Tenofovir disoproxil accordpharma

Package leaflet: Information for the patient

Tenofovir disoproxil Accordpharma, 245 mg, film-coated tablets
Tenofovirum disoproxilum
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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

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

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

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

Tenofovir disoproxil Accordpharma tablets are also intended for the treatment of
chronic hepatitis B, an infection caused by HBV (hepatitis B virus). The tablets are suitable for:

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

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

2. Important information before using Tenofovir disoproxil Accordpharma

When not to use Tenofovir disoproxil Accordpharma

• 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 the doctor and must not take
Tenofovir disoproxil Accordpharma.
Warnings and precautions

• Tenofovir disoproxil Accordpharma does not reduce the risk of transmission of HBV to others through sexual contact or infected blood. Precautions should still be taken to prevent transmission.

Before starting treatment with Tenofovir disoproxil Accordpharma, 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 Accordpharma should not be given to adolescents with kidney disease. Before starting treatment, the doctor may order blood tests to assess kidney function. Tenofovir disoproxil Accordpharma may harm 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 Accordpharma is generally not used together with other medicines
that may harm the kidneys (see, Tenofovir disoproxil Accordpharma and other medicines). If this cannot be avoided, the doctor will monitor kidney function weekly.

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

Bone disorders (manifesting as persistent or worsening bone pain and sometimes leading to fractures) may also occur due to damage to renal tubular cells (see section 4, Possible side effects). If the patient experiences bone pain or fractures, inform the doctor.
Tenofovir disoproxil may also cause loss of bone mineral density. The most significant bone loss was observed in clinical trials where patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the long-term impact of tenofovir disoproxil on bone health and the risk of future fractures in adult patients, as well as in children and adolescents, is uncertain.
In some adult HIV patients receiving combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to poor 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, and 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 the 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. In 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 yourself from infections. In patients with advanced HIV infection (AIDS), after starting treatment with Tenofovir disoproxil Accordpharma, 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 Accordpharma, 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 occur 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 aged 65 years and older should consult their doctor or pharmacist. Tenofovir disoproxil Accordpharma has not been studied in patients aged 65 years and older. Patients in this age group prescribed Tenofovir disoproxil Accordpharma will remain under medical supervision.

Children and adolescents
Tenofovir disoproxil Accordpharma 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 Accordpharma 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 Accordpharma.
Tenofovir disoproxil Accordpharma and other medicines
Inform the doctor or pharmacist about all medicines currently taken 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 Accordpharma, if there is a concurrent HBV and HIV infection.
• Do not take Tenofovir disoproxil Accordpharma together with any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Accordpharma 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 Accordpharma and other antiviral medicines containing didanosine may increase blood levels of didanosine and may also reduce CD4 cell count. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes leading to death, have been observed with concomitant use of tenofovir disoproxil and didanosine. The treating doctor will carefully consider whether tenofovir can be used together with didanosine in the patient.
• Also inform the doctor about taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir for the treatment of hepatitis C virus infection.

Tenofovir disoproxil Accordpharma with food and drink
Tenofovir disoproxil Accordpharma 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 Accordpharma 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 reducing the risk of HIV transmission outweighs the risk of adverse reactions.
• If the mother has HBV and her child received medicines to prevent transmission of hepatitis B virus during delivery, the patient may be able to breastfeed, but should first talk to the 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 Accordpharma may cause dizziness. If dizziness occurs while taking Tenofovir
disoproxil Accordpharma, do not drive or ride a bicycle, and do not use any tools or operate any machinery.
Tenofovir disoproxil Accordpharma contains lactose.
Before taking Tenofovir disoproxil Accordpharma, inform the doctor.
If the patient has been informed by the doctor that they have an intolerance to certain sugars, they should
contact the doctor before taking this medicine.
Tenofovir disoproxil Accordpharma 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 Accordpharma

This medicine should always be taken exactly as prescribed by your doctor. If you have any
doubts, you should
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 may be crushed with a spoon, the resulting
powder mixed with 100 ml (half a glass) of water, orange juice or grape juice, and the
suspension drunk.

