Tenofovir Zentiva

Leaflet accompanying the packaging: patient information

Tenofovir Zentiva, 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tenofovir Zentiva and what is it used for
• 2. Important information before taking Tenofovir Zentiva
• 3. How to take Tenofovir Zentiva
• 4. Possible side effects
• 5. How to store Tenofovir Zentiva
• 6. Contents of the pack and other information

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

1. What is Tenofovir Zentiva and what is it used for

Tenofovir Zentiva contains the active substance tenofovir disoproxil. This active substance is an antiretroviralmedicine, used to treat HIV (human immunodeficiency virus) or HBV (hepatitis B virus) or both infections. Tenofovir is a nucleotide reverse transcriptase inhibitor, usually referred to as NRTI, and works by disrupting the normal functioning of enzymes (in HIV reverse transcriptase, in hepatitis B virus - DNA polymerase). Both enzymes are crucial for the replication of viruses. In people with HIV infection, Tenofovir Zentiva should always be used in combination with other medicines for the treatment of such infections.
Tenofovir Zentiva is intended for the treatment of HIV infection(English: Human Immunodeficiency Virus, human immunodeficiency virus). Tablets can be used in:

• 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 Zentiva is also intended for the treatment of chronic hepatitis B,

infection caused by HBV.Tablets can be used in:

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

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

2. Important information before taking Tenofovir Zentiva

When not to take Tenofovir Zentiva

• If the patient is allergic to tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6). The patient should immediately inform their doctor and not take Tenofovir Zentiva.

Warnings and precautions

Tenofovir Zentiva does not reduce the risk of transmitting HBV to other people through sexual contact or contaminated blood. Precautions should still be taken to prevent this.
Before starting treatment with Tenofovir Zentiva, the patient should discuss this with their doctor or pharmacist.

• If the patient has had kidney disease or if tests indicate kidney disease.Tenofovir Zentiva should not be given to adolescents with kidney disease. Before starting treatment, the doctor may order blood tests to assess kidney function. Tenofovir Zentiva may affect 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 Zentiva is not usually taken with other medicines that may harm the kidneys (see Tenofovir Zentiva 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 disease(manifested as persistent or worsening bone pain, and sometimes leading to fractures) may also occur due to damage to the renal tubular 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 a decrease in 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.
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 not clear.
In some adult patients with HIV infection 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, intense 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, and discomfort (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, treated with antiretroviral medicines, are at increased risk of severe and potentially life-threatening side effects affecting 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, the doctor may recommend blood tests to monitor liver function.

Protect yourself from infections.In patients with advanced HIV infection (AIDS), who develop an infection after starting treatment with Tenofovir Zentiva, symptoms of the infection and inflammation or worsening of existing infection may occur. These symptoms may indicate that the immune system has strengthened and is fighting the infection. After starting Tenofovir Zentiva, the patient should be aware of symptoms of inflammation or infection. If symptoms of inflammation or infection occur, the doctor should be informed immediately.
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 with Tenofovir Zentiva in patients over 65 years of age. Patients over 65 years of age who have been prescribed Tenofovir Zentiva will be under medical supervision.

Children and adolescents

Tenofovir Zentiva can be used in:

• HIV-1 infected adolescents from 12 to less than 18 years of age, with a body weight of at least 35 kg, and previously treated with 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 Zentiva should not be used in:

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

Dosing, see section 3. How to take Tenofovir Zentiva.

Tenofovir Zentiva and other medicines

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

• Do not stop taking HIV medicinesprescribed by your doctor when starting Tenofovir Zentiva, if you have both HBV and HIV.
• Do not take Tenofovir Zentivaat the same time as any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Zentiva 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 medicines 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 (to reduce the immune system's response),
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone and muscle pain).
• Other medicines containing didanosine (against HIV infection):Taking Tenofovir Zentiva with other antiviral medicines that contain didanosine may increase the level of didanosine in the blood and 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 sometimes been observed, which can be fatal. The doctor will carefully consider whether to use a combination of tenofovir and didanosine in the patient.
• Also, inform your doctorabout taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

Taking Tenofovir Zentiva with food and drink

Tenofovir Zentiva should be taken with food(e.g., with a meal or snack).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

• If you have taken Tenofovir Zentivaduring pregnancy, your doctor may order regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit of reducing the risk of HIV transmission outweighs the risk of side effects.
• If the mother has HBV and her child has been given medicines to prevent the transmission of hepatitis B virus during birth, the mother may be able to breastfeed, but she should first discuss this with her doctor to get detailed information.
• Breastfeeding is not recommended for women with HIV infection, as HIV can be transmitted to the child through breast milk. If you are breastfeeding or planning to breastfeed, you should talk to your doctor as soon as possible.

Driving and using machines

Tenofovir Zentiva may cause dizziness. If you experience dizziness while taking Tenofovir Zentiva, do not drive or ride a bike, use any tools, or operate any machinery.

Tenofovir Zentiva contains lactose and sodium

Tenofovir Zentiva contains lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Tenofovir Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your 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 you have difficulty swallowing, the tablet can be crushed with the tip of a spoon. Then mix the powder with about 100 ml (half a glass) of water, orange juice, or grape juice and drink it immediately.
Always take the dose recommended by your doctor.This is to ensure the full effectiveness of the medicine and to reduce the development of resistance to the medicine. Do not change the dose of the medicine unless your doctor recommends it.
If you are an adult and have kidney problems,your doctor may recommend taking Tenofovir Zentiva less frequently or taking a lower dose available on the market.
If you have HBV infection, your doctor may offer to perform a test for the presence of HIV to check if you have both HBV and HIV infections.
Read the patient information leaflets of other antiretroviral medicines to learn about their use.

Taking a higher dose of Tenofovir Zentiva than recommended

Accidentally taking too many Tenofovir Zentiva tablets may increase the risk of possible side effects of this medicine (see section 4, "Possible side effects").
Consult your doctor or the emergency department of the nearest hospital for advice. Take the package leaflet with you to show the doctor which medicine you have taken.

Missing a dose of Tenofovir Zentiva

It is essential not to miss any dose of Tenofovir Zentiva.
If you miss a dose of Tenofovir Zentiva, calculate how much time has passed since you were supposed to take it.

• If it has been less than 12 hours since the usual time for taking the dose, take it as soon as possible, and then take the next dose at the usual time.
• If it has been more than 12 hours 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 the missed tablet.

If you vomit within 1 hour of taking Tenofovir Zentiva,take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking Tenofovir Zentiva.

Stopping treatment with Tenofovir Zentiva

• Do not stop taking Tenofovir Zentiva without consulting your doctor. Stopping treatment with Tenofovir Zentiva may reduce the effectiveness of the treatment prescribed by your doctor.
• It is very important that patients with hepatitis B virus or both HIV and hepatitis B virus infectionsdo not stop taking Tenofovir Zentiva without first consulting their doctor. In some patients, after stopping Tenofovir Zentiva, 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 it may lead to a worsening of hepatitis.
• Before stopping Tenofovir Zentiva for any reason, consult your doctor, especially if you have experienced any side effects or have another illness.
• You should immediately inform your doctor about any new or unusual symptoms you notice after stopping treatment, especially those that are usually associated with hepatitis B virus infection.
• Before restarting Tenofovir Zentiva tablets, consult your doctor.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Possible serious side effects: consult your doctor immediately

Lactic acidosis(excessive lactic acid in the blood) is a rare(may occur in less than 1 in 1000 people) but serious side effect that can be fatal. The following side effects may be signs of lactic acidosis:

• deep, rapid breathing
• drowsiness
• nausea (nausea), vomiting, and abdominal pain.

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

Other possible serious side effects

The following side effects occur uncommonly(may occur in less than 1 in 100 people):

• abdominal pain(abdominal cavity) caused by pancreatitis and kidney tubular cell damage.

The following side effects occur rarely(may occur in 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 painand sometimes leading to fractures), which may occur due to damage to the renal tubular cells
• fatty liver.

If you think you have experienced any of the above serious side effects, consult your doctor.

Most common side effects

The following side effects occur very commonly(may occur in more than 1 in 10 people):

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

Tests may also show:

• decreased phosphate levels in the blood.

Other possible side effects

The following side effects occur commonly(may occur in less than 1 in 10 people):

• headache, stomach pain, feeling tired, bloating, bone loss.

Tests may also show:

• liver function disorders.

The following side effects occur uncommonly(may occur in 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 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 damage to the renal tubular cells.
The following side effects occur rarely(may occur in less than 1 in 1000 people):

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02 222 Warsaw
Phone: +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 or its representative in Poland.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Tenofovir Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Expiry Date (EXP):". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
After opening the bottle for the first time, the medicine should be used within 60 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tenofovir Zentiva contains

• The active substance of the medicine is tenofovir disoproxil. Each Tenofovir Zentiva tablet contains 245 mg of tenofovir disoproxil (in the form of fumarate).
• The other ingredients are: lactose monohydrate, povidone, croscarmellose sodium (E468), microcrystalline cellulose, magnesium stearate (E572), hypromellose, titanium dioxide (E 171), triacetin, indigo carmine (E132).

What Tenofovir Zentiva looks like and contents of the pack

Tenofovir Zentiva is a light blue, elongated, biconvex, film-coated tablet, approximately 17 mm x 8 mm in size.
Contents of the pack:
Tenofovir Zentiva, 245 mg, film-coated tablets, are supplied in an HDPE bottle with a child-resistant closure and a desiccant in the form of silica gel (in a container) containing 30 film-coated tablets or in OPA/Aluminum/PVC/Aluminum blisters containing 10 film-coated tablets.
The following pack sizes are available: cardboard boxes containing three blisters of 10 film-coated tablets each or one bottle of 30 film-coated tablets or three bottles of 30 film-coated tablets each.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic

Importer

Zentiva, k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic
S.C. Zentiva S.A., B-dul Theodor Pallady nr.50, sector3, Bucharest, cod 032266, Romania

This medicine has been authorized in the Member States of the European Economic Area under the following names:

Bulgaria Тенофовир Зентива 245 mg филмирани таблетки
Czech Republic Tenofovir disoproxil Zentiva k.s.
Denmark Tenofovir disoproxil Zentiva k.s.
France Tenofovir Disoproxil Zentiva Lab 245 mg, comprimé pelliculé
Germany Tenofovirdisoproxil Zentiva 245 mg Filmtabletten
Norway Tenofovir disoproxil Zentiva k.s.
Poland Tenofovir Zentiva, 245 mg, tabletki powlekane
Sweden Tenofovir disoproxil Zentiva k.s.
United Kingdom (Northern Ireland) Tenofovir Zentiva 245 mg film coated tablets

For more information about this medicine, contact the representative of the marketing authorization holder in Poland:

Zentiva Poland Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:July 2024