Tenofovir disoproxil accord

Package leaflet: Information for the patient

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

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you personally. Do not share it with others. It may harm other people, 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, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Tenofovir disoproxil Accord is and what it is used for
2. What you need to know before you take Tenofovir disoproxil Accord
3. How to take Tenofovir disoproxil Accord
4. Possible side effects
5. How to store Tenofovir disoproxil Accord
6. Contents of the pack and other information

If Tenofovir disoproxil Accord has been prescribed for a child, please note that all
information in this leaflet applies to the child (in such cases, please read “child” instead of “adult patient”).

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

Tenofovir disoproxil Accord contains the active substance tenofovir disoproxil. This active substance
is an antiretroviral medicine, which means it is an antiviral drug used in the treatment of
HIV or HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor.
This type of medicine is commonly referred to as an NRTI and works by interfering with the normal function of certain enzymes (in HIV, reverse transcriptase; in hepatitis B virus, DNA polymerase), which are essential for viral replication.
Tenofovir disoproxil Accord must always be used in combination with other antiretroviral medicines when treating HIV infection.
Tenofovir disoproxil Accord tablets are indicated for the treatment of HIV infection (human immunodeficiency virus). The tablets are suitable for:

• adults
• adolescents aged 12 to less than 18 years who have been previously treated with other HIV medicines that are no longer fully effective due to resistance development or have caused side effects.

Tenofovir disoproxil Accord tablets are also indicated for the treatment of chronic
hepatitis B, a viral infection caused by HBV (hepatitis B virus). The tablets are suitable for:

• adults
• adolescents aged 12 to less than 18 years.

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

2. Important information before using Tenofovir disoproxil Accord

When not to use Tenofovir disoproxil Accord

• if the patient is allergic to tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6);

The patient concerned should immediately inform their doctor and must not take
Tenofovir disoproxil Accord.
Warnings and precautions
Tenofovir disoproxil Accord does not reduce the risk of transmitting HBV to others through
sexual contact or infected blood. Precautions should still be taken to prevent transmission.
Before starting treatment with Tenofovir disoproxil Accord, discuss this with your
doctor or pharmacist.

• If the patient has had kidney disease or if tests indicate kidney problems, consult a doctor or pharmacist. Tenofovir disoproxil Accord should not be given to adolescents with kidney disease. Before starting treatment, the doctor may order blood tests to assess kidney function. Tenofovir disoproxil Accord may have harmful effects on the kidneys during treatment. During treatment, the doctor may order regular blood tests to monitor kidney function. If the patient is an adult, the doctor may recommend less frequent dosing. Do not reduce the prescribed dose unless instructed by the doctor.

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

• If the patient has osteoporosis, a history of bone fractures, or bone problems.
• Bone disorders. (manifesting as persistent or worsening bone pain and sometimes leading to fractures) may also occur due to damage to renal tubular cells (see section 4, Possible side effects). If the patient experiences bone pain or fractures, inform the doctor.

Tenofovir disoproxil may also cause loss of 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.
Overall, the long-term impact of tenofovir disoproxil on bone health and the risk of future fractures in adult patients, as well as in children and adolescents, is uncertain.

• In some adult HIV patients receiving combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone) may develop. Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and increased body mass index may be among the many risk factors for developing this condition. Symptoms of osteonecrosis include: joint stiffness, pain (especially in the hip, knee, or shoulder), and difficulty moving. If the patient experiences any of these symptoms, inform the doctor.
• If the patient has previously had liver disease, including hepatitis, consult a doctor. Patients with liver disease, including chronic viral hepatitis B or C, treated with antiretroviral medicines are at increased risk of severe and potentially fatal liver-related adverse reactions. For patients with hepatitis B, the doctor will determine the most appropriate treatment. If the patient has previously had liver disease or chronic hepatitis B, the doctor may recommend regular blood tests to monitor liver function.
• Protect against infections. In patients with advanced HIV infection (AIDS), after starting treatment with Tenofovir disoproxil Accord, symptoms of infection and inflammatory conditions may develop or existing infections may worsen. These symptoms may indicate that the immune system has become stronger and has started fighting the infection. Immediately after starting Tenofovir disoproxil Accord, be alert for signs of inflammation or infection. If symptoms of inflammation or infection occur, contact the doctor immediately.

