Tenofovir disoproxil Zentiva: detailed information

Package leaflet: Information for the user

Tenofovir disoproxil Zentiva 245 mg film-coated tablets

Tenofovir disoproxil
Please read this leaflet carefully before you start taking this medicine, as it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tenofovir disoproxil Zentiva is and what it is used for
What you need to know before you take Tenofovir disoproxil Zentiva
How to take Tenofovir disoproxil Zentiva
Possible side effects
How to store Tenofovir disoproxil Zentiva
Contents of the pack and other information

If Tenofovir disoproxil Zentiva has been prescribed for a child, all the information in this
package leaflet refers to the child (in such case, "the child" is meant instead of "you").

What Tenofovir disoproxil Zentiva is and what it is used for

Tenofovir disoproxil Zentiva contains the active substance tenofovir disoproxil. This active substance is
an antiretroviral or antiviral medicine used to treat HIV or HBV infection, or both. Tenofovir is a
nucleotide reverse transcriptase inhibitor (NRTI), which works by interfering with the normal activity of enzymes (
reverse transcriptase in HIV; DNA polymerase in hepatitis B) that are essential for the viruses to replicate. Tenofovir disoproxil
Zentiva must always be used in combination with other medicines when treating HIV infection.
Tenofovir disoproxil Zentiva is a treatment for HIV infection (human
immunodeficiency virus).
The tablets are indicated for:

adults
adolescents aged 12 to less than 18 years who have previously been treated with other anti-HIV medicines that are no longer fully effective due to the development of resistance, or that have caused side effects.

Tenofovir disoproxil Zentiva is also used for the treatment of chronic hepatitis B,
an HBV (hepatitis B virus) infection.
The tablets are indicated for:

adults
adolescents aged 12 to less than 18 years.

You do not need to have HIV infection to be treated with Tenofovir disoproxil Zentiva for HBV.
This medicine is not a cure for HIV infection. While taking Tenofovir disoproxil
Zentiva, you may still develop infections or other illnesses associated with HIV infection.
You may also transmit HBV to others; therefore, it is important that you take precautions to
avoid infecting other people.

2. What you should know before taking Tenofovir disoproxil Zentiva

Do not take Tenofovir disoproxil Zentiva

If you are allergic to tenofovir, tenofovir disoproxil fumarate, or any of the other ingredients of this medicine listed in section 6.

→ If this applies to you, inform your doctor immediately and do not take Tenofovir disoproxil Zentiva.

Warnings and precautions

Tenofovir disoproxil Zentiva does not reduce the risk of transmitting HBV to others through sexual contact or blood contamination. You must continue to take precautions to prevent transmission.

Talk to your doctor or pharmacist before taking Tenofovir disoproxil Zentiva.

If you have had kidney disease, or if blood tests have shown kidney problems. Tenofovir disoproxil Zentiva must not be administered to adolescents who already have kidney problems. Before starting treatment, your doctor may prescribe blood tests to assess kidney function. Tenofovir disoproxil Zentiva may have effects on the kidneys during treatment. Your doctor may prescribe blood tests during treatment to monitor kidney function. If you are an adult, your doctor may advise you to take the tablets less frequently. Do not reduce the prescribed dose unless instructed by your doctor.

Tenofovir disoproxil Zentiva should not be taken with other medicines that may damage the kidneys (see Other medicines and Tenofovir disoproxil Zentiva). If this is unavoidable, your doctor will monitor kidney function once a week.

If you have osteoporosis, have had bone fractures in the past, or have bone problems.

Bone problems (manifesting as persistent or worsening bone pain, and sometimes resulting in fractures) may occur due to damage to the renal tubular cells (see section 4, Possible side effects). Inform your doctor if the child has bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mineral density. The most pronounced loss of bone mineral density has been observed in clinical studies where patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the long-term effects of tenofovir disoproxil on bone health and the risk of future fractures in adult and pediatric patients are uncertain.
Some adult HIV patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply). Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in hips, knees, and shoulders), and difficulty moving. Contact your doctor if you notice any of these symptoms.

Inform your doctor if you have previously had liver problems, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals have a higher risk of serious and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully evaluate the most appropriate treatment regimen for you. If you have had liver disease or chronic hepatitis B, your doctor may request blood tests to monitor liver function.
Be cautious about infections. If you have advanced HIV (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of existing infection symptoms when starting treatment with Tenofovir disoproxil Zentiva. These symptoms may indicate that your body's immune system is fighting the infection. Monitor for signs of inflammation or infection shortly after starting Tenofovir disoproxil Zentiva. If you notice signs of inflammation or infection, inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting medicines for the treatment of HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

Inform your doctor or pharmacist if you are over 65 years old. Tenofovir disoproxil Zentiva has not been studied in patients over 65 years of age. If you are older than this and have been prescribed Tenofovir disoproxil Zentiva, your doctor will monitor you closely.

