Tenofovir disoproxil aurovitas: detailed information

Package leaflet: Information for the patient

Tenofovir disoproxil Aurovitas, 245 mg, film-coated tablets
Tenofowir dizoproksyl
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Tenofovir disoproxil Aurovitas is and what it is used for
Important information before taking Tenofovir disoproxil Aurovitas
How to take Tenofovir disoproxil Aurovitas
Possible side effects
How to store Tenofovir disoproxil Aurovitas
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 case, 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, meaning 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 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 (human immunodeficiency virus) infection. 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 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 aged 12 to less than 18 years.

You do not need to have HIV to be treated with Tenofovir disoproxil Aurovitas for hepatitis B virus infection.
This medicine will not cure HIV infection. People taking Tenofovir disoproxil Aurovitas may still develop infections or other HIV-related diseases. It is also possible to transmit HBV to others, so it is important to take precautions to avoid infecting other people.

2. Important information before taking Tenofovir disoproxil Aurovitas

When not to 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, you should immediately inform your 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. You should continue to take precautions to prevent transmission. Please discuss this with your doctor or pharmacist before starting treatment.

If you have had kidney disease or if tests indicate kidney problems. Tenofovir disoproxil Aurovitas should not be given to adolescents with kidney disease. Before starting treatment, your doctor may order blood tests to assess kidney function. Tenofovir disoproxil Aurovitas may harm the kidneys during treatment. During treatment, your doctor may order regular blood tests to monitor kidney function. If you are an adult, your doctor may recommend less frequent dosing. Do not reduce the prescribed dose unless instructed by your 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, your doctor will monitor kidney function weekly.
If you have osteoporosis, have had bone fractures in the past, or have 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 you experience bone pain or fractures, inform your 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.
In general, 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 clear.
Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). 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 you experience any of these symptoms, inform your doctor.

If you have had liver disease in the past, including hepatitis, please consult your doctor. Patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral medicines are at increased risk of severe and potentially fatal liver-related side effects. For patients with hepatitis B, your doctor will determine the most appropriate treatment. If you have had liver disease or chronic hepatitis B in the past, your doctor may recommend regular blood tests to monitor liver function.
You should 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 you notice any inflammatory or infectious symptoms, contact your doctor immediately.

In addition to opportunistic infections, autoimmune diseases (conditions 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 toward the trunk, palpitations, tremors, or hyperexcitability, contact your doctor as soon as possible to begin necessary treatment.

Patients over 65 years of age should consult their doctor or pharmacist. Studies on Tenofovir disoproxil Aurovitas have not been conducted in patients over 65 years of age. Patients over this age who are 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 side 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 or have recently taken, as well as any medicines you 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 simultaneously with any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Aurovitas simultaneously with medicines containing adefovir dipivoxil (a medicine used in the treatment of chronic hepatitis B).
It is very important to inform your doctor if you are 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),
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 and other antiviral medicines containing didanosine may increase didanosine blood levels and may also reduce CD4 cell counts. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal, have been observed when tenofovir disoproxil and didanosine-containing medicines are used together. Your 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 and voxilaprevir for the treatment of hepatitis C virus infection.

Tenofovir disoproxil Aurovitas with food and drink
Tenofovir disoproxil Aurovitas should be taken with food (for example, with a meal or a snack).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should consult your doctor or pharmacist before using this medicine.

Tenofovir disoproxil Aurovitas should not be taken during pregnancy without detailed discussion with your doctor. Although clinical data on the use of Tenofovir disoproxil Aurovitas in pregnant women are limited, it is generally not used unless absolutely necessary.
If you are pregnant or planning to become pregnant, you must contact your doctor to discuss the potential benefits and risks of antiretroviral therapy for you and your child.
If you have taken Tenofovir disoproxil Aurovitas during pregnancy, your doctor may order regular blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of reduced risk of HIV transmission outweighs the risk of side effects.
If you have HBV and your child has received medicines to prevent transmission of hepatitis B virus during delivery, you may be able to breastfeed, but you should first talk to your 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 you are breastfeeding or considering breastfeeding, you should talk to your doctor as soon as possible.

Driving and operating machinery
Tenofovir disoproxil may cause dizziness. If you feel dizzy while taking Tenofovir disoproxil Aurovitas, do not drive or ride a bicycle, and do not use tools or operate machinery.

Tenofovir disoproxil Aurovitas contains lactose
Talk to your doctor before taking Tenofovir disoproxil Aurovitas. If your doctor has previously informed you of an intolerance to certain sugars, you should contact 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 directed by the doctor or pharmacist. If in
doubt, consult the doctor or pharmacist.
Recommended dose:

Adults: 1 tablet taken once daily with food (for example, with a meal or 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 snack).

If swallowing is difficult, 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 taken immediately.

Always take the dose prescribed by the 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 the doctor.
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 suggest an HIV test to check whether the patient has both HBV and HIV infection.

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

If less than 12 hours have passed since the usual time of dosing, take the missed dose as soon as possible, then take the next dose at the usual time.
If more than 12 hours have passed since the time the dose should have been taken, 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. Do not take another tablet if vomiting occurs more than 1 hour after taking Tenofovir disoproxil Aurovitas.
Stopping treatment with Tenofovir disoproxil Aurovitas
Do not stop taking Tenofovir disoproxil Aurovitas without consulting the doctor.
Stopping treatment with Tenofovir disoproxil Aurovitas may reduce the effectiveness of the treatment prescribed by the 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 consulting 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 a worsening of hepatitis in some patients.

Before stopping Tenofovir disoproxil Aurovitas for any reason, consult the doctor, especially if any side effects occur or if another illness develops.
Inform the doctor immediately about any new or unusual symptoms noticed after stopping treatment, particularly those typically associated with hepatitis B virus infection.
Before restarting Tenofovir disoproxil Aurovitas tablets, contact the doctor.

If there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

During treatment for HIV infection, increases in body weight as well as blood levels of lipids and glucose may occur. This is partly related to improved health and lifestyle, and in the case of blood lipid levels, sometimes to the use of antiretroviral medications themselves. 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 tubular cell damage.

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

kidney inflammation, excessive urination, and increased thirst
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 tubular cell damage
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 1 in 10 patients):

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

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 tubular 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 or pharmacist. Adverse reactions can 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, Poland, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to 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 carton, blister, and bottle
after: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
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 pack 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).

The other ingredients are:
Tablet core: lactose monohydrate, sodium croscarmellose, microcrystalline cellulose, pregelatinized maize starch, magnesium stearate.
Film coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin, indigo carmine, lac (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 "300" debossed on one side and "T" on the other side.
Tenofovir disoproxil Aurovitas film-coated tablets are available in blisters and HDPE bottles.
Pack sizes:
Blisters: 30 film-coated tablets.
HDPE bottles: 30, 90 and 90 (3 x 30) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lok. 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Arrow Generiques - Lyon
26 avenue Tony Garnier
69007 Lyon
France
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised 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 245mg, filmomhulde tabletten
Poland: Tenofovir disoproxil Aurovitas
Portugal: Tenofovir Aurobindo
Spain: Tenofovir disoproxilo Aurovitas 245 mg comprimidos recubiertos con película EFG