In addition to opportunistic infections, autoimmune diseases (conditions
occurring when the immune system attacks healthy body tissues) may also
develop after starting antiretroviral therapy for HIV infection. Autoimmune diseases
may appear several months after starting treatment. If symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and progressing toward the trunk, palpitations,
tremor, or hyperexcitability are observed, contact the doctor as soon as possible to
initiate necessary treatment.

• Patients over 65 years of age should consult their doctor or pharmacist. Tenofovir disoproxil Accord has not been studied in patients over 65 years of age. Elderly patients prescribed Tenofovir disoproxil Accord will remain under medical supervision.

Children and adolescents
Tenofovir disoproxil Accord is appropriate for:

• HIV-1 infected adolescents aged 12 to less than 18 years, weighing at least 35 kg, and previously treated with other HIV medicines that are no longer fully effective due to resistance or caused adverse reactions
• HBV infected adolescents aged 12 to less than 18 years, weighing at least 35 kg.

Tenofovir disoproxil Accord is not appropriate for the following groups:

• HIV-1 infected children under 12 years of age
• HBV infected children under 12 years of age.

Dosage, see section 3, How to take Tenofovir disoproxil Accord.
Tenofovir disoproxil Accord and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

• Do not stop taking HIV medicines prescribed by the doctor when starting Tenofovir disoproxil Accord, if there is a concurrent HBV and HIV infection.
• Do not take Tenofovir disoproxil Accord together with any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Accord together with medicines containing adefovir dipivoxil (a medicine used in the treatment of chronic hepatitis B).
• It is very important to inform the doctor about taking other medicines that may damage the kidneys.

These include:

• aminoglycosides, pentamidine, or vancomycin (used in bacterial infections),
• amphotericin B (used in fungal infections),
• foscarnet, ganciclovir, or cidofovir (used in viral infections),
• interleukin-2 (used in cancer treatment),
• adefovir dipivoxil (used in HBV infections),
• tacrolimus (used to suppress immune system function),
• non-steroidal anti-inflammatory drugs (NSAIDs, used for bone or muscle pain).
• Other medicines containing didanosine (used in HIV infection): concomitant use of Tenofovir disoproxil Accord and other antiviral medicines containing didanosine may increase blood levels of didanosine and may also reduce CD4 cell count. Pancreatitis and lactic acidosis (excess lactic acid in the blood) have been rarely observed during concomitant use of tenofovir disoproxil and didanosine, sometimes leading to death. The treating doctor will carefully consider whether tenofovir can be used together with didanosine.
• Also inform the doctor about taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir for the treatment of hepatitis C virus infection.

Tenofovir disoproxil Accord with food and drink
Tenofovir disoproxil Accord should be taken with food (e.g., with a meal or snack).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a
child, she should consult her doctor or pharmacist before using this medicine.

• If the patient took Tenofovir disoproxil Accord during pregnancy, the doctor may order regular blood tests and other diagnostic tests to monitor the child's development. In children whose mothers took NRTIs during pregnancy, the benefit of reduced risk of HIV transmission outweighs the risk of adverse reactions.
• If the mother has HBV and the newborn received medicines to prevent transmission of hepatitis B during delivery, the patient may be able to breastfeed, but she should first talk to her doctor to obtain detailed information.
• Breastfeeding is not recommended for women with HIV, as the HIV virus can be transmitted to the child through breast milk. If the patient is breastfeeding or plans to breastfeed, she should discuss this with her doctor as soon as possible.

Driving and operating machinery
Tenofovir disoproxil Accord may cause dizziness. If dizziness occurs while taking Tenofovir
disoproxil Accord, do not drive or ride a bicycle, and do not use any tools or operate any machinery.
Tenofovir disoproxil Accord contains lactose.
Before taking Tenofovir disoproxil Accord, inform the doctor. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
Tenofovir disoproxil Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Tenofovir disoproxil Accord

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose:

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

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

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

Please read the patient leaflets of the appropriate antiretroviral medicines to become familiar with their proper use.

