Tenofovir disoproxil Accord

Leaflet attached to the packaging: patient information

Tenofovir disoproxil Accord, 245 mg, coated tablets

Tenofovir disoproxil

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Tenofovir disoproxil Accord and what is it used for
• 2. Important information before taking 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 is prescribed for a child, note that all the information in this leaflet is addressed to the child (in this case, read "child" instead of "adult patient").

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

Tenofovir disoproxil Accord contains the active substance tenofovir disoproxil. This active substance is an antiretroviralmedicine, i.e., an antiviral medicine used to treat HIV or HBV infection or both. Tenofovir is a nucleotide inhibitorof reverse transcriptase. This substance is generally referred to as NRTI and works by disrupting the normal functioning of enzymes (in HIV, reverse transcriptase, in hepatitis B virus - DNA polymerase), which are essential for the replication of viruses. In the case of HIV, Tenofovir disoproxil Accord should always be used in combination with other medicines for the treatment of HIV infection. Tenofovir disoproxil Accord tablets are intended for the treatment of HIV infection(human immunodeficiency virus). The tablets are suitable for:

• adults
• adolescents from 12 to less than 18 years of age, previously treatedwith other HIV medicines that are no longer fully effective due to the development of resistance or have caused side effects.

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

The tablets are suitable for:

• adults
• adolescents from 12 to less than 18 years of age.

The patient does not need to have HIV to be treated with Tenofovir disoproxil Accord for hepatitis B. This medicine will not cure HIV infection. People taking Tenofovir disoproxil Accord may still develop infections or other diseases related to HIV infection. It is also possible to transmit HIV to others, so it is essential to take precautions to avoid infecting others.

2. Important information before taking Tenofovir disoproxil Accord

When not to take Tenofovir disoproxil Accord

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

The patient to whom this applies should immediately inform their doctor and 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 contaminated blood. Precautions should still be taken to prevent this. Before starting treatment with Tenofovir disoproxil Accord, the patient should discuss this with their doctor or pharmacist.

• If the patient has had kidney disease or if tests indicate kidney disease, they should consult their 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 harm the kidneys during treatment. During treatment, the doctor may order blood tests to monitor kidney function. If the patient is an adult, the doctor may recommend taking the tablets less frequently. The prescribed dose should not be reduced unless the doctor recommends it.

Tenofovir disoproxil Accord is not usually taken with other medicines that may harm the kidneys (see Tenofovir disoproxil Accord and other medicines). If this cannot be avoided, the doctor will check kidney function every week.

• If the patient has osteoporosis, has had a bone fracture, or has bone problems.
• Bone disorders(manifested as persistent or worsening bone pain and sometimes leading to fractures) may also occur due to damage to the kidney tubule cells (see section 4, Possible side effects). If the patient experiences bone pain or fractures, they should inform their doctor.

Tenofovir disoproxil may also cause bone loss. 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 effect of tenofovir disoproxil on bone health and the risk of fractures in the future in adult patients and in children and adolescents is uncertain.

• Some adult patients with HIV who have received combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone). The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and increased body mass index may be some of the risk factors for the development of the disease. Symptoms of osteonecrosis are joint stiffness, pain (especially in the hip, knee, and shoulder), and difficulty moving. If the patient experiences any of these symptoms, they should tell their doctor.
• If the patient has had liver disease, including hepatitis, they should consult their doctor.Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretroviral medicines are at increased risk of severe and potentially life-threatening side effects related to the liver. In patients with hepatitis B, the doctor will determine the most appropriate treatment. If the patient has had liver disease or chronic hepatitis B in the past, the doctor may recommend blood tests to monitor liver function.
• Protect yourself from infections.In patients with advanced HIV infection (AIDS), when they start taking Tenofovir disoproxil Accord, they may develop symptoms of infection and inflammation or worsening of existing infection symptoms. These symptoms may indicate that the immune system is strengthening and starting to fight the infection. Soon after starting Tenofovir disoproxil Accord, the patient should be aware of symptoms of inflammation or infection. If symptoms of inflammation or infection occur, the patient should immediately inform their doctor.

In addition to opportunistic infections, autoimmune diseases (diseases that occur when the immune system attacks healthy tissues) may also occur after starting antiretroviral therapy. Autoimmune diseases may occur several months after starting treatment. If the patient notices symptoms of infection or other symptoms, such as muscle weakness, weakness starting from the hands and feet and progressing towards the torso, heart palpitations, tremors, or hyperactivity, they should contact their doctor as soon as possible to start the necessary treatment.

• Patients over 65 years of age should consult their doctor or pharmacist.No studies have been conducted on Tenofovir disoproxil Accord in patients over 65 years of age. People over this age who are prescribed Tenofovir disoproxil Accord will be under medical supervision.

Children and adolescents

Tenofovir disoproxil Accord is suitablefor:

• HIV-1 infected adolescents from 12 to less than 18 years of age, with a body weight of at least 35 kg and previously treatedwith other HIV medicines that are no longer fully effective due to the development of resistance or have caused side effects.
• HBV infected adolescents from 12 to less than 18 years of age, with a body weight of at least 35 kg.

Tenofovir disoproxil Accord is notsuitable for the following groups:

• HIV-1 infected childrenunder 12 years of age.
• HBV infected childrenunder 12 years of age.

Dosing, see section 3, How to take Tenofovir disoproxil Accord.

Tenofovir disoproxil Accord and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken, or plan to take.

• Do not stop taking HIV medicinesprescribed by the doctor when starting Tenofovir disoproxil Accord, if the patient has both HBV and HIV infection.
• Do not take Tenofovir disoproxil Accordat the same time as any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Accord at the same time as medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
• It is very important to inform the doctor about taking other medicines that may harm the kidneys.

These include:

• aminoglycosides, pentamidine, or vancomycin (used to treat bacterial infections),
• amphotericin B (used to treat fungal infections),
• foscarnet, ganciclovir, or cidofovir (used to treat viral infections),
• interleukin-2 (used to treat cancer),
• adefovir dipivoxil (used to treat HBV),
• tacrolimus (used to suppress the immune system),
• non-steroidal anti-inflammatory drugs (NSAIDs, used to treat bone or muscle pain).
• Other medicines containing didanosine (used to treat HIV):taking Tenofovir disoproxil Accord and other antiviral medicines that contain didanosine at the same time may increase the level of didanosine in the blood and may also decrease the number of CD4 cells. When taking medicines containing tenofovir disoproxil and didanosine, rare cases of pancreatitis and lactic acidosis (excessive lactic acid in the blood) have been observed, sometimes leading to death. The doctor will carefully consider whether to use tenofovir with didanosine in the patient.
• The patient should also inform the doctorabout taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

• If the patient took Tenofovir disoproxil Accordduring pregnancy, the doctor may order regular blood tests and other diagnostic tests to monitor the development of the child. In children whose mothers took NRTI during pregnancy, the benefit of reducing the risk of HIV transmission outweighs the risk of side effects.
• If the mother has HBV and the child was given medicine to prevent the transmission of hepatitis B during birth, the patient may be able to breastfeed, but they should first discuss this with their doctor to get 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, they should discuss this with their doctor as soon as possible.

Driving and using machines

Tenofovir disoproxil Accord may cause dizziness. If the patient experiences dizziness when taking Tenofovir disoproxil Accord, they should not drive or ride a bicycleand should not operate any tools or machines.

Tenofovir disoproxil Accord contains lactose

Before taking Tenofovir disoproxil Accord, the patient should tell their doctor if they have been diagnosed with an intolerance to some sugars. If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

Tenofovir disoproxil Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Tenofovir disoproxil Accord

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Recommended dose:

• adults:1 tablet taken once a day with food (e.g., with a meal or snack).
• adolescents from 12 to less than 18 years of age, with a body weight of at least 35 kg:1 tablet taken once a day with food (e.g., with a meal or snack).

If the patient has difficulty swallowing, they can crush the tablet using a spoon, mix the resulting powder with 100 ml (half a glass) of water, orange juice, or grape juice, and drink the suspension.

• The patient should always take the dose prescribed by their doctor.This is to ensure the full effectiveness of the medicine and to limit the development of resistance to the medicine. The patient should not change the dose of the medicine unless their doctor recommends it.
• If the patient is an adult and has kidney problems,the doctor may recommend taking Tenofovir disoproxil Accord less frequently.
• If the patient has HBV, the doctor may offer to perform an HIV test to check if the patient also has HIV and HBV infection.

The patient should read the patient information leaflets for the other antiretroviral medicines to learn about their use.

Taking more than the recommended dose of Tenofovir disoproxil Accord

Taking more than the recommended dose of Tenofovir disoproxil Accord may cause numbness, tingling, or tingling sensations. If it is discovered that the patient has taken more medicine than prescribed, they should immediately contact their doctor or go to the emergency room of the nearest hospital.

Missing a dose of Tenofovir disoproxil Accord

It is essential not to miss any dose of Tenofovir disoproxil Accord. If the patient misses a dose, they should calculate how much time has passed since they were supposed to take it.

