Tenofovir Sinoptis

Leaflet accompanying the packaging: patient information

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

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

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

Tenofovir Synoptis 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, commonly referred to as NRTI, and works by disrupting the normal functioning of enzymes (reverse transcriptase in the case of HIV, DNA polymerase in the case of hepatitis B virus) that are essential for the replication of viruses. In the case of HIV, Tenofovir Synoptis should always be used in combination with other HIV medicines.

Tenofovir Synoptis is 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 treated with other HIV medicinesthat are no longer fully effective due to the development of resistance or have caused side effects.

Tenofovir Synoptis is 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.

The patient does not need to have HIV to be treated with Tenofovir Synoptis for hepatitis B.
Tenofovir Synoptis will not cure HIV infection. Patients taking Tenofovir Synoptis may 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 Synoptis

When not to take Tenofovir Synoptis

• 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 Synoptis.

Warnings and precautions

Before starting treatment with Tenofovir Synoptis, the patient should discuss it with their doctor or pharmacist.

• Be careful not to infect others.The patient can still transmit the HIV virus while taking this medicine, even if effective antiretroviral therapy reduces this risk. The patient should discuss with their doctor the precautions necessary to avoid infecting others. Tenofovir Synoptis does not reduce the risk of transmitting HBV to others through sexual contact or contaminated blood. Precautions should still be taken to prevent this.
• If the patient has had kidney disease or if tests show kidney disease, they should consult their doctor or pharmacist.Tenofovir Synoptis should not be given to adolescents with kidney disease. Before starting treatment, the doctor may order blood tests to assess kidney function. Tenofovir Synoptis 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 Synoptis is not usually taken with other medicines that can harm the kidneys (see Tenofovir Synoptis and other medicines). If this cannot be avoided, the doctor will check kidney function every week.

• Bone disorders.In some adult patients with HIV taking 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, 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.

Adults:
Bone disorders (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 tell their 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 not clear.
If the patient has osteoporosis, they should tell their doctor. Patients with osteoporosis are more likely to experience fractures.
Children and adolescents:
Bone disorders (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 child experiences bone pain or fractures, they should tell their 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 not clear.
If the child has osteoporosis, they should tell their doctor. Patients with osteoporosis are more likely to experience fractures.

• If the patient has had liver disease, including hepatitis, they should consult their 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 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), when treatment with Tenofovir Synoptis is started, symptoms of infection and inflammation or worsening of existing infection symptoms may occur. These symptoms may indicate that the immune system is recovering and starting to fight the infection. After starting treatment with Tenofovir Synoptis, 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 treatment with HIV medicines. Autoimmune diseases may occur several months after starting treatment. If the patient experiences 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, 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.Tenofovir Synoptis has not been studied in patients over 65 years of age. Patients over this age who are prescribed Tenofovir Synoptis will be under medical supervision.

Children and adolescents

Tenofovir Synoptis 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 treated with other HIV medicinesthat 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 Synoptis 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 Synoptis.

Tenofovir Synoptis and other medicines

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

• Do not stop taking HIV medicinesprescribed by the doctor when starting treatment with Tenofovir Synoptis, if the patient has both HBV and HIV.
• Do not take Tenofovir Synoptisat the same time as any medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Synoptis at the same time as medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
• It is very important to inform the doctorabout 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 Synoptis 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 at the same time, 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 in the patient.
• The patient should also inform their doctorabout taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

Tenofovir Synoptis with food and drink

Tenofovir Synoptis 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 Synoptisduring 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.

Adults:

• If the mother has HBV and her child has been given medicines to prevent the transmission of hepatitis B virus during birth, the patient may be able to breastfeed, but they should first discuss this with their doctor to get detailed information.
• If the mother has HIV, she should not breastfeed to avoid transmitting the virus to the child through milk.

Children and adolescents:

• If the girl has HBV and her child has been given medicines to prevent the transmission of hepatitis B virus during birth, the girl may be able to breastfeed, but she should first discuss this with her doctor to get detailed information.
• If the girl has HIV, she should not breastfeed to avoid transmitting the virus to the child through milk.

Driving and using machines

Tenofovir Synoptis may cause dizziness. If the patient experiences dizziness while taking Tenofovir Synoptis, they should not drive or ride a bike, or operate any tools or machines.

Tenofovir Synoptis contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Tenofovir Synoptis contains sodium

The 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 Synoptis

This medicine should always be taken exactly as prescribed by the doctor or pharmacist.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, the tablet can be crushed using a spoon, and the resulting powder can be mixed with approximately 100 ml (half a glass) of water, orange juice, or grape juice and taken immediately.

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

The patient should read the patient information leaflets for the other antiretroviral medicines to understand how to take them.

Taking a higher dose of Tenofovir Synoptis than recommended

Accidentally taking too many Tenofovir Synoptis tablets may increase the risk of possible side effects of this medicine (see section 4, Possible side effects).
The patient should contact their doctor or the emergency department of the nearest hospital for advice.
The patient should take the bottle of tablets with them so that they can show the doctor the medicine they have taken.

Missing a dose of Tenofovir Synoptis

It is essential not to miss any dose of Tenofovir Synoptis. 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 Synoptis,they should take another tablet. The patient does not need to take another tablet if they vomit more than 1 hour after taking Tenofovir Synoptis.

Stopping treatment with Tenofovir Synoptis

The patient should not stop taking Tenofovir Synoptis without consulting their doctor. Stopping treatment with Tenofovir Synoptis may lead to a decrease in the effectiveness of the treatment prescribed by the doctor.
It is essential for patients with hepatitis B virus infection or both HIV and hepatitis B virus infectionnot to stop taking Tenofovir Synoptis without first consulting their doctor. In some patients, after stopping Tenofovir Synoptis, 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 Synoptis for any reason, the patient should consult their doctor, especially if they experience any side effects or develop 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 treatment with Tenofovir Synoptis, 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 treatment for HIV infection, an increase in body weight and 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 use of HIV medicines themselves. The doctor will order the necessary tests for these changes.
Like all medicines, Tenofovir Synoptis can cause side effects, although not everybody gets them.

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

• Lactic acidosis(excessive amount of lactic acid in the blood) is a rare(may occur in less than 1 in 1000 patients) but serious side effect that can lead to death. 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

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

• abdominal paincaused by pancreatitis
• damage to the renal tubular cells

The following side effects occur rarely(may occur in less than 1 in 1000 patients):

• 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 damage to the renal tubular cells
• fatty liver

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

Very common side effects

The following side effects occur very commonly(may occur in more than 10 in 100 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 occur commonly(may occur in less than 10 in 100 patients):

• headache, stomach pain, feeling tired, feeling bloated, bloating

Tests may also show:

• liver function disorders

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

• abdominal pain caused by liver inflammation
• 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 the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tenofovir Synoptis

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after EXP.
The expiry date refers to the last day of the month stated.
Do not store above 30°C.
The medicine should be used within 30 days of opening the bottle.
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 Synoptis contains

• The active substance of the medicine is tenofovir. Each tablet contains 245 mg of tenofovir disoproxil (in the form of tenofovir disoproxil fumarate).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, magnesium stearate. Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, indigo carmine, lake (E 132).

See section 2 "Tenofovir Synoptis contains lactose".

What Tenofovir Synoptis looks like and contents of the pack

Blue, oval, biconvex, film-coated tablets with "CL 77" embossed on one side and plain on the other.
HDPE bottle with a desiccant, a strip of silicon dioxide, closed with a PP cap with a child-resistant closure and a seal, containing 30 film-coated tablets.
Available pack sizes: cardboard boxes containing 1 bottle of 30 film-coated tablets, cardboard boxes containing 60 film-coated tablets (2 bottles of 30 tablets), and cardboard boxes containing 90 film-coated tablets (3 bottles of 30 tablets).
Tenofovir Synoptis is also available in OPA/Aluminum/PVC-Aluminum blisters.
Blisters containing 30, 60, and 90 film-coated tablets.
Blisters divided into single doses, containing 30, 60, and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer/Importer

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz

Importer

Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany

Date of last revision of the leaflet: March 2021