TENOFOVIR 245 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Tenofovir disoproxil Aurovitas, 245 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
   3. If Tenofovir disoproxil Aurovitas is prescribed for a child, note that all information in this leaflet is addressed to the child (in this case, read "child" instead of "adult patient").
   4. What is Tenofovir disoproxil Aurovitas and what is it used for
   5. Tenofovir disoproxil Aurovitas 245 mg tablets are intended for the treatment of HIV infection
   6. Tenofovir disoproxil Aurovitas 245 mg tablets are also intended for the treatment of
3. Important information before taking Tenofovir disoproxil Aurovitas
   1. When not to take Tenofovir disoproxil Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Tenofovir disoproxil Aurovitas and other medicines
   5. Tenofovir disoproxil Aurovitas with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Tenofovir disoproxil Aurovitas contains lactose
   9. Tenofovir disoproxil Aurovitas contains sodium
4. How to take Tenofovir disoproxil Aurovitas
   1. Recommended dose:
   2. Taking a higher dose of Tenofovir disoproxil Aurovitas than recommended
   3. Missing a dose of Tenofovir disoproxil Aurovitas
   4. If you vomit within 1 hour of taking Tenofovir disoproxil Aurovitas
   5. Stopping Tenofovir disoproxil Aurovitas
5. Possible side effects
   1. Possible serious side effects: consult your doctor immediately
   2. Other possible serious side effects
   3. If you think you have any of the above serious side effects, contact your doctor.
   4. Very common side effects
   5. Other possible side effects
   6. Reporting side effects
6. How to store Tenofovir disoproxil Aurovitas
7. Contents of the pack and other information
   1. What Tenofovir disoproxil Aurovitas contains
   2. What Tenofovir disoproxil Aurovitas looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 04/2024

Leaflet accompanying the packaging: patient information

Tenofovir disoproxil Aurovitas, 245 mg, film-coated tablets

Tenofovir disoproxil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• -If you have any further questions, ask your doctor or pharmacist.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• -If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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 pack and other information

If Tenofovir disoproxil Aurovitas is prescribed for a child, note that all information in this leaflet is addressed to the child (in this case, read "child" 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 essential 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 aged 12 to less than 18 years, 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 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.
Tenofovir disoproxil Aurovitas will not cure HIV infection. In patients taking Tenofovir disoproxil Aurovitas, infections or other diseases related to HIV infection may still develop. It is also possible to transmit HBV to other people, 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 concerned 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 other people through
sexual contact or contaminated blood. Precautions should still be taken to prevent this.
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 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. Do not reduce the prescribed dose unless the doctor recommends it.

Tenofovir disoproxil Aurovitas is not usually taken with other medicines that can 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 disease(manifested as persistent or worsening bone pain, and sometimes leading to fractures) can also occur due to damage to the kidney tubular cells (see section 4, Possible side effects). If the patient experiences bone pain or fractures, they should tell 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, 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 hips, knees, and shoulders) and difficulty moving. If the patient experiences any of these symptoms, they should tell their doctor.

• 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 liver side effects. 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.
• Protect yourself from infections.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 is strengthening and starting to fight the infection. Soon after starting Tenofovir disoproxil Aurovitas, pay attention to symptoms of inflammation or infection. If symptoms of inflammation or infection are noticed inform your doctor immediately.

In addition to opportunistic infections, after starting antiretroviral treatment, autoimmune diseases (diseases that occur when the immune system attacks healthy tissues) may also occur. Autoimmune diseases may occur several months after starting treatment. If 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 are observed, contact your doctor as soon as possibleto start the necessary treatment.

• Patients 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 suitablefor:

• HIV-1 infected adolescents aged 12 to less than 18 years, weighing 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 aged 12 to less than 18 years, weighing at least 35 kg.

Tenofovir disoproxil Aurovitas 245 mg tablets are notsuitable 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• Do not stop taking HIV medicinesprescribed by your doctor when starting Tenofovir disoproxil Aurovitas, if you have 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).
• It is very important to inform your doctorabout 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 and other antiviral medicines that contain didanosine at the same time 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 treating doctor will carefully consider whether to use tenofovir with didanosine in the patient.
• Also, inform your 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Tenofovir disoproxil Aurovitas should not be taken during pregnancywithout discussing it with your doctor in detail. Although there are limited clinical data on the use of Tenofovir disoproxil Aurovitas in pregnant women, it is not usually used unless it is absolutely necessary.
• If you are pregnantor planning to become pregnant, you must contact your treating doctor to discuss the possible benefits and risks for you and your baby from the antiretroviral therapy used.

If you have taken Tenofovir disoproxil Aurovitas during pregnancy, your doctor may order regular blood tests and other diagnostic tests to monitor the development of your baby. In children whose mothers took NRTI during pregnancy, the benefit of reducing the risk of HIV transmission outweighs the risk of side effects. If the mother has HBV and her baby has been given medicine to prevent the transmission of hepatitis B during delivery, the mother may be able to breastfeed, but she should first discuss this with her doctor to get detailed information.

• Do not breastfeed if you have HIV, as HIV can be passed to the baby through breast milk. If you are breastfeeding or thinking of breastfeeding, contact your doctor as soon as possible.

Driving and using machines

Tenofovir disoproxil may cause dizziness. If you experience dizziness while taking Tenofovir disoproxil Aurovitas, do not driveor do not ride a bicycleand do not operate any tools or machines.

Tenofovir disoproxil Aurovitas contains lactose

Before taking Tenofovir disoproxil Aurovitas, talk to your doctor.If your doctor has previously told you that you have an intolerance to some sugars, 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, which means it is essentially '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 are unsure, consult your doctor or pharmacist.

Recommended dose:

• adults:1 tablet taken once a day with food (e.g. with a meal or snack).
• adolescents aged 12 to less than 18 years, weighing 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 mix the powder with about 100 ml (half a glass) of water, orange juice, or grape juice and drink immediately.

• Always take the dose prescribed by your doctor.This is to ensure the full effectiveness of the medicine and to limit the development of resistance to the medicine. Do not change the dose of the medicine unless your doctor recommends it.
• 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 offer an HIV test to check if you also have HIV and HBV infection.

Read the patient information leaflets for the antiretroviral medicines to learn about their use.

Taking a higher dose of Tenofovir disoproxil Aurovitas than recommended

Accidentally taking too many Tenofovir disoproxil Aurovitas tablets may increase the risk of side effects (see section 4, Possible side effects). Contact your doctor or the emergency department of your nearest hospital for advice. Take the package leaflet with you to show the medicine you have taken.

Missing a dose of Tenofovir disoproxil Aurovitas

It is essential not to miss any dose of Tenofovir disoproxil Aurovitas. If you miss a dose, calculate how much time has passed since you should have taken it.

• If it has been less than 12 hourssince the usual time of taking the dose, take it as soon as possible, and then take the next dose at the usual time.
• If it has been more than 12 hourssince 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 the missed tablet.

If you vomit within 1 hour of taking Tenofovir disoproxil Aurovitas

take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking Tenofovir disoproxil Aurovitas.

Stopping Tenofovir disoproxil Aurovitas

Do not stop taking Tenofovir disoproxil Aurovitas without consulting your doctor.
Stopping treatment with Tenofovir disoproxil Aurovitas may lead to a decrease in the effectiveness of the treatment prescribed by your doctor.
It is very important that patients with hepatitis B or both HIV and hepatitis Bdo 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, consult your doctor, especially if you have experienced any side effects or have another illness.
• Immediately inform your doctor about any new or unusual symptoms you notice after stopping treatment, especially those that are usually associated with hepatitis B virus infection.
• Before restarting Tenofovir disoproxil Aurovitas tablets, consult your doctor.

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

4. Possible side effects

During HIV treatment, weight gain and increased lipid and glucose levels 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. Your doctor will check for these changes.
Like all medicines, Tenofovir disoproxil Aurovitas can cause side effects, although not everybody gets them.

Possible serious side effects: consult your doctor immediately

• 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 you think you have lactic acidosis, contact your doctor immediately.

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 tubular 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 kidney tubular cell damage
• fatty liver.

If you think you have any of the above serious side effects, contact your 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, gas, 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
• pancreatic 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 kidney tubular cell damage.
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 you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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 month stated.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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).

• 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, indigo carmine, lake (E 132).

What Tenofovir disoproxil Aurovitas looks like and contents of the pack

Film-coated tablet.
Blue, oval, biconvex film-coated tablets with dimensions 18 mm x 8.6 mm, with "300" embossed on one side and "T" on the other side.
Tenofovir disoproxil Aurovitas film-coated tablets are available in blisters and HDPE bottles.
Package 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 authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 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 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 245mg, film-coated tablets
Poland:
Tenofovir disoproxil Aurovitas
Portugal:
Tenofovir Aurobindo
Spain:
Tenofovir disoproxilo Aurovitas 245 mg film-coated tablets EFG

Date of last revision of the leaflet: 04/2024