• If it has been less than 12 hourssince the usual time of taking the dose, the patient should take it as soon as possible and then take the next dose at the usual time.
• If it has been more than 12 hourssince the time the patient was supposed to take the dose, they should not take the missed dose. The patient should wait and take the next dose at the usual time. The patient should not take a double dose to make up for the missed tablet.

If the patient vomits within 1 hour of taking Tenofovir disoproxil Accord

If the patient vomits, they should take another tablet. The patient does not need to take another tablet if they vomit later than 1 hour after taking Tenofovir disoproxil Accord.

Stopping treatment with Tenofovir disoproxil Accord

The patient should not stop taking Tenofovir disoproxil Accord without consulting their doctor. Stopping treatment with Tenofovir disoproxil Accord may lead to a decrease in the effectiveness of the treatment prescribed by the doctor. It is essential that patients with hepatitis B or both HIV and hepatitis Bdo not stop taking Tenofovir disoproxil Accord without first consulting their doctor. In some patients, after stopping Tenofovir disoproxil Accord, blood test results or symptoms indicated a worsening of hepatitis. For several months after stopping the medicine, it may be necessary to perform blood tests. In patients with advanced liver disease or liver cirrhosis, it is not recommended to stop treatment, as this may lead to a worsening of hepatitis.

• Before stopping Tenofovir disoproxil Accord for any reason, the patient should consult their doctor, especially if they have experienced any side effects or have another illness.
• The patient should immediately inform their doctor about any new or unusual symptoms they notice after stopping treatment, especially those that are usually associated with hepatitis B.
• Before restarting Tenofovir disoproxil Accord, the patient should consult their doctor.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

During HIV treatment, the patient may experience weight gain and increased levels of lipids and glucose in the blood. This is partly related to the improvement in health and lifestyle, and in the case of lipid levels in the blood, sometimes to the use of HIV medicines themselves. The doctor will order tests to monitor these changes. Like all medicines, Tenofovir disoproxil Accord can cause side effects, although not everybody gets them.

Possible serious side effects: the patient should immediately inform their doctor

• Lactic acidosis(excessive lactic acid in the blood) is a rare(may occur in less than 1 in 1000 patients) but serious side effect that can be fatal. Symptoms that may be signs of lactic acidosis are:
• deep, rapid breathing
• drowsiness
• nausea, vomiting, and abdominal pain.

If the patient thinks they have lactic acidosis, they should immediately contact their doctor.

Other possible serious side effects

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

• abdominal paincaused by pancreatitis
• kidney tubule cell damage Rare(may affect less than 1 in 1000 people):
• kidney inflammation, excessive urination, and thirst
• changes in urine test resultsand back paincaused by kidney problems, including kidney failure
• bone softening (manifested as bone painand sometimes leading to fractures), which may occur due to kidney tubule cell damage
• fatty liver

If the patient thinks they have experienced any of the above serious side effects, they should contact their doctor.

Most common side effects

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

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

Tests may also show:

• decreased phosphate levels in the blood.

Other possible side effects

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

• headache, stomach pain, feeling tired, feeling bloated, gas, weight loss.

Tests may also show:

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

Tests may also show:

• decreased potassium levels in the blood
• increased creatinine levels in the blood
• pancreatic problems.

Muscle breakdown, bone softening (manifested as bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur due to kidney tubule cell damage. Rare(may affect less than 1 in 1000 people):

• abdominal pain caused by hepatitis
• swelling of the face, lips, tongue, or throat.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Tenofovir disoproxil Accord

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and bottle after: Expiry date (EXP). The expiry date refers to the last day of the month stated. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack 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, cornstarch, crospovidone (type B), magnesium stearate. Coating: Opadry white 15B580017, which contains titanium dioxide (E 171), hypromellose 3 mPa s, hypromellose 6 mPa s, macrogol 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 with "H" engraved on one side and "T11" on the other side, approximately 16 mm long and 10 mm wide. Tenofovir disoproxil Accord is available in single-dose aluminum/PVC/aluminum/OPA blisters containing 30 coated tablets, in a cardboard box. Tenofovir disoproxil Accord is also available in bottles containing 30 coated tablets, in a cardboard box. Each bottle contains a desiccant, which should be kept in the bottle to protect the tablets, as well as a silica gel bag. The desiccant is in a separate bag or container and should not be swallowed. Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, Tel: +48 22 577 28 00

Manufacturer/Importer:

Pharmadox Healthcare Limited, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: October 2024