Children and adolescents
Tenofovir disoproxil Zentiva 245 mg tablets are indicated for:

HIV-1 infected adolescents aged 12 to less than 18 years with body weight of at least 35 kg who have previously been treated with other HIV medicines that are no longer fully effective due to development of resistance, or that have caused side effects.
HBV-infected adolescents aged 12 to less than 18 years with body weight of at least 35 kg.

Tenofovir disoproxil Zentiva is not indicated for the following categories:

not indicated in children infected with HIV-1 under 12 years of age
not indicated in children infected with HBV under 12 years of age.

For dosage, see section 3, How to take Tenofovir disoproxil Zentiva.

Other medicines and Tenofovir disoproxil Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

When starting therapy with Tenofovir disoproxil Zentiva, do not stop taking any anti-HIV medicines prescribed by your doctor if you have both HBV and HIV infection.
Do not take Tenofovir disoproxil Zentiva if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Zentiva together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
It is particularly important to inform your doctor if you are taking other medicines that may damage your kidneys.

These include:

aminoglycosides, pentamidine, or vancomycin (for bacterial infection).
amphotericin B (for fungal infection).
foscarnet, ganciclovir, or cidofovir (for viral infection).
interleukin-2 (to treat cancer).
tacrolimus (for immunosuppression).
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).
- Other medicines containing didanosine (for HIV infection): Taking Tenofovir disoproxil Zentiva with other antiviral medicines containing didanosine may increase didanosine levels in the blood and may reduce CD4 cell count. When medicines containing tenofovir disoproxil and didanosine have been taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, sometimes resulting in death. Your doctor must carefully consider whether to treat you with tenofovir and didanosine in combination.
- It is also important to inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

If you have already taken Tenofovir disoproxil Zentiva during pregnancy, your doctor may request regular blood tests and other diagnostic examinations to monitor the child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
If you are a mother with HBV and the newborn has received treatment to prevent transmission of hepatitis B at birth, you may be able to breastfeed the newborn, but you should discuss this with your doctor first to obtain further information.
Women with HIV are advised not to breastfeed in order to avoid transmitting HIV to the infant through breast milk. If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Tenofovir disoproxil Zentiva may cause dizziness. If dizziness occurs while taking Tenofovir disoproxil Zentiva, do not drive or ride a bicycle and do not operate tools or machinery.

Tenofovir disoproxil Zentiva contains lactose monohydrate.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Tenofovir disoproxil Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Tenofovir disoproxil Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
The recommended dose is:

Adults: 1 tablet daily, taken with food (for example, a meal or a snack).
Adolescents aged 12 to less than 18 years with body weight of at least 35 kg: 1 tablet daily, taken with food (for example, a meal or a snack).

If you have difficulty swallowing, you may use the back of a spoon to crush the tablet. Then mix the powder in approximately 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 important to ensure that the medicines are fully effective and to reduce the risk of developing resistance to treatment. Do not change your dose unless your doctor tells you to do so.
If you are an adult and have kidney problems, your doctor may prescribe Tenofovir disoproxil Zentiva to be taken less frequently.
If you have HBV, your doctor may recommend an HIV test to determine whether you have both HBV and HIV.

Refer to the package leaflets of other antiretrovirals for guidance on how to take these medicines.
If you take more Tenofovir disoproxil Zentiva than you should
If you accidentally take too many tablets of Tenofovir disoproxil Zentiva, you may increase your risk of experiencing possible side effects of this medicine (see section 4, Possible side effects). Contact your doctor or the nearest emergency department. Bring the bottle of tablets with you so that you can easily describe what you have taken.
If you forget to take Tenofovir disoproxil Zentiva
It is important not to miss any dose of Tenofovir disoproxil Zentiva. If you forget a dose, consider how much time has passed since the missed dose.

If less than 12 hours have passed since the usual time of intake, take the missed dose as soon as possible, then take the next dose at the regular time.
If more than 12 hours have passed since the usual time of intake, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten tablet.

If you vomit within 1 hour of taking Tenofovir disoproxil Zentiva, take another tablet. You should not take another tablet if you vomit more than 1 hour after taking Tenofovir disoproxil Zentiva.
If you stop taking Tenofovir disoproxil Zentiva
Do not stop taking Tenofovir disoproxil Zentiva without consulting your doctor.
Stopping Tenofovir disoproxil Zentiva may reduce the effectiveness of the treatment prescribed by your doctor.
If you have hepatitis B infection or both HIV and hepatitis B (co-infection), it is especially important not to stop treatment with Tenofovir disoproxil Zentiva without first contacting your doctor. Some patients have experienced worsening of their hepatitis, as shown by symptoms or blood tests, after stopping Tenofovir disoproxil Zentiva. Blood tests may need to be repeated for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of hepatitis in some patients.

Talk to your doctor before stopping Tenofovir disoproxil Zentiva for any reason, especially if you have experienced a side effect or have another illness.
Inform your doctor immediately of any new or unusual symptoms observed after stopping treatment, particularly symptoms normally associated with hepatitis B infection.
Contact your doctor before restarting Tenofovir disoproxil Zentiva tablets.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

During HIV therapy, weight gain and increases in blood lipid and glucose levels may occur. This is partly related to the recovery of health status and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious possible side effects: inform your doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 people) but serious side effect, which can be fatal. The following side effects may be signs of lactic acidosis:

deep and rapid breathing,
drowsiness,
nausea, vomiting, and stomach pain.

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

Other possible serious side effects

The following side effects are not common (may affect up to 1 in 100 people):

abdominal pain caused by inflammation of the pancreas,
damage to specific kidney cells (tubular cells).

The following side effects are rare (may affect up to 1 in 1,000 people):

kidney inflammation, excessive urination and thirst,
urine abnormalities and back pain due to kidney problems, including kidney failure,
softening of the bones (with bone pain and sometimes fractures), which may occur due to damage to renal tubular cells,
fatty liver.

→ If you think you are experiencing any of these serious side effects, consult your doctor.

More frequent side effects

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

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

Laboratory tests have also shown:

decreased phosphate levels in the blood.

Other possible side effects

The following side effects are common (may affect up to 1 in 10 people):

headache,
stomach pain,
fatigue,
feeling of fullness,
intestinal gas,
loss of bone mass.

Laboratory tests have also shown:

liver problems.

The following side effects are uncommon (may affect up to 1 in 100 people):

muscle weakness, muscle pain, or muscle weakness.

Laboratory tests have also shown:

decreased potassium levels in the blood,
increased creatinine levels in the blood,
pancreas problems.

Muscle weakness, softening of the bones (with bone pain and sometimes fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur due to damage to renal tubular cells.

The following side effects are rare (may affect up to 1 in 1,000 people):

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

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tenofovir disoproxil 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 Exp.
The expiry date refers to the last day of that month.
Use within 60 days after first opening. Do not store above 30°C. Keep in the original packaging to
protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tenofovir disoproxil Zentiva contains

The active substance is tenofovir. Each tablet contains tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil).
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, povidone, magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide, triacetin, aluminium lake containing indigo carmine.

Description of the appearance of Tenofovir disoproxil Zentiva and contents of the pack
Tenofovir disoproxil Zentiva 245 mg film-coated tablets are blue, oblong-shaped film-coated tablets, approximately 17.2 mm x 8.2 mm in size.
The following pack sizes are available:
Outer packs containing 1 bottle with 30 film-coated tablets and packs containing 3 bottles with 30 film-coated tablets each.
Not all pack sizes may be marketed.
To open the bottle, press down on the child-resistant cap and turn it counterclockwise.
Each bottle contains silica gel as a desiccant to protect the tablets. The silica gel is contained in a separate container within the bottle and must not be ingested.

Marketing Authorisation Holder
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer:
S.C. Zentiva S.A.
50 Theodor Pallady Blvd.
Bucharest 032266
Romania
or
Winthrop Arzneimittel GmbH
Brüningstraße 50
65926 Frankfurt am Main
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 (78) 700 112 Tel: +370 52152025
[email protected] [email protected]

България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: +35924417136 Tél/Tel: +352 208 82330
[email protected] [email protected]

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Zentiva, k.s. Zentiva Pharma Kft.
Tel: +420 267 241 111 Tel.: +36 1 299 1058
[email protected] [email protected]

Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf.: +45 787 68 400 Tel: +356 2034 1796
[email protected] [email protected]

Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]

Eesti Norge
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Tel: +372 52 70308 Tlf: +45 787 68 400
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Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
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España Polska
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Tel: +34 671 365 828 Tel: +48 22 375 92 00
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France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351 210601360
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Hrvatska România
Zentiva d.o.o. ZENTIVA S.A.
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[email protected] [email protected]

Ireland Slovenija
Zentiva, k.s. Zentiva, k.s.
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Ísland Slovenská republika
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Italia Suomi/Finland
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[email protected] [email protected]

Latvija
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Tel: +371 67893939
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/