Tenofovir disoproxil Teva: detailed information

Package leaflet: Information for the patient

Tenofovir Disoproxil Teva

245 mg film-coated tablets
tenofovir disoproxil
Please read this leaflet carefully before taking this medicine because 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 pass it on to other people, even if their symptoms are the same as yours, 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 Teva is and what it is used for
What you need to know before taking Tenofovir Disoproxil Teva
How to take Tenofovir Disoproxil Teva
Possible side effects
How to store Tenofovir Disoproxil Teva
Contents of the pack and other information

If Tenofovir Disoproxil Teva has been prescribed for a child, all the information in this patient leaflet refers to the child (in this case, "the child" means the child instead of "you").

1. What Tenofovir Disoproxil Teva is and what it is used for

Tenofovir Disoproxil Teva 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, commonly known as 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 Teva must always be used in combination with other medicines when treating HIV infection.

Tenofovir Disoproxil Teva tablets are 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 HIV medicines that are no longer fully effective due to the development of resistance, or that have caused undesirable effects.

Tenofovir Disoproxil Teva tablets are also used for the treatment of chronic hepatitis B,
a HBV infection (hepatitis B virus). 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 Teva for HBV.
This medicine is not a cure for HIV infection. While taking Tenofovir Disoproxil Teva, you may still develop infections or other illnesses associated with HIV infection. You may also transmit the HIV or HBV virus to others; therefore, it is important that you take precautions to avoid infecting other people.

2. What you need to know before taking Tenofovir Disoproxil Teva

Do not take Tenofovir Disoproxil Teva

If you are allergic to tenofovir, tenofovir disoproxil, 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 Teva.
Warnings and precautions

Tenofovