspect you have experienced any of the above serious adverse reactions, contact your doctor immediately.

Most common adverse reactions

The following adverse reactions occur very commonly (may affect more than 10 in 100 patients):

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

Tests may also show:

• decreased blood phosphate levels.

Other possible adverse reactions

The following adverse reactions occur commonly (may affect up to 10 in 100 patients):

• headache, stomach pain, feeling tired, bloating, flatulence, loss of bone mineral density.

Tests may also show:

• liver function abnormalities.

The following adverse reactions occur uncommonly (may affect up to 1 in 100 patients):

• muscle cell breakdown, muscle pain, or muscle weakness.

Tests may also show:

• decreased blood potassium levels
• increased blood creatinine levels
• pancreatic function abnormalities.

Muscle cell breakdown, softening of the bones (manifesting as bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased blood potassium or phosphate levels may occur due to kidney tubule cell damage.

The following adverse reactions occur rarely (may affect up to 1 in 1,000 patients):

• abdominal pain due to inflammation of the liver (hepatitis)
• swelling of the face, lips, tongue, or throat.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store 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 packaging. The expiry date refers to the last day of the stated month.
Store below 30°C.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Tenofovir disoproxil Aurovitas contains

• The active substance is tenofovir disoproxil. Each film-coated tablet contains 245 mg of tenofovir disoproxil (as tenofovir disoproxil fumarate).
• Other ingredients are:
  Tablet core: lactose monohydrate, sodium croscarmellose, microcrystalline cellulose, pregelatinized starch, maize starch, magnesium stearate.
  Tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin, FD&C Blue 2 aluminium lake (3-5%) EHD (E 132), FD&C Blue 2 aluminium lake (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 measuring 18 mm x 8.6 mm,
with the imprint “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, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, country of export:
Aurobindo Pharma B.V., Baarnsche Dijk 1, 3741 LN Baarn, the 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 medicinal product is authorised for marketing in the European Economic Area under the following names:
France: TENOFOVIR DISOPROXIL ARROW 245 mg, comprimé pelliculé
Germany: Tenofovirdisoproxil PUREN 245 mg Filmtabletten
Italy: Tenofovir disoproxil Aurobindo
Netherlands: Tenofovirdisoproxil Aurobindo
Poland: Tenofovir disoproxil Aurovitas
Portugal: Tenofovir Aurobindo
Spain: Tenofovir disoproxilo Aurovitas 245 mg comprimidos recubiertos con película EFG
Marketing authorisation number in the Netherlands, country of export: RVG 119096
Parallel import authorisation number: 420/24
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