Tenofovir polpharma

Patient Information Leaflet

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• 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, please inform your doctor or pharmacist. See section 4.

Table of contents

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

If Tenofovir Polpharma 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 Polpharma is and what it is used for

Tenofovir Polpharma contains the active substance tenofovir disoproxil. This active substance is an antiretroviral (antiviral) medicine used in the treatment of HIV or HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor. It is commonly referred to as an NRTI and works by interfering with the normal function of certain enzymes (reverse transcriptase in HIV, DNA polymerase in hepatitis B virus), which are essential for viral replication. In the case of HIV, Tenofovir Polpharma must always be taken in combination with other antiretroviral medicines for HIV infection.

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

2. Important information before using Tenofovir Polpharma

When not to use Tenofovir Polpharma:

• if the patient is allergic to 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 Polpharma.
Warnings and precautions
Tenofovir Polpharma does not reduce the risk of transmitting HBV to others through
sexual contact or exposure to infected blood. Preventive measures should still be taken to avoid transmission.
Before starting treatment with Tenofovir Polpharma, discuss the following with your doctor or
pharmacist:

• If the patient has a history of kidney disease or if tests indicate kidney problems. Tenofovir Polpharma should not be administered to adolescents with kidney disease. Before starting treatment, the doctor may order blood tests to evaluate kidney function. Tenofovir Polpharma 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 Polpharma is generally not used together with other medicines that may harm the kidneys (see Tenofovir Polpharma and other medicines). If such combination 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, they should inform their doctor.
Tenofovir disoproxil may also cause a reduction in 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.
Overall, the long-term impact of tenofovir disoprox,il 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, they should inform their doctor.

• If the patient has a history of liver disease, including hepatitis, they should consult their doctor. Patients with liver disease, including chronic viral hepatitis B or C, who are taking antiretroviral medicines, are at an increased risk of severe, potentially fatal, liver-related adverse reactions. For patients with hepatitis B, the doctor will determine the most appropriate treatment. If the patient has a history of liver disease or chronic hepatitis B, the doctor may recommend regular blood tests to monitor liver function.
• The patient should protect themselves from infections. In patients with advanced HIV infection (AIDS), after starting treatment with Tenofovir Polpharma, symptoms of infection and inflammatory conditions may develop, or symptoms of an existing infection may worsen. These symptoms may indicate immune reconstitution, where the immune system begins to recover and starts fighting the infection. Immediately after starting Tenofovir Polpharma, patients should be vigilant for signs of inflammation or infection. If any signs of inflammation or infection occur, the patient should inform their doctor immediately.

In addition to opportunistic infections, autoimmune diseases (conditions where the immune system attacks healthy body tissues) may also occur after starting antiretroviral therapy for HIV. 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, tremors, or hyperexcitability occur, the patient should contact their doctor as soon as possible to begin necessary treatment.

• Patients aged 65 years and older should consult their doctor or pharmacist. Studies on the effect of tenofovir disoproxil in patients aged 65 years and older have not been conducted. Patients in this age group prescribed Tenofovir Polpharma will remain under medical supervision.

Children and adolescents
Tenofovir Polpharma 245 mg, film-coated tablets are suitable 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 have caused adverse reactions;
• HBV infected adolescents aged 12 to less than 18 years, weighing at least 35 kg.

Tenofovir Polpharma 245 mg, film-coated tablets are not suitable for the following groups:

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

Dosage, see section 3. How to use Tenofovir Polpharma.
Tenofovir Polpharma and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

• Do not stop taking HIV medicines prescribed by your doctor when starting Tenofovir Polpharma, if both HBV and HIV infections are present.
• Do not take Tenofovir Polpharma together with any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Polpharma together with medicines containing adefovir dipivoxil (used to treat chronic hepatitis B).

It is very important to inform your doctor about taking other medicines that may damage the kidneys, such as:

• aminoglycosides, pentamidine, or vancomycin (used for bacterial infections),
• amphotericin B (used for fungal infections),
• foscarnet, ganciclovir, or cidofovir (used for viral infections),
• interleukin-2 (used in cancer treatment),
• adefovir dipivoxil (used to treat HBV infection),
• tacrolimus (used to suppress immune system activity),
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).
• Other medicines containing didanosine (for HIV infection): concomitant use of Tenofovir Polpharma 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 rarely been observed when tenofovir disoproxil and didanosine are used together, sometimes resulting in death. The treating doctor will carefully consider whether tenofovir can be used together with didanosine in the patient.
• Also inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir for the treatment of hepatitis C virus infection.

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

• If the patient took Tenofovir Polpharma 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 effects.
• 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 she should first talk to her doctor to obtain detailed information.
• Breastfeeding is not recommended for women infected with HIV, as HIV can be transmitted to the child through breast milk. If the patient is breastfeeding or considering breastfeeding, she should consult her doctor as soon as possible.

Driving and operating machinery
Tenofovir Polpharma may cause dizziness. If the patient experiences dizziness while taking Tenofovir Polpharma, they should not drive or ride a bicycle, and should not use tools or operate machinery.
Tenofovir Polpharma contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tenofovir Polpharma

This medicine should always be taken exactly as directed by your doctor or pharmacist. 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 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 snack).

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

• Always take the dose prescribed by your doctor. This is important to ensure full effectiveness of the medicine and to reduce the risk of developing drug resistance. 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 Polpharma 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 infections simultaneously.

Please read the patient leaflets of the respective antiretroviral medicines to learn about their proper use.
Taking more Tenofovir Polpharma than recommended
Accidentally taking too many tablets of Tenofovir Polpharma may increase the risk of side effects
associated with this medicine (see section 4. Possible side effects). You should contact your doctor or the
emergency department of the nearest hospital for advice. Take the medicine packaging with you so that
you can quickly identify which medicine has been taken.
Missing a dose of Tenofovir Polpharma
It is important not to miss any dose of Tenofovir Polpharma. If you miss a dose, calculate how much time has passed since the usual time for taking it.

• 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 the missed tablet.
• If vomiting occurs within 1 hour after taking Tenofovir Polpharma, take another tablet. You do not need to take another tablet if vomiting occurs more than 1 hour after taking Tenofovir Polpharma.

Stopping treatment with Tenofovir Polpharma
Do not stop taking Tenofovir Polpharma without consulting your doctor. Stopping treatment with
Tenofovir Polpharma 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 both HIV and
hepatitis B virus do not stop taking Tenofovir Polpharma without first consulting their doctor. In some patients, blood test results or symptoms have indicated a worsening of hepatitis after stopping Tenofovir Polpharma. 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 in some patients this may lead to a flare-up of hepatitis.

• Before stopping Tenofovir Polpharma for any reason, you should consult your doctor, especially if you experience any side effects or develop another illness.
• Inform your doctor immediately about any new or unusual symptoms noticed after stopping treatment, particularly symptoms related to hepatitis B virus infection.
• Before restarting Tenofovir Polpharma, you should contact your doctor.

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

4. Possible side effects

During treatment for HIV infection, increases in body weight, as well as blood lipid and glucose levels, 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 medications 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: contact your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare (affects fewer than 1 in 1,000 patients), but serious and potentially life-threatening side effect. Symptoms that may indicate lactic acidosis include:

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

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

Other possible serious side effects
The following side effects occur uncommonly (affect fewer than 1 in 100 patients):

• abdominal pain due to pancreatitis
• kidney tubule cell damage

The following side effects occur rarely (affect fewer than 1 in 1,000 patients):

• kidney inflammation, passing large amounts of urine 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 kidney tubule cell damage
• fatty liver

• If you suspect you have developed any of the above serious side effects, contact your doctor immediately.

Most common side effects
The following side effects occur very commonly (affect more than 1 in 10 patients):

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

Blood tests may also show:

• decreased blood phosphate levels.

Other possible side effects
The following side effects occur commonly (affect fewer than 1 in 10 patients):

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

Blood tests may also show:

• liver function abnormalities.

The following side effects occur uncommonly (affect fewer than 1 in 100 patients):

• muscle cell breakdown, muscle pain, or muscle weakness.

Blood tests may also show:

• decreased blood potassium levels
• increased blood creatinine levels
• pancreas function abnormalities.

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 kidney tubule cell damage.

The following side effects occur rarely (affect fewer than 1 in 1,000 patients):

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

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tenofovir Polpharma

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 blister marked EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Do not store above 25°C.
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 package and other information

What Tenofovir Polpharma contains

• The active substance is tenofovir. Each Tenofovir Polpharma tablet contains 245 mg of tenofovir disoproxil (as fumarate).
• The other ingredients are: sodium croscarmellose, monohydrate lactose, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, forming the tablet core; and hypromellose (type 2910), monohydrate lactose, titanium dioxide (E 171), triacetin, indigo carmine, shellac 3-5% (E 132), forming the tablet coating.

What Tenofovir Polpharma looks like and contents of the pack
Tenofovir Polpharma 245 mg tablets are light blue, film-coated, oval, biconvex tablets with dimensions: 17.4 mm – 17.9 mm (length) x 8.1 mm – 8.6 mm (width).
Pack size: 30 film-coated tablets in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01