Tenofovir Polpharma

Package Leaflet: Information for the Patient

Tenofovir Polpharma, 245 mg, Film-Coated Tablets

Tenofovir Disoproxil

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Tenofovir Polpharma and what is it used for
• 2. Important information 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 is prescribed for 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 Polpharma and what is it used for

Tenofovir Polpharma contains the active substance tenofovir disoproxil. This active substance is an antiretroviral medicine, used to treat HIV or HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor. 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 Polpharma should always be taken in combination with other medicines to treat HIV infection.

Tenofovir Polpharma 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 Polpharma tablets are also intended for the treatment of chronic hepatitis B

infection, caused by HBV (hepatitis B virus). The tablets are suitable for:

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

A patient does not need to have HIV 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 illnesses associated with HIV. It is also possible to transmit HBV to others, so it is essential to take precautions to avoid infecting others.

2. Important information before taking Tenofovir Polpharma

When not to take Tenofovir Polpharma:

• if you are allergic to tenofovir disoproxil or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, you should immediately inform your doctor and not take Tenofovir Polpharma.

Warnings and precautions

Tenofovir Polpharma does not reduce the risk of transmitting HBV to others through sexual contact or contaminated blood. You should continue to take precautions to prevent this.
Before starting treatment with Tenofovir Polpharma, you should discuss this with your doctor or pharmacist:

• If you have had kidney disease or if tests show that you have kidney disease.Tenofovir Polpharma should not be given to adolescents with kidney disease. Before starting treatment, your doctor may order blood tests to assess kidney function. Tenofovir Polpharma may harm your kidneys during treatment. During treatment, your doctor may order blood tests to monitor kidney function. If you are an adult, your doctor may recommend taking the tablets less frequently. Do not reduce the prescribed dose unless your doctor advises you to do so.
• Tenofovir Polpharma is not usually taken with other medicines that may harm your kidneys (see Tenofovir Polpharma and other medicines). If this cannot be avoided, your doctor will check your kidney function every week.
• If you have had bone problems, have had a bone fracture, or have problems with your bones.

Bone problems(manifested as persistent or worsening bone pain, and sometimes leading to fractures) can also occur due to damage to the kidney tubule cells (see section 4. Possible side effects). If you experience bone pain or fractures, tell your doctor.
Tenofovir disoproxil may also cause a decrease in bone mass. The most significant bone loss was observed in clinical trials in which 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 combination 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 combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, 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 hips, knees, and shoulders), and difficulty moving. If you experience any of these symptoms, tell your doctor.

• If you have had liver problems, including hepatitis, you should consult your doctor.Patients with liver disease, including chronic hepatitis B or C, taking 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 you have had liver disease or chronic hepatitis B, your doctor may recommend blood tests to monitor liver function.
• Protect yourself from infections.In patients with advanced HIV infection (AIDS), when they become infected, after starting treatment with Tenofovir Polpharma, symptoms of infection and inflammation or worsening of existing infection symptoms may occur. These symptoms may indicate that the immune system is strengthening and starting to fight the infection. Soon after starting Tenofovir Polpharma, pay attention to symptoms of inflammation or infection. If you notice symptoms of inflammation or infection, you should immediately inform your doctor.

In addition to opportunistic infections, after starting antiretroviral treatment, autoimmune diseases (diseases that occur when the immune system attacks healthy tissues) may also occur. Autoimmune diseases can occur many months after starting treatment. If you notice symptoms of infection or other symptoms, such as muscle weakness, weakness starting from the hands and feet and progressing towards the torso, palpitations, tremors, or hyperactivity, you should contact your 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 the effect of tenofovir disoproxil in patients over 65 years of age. Patients over this age who are prescribed Tenofovir Polpharma will be under medical supervision.

Children and Adolescents

Tenofovir Polpharma, 245 mg, film-coated tablets are suitablefor:

• HIV-1 infected adolescents from 12 to less than 18 years of age, weighing 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, weighing at least

35 kg.

Tenofovir Polpharma, 245 mg, film-coated tablets are notsuitable for:

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

Dosage, see section 3. How to take Tenofovir Polpharma.