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

You should read the patient leaflets of the appropriate antiretroviral medicines to
learn about their proper use.
Taking more Tenofovir disoproxil Accordpharma than recommended
Taking too much Tenofovir disoproxil Accordpharma may cause numbness, tingling, or
pins and needles sensations. If you take more medicine than prescribed, you should contact your
doctor immediately or go to the nearest hospital emergency department.
Missing a dose of Tenofovir disoproxil Accordpharma
It is important not to miss any dose of Tenofovir disoproxil Accordpharma. 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 for taking the dose, take it as soon as possible, then take the next dose at the usual time.
• If more than 12 hours have passed since the time you should have taken the dose, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for a missed tablet.

If vomiting occurs within 1 hour after taking Tenofovir disoproxil Accordpharma,
take another tablet. You do not need to take another tablet if vomiting occurs more than 1 hour
after taking Tenofovir disoproxil Accordpharma.
Stopping treatment with Tenofovir disoproxil Accordpharma
Do not stop taking Tenofovir disoproxil Accordpharma without consulting your doctor.
Stopping treatment with Tenofovir disoproxil Accordpharma may reduce the effectiveness of the
treatment prescribed by your doctor.
It is very important that patients with hepatitis B virus infection or co-infected with HIV and
hepatitis B virus do not stop taking Tenofovir disoproxil Accordpharma without first consulting
their doctor. In some patients, blood test results or symptoms have indicated a worsening of
liver inflammation after stopping Tenofovir disoproxil Accordpharma. Blood tests may be
necessary for several months after stopping the medicine. Discontinuation of treatment is not
recommended in patients with advanced liver disease or cirrhosis, as in some patients this may
lead to worsening of liver inflammation.

• Before stopping Tenofovir disoproxil Accordpharma 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 Accordpharma, contact your doctor.

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

4. Possible adverse reactions

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

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

Serious possible adverse reaction: contact your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 patients), but serious adverse reaction, which can be fatal. Symptoms that may indicate lactic acidosis include:
  • deep, rapid breathing
  • drowsiness
  • nausea, vomiting, and abdominal pain.

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

Other possible serious adverse reactions

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 you think you may have experienced any of the above serious adverse reactions, contact your doctor.

Most frequent adverse reactions

Very common (may affect more than 10 in 100 people):

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

Blood tests may also show:

• decreased blood phosphate levels.

Other possible adverse reactions

Common (may affect less than 10 in 100 people):

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

Blood tests may also show:

• liver function abnormalities.

Uncommon (may affect less than 1 in 100 people):

• muscle cell breakdown, muscle pain or muscle weakness.

Blood 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 reactions

If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 reactions can also be reported to the marketing authorization holder.

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

5. How to store Tenofovir disoproxil Accordpharma

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

6. Contents of the packaging and other information

What Tenofovir disoproxil Accordpharma contains
The active substance is tenofovir. Each coated tablet contains 245 mg of tenofovir disoproxil (as tenofovir disoproxil fumarate).
The other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, sodium croscarmellose, magnesium stearate.
Coating: titanium dioxide (E 171), hypromellose 15 mPas, lactose monohydrate, triacetin.
See section 2, Tenofovir disoproxil Accordpharma contains lactose.

What Tenofovir disoproxil Accordpharma looks like and contents of the pack
Tenofovir disoproxil Accordpharma tablets are white, film-coated, almond-shaped tablets, 16.9 mm long and 10.4 mm wide, with the imprint “H” on one side and “123” on the other side of the tablet.
Tenofovir disoproxil Accordpharma is available in unit-dose blisters made of Aluminium/PVC/Aluminium/OPA, containing 30 film-coated tablets, packed in a cardboard box.

Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Poland
Tel: +48 22 577 28 00

Manufacturer/Importer:
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Laboratori Fundació Dau
C/ C 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain

This medicinal product is authorised for sale in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: