Tenofovir disoproxil Aurobindo: detailed information

Package leaflet: Information for the user

Tenofovir disoproxil Aurobindo 123 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before the child takes this medicine because
it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask the child's doctor or pharmacist.
This medicine has been prescribed for the child only. Do not give it to others, even if their symptoms are the same as the child's, because it could be harmful.
If the child experiences any side effects, including those not listed in this leaflet, contact the child's doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tenofovir disoproxil Aurobindo is and what it is used for
What you need to know before the child takes Tenofovir disoproxil Aurobindo
How to take Tenofovir disoproxil Aurobindo
Possible side effects
How to store Tenofovir disoproxil Aurobindo
Contents of the pack and other information

1. What Tenofovir disoproxil Aurobindo is and what it is used for

Tenofovir disoproxil Aurobindo contains the active substance tenofovir disoproxil. This active substance
is an antiretroviral or antiviral medicine used to treat HIV infection.
Tenofovir is a nucleotide reverse transcriptase inhibitor, commonly known as an NRTI, and
works by interfering with the normal activity of an enzyme (reverse transcriptase) that is essential for
the virus to replicate. Tenofovir disoproxil Aurobindo must always be used in combination with other medicines for the treatment of HIV infection.
Tenofovir disoproxil Aurobindo 123 mg tablets is a treatment for HIV (human immunodeficiency virus) infection.
Tenofovir disoproxil Aurobindo 123 mg tablets is intended for use in children. It is indicated exclusively for:

- children aged between 6 and less than 12 years
- weighing between 17 kg and less than 22 kg
- who have already been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused undesirable effects.

This medicine is not a cure for HIV infection. While taking Tenofovir disoproxil
Aurobindo, the child may still contract infections or other diseases associated with HIV infection.
The child may also transmit the HIV virus to others, so it is important that precautions are taken to avoid infecting other people.

2. What you should know before your child takes Tenofovir disoproxil Aurobindo

Do not give Tenofovir disoproxil Aurobindo to your child

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

If this applies to your child, inform the doctor immediately and do not give
Tenofovir disoproxil Aurobindo.
Warnings and precautions

Tenofovir disoproxil Aurobindo 123 mg tablets is intended only for children who have already been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused side effects.
Check your child’s age and weight to determine whether Tenofovir disoproxil Aurobindo 123 mg tablets are suitable for them. See Children and adolescents.

Talk to your doctor or pharmacist before giving Tenofovir disoproxil Aurobindo to your child.

Be careful not to transmit the infection to others. Your child can still transmit HIV while taking this medicine, although the risk is reduced by the effect of antiretroviral therapy. Discuss with the doctor the necessary precautions to avoid transmitting the infection to others.
Inform your child’s doctor or pharmacist if your child has had kidney disease or if blood tests have shown kidney problems. Tenofovir disoproxil must not be given to children who already have kidney problems. Tenofovir disoproxil may affect your child’s kidneys during treatment. Before starting treatment, the doctor may order blood tests to assess kidney function. The doctor may also order blood tests during treatment to monitor how well your child’s kidneys are working.

Tenofovir disoproxil must not be taken with other medicines that can damage the kidneys (see
Other medicines and Tenofovir disoproxil Aurobindo). If this is unavoidable, the doctor will monitor your
child’s kidney function once a week.

Bone problems. Some adult HIV patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in the hips, knees, and shoulders), and difficulty moving. Contact the doctor if you notice any of these symptoms.

Bone problems (sometimes resulting in fractures) may also occur due to damage to the renal
tubular cells (see section 4, Possible side effects).

Inform the doctor if your child has previously had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals have a higher risk of serious and potentially fatal liver complications. If your child has hepatitis B, the doctor will carefully evaluate the best treatment regimen for them. If your child has had liver disease or chronic hepatitis B, the doctor may request blood tests to monitor liver function.
Be cautious about infections. If your child has advanced HIV (AIDS) and has an infection, they may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when starting treatment with tenofovir disoproxil. These symptoms may indicate that the body’s immune system is fighting the infection. Monitor for signs of inflammation or infection shortly after your child starts taking tenofovir disoproxil. If you notice signs of inflammation or infection, inform the doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after your child starts taking medicines for HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading toward the trunk, palpitations, tremor, or hyperactivity, inform the doctor immediately to receive necessary treatment.
Children and adolescents
Tenofovir disoproxil Aurobindo 123 mg tablets is only suitable for:

children aged between 6 and less than 12 years
with body weight between 17 kg and less than 22 kg
who have already been treated with other HIV medicines that are no longer fully effective due to development of resistance, or that have caused side effects.

Tenofovir disoproxil Aurobindo 123 mg tablets is not suitable for the following categories:

not indicated in children with body weight below 17 kg or equal to or above 22 kg. Contact the doctor if your child’s weight is outside the permitted range.
not indicated in children and adolescents under 6 years of age or equal to or above 12 years of age.
not indicated in children and adolescents infected with HBV (hepatitis B virus) of any age.

For dosage, see section 3, How to take Tenofovir disoproxil Aurobindo.
Other medicines and Tenofovir disoproxil Aurobindo
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

Do not give Tenofovir disoproxil to your child if they are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not give Tenofovir disoproxil Aurobindo together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
It is particularly important to inform the doctor if your child is taking other medicines that can damage the kidneys.

These include:

aminoglycosides, pentamidine, or vancomycin (for a bacterial infection);
amphotericin B (for a fungal infection);
foscarnet, ganciclovir, or cidofovir (for a viral infection);
interleukin-2 (to treat cancer);
adefovir dipivoxil (for HBV);
tacrolimus (for immune system suppression);
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).
Other medicines containing didanosine (for HIV infection): Taking tenofovir disoproxil with other antiviral medicines containing didanosine may increase didanosine levels in the blood and may reduce CD4 cell count. When medicines containing tenofovir disoproxil and didanosine have been taken together, cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have rarely been reported, sometimes resulting in death. Your child’s doctor must carefully consider whether to treat your child with tenofovir and didanosine in combination.
It is also important to inform the doctor if your child is taking ledipasvir/sofosbuvir or sofosbuvir/velpatasvir to treat hepatitis C infection.

Tenofovir disoproxil Aurobindo with food and drink
Tenofovir disoproxil Aurobindo must be taken with food (e.g., a meal or a snack).
Pregnancy and breastfeeding
If your daughter suspects she is pregnant, is pregnant, or is breastfeeding, consult her doctor or pharmacist before taking this medicine.

Your daughter must not take Tenofovir disoproxil Aurobindo during pregnancy unless she has specifically discussed it with her doctor. Although clinical data on the use of tenofovir disoproxil in pregnant women are limited, it is generally not used unless strictly necessary.
Your daughter should try to avoid pregnancy during treatment with tenofovir disoproxil. If she is sexually active, she must use an effective contraceptive method to avoid pregnancy.
If your daughter becomes pregnant, consult the doctor about the potential benefits and risks of antiretroviral therapy for her and the baby.
If your daughter has already taken tenofovir disoproxil during pregnancy, the doctor may require regular blood tests and other diagnostic examinations to monitor the baby’s development. In children whose mothers took medicines such as tenofovir disoproxil (NRTIs) during pregnancy, the benefit of protection against the virus has outweighed the risk of side effects.
Your daughter must not breastfeed during treatment with tenofovir disoproxil. This is because the active substance of this medicine is excreted in human breast milk.
Your daughter must not breastfeed to avoid transmitting the virus to the newborn through breast milk.

Driving and using machines
Tenofovir disoproxil may cause dizziness. If dizziness occurs while taking tenofovir
disoproxil, your child must not drive or ride a bicycle and must not operate tools or
machinery.
Tenofovir disoproxil Aurobindo contains lactose
Inform the doctor before administering Tenofovir disoproxil Aurobindo if your child is
lactose intolerant or has intolerance to other sugars.

3. How to take Tenofovir disoproxil Aurobindo

The child must take this medicine exactly as instructed by the child's doctor or pharmacist.
If you have any doubts, consult the doctor or pharmacist.
The recommended dose is:

Children aged 6 to less than 12 years with body weight between 17 kg and less than 22 kg: 1 tablet daily taken with food (for example, a meal or a snack).

The doctor will monitor the child's weight.
The child must always take the dose prescribed by the doctor. This is important to ensure that the medicine remains fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless instructed by the doctor.
The doctor will prescribe Tenofovir disoproxil Aurobindo together with other antiretroviral medicines.
Refer to the package leaflet of the other antiretrovirals for guidance on how to take them.

If the child takes more Tenofovir disoproxil Aurobindo than they should
If the child accidentally takes too many tablets of Tenofovir disoproxil Aurobindo, the risk of experiencing possible side effects may increase (see section 4, Possible side effects). Contact the doctor or the nearest emergency department. Bring the medicine container with you so that you can clearly describe what the child has taken.

If the child forgets to take Tenofovir disoproxil Aurobindo
It is important not to miss any doses of Tenofovir disoproxil Aurobindo. If the child misses a dose, consider how much time has passed since the missed dose.

If less than 12 hours have passed since the usual dosing time, the child should take the medicine as soon as possible and then take the next dose at the regular time.
If more than 12 hours have passed since the usual dosing time, the child should not take the missed dose. Wait and take the next dose at the regular time. Do not give a double dose to make up for the forgotten tablet.

If the child vomits within 1 hour of taking Tenofovir disoproxil Aurobindo,
give another tablet. The child should not take another tablet if vomiting occurs more than 1 hour after taking Tenofovir disoproxil Aurobindo.

If the child stops taking Tenofovir disoproxil Aurobindo
The child must not stop taking Tenofovir disoproxil Aurobindo without consulting the doctor. Stopping Tenofovir disoproxil Aurobindo may reduce the effectiveness of the treatment prescribed by the doctor.
If the child has HIV and hepatitis B infection, it is particularly important not to stop treatment with Tenofovir disoproxil Aurobindo without first contacting the doctor. Some patients have experienced worsening of hepatitis, as shown by symptoms or blood tests, after stopping Tenofovir disoproxil Aurobindo. Blood tests may need to be repeated for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of hepatitis in some patients.

Talk to the doctor before the child stops taking Tenofovir disoproxil Aurobindo for any reason, especially if the child has experienced a side effect or has another illness.
Inform the doctor immediately about any new or unusual symptoms observed after stopping treatment, particularly symptoms usually associated with hepatitis B infection.
Contact the doctor before the child restarts taking Tenofovir disoproxil Aurobindo tablets.

If you have any questions about the use of this medicine, consult the child's doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight and in blood lipid and glucose levels may occur. This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your child's doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious possible side effects: inform the doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 patients), but serious side effect, which can be fatal. The following side effects may be signs of lactic acidosis:
- deep and rapid breathing
- drowsiness
- nausea, vomiting and stomach ache

If you think your child has lactic acidosis, contact the doctor immediately.

Other possible serious side effects

The following side effects are not common (may affect up to 1 in 100 patients):

abdominal pain caused by inflammation of the pancreas;
damage to renal tubular cells.

The following side effects are rare (may affect up to 1 in 1,000 patients):

kidney inflammation, excessive urination and thirst;
urine abnormalities and back pain due to kidney problems, including kidney failure;
softening of the bones (with bone pain and sometimes fractures), which may occur due to damage to renal tubular cells;
fatty liver.

If you think your child is experiencing any of these serious side effects, consult the doctor.

More frequent side effects

The following side effects are very common (may affect at least 10 out of 100 patients):

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

Laboratory tests may also show:

decreased phosphate levels in the blood.

Other possible side effects

The following side effects are common (may affect up to 10 in 100 patients):

flatulence.

Laboratory tests may also show:

liver problems.

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

muscle breakdown, muscle pain or muscle weakness.

Laboratory tests may also show:

decreased potassium levels in the blood;
increased creatinine levels in your child's blood;
pancreas problems.

Muscle breakdown, softening of the bones (with bone pain and sometimes fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur due to damage to renal tubular cells.

The following side effects are rare (may affect up to 1 in 1,000 patients):

abdominal pain caused by inflammation of the liver;
swelling of the face, lips, tongue or throat.

Reporting of side effects

If your child experiences any side effect, including those not listed in this leaflet, consult your child's doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tenofovir disoproxil Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, the carton, and the
bottle after EXP. The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tenofovir disoproxil Aurobindo contains

The active substance is tenofovir disoproxil.

Each film-coated tablet contains 123 mg of tenofovir disoproxil (as fumarate).

The other components are:
Tablet core: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn starch), and magnesium stearate.
Tablet coating: hypromellose 2910, lactose monohydrate, titanium dioxide (E171), and triacetin.

Description of the appearance of Tenofovir disoproxil Aurobindo and contents of the pack
Film-coated tablet.
White to almost white, capsule-shaped, biconvex, film-coated tablets, marked with
“150” on one side and “T” on the other side.
Tenofovir disoproxil Aurobindo film-coated tablets are available in blister packs and
in HDPE bottles.
Packs:
Blister packs: 30 film-coated tablets.
HDPE bottles: 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA), Italy
Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD
United Kingdom
Arrow Génériques - Lyon
26 avenue Tony Garnier, 69007 Lyon
France

This medicinal product is authorized in the European Economic Area countries under the following names:
France: TENOFOVIR DISOPROXIL ARROW 123 mg, comprimé pelliculé
Germany: Tenofovirdisoproxil PUREN 123 mg Filmtabletten
Italy: Tenofovir disoproxil Aurobindo
Portugal: Tenofovir Aurobindo
United Kingdom: Tenofovir disoproxil Milpharm 123 mg film-coated tablets

Package leaflet: Information for the user

Tenofovir disoproxil Aurobindo 163 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before the child takes this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult the child's doctor or pharmacist.
This medicine has been prescribed for the child only. Do not give it to others, even if their symptoms are the same as the child's, because it could be harmful.
If the child experiences any side effects, including those not listed in this leaflet, consult the child's doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tenofovir disoproxil Aurobindo is and what it is used for
What you need to know before the child takes Tenofovir disoproxil Aurobindo
How to take Tenofovir disoproxil Aurobindo
Possible side effects
How to store Tenofovir disoproxil Aurobindo
Contents of the pack and other information

1. What Tenofovir disoproxil Aurobindo is and what it is used for

Tenofovir disoproxil Aurobindo contains the active substance tenofovir disoproxil. This active substance
is an antiretroviral or antiviral medicine used to treat HIV infection.
Tenofovir is a nucleotide reverse transcriptase inhibitor, commonly known as NRTI, and
works by interfering with the normal activity of an enzyme (reverse transcriptase) that is essential
for the virus to replicate. Tenofovir disoproxil Aurobindo for the treatment of HIV infection must
always be used in combination with other medicines.
Tenofovir disoproxil Aurobindo 163 mg tablets is a treatment for HIV infection
(human immunodeficiency virus).
Tenofovir disoproxil Aurobindo 163 mg tablets is intended for use in children. It is indicated
exclusively for:

- children aged between 6 and less than 12 years
- with body weight between 22 kg and less than 28 kg
- children who have previously been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused undesirable effects.

This medicine is not a cure for HIV infection. While taking Tenofovir disoproxil
Aurobindo, the child may still contract infections or other diseases associated with
HIV infection. The child may also transmit the HIV virus to others; therefore, it is important that precautions are taken to avoid infecting other people.

2. What you should know before the child takes Tenofovir disoproxil Aurobindo

Do not give Tenofovir disoproxil Aurobindo to the child

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

If this applies to the child, inform the doctor immediately and do not give
Tenofovir disoproxil Aurobindo.
Warnings and precautions

Tenofovir disoproxil Aurobindo 163 mg tablets are indicated only for children who have already been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused adverse effects.
Check the child’s age and weight to determine whether Tenofovir disoproxil Aurobindo 163 mg tablets are suitable for him/her; see Children and adolescents.

Talk to the doctor or pharmacist before giving Tenofovir disoproxil Aurobindo to the child.

Take care not to transmit the infection to other people. The child can still transmit HIV while taking this medicine, although the risk is reduced by the effect of antiretroviral therapy. Discuss with the doctor the necessary precautions to avoid transmitting the infection to others.
Inform the child’s doctor or pharmacist if the child has had kidney problems, or if blood tests have shown kidney problems. Tenofovir disoproxil must not be given to children who already have kidney problems. Tenofovir disoproxil may affect the child’s kidneys during treatment. Before starting treatment, the doctor may prescribe blood tests to assess kidney function. The doctor may also prescribe blood tests during treatment to monitor how the child’s kidneys are functioning.

Tenofovir disoproxil must not be taken with other medicines that can damage the kidneys (see
Other medicines and Tenofovir disoproxil Aurobindo ). If this is unavoidable, the doctor will monitor the
child’s kidney function once a week.

Bone problems. Some adult HIV patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in the hips, knees, and shoulders), and difficulty moving. Consult the doctor if any of these symptoms appear.

Bone problems (sometimes leading to fractures) may also occur due to damage to renal
tubular cells (see section 4, Possible side effects ).

Inform the doctor if the child has previously had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have an increased risk of serious and potentially fatal liver complications. If the child has hepatitis B, the doctor will carefully evaluate the best treatment regimen for him/her. If the child has had liver disease or chronic hepatitis B, the doctor may request blood tests to monitor liver function.
Be cautious about infections. If the child has advanced HIV (AIDS) and has an infection, he or she may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when starting treatment with tenofovir disoproxil. These symptoms may indicate that the body’s immune system is fighting the infection. Monitor for signs of inflammation or infection shortly after the child starts taking tenofovir disoproxil. If signs of inflammation or infection occur, inform the doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after the child starts taking medicines for HIV infection. Autoimmune disorders may occur many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading toward the trunk, palpitations, tremor, or hyperactivity, inform the doctor immediately to receive the necessary treatment.
Children and adolescents
Tenofovir disoproxil Aurobindo 163 mg tablets are only suitable for:

children aged between 6 and under 12 years
with body weight between 22 kg and under 28 kg
who have already been treated with other HIV medicines that are no longer fully effective due to resistance development, or that have caused adverse effects.

Tenofovir disoproxil Aurobindo 163 mg tablets are not suitable for the following categories:

not indicated in children with body weight below 22 kg or equal to or above 28 kg. Contact the doctor if the child’s weight is outside the permitted range.
not indicated in children and adolescents under 6 years of age or equal to or over 12 years of age.
not indicated in children and adolescents infected with HBV (hepatitis B virus) of any age.

For dosage, see section 3, How to take Tenofovir disoproxil Aurobindo.
Other medicines and Tenofovir disoproxil Aurobindo
Inform the doctor or pharmacist if the child is taking, has recently taken, or might take any other medicine.

Do not give Tenofovir disoproxil to the child if he or she is already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not give Tenofovir disoproxil Aurobindo together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
It is particularly important to inform the doctor if the child is taking other medicines that may damage the kidneys.

These include:

aminoglycosides, pentamidine, or vancomycin (for a bacterial infection);
amphotericin B (for a fungal infection);
foscarnet, ganciclovir, or cidofovir (for a viral infection);
interleukin-2 (to treat cancer);
adefovir dipivoxil (for HBV);
tacrolimus (for immunosuppression);
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).
Other medicines containing didanosine (for HIV infection): Taking tenofovir disoproxil with other antiviral medicines containing didanosine may increase didanosine levels in the blood and may reduce CD4 cell count. When medicines containing tenofovir disoproxil and didanosine have been taken together, cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have rarely been reported, sometimes resulting in death. The child’s doctor must carefully consider whether to treat the child with tenofovir and didanosine in combination.
It is also important to inform the doctor if the child is taking ledipasvir/sofosbuvir or sofosbuvir/velpatasvir to treat hepatitis C infection.

Tenofovir disoproxil Aurobindo with food and drink
Tenofovir disoproxil Aurobindo must be taken with food (e.g., a meal or a snack).
Pregnancy and breastfeeding
If your daughter suspects she is pregnant, is pregnant, or is breastfeeding, consult the doctor or pharmacist before taking this medicine.

The girl must not take Tenofovir disoproxil Aurobindo during pregnancy unless she has specifically discussed it with her doctor. Although clinical data on the use of tenofovir disoproxil in pregnant women are limited, it is generally not used unless strictly necessary.
The girl should try to avoid pregnancy during treatment with tenofovir disoproxil. If sexually active, she must use an effective contraceptive method to avoid pregnancy.
If the girl becomes pregnant, consult the doctor about the potential benefits and risks of antiretroviral therapy for her and the baby.
If the girl has already taken tenofovir disoproxil during pregnancy, the doctor may request regular blood tests and other diagnostic examinations to monitor the baby’s development. In babies whose mothers took medicines such as tenofovir disoproxil (NRTIs) during pregnancy, the benefit of protection against the virus has outweighed the risk of side effects.
The girl must not breastfeed during treatment with tenofovir disoproxil. This is because the active ingredient of this medicine is excreted in human breast milk.
The girl must not breastfeed, to avoid transmitting the virus to the newborn through breast milk.

Driving and using machines
Tenofovir disoproxil may cause dizziness. If dizziness occurs while taking tenofovir
disoproxil, the child must not drive or ride a bicycle and must not operate tools or
machinery.
Tenofovir disoproxil Aurobindo contains lactose
Inform the doctor before administering Tenofovir disoproxil Aurobindo if the child is
lactose intolerant or has intolerance to other sugars.

3. How to take Tenofovir disoproxil Aurobindo

The child must take this medicine exactly as instructed by the child's doctor or pharmacist.
If you have any doubts, consult the doctor or pharmacist.
The recommended dose is:

Children aged 6 to less than 12 years weighing between 22 kg and less than 28 kg: 1 tablet daily to be taken with food (for example, a meal or a snack).

The doctor will monitor the child's weight.
The child must always take the dose recommended by the doctor. This is important to ensure that the medicine remains fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless instructed by the doctor.
The doctor will prescribe Tenofovir disoproxil Aurobindo together with other antiretroviral medicines.
Please refer to the package leaflet of the other antiretrovirals for guidance on how to take them.

If the child takes more Tenofovir disoproxil Aurobindo than prescribed
If the child accidentally takes too many tablets of Tenofovir disoproxil Aurobindo, the risk of experiencing possible side effects from this medicine may increase (see section 4, Possible side effects). Contact the doctor or the nearest emergency centre immediately. Bring the bottle of tablets with you so that you can easily describe what the child has taken.

If the child forgets to take Tenofovir disoproxil Aurobindo
It is important that no dose of Tenofovir disoproxil Aurobindo is missed. If the child forgets a dose, consider how much time has passed since the missed dose.

If less than 12 hours have passed since the usual dosing time, the child should take the medicine as soon as possible and then take the next dose at the usual scheduled time.
If more than 12 hours have passed since the usual dosing time, the child should not take the missed dose. Wait and administer the next dose at the regular time. Do not give a double dose to make up for the missed tablet.

If the child vomits within 1 hour after taking Tenofovir disoproxil Aurobindo,
give the child another tablet. The child should not take another tablet if vomiting occurred more than 1 hour after taking Tenofovir disoproxil Aurobindo.

If the child stops treatment with Tenofovir disoproxil Aurobindo
The child must not stop taking Tenofovir disoproxil Aurobindo without consulting the doctor. Stopping Tenofovir disoproxil Aurobindo may reduce the effectiveness of the treatment prescribed by the doctor.
If the child has HIV and hepatitis B infection, it is especially important not to stop treatment with Tenofovir disoproxil Aurobindo without first contacting the doctor.
Some patients have experienced worsening of hepatitis, as shown by symptoms or blood test results, after stopping Tenofovir disoproxil Aurobindo. Blood tests may need to be repeated for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of hepatitis in some patients.

Talk to the doctor before the child stops taking Tenofovir disoproxil Aurobindo for any reason, especially if the child has experienced a side effect or has another illness.
Inform the doctor immediately of any new or unusual symptoms observed after stopping treatment, particularly symptoms typically associated with hepatitis B infection.
Contact the doctor before the child restarts taking Tenofovir disoproxil Aurobindo tablets.

If you have any questions about the use of this medicine, consult the child's doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight as well as in blood lipid and glucose levels may occur.
This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes also to the HIV medications themselves. The child's doctor will monitor these changes.
Like all medicines, this medicinal product can cause side effects, although not everyone experiences them.

Possible serious side effects: inform the doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 patients) but serious side effect, which may be fatal. The following side effects may be signs of lactic acidosis:
- deep and rapid breathing
- drowsiness
- nausea, vomiting, and stomach pain

If you suspect the child has lactic acidosis, contact the doctor immediately.

Other possible serious side effects
The following side effects are uncommon (may affect up to 1 in 100 patients):

abdominal pain caused by inflammation of the pancreas;
damage to renal tubular cells.

The following side effects are rare (may affect up to 1 in 1,000 patients):

kidney inflammation, excessive urination and thirst;
urine abnormalities and back pain due to kidney problems, including kidney failure;
softening of the bones (with bone pain and sometimes fractures), which may occur due to damage to renal tubular cells;
fatty liver.

If you think the child is experiencing any of these serious side effects, consult the doctor.

More frequent side effects
The following side effects are very common (may affect at least 10 out of 100 patients):

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

Laboratory tests may also show:

reduced phosphate levels in the blood.

Other possible side effects
The following side effects are common (may affect up to 10 out of 100 patients):

flatulence.

Laboratory tests may also show:

liver problems.

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

muscle weakness, muscle pain, or muscle wasting.

Laboratory tests may also show:

reduced potassium levels in the blood;
increased creatinine levels in the child's blood;
pancreas problems.

Muscle weakness, softening of the bones (with bone pain and sometimes fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur due to damage to renal tubular cells.

The following side effects are rare (may affect up to 1 in 1,000 patients):

abdominal pain caused by liver inflammation;
swelling of the face, lips, tongue, or throat.

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, consult the child's doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Tenofovir disoproxil Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, on the box, on the bottle after EXP. The expiry date refers to the last day of that month.
Store below 30  C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tenofovir disoproxil Aurobindo contains

The active substance is tenofovir disoproxil.

Each film-coated tablet contains 163 mg of tenofovir disoproxil (as fumarate).

The other components are:
Tablet core: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn starch) and magnesium stearate.
Tablet coating: hypromellose 2910, lactose monohydrate, titanium dioxide (E171) and triacetin.

Description of the appearance of Tenofovir disoproxil Aurobindo and pack contents
Film-coated tablet.
White to almost white, round, biconvex, film-coated tablets, marked with "200" on one side and "T" on the other side.
Tenofovir disoproxil Aurobindo film-coated tablets are available in blister packs and in HDPE containers.
Pack sizes:
Blister packs: 30 film-coated tablets.
HDPE containers: 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA), Italy

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD
United Kingdom
Arrow Génériques - Lyon
26 avenue Tony Garnier, 69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:
France: TENOFOVIR DISOPROXIL ARROW 163 mg, comprimé pelliculé
Germany: Tenofovirdisoproxil PUREN 163 mg Filmtabletten
Italy: Tenofovir disoproxil Aurobindo
Portugal: Tenofovir Aurobindo
United Kingdom: Tenofovir disoproxil Milpharm 163 mg film-coated tablets

Package leaflet: information for the user

Tenofovir disoproxil Aurobindo 204 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before the child takes this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult the child’s doctor or pharmacist.
This medicine has been prescribed for the child only. Do not give it to others, even if their symptoms are the same as the child’s, because it could be harmful.
If the child experiences any adverse reaction, including those not listed in this leaflet, contact the child’s doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tenofovir disoproxil Aurobindo is and what it is used for
What you need to know before the child takes Tenofovir disoproxil Aurobindo
How to take Tenofovir disoproxil Aurobindo
Possible side effects
How to store Tenofovir disoproxil Aurobindo
Contents of the pack and other information

1. What Tenofovir disoproxil Aurobindo is and what it is used for

Tenofovir disoproxil Aurobindo contains the active substance tenofovir disoproxil. This active substance
is an antiretroviral or antiviral medicine used to treat HIV infection.
Tenofovir is a nucleotide reverse transcriptase inhibitor, commonly known as NRTI, and
works by interfering with the normal activity of an enzyme (reverse transcriptase) that is essential for
the virus to replicate. Tenofovir disoproxil Aurobindo must always be used in combination with other medicines for the treatment of HIV infection.
Tenofovir disoproxil Aurobindo 204 mg tablets is a treatment for HIV (human immunodeficiency virus) infection.
Tenofovir disoproxil Aurobindo 204 mg tablets are intended for use in children. It is indicated exclusively for:

- children aged 6 to less than 12 years
- weighing between 28 kg and less than 35 kg
- who have already been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused undesirable effects.

This medicine is not a cure for HIV infection. While taking Tenofovir disoproxil
Aurobindo, the child may still develop infections or other diseases associated with
HIV infection. The child may also transmit the HIV virus to others; therefore, it is important that precautions are taken to avoid infecting other people.

2. What you should know before your child takes Tenofovir disoproxil Aurobindo

Do not give Tenofovir disoproxil Aurobindo to your child

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

If this applies to your child, inform the doctor immediately and do not administer
Tenofovir disoproxil Aurobindo.
Warnings and precautions

Tenofovir disoproxil Aurobindo 204 mg tablets are indicated only for children who have already been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused adverse effects.
Check your child’s age and weight to determine whether Tenofovir disoproxil Aurobindo 204 mg tablets are suitable for them. See Children and adolescents.

Talk to your doctor or pharmacist before giving Tenofovir disoproxil Aurobindo to your child.

Be careful not to transmit the infection to others. Your child may still transmit HIV while taking this medicine, although the risk is reduced by the effect of antiretroviral therapy. Discuss with the doctor the necessary precautions to avoid transmitting the infection to others.
Inform your child’s doctor or pharmacist if your child has had kidney disease, or if blood tests have shown kidney problems. Tenofovir disoproxil must not be given to children who already have kidney problems. Tenofovir disoproxil may affect your child’s kidneys during treatment. Before starting treatment, the doctor may prescribe blood tests to assess kidney function. The doctor may also prescribe blood tests during treatment to monitor how well your child’s kidneys are working.

Bone problems. Some adult HIV patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort and pain (especially in the hips, knees, and shoulders), and difficulty moving. Contact the doctor if you notice any of these symptoms.

Bone problems (sometimes leading to fractures) may also occur due to damage to renal tubular cells (see section 4, Possible side effects).

Inform the doctor if your child has previously had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of serious and potentially fatal liver complications. If your child has hepatitis B, the doctor will carefully evaluate the most appropriate treatment regimen for them. If your child has had liver disease or chronic hepatitis B, the doctor may request blood tests to monitor liver function.
Be cautious about infections. If your child has advanced HIV (AIDS) and has an infection, they may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when starting treatment with tenofovir disoproxil. These symptoms may indicate that the body’s immune system is fighting the infection. Monitor for signs of inflammation or infection shortly after your child starts taking tenofovir disoproxil. If you notice signs of inflammation or infection, inform the doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after your child starts taking medicines for HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet progressing toward the trunk, palpitations, tremor, or hyperactivity, inform the doctor immediately to receive necessary treatment.
Children and adolescents
Tenofovir disoproxil Aurobindo 204 mg tablets are only suitable for:

children aged between 6 and under 12 years
with body weight between 28 kg and under 35 kg
children who have already been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused adverse effects.

Tenofovir disoproxil Aurobindo 204 mg tablets are not suitable for the following categories:

not indicated in children with body weight below 28 kg or equal to or above 35 kg. Contact the doctor if your child’s weight is outside the permitted range.
not indicated in children and adolescents under 6 years of age or equal to or over 12 years of age.
not indicated in children and adolescents infected with HBV (hepatitis B virus) of any age.

Do not administer Tenofovir disoproxil to your child if they are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not administer Tenofovir disoproxil Aurobindo together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
It is particularly important to inform the doctor if your child is taking other medicines that may damage the kidneys.

These include:

aminoglycosides, pentamidine, or vancomycin (for bacterial infection);
amphotericin B (for fungal infection);
foscarnet, ganciclovir, or cidofovir (for viral infection);
interleukin-2 (for cancer treatment);
adefovir dipivoxil (for HBV);
tacrolimus (for immunosuppression);
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).
Other medicines containing didanosine (for HIV infection): Taking tenofovir disoproxil with other antiviral medicines containing didanosine may increase didanosine levels in the blood and may reduce CD4 cell count. When medicines containing tenofovir disoproxil and didanosine have been taken together, cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have rarely been reported, sometimes resulting in death. Your child’s doctor must carefully consider whether to treat your child with tenofovir and didanosine in combination.
It is also important to inform the doctor if your child is taking ledipasvir/sofosbuvir or sofosbuvir/velpatasvir to treat hepatitis C infection.

Tenofovir disoproxil Aurobindo with food and drink
Tenofovir disoproxil Aurobindo must be taken with food (e.g., a meal or a snack).
Pregnancy and breastfeeding
If your daughter suspects she is pregnant, is pregnant, or is breastfeeding, ask her doctor or pharmacist for advice before taking this medicine.

Your daughter must not take Tenofovir disoproxil Aurobindo during pregnancy unless she has specifically discussed it with her doctor. Although clinical data on the use of tenofovir disoproxil in pregnant women are limited, it is generally not used unless strictly necessary.
Your daughter should try to avoid becoming pregnant during treatment with tenofovir disoproxil. If she is sexually active, she must use an effective contraceptive method to prevent pregnancy.
If your daughter becomes pregnant, consult the doctor about the potential benefits and risks of antiretroviral therapy for her and her baby.
If your daughter has already taken tenofovir disoproxil during pregnancy, the doctor may require regular blood tests and other diagnostic examinations to monitor the baby’s development. In babies whose mothers have taken medicines such as tenofovir disoproxil (NRTIs) during pregnancy, the benefit of protection against the virus has outweighed the risk of adverse effects.
Your daughter must not breastfeed during treatment with tenofovir disoproxil. This is because the active substance of this medicine is excreted in human breast milk.
Your daughter must not breastfeed, to avoid transmitting the virus to the newborn through breast milk.

Driving and using machines
Tenofovir disoproxil may cause dizziness. If dizziness occurs while taking tenofovir
disoproxil, your child must not drive or ride a bicycle and must not use tools or
machinery.
Tenofovir disoproxil Aurobindo contains lactose
Inform the doctor before administering Tenofovir disoproxil Aurobindo if your child is
lactose intolerant or has intolerance to other sugars.

3. How to take Tenofovir disoproxil Aurobindo

The child must always take this medicine exactly as instructed by the child's doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
The recommended dose is:

Children aged 6 to less than 12 years with a body weight between 28 kg and less than 35 kg: 1 tablet daily taken with food (for example, a meal or a snack).

The doctor will monitor the child's weight.
The child must always take the dose recommended by the doctor. This is important to ensure that the medicines are fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless instructed by the doctor.
The doctor will prescribe Tenofovir disoproxil Aurobindo together with other antiretroviral medicines.
Please refer to the package leaflet of the other antiretrovirals for guidance on how to take these medicines.

If the child takes more Tenofovir disoproxil Aurobindo than they should
If the child accidentally takes too many tablets of Tenofovir disoproxil Aurobindo, the risk of experiencing possible side effects with this medicine may increase (see section 4, Possible side effects). Contact the doctor or the nearest emergency centre. Take the bottle of tablets with you so that you can easily describe what the child has taken.

If the child forgets to take Tenofovir disoproxil Aurobindo
It is important not to miss any doses of Tenofovir disoproxil Aurobindo. If the child forgets a dose, consider how much time has passed since the missed dose.

If less than 12 hours have passed since the usual time of administration, the child should take the medicine as soon as possible, then take the next dose at the scheduled time.
If more than 12 hours have passed since the usual time of administration, the child should not take the missed dose. Wait and administer the next dose at the regular time. Do not give a double dose to make up for the forgotten tablet.

If the child vomits within 1 hour after taking Tenofovir disoproxil Aurobindo,
give the child another tablet. The child should not take another tablet if they vomited more than one hour after taking Tenofovir disoproxil Aurobindo.

If the child stops treatment with Tenofovir disoproxil Aurobindo
The child must not stop taking Tenofovir disoproxil Aurobindo without consulting the doctor. Stopping Tenofovir disoproxil Aurobindo may reduce the effectiveness of the treatment prescribed by the doctor.
If the child has HIV and hepatitis B infection, it is particularly important not to stop treatment with Tenofovir disoproxil Aurobindo without first contacting the doctor.
Some patients have experienced worsening of their hepatitis, as shown by symptoms or blood tests, after stopping Tenofovir disoproxil Aurobindo. Blood tests may need to be repeated for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of hepatitis in some patients.

Talk to the doctor before the child stops taking Tenofovir disoproxil Aurobindo for any reason, especially if they have experienced a side effect or have another illness.
Inform the doctor immediately of any new or unusual symptoms observed after stopping treatment, particularly symptoms normally associated with hepatitis B infection.
Contact the doctor before the child restarts taking Tenofovir disoproxil Aurobindo tablets.

If you have any doubts about how to use this medicine, consult the child's doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in body weight and in blood levels of lipids and glucose may occur.
This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes also to the HIV medicines themselves. The child’s doctor will monitor these changes in the child.

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Possible serious side effects: inform the doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 patients), but serious side effect, which can be fatal. The following side effects may be signs of lactic acidosis:
- deep, rapid breathing;
- drowsiness;
- nausea, vomiting, and stomach pain.

If you think the child has lactic acidosis, contact the doctor immediately.

Other possible serious side effects

The following side effects are not common (may affect up to 1 in 100 patients):

abdominal pain caused by inflammation of the pancreas;
damage to renal tubular cells.

The following side effects are rare (may affect up to 1 in 1,000 patients):

kidney inflammation, excessive urination and thirst;
urine abnormalities and back pain due to kidney problems, including kidney failure;
softening of the bones (with bone pain and sometimes fractures), which may occur due to damage to renal tubular cells;
fatty liver.

If you think the child is experiencing any of these serious side effects, consult the doctor.

More frequent side effects

The following side effects are very common (may affect at least 10 out of 100 patients):

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

Laboratory tests may also show:

decreased phosphate levels in the blood.

Other possible side effects

The following side effects are common (may affect up to 10 out of 100 patients):

flatulence.

Laboratory tests may also show:

liver problems.

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

muscle weakness, muscle pain, or muscle weakness.

Laboratory tests may also show:

decreased potassium levels in the blood;
increased creatinine levels in the child’s blood;
pancreas problems.

The following side effects are rare (may affect up to 1 in 1,000 patients):

abdominal pain caused by inflammation of the liver;
swelling of the face, lips, tongue, or throat.

Reporting of side effects

If the child experiences any side effect, including those not listed in this leaflet, consult the child’s doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tenofovir disoproxil Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, on the box, on the bottle after EXP. The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tenofovir disoproxil Aurobindo contains

The active substance is tenofovir disoproxil.

Each film-coated tablet contains 204 mg of tenofovir disoproxil (as fumarate).

The other components are:
Tablet core: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn starch) and magnesium stearate
Tablet coating: hypromellose 2910, lactose monohydrate, titanium dioxide (E171) and triacetin.

Description of the appearance of Tenofovir disoproxil Aurobindo and package contents
Film-coated tablet.
White to almost white, capsule-shaped, biconvex, film-coated tablets, marked with
“250” on one side and “T” on the other side.
Tenofovir disoproxil Aurobindo film-coated tablets are available in blister packs and
in HDPE bottles.
Pack sizes:
Blister packs: 30 film-coated tablets.
HDPE bottles: 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)

This medicinal product is authorized in the European Economic Area countries under the following names:
France: TENOFOVIR DISOPROXIL ARROW 204 mg, comprimé pelliculé
Germany: Tenofovirdisoproxil PUREN 204 mg Filmtabletten
Italy: Tenofovir disoproxil Aurobindo
Netherlands: Tenofovirdisoproxil Aurobindo 204 mg, filmomhulde tabletten
Portugal: Tenofovir Aurobindo
United Kingdom: Tenofovir disoproxil Milpharm 204 mg film-coated tablets

Patient Information Leaflet

Tenofovir disoproxil Aurobindo 245 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tenofovir disoproxil Aurobindo is and what it is used for
What you need to know before taking Tenofovir disoproxil Aurobindo
How to take Tenofovir disoproxil Aurobindo
Possible side effects
How to store Tenofovir disoproxil Aurobindo
Contents of the pack and other information

If Tenofovir disoproxil Aurobindo has been prescribed for the child, all information
contained in this leaflet refers to the child (in this case, “child” instead of “you”).

1. What Tenofovir disoproxil Aurobindo is and what it is used for

Tenofovir disoproxil Aurobindo contains the active substance tenofovir disoproxil. This active substance
is an antiretroviral or antiviral medicine used to treat HIV infection, HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor,
commonly known as an NRTI, and works by interfering with the normal activity of enzymes (reverse transcriptase in HIV; DNA polymerase in hepatitis B) that are essential for viruses to replicate. Tenofovir disoproxil Aurobindo for the treatment of HIV infection must always be used in combination with other medicines.
Tenofovir disoproxil Aurobindo 245 mg tablets are a treatment for HIV infection
(human immunodeficiency virus).
The tablets are indicated 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 that have caused undesirable effects.

Tenofovir disoproxil Aurobindo 245 mg tablets are also used for the treatment
of chronic hepatitis B, an HBV infection (hepatitis B virus). The tablets are indicated for:

Adults;
Adolescents aged 12 to less than 18 years.

You do not need to have HIV infection to be treated with Tenofovir disoproxil Aurobindo for HBV.
This medicine is not a cure for HIV infection. While taking Tenofovir disoproxil Aurobindo, you may still develop infections or other diseases associated with HIV infection. You may also transmit the HIV or HBV virus to others; therefore, it is important that you take precautions to avoid infecting other people.

2. What you should know before taking Tenofovir disoproxil Aurobindo

Do not take Tenofovir disoproxil Aurobindo

If you are allergic to tenofovir, tenofovir disoproxil, or to any of the other ingredients of this medicine listed in section 6.

If this applies to you, inform your doctor immediately and do not take Tenofovir disoproxil Aurobindo.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tenofovir disoproxil Aurobindo.

Be careful not to transmit the infection to other people. You may still transmit HIV while taking this medicine, although the risk is reduced by the effect of antiretroviral therapy. Discuss with your doctor the necessary precautions to avoid transmitting the infection to others. Tenofovir disoproxil Aurobindo does not reduce the risk of transmitting HBV to others through sexual contact or blood contamination. You must continue to take precautions to prevent transmission.
Inform your doctor or pharmacist if you have had kidney disease, or if blood tests have shown kidney problems. Tenofovir disoproxil must not be administered to adolescents who already have kidney problems. Before starting treatment, your doctor may prescribe blood tests to assess kidney function. Tenofovir disoproxil Aurobindo may have effects on your kidneys during treatment. Your doctor may also prescribe blood tests during treatment to monitor kidney function. If you are an adult, your doctor may advise you to take the tablets less frequently. Do not reduce the prescribed dose unless instructed by your doctor.

Tenofovir disoproxil must not be taken with other medicines that can damage your kidneys
(see Other medicines and Tenofovir disoproxil Aurobindo). If this is unavoidable, your doctor
will monitor kidney function once a week.

Bone problems. Some adult HIV patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in the hips, knees, and shoulders), and difficulty moving. Contact your doctor if you notice any of these symptoms.

Bone problems (sometimes resulting in fractures) may also occur due to damage to renal tubular cells (see section 4, Possible side effects).

Inform your doctor if you have previously had liver problems, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals, have an increased risk of serious and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully evaluate the best treatment for you. If you have had liver disease or chronic hepatitis B, your doctor may request blood tests to monitor liver function.
Be cautious about infections. If you have advanced HIV (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of symptoms of an existing infection when starting treatment with tenofovir disoproxil. These symptoms may indicate that your body's immune system is fighting the infection. Monitor for signs of inflammation or infection shortly after starting tenofovir disoproxil. If you notice signs of inflammation or infection, inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after starting medicines for treating HIV infection. Autoimmune disorders may occur many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet progressing toward the trunk, palpitations, tremor, or hyperactivity, inform your doctor immediately to receive necessary treatment.

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

Children and adolescents

Tenofovir disoproxil Aurobindo 245 mg tablets are suitable for:

Adolescents with HCV-1 infection aged 12 to less than 18 years who weigh at least 35 kg and who have previously been treated with other HIV medicines that are no longer fully effective due to resistance development, or that have caused side effects;
Adolescents infected with HBV aged 12 to less than 18 years who weigh at least 35 kg.

Tenofovir disoproxil Aurobindo 245 mg tablets are not suitable for the following categories:

Not indicated in children infected with HIV-1 under 12 years of age;
Not indicated in children infected with HBV under 12 years of age.

For dosage information, see section 3, How to take Tenofovir disoproxil Aurobindo.

Other medicines and Tenofovir disoproxil Aurobindo

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

When starting therapy with Tenofovir disoproxil, do not stop taking any anti-HIV medicines prescribed by your doctor if you are co-infected with both HBV and HIV.
Do not take Tenofovir disoproxil if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Aurobindo together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
It is particularly important to inform your doctor if you are taking other medicines that may damage the kidneys.

These include:

aminoglycosides, pentamidine, or vancomycin (for a bacterial infection);
amphotericin B (for a fungal infection);
foscarnet, ganciclovir, or cidofovir (for a viral infection);
interleukin-2 (to treat cancer);
adefovir dipivoxil (for HBV);
tacrolimus (for immunosuppression);
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).
Other medicines containing didanosine (for HIV infection): Taking tenofovir disoproxil with other antiviral medicines containing didanosina may increase didanosine levels in the blood and may reduce CD4 cell count. When medicines containing tenofovir disoproxil and didanosine have been taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, sometimes leading to death. Your doctor must carefully consider whether to treat you with tenofovir and didanosine in combination.
It is also important to inform your doctor if you are taking ledipasvir/sofosbuvir or sofosbuvir/velpatasvir to treat hepatitis C infection.

Tenofovir disoproxil Aurobindo with food and drink

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

You must not take Tenofovir disoproxil Aurobindo during pregnancy unless you have specifically discussed it with your doctor. Although clinical data on the use of tenofovir disoproxil in pregnant women are limited, it is generally not used unless strictly necessary.
Try to avoid pregnancy during treatment with tenofovir disoproxil. You must use an effective contraceptive method to avoid pregnancy.
If you know you are pregnant or plan to become pregnant, ask your doctor about the potential benefits and risks of antiretroviral therapy for you and your baby.
If you have already taken tenofovir disoproxil during pregnancy, your doctor may regularly request blood tests and other diagnostic examinations to monitor the baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
You must not breastfeed during treatment with tenofovir disoproxil. The reason is that the active substance of this medicine is excreted in human breast milk.
If you are a woman infected with HIV or HBV, you are advised not to breastfeed, to avoid transmitting the viruses to the newborn through breast milk.

Driving and using machines

Tenofovir disoproxil may cause dizziness. If dizziness occurs while taking tenofovir disoproxil, you must not drive or ride a bicycle and must not use tools or machinery.

Tenofovir disoproxil Aurobindo contains lactose

Inform your doctor before taking Tenofovir disoproxil Aurobindo if you are intolerant to lactose or other sugars.

3. How to take Tenofovir disoproxil Aurobindo

You must take this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

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

A granule formulation of tenofovir disoproxil is available for patients who have difficulty
swallowing film-coated tablets. However, in exceptional cases, you may use the edge of a
spoon to crush the tablet. Then mix the powder in approximately 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 important to ensure that the medicines are fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to do so.
If you are an adult and have kidney problems, your doctor may prescribe Tenofovir disoproxil Aurobindo to be taken less frequently.
If you have HBV, your doctor may recommend an HIV test to determine whether you have both HBV and HIV.

Refer to the package leaflets of other antiretrovirals for guidance on how to take these medicines.
If you take more Tenofovir disoproxil Aurobindo than you should
If you accidentally take too many tablets of Tenofovir disoproxil Aurobindo, the risk of
experiencing possible side effects with this medicine may increase (see section 4,
Possible side effects). Contact your doctor or the nearest emergency department. Take the
bottle of tablets with you so that you can easily describe what you have taken.
If you forget to take Tenofovir disoproxil Aurobindo
It is important that you do not miss any doses of Tenofovir disoproxil Aurobindo. If you miss a
dose, consider how much time has passed since the missed dose.

If less than 12 hours have passed since the usual time of administration, take the medicine as soon as possible, then take the next dose at the scheduled time.
If more than 12 hours have passed since the usual time of administration, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for the missed tablet.

If you vomit within 1 hour after taking Tenofovir disoproxil Aurobindo, take another
tablet. You should not take another tablet if you vomit more than one hour after taking
Tenofovir disoproxil Aurobindo.
If you stop taking Tenofovir disoproxil Aurobindo
Do not stop taking Tenofovir disoproxil Aurobindo without consulting your doctor.
Stopping Tenofovir disoproxil Aurobindo may reduce the effectiveness of the treatment prescribed by
your doctor.
If you have hepatitis B infection or both HIV and hepatitis B (co-infection), it is particularly
important not to stop treatment with Tenofovir disoproxil Aurobindo without first contacting
your doctor. Some patients have experienced worsening of their hepatitis, as indicated by
symptoms or blood tests, after stopping Tenofovir disoproxil Aurobindo. Blood tests may need to be
repeated for several months after stopping treatment. In patients with advanced liver disease or cirrhosis,
stopping treatment is not recommended, as it may lead to worsening of hepatitis in some patients.

Talk to your doctor before stopping Tenofovir disoproxil Aurobindo for any reason, especially if you have experienced a side effect or have another illness.
Inform your doctor immediately of any new or unusual symptoms observed after stopping treatment, particularly symptoms normally associated with hepatitis B infection.
Contact your doctor before restarting Tenofovir disoproxil Aurobindo tablets.

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

4. Possible side effects

During HIV therapy, an increase in body weight and in blood lipid and glucose levels may occur. This is partly related to the recovery of health status, lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious possible side effects: inform your doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 patients) but serious side effect, which can be fatal. The following side effects may be signs of lactic acidosis:
- deep, rapid breathing
- drowsiness
- nausea, vomiting, and stomach pain

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

Other possible serious side effects
The following side effects are not common (may affect up to 1 in 100 patients):

abdominal pain caused by inflammation of the pancreas;
damage to renal tubular cells.

The following side effects are rare (may affect up to 1 in 1,000 patients):

kidney inflammation, excessive urination and thirst;
changes in urine and back pain due to kidney problems, including kidney failure;
softening of the bones (with bone pain and sometimes fractures), which may occur due to damage to renal tubular cells;
fatty liver.

If you think you have any of these serious side effects, consult your doctor.

More frequent side effects
The following side effects are very common (may affect at least 10 in 100 patients):

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

Laboratory tests may also show:

decreased phosphate levels in the blood.

Other possible side effects
The following side effects are common (may affect up to 10 in 100 patients):

headache, stomach ache, feeling tired, feeling bloated, flatulence.

Laboratory tests may also show:

liver problems.

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

muscle weakness, muscle pain, or muscle wasting.

Laboratory tests may also show:

decreased potassium levels in the blood;
increased creatinine levels in the blood;
pancreas problems.

The following side effects are rare (may affect up to 1 in 1,000 patients):

abdominal pain caused by inflammation of the liver;
swelling of the face, lips, tongue, or throat.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tenofovir disoproxil Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the packaging, or the bottle after EXP. The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tenofovir disoproxil Aurobindo contains

The active substance is tenofovir disoproxil.

Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).

The other components are:
Tablet core: croscarmellose sodium, monohydrate lactose, microcrystalline cellulose, pregelatinized starch (corn starch), and magnesium stearate;
Tablet coating: hypromellose 2910, monohydrate lactose, titanium dioxide (E171), triacetin, indigo carmine aluminium lake (3-5%) EHD (E132) and indigo carmine aluminium lake (3-5%) SEN (E132).

Description of the appearance of Tenofovir disoproxil Aurobindo and package contents
Film-coated tablet.
Blue, oval, biconvex, film-coated tablets, marked “300” on one side and “T” on the other side.
Tenofovir disoproxil Aurobindo film-coated tablets are available in blister packs and in HDPE bottles.
Pack sizes:
Blister packs: 30 film-coated tablets.
HDPE bottles: 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
France: TENOFOVIR DISOPROXIL ARROW 245 mg, film-coated tablet
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
United Kingdom: Tenofovir disoproxil Milpharm 245 mg film-coated tablets
Czech Republic: Tenofovir disoproxil Aurovitas
Romania: Tenofovir disoproxil Aurobindo 245 mg comprimate filmate