Tenofovir Polpharma and other medicines

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

• Do not stop taking HIV medicinesprescribed by your doctor when starting Tenofovir Polpharma, if you have both HBV and HIV.
• Do not take Tenofovir Polpharmaat the same time as any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Polpharma at the same time as medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).

It is very important to inform your doctor about taking other medicines that

can harm your kidneys,such as:

• 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 infection),
• tacrolimus (used to suppress the immune system),
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).
• Other medicines containing didanosine (against HIV):taking Tenofovir Polpharma 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 amount of 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.
• You should also inform your doctorabout 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., with a meal or snack).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice.

• If you have taken Tenofovir Polpharma during pregnancy,your doctor may order regular blood tests and other diagnostic tests to monitor the development of your 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 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, as HIV can be transmitted to the child through breast milk. If you are breastfeeding or thinking about breastfeeding, you should contact your doctor as soon as possible.

Driving and using machines

Tenofovir Polpharma may cause dizziness. If you experience dizziness while taking Tenofovir Polpharma, do not drive or ride a bike and do not use any tools or machines.

Tenofovir Polpharma contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is essentially "sodium-free".

3. How to take Tenofovir Polpharma

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, ask 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, weighing 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 immediately.

• Always take the dose prescribed 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 advises you to do so.
• If you are an adult and have kidney problems,your doctor may recommend taking Tenofovir Polpharma less frequently.
• If you have HBV infection, your doctor may offer to perform a test for HIV infection to check if you have both HBV and HIV infections.

Read the patient information leaflets for the antiretroviral medicines to learn about their use.

Taking more than the recommended dose of Tenofovir Polpharma

Accidentally taking too many Tenofovir Polpharma tablets may increase the risk of side effects associated with this medicine (see section 4. Possible side effects). Contact your doctor or the emergency department of your nearest hospital for advice. Take the package leaflet with you to describe the medicine you have taken.

Missing a dose of Tenofovir Polpharma

It is essential not to miss any dose of Tenofovir Polpharma. If you miss a dose, calculate how much time has passed since you should have taken it.

• If it has been less than 12 hourssince the usual time of 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 hourssince 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 Polpharma,take another tablet. You do not need to take another tablet if you vomit later 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 lead to a decrease in the effectiveness of the treatment prescribed by your doctor.
It is very important that patients with hepatitis B virus infection or both HIV and hepatitis B virus infectiondo not stop taking Tenofovir Polpharma without first consulting their doctor. In some patients, after stopping Tenofovir Polpharma, 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.

• Before stopping Tenofovir Polpharma 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 symptoms related to hepatitis B virus infection.
• Before restarting treatment with Tenofovir Polpharma, contact your doctor.

If you have any further questions about taking this medicine, ask 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 the improvement in health and lifestyle, and in the case of lipid levels in the blood, sometimes to the antiretroviral treatment itself. Your doctor will order tests to check 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(excessive amount of lactic acid in the blood) is a rare(affects less than 1 in 1,000 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 you think you have lactic acidosis, you should contact your doctor immediately.

Other possible serious side effects

The following side effects are uncommon(affect less than 1 in 100 patients):

• abdominal paincaused by pancreatitis and kidney tubule cell damage. The following side effects are rare(affect less than 1 in 1,000 patients):
• kidney inflammation, excessive urine production, and thirst
• changes in urine test resultsand back paincaused by kidney damage, 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 you think you have any of the above serious side effects, you should contact your doctor.

Most common side effects

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

• 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 are common(affect less than 1 in 10 patients):

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

Tests may also show:

• liver function disorders.

The following side effects are uncommon(affect less than 1 in 100 patients):

• 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 kidney tubule cell damage.
The following side effects are rare(affect less than 1 in 1,000 patients):

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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
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.
By reporting side effects, you can help 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 after EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tenofovir Polpharma contains

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

What Tenofovir Polpharma looks like and contents of the pack

Tenofovir Polpharma, 245 mg, film-coated tablets are light blue, 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 authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Date of last revision of the leaflet:June 2024