Tenofovir disoproxil Accordpharma

Leaflet accompanying the packaging: patient information

Tenofovir disoproxil Accordpharma, 245 mg, film-coated tablets

Tenofovir disoproxil

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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 Accordpharma and what is it used for
• 2. Important information before taking Tenofovir disoproxil Accordpharma
• 3. How to take Tenofovir disoproxil Accordpharma
• 4. Possible side effects
• 5. How to store Tenofovir disoproxil Accordpharma
• 6. Package contents and other information

If Tenofovir disoproxil Accordpharma is prescribed to a child, note that all information in this leaflet is addressed to the child (in this case, read "child" instead of "adult patient").

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

Tenofovir disoproxil Accordpharma 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) that are crucial for the replication of viruses.

Tenofovir disoproxil Accordpharma 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 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 from 12 to less than 18 years of age.

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

2. Important information before taking Tenofovir disoproxil Accordpharma

When not to take Tenofovir disoproxil Accordpharma

• 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 not take
Tenofovir disoproxil Accordpharma.

Warnings and precautions

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

Before starting treatment with Tenofovir disoproxil Accordpharma, the patient should discuss it 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 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 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 Accordpharma is not usually taken with other medicines that can harm the kidneys (see Tenofovir disoproxil Accordpharma 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) can also occur due to kidney tubule cell damage (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.
Generally, the long-term effect of tenofovir disoproxil on bone health and the risk of fractures in the future in adult patients, as well as in children and adolescents, is uncertain.
In some adult HIV patients undergoing antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone) may develop. The duration of 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 in the past, including hepatitis, they should consult their doctor.Patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral medicines, are at increased risk of severe and potentially fatal 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 Accordpharma, 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 fighting the infection. Soon after starting Tenofovir disoproxil Accordpharma, 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 can occur 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.

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

Children and adolescents

Tenofovir disoproxil Accordpharma 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 Accordpharma is not suitable for the following groups:

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

Dosage, see section 3, How to take Tenofovir disoproxil Accordpharma.

Tenofovir disoproxil Accordpharma and other medicines

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

• Do not stop taking HIV medicinesprescribed by your doctor when starting Tenofovir disoproxil Accordpharma if you have both HBV and HIV infection.
• Do not take Tenofovir disoproxil Accordpharmaat the same time as any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Accordpharma at the same time as medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
• It is very important to inform your doctorabout taking other medicines that may harm your 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 Accordpharma and other antiviral medicines that contain didanosine at the same time may increase the level of didanosine in the blood and may also decrease the number of CD4 cells. When taking medicines containing tenofovir disoproxil and didanosine, pancreatitis and lactic acidosis (excessive lactic acid in the blood) have been rarely observed, sometimes leading to death. The treating doctor will carefully consider whether to use tenofovir with didanosine.
• Also, inform your doctorabout taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat 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, 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 Accordpharmaduring 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 possibility of HIV infection outweighs the risk of side effects.
• If the mother has HBV and the child was given medicineto 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 Accordpharma can cause dizziness. If the patient experiences dizziness while taking Tenofovir disoproxil Accordpharma, they should not drive vehicles or ride bicycles, and should not operate any tools or machines.

Tenofovir disoproxil Accordpharma contains lactose.

Before taking Tenofovir disoproxil Accordpharma, the patient should tell their doctor.

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

Tenofovir disoproxil Accordpharma contains sodium

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

3. How to take Tenofovir disoproxil Accordpharma

This medicine should always be taken as directed by the doctor.In case of doubts, the patient 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).

In case of difficulty swallowing, the tablet can be crushed using a spoon, the resulting powder can be mixed with 100 ml (half a glass) of water, orange juice, or grape juice, and the suspension can be drunk.

• 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 function disorders,the doctor may recommend taking Tenofovir disoproxil Accordpharma less frequently.
• If the patient has HBV, the doctor may offer to perform an HIV test to check if the patient has both HBV and HIV infection.

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

Taking a higher dose of Tenofovir disoproxil Accordpharma than recommended

Taking too much Tenofovir disoproxil Accordpharma may cause numbness, tingling, or prickling. 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 Accordpharma

It is essential not to miss any dose of Tenofovir disoproxil Accordpharma. 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 Accordpharma

they should take another tablet.The patient does not need to take another tablet if the vomiting occurs later than 1 hour after taking Tenofovir disoproxil Accordpharma.

Stopping treatment with Tenofovir disoproxil Accordpharma

The patient should not stop taking Tenofovir disoproxil Accordpharma without consulting their doctor. Stopping treatment with Tenofovir disoproxil Accordpharma may lead to a decrease in the effectiveness of the treatment prescribed by the doctor.
It is very important that patients with hepatitis B or both HIV and hepatitis Bdo not stop taking Tenofovir disoproxil Accordpharma without first consulting their doctor. In some patients, after stopping Tenofovir disoproxil Accordpharma, 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 Accordpharma 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 virus infection.
• Before restarting Tenofovir disoproxil Accordpharma, the patient should contact 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, weight gain and increased lipid and glucose levels in the blood may occur. This is partly related to the improvement in health and lifestyle, and in the case of lipid levels in the blood, sometimes to the antiretroviral medicines themselves. The doctor will order tests to check these changes.
Like all medicines, Tenofovir disoproxil Accordpharma 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. Side effects 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 function disorders, including kidney failure
• bone softening(manifested as bone pain and 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, bloating, gas.

Tests may also show:

• liver function disorders.

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
• pancreas function disorders.

Muscle breakdown, bone softening (manifested as bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur due to kidney 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 the medicine.

5. How to store Tenofovir disoproxil Accordpharma

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.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tenofovir disoproxil Accordpharma contains

The active substance is tenofovir. Each film-coated tablet contains 245 mg of tenofovir disoproxil (as tenofovir disoproxil fumarate).
The other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, maize starch, croscarmellose sodium, 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 package contents

Tenofovir disoproxil Accordpharma tablets are white, film-coated, almond-shaped tablets, 16.9 mm long and 10.4 mm wide, with the inscription "H" on one side and "123" on the other side of the tablet.
Tenofovir disoproxil Accordpharma is available in single-dose blisters of Aluminum/PVC/Aluminum/OPA containing 30 film-coated tablets, in a cardboard box.

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

Date of last revision of the leaflet: August 2024