Taking more Tenofovir disoproxil Accord than prescribed

Taking too much Tenofovir disoproxil Accord may cause numbness, tingling, or pins and needles sensations. If you take more than the prescribed dose, contact your doctor immediately or go to the nearest hospital emergency department.

Missing a dose of Tenofovir disoproxil Accord

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

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

If vomiting occurs within 1 hour of taking Tenofovir disoproxil Accord, take another tablet. There is no need to take another tablet if vomiting occurs more than 1 hour after taking Tenofovir disoproxil Accord.

Stopping treatment with Tenofovir disoproxil Accord

Do not stop taking Tenofovir disoproxil Accord without consulting your doctor. Stopping treatment with Tenofovir disoproxil Accord may reduce the effectiveness of the treatment prescribed by your doctor.

It is very important that patients with hepatitis B virus infection or those co-infected with both HIV and hepatitis B virus do not stop taking Tenofovir disoproxil Accord without first discussing it with their doctor. In some patients, blood test results or symptoms have indicated a worsening of hepatitis after stopping Tenofovir disoproxil Accord. Blood tests may be required for several months after stopping the medicine. Discontinuation of treatment is not recommended in patients with advanced liver disease or cirrhosis, as this may lead to a worsening of hepatitis in some individuals.

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

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

4. Possible adverse effects

During treatment for HIV infection, increases in body weight and in blood levels of lipids and
glucose may occur. This is partly related to improved health and lifestyle, and in the case of blood lipid levels, sometimes to the use of antiretroviral drugs themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Serious possible adverse 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 adverse effect, which can be fatal. Symptoms that may indicate lactic acidosis include:
• deep, rapid breathing
• drowsiness
• nausea, vomiting and abdominal pain.

If a patient suspects they have developed lactic acidosis, they should contact their doctor immediately.
Other possible serious adverse effects
Uncommon (may affect less than 1 in 100 people):

• abdominal pain due to pancreatitis
• damage to renal tubular cells Rare (may affect less than 1 in 1,000 people):
• kidney inflammation, excessive urination and feeling thirsty
• changes in urine test results and back pain due to kidney dysfunction, including kidney failure
• bone softening (manifesting as bone pain and sometimes leading to fractures), which may occur due to damage to renal tubular cells
• fatty liver

If a patient suspects they have experienced any of the above serious adverse effects,
they should contact their doctor.
Most common adverse effects
Very common (may affect more than 10 in 100 people):

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

Tests may also show:

• decreased blood phosphate levels.

Other possible adverse effects
Common (may affect less than 10 in 100 people):

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

Tests may also show:

• liver function abnormalities. Uncommon (may affect less than 1 in 100 people):
• muscle cell breakdown, muscle pain or muscle weakness.

Tests may also show:

• decreased blood potassium levels
• increased blood creatinine levels
• pancreatic dysfunction.

Muscle cell breakdown, bone softening (manifesting as bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased blood potassium or phosphate levels may occur due to damage to renal tubular cells.
Rare (may affect less than 1 in 1,000 people):

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Tenofovir disoproxil Accord

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Tenofovir disoproxil Accord contains
The active substance is tenofovir. Each coated tablet contains 245 mg of tenofovir disoproxil.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch,
crospovidone (type B), magnesium stearate.
Coating:
Opadry white 15B580017 with the following composition: titanium dioxide (E 171), hypromellose 3 mPa s, hypromellose 6 mPa s, polyethylene glycol 400, polysorbate 80.
See section 2, Tenofovir disoproxil Accord contains lactose.
What Tenofovir disoproxil Accord looks like and contents of the pack
Tenofovir disoproxil Accord tablets are white, biconvex, film-coated almond-shaped tablets,
imprinted with "H" on one side and "T11" on the other side, approximately 16 mm in length and 10 mm in width.
Tenofovir disoproxil Accord is available in unit dose blisters made of Aluminium/PVC/Aluminium/OPA,
containing 30 film-coated tablets, in a cardboard box.
Tenofovir disoproxil Accord is also available in bottles containing 30 film-coated tablets, in a cardboard box.
Each bottle contains a desiccant to keep in the bottle to protect the tablets and a silk plug. The desiccant is contained in a separate sachet or container and must not be swallowed.
Not all pack types may be marketed.
Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warszawa
Tel: + 48 22 577 28 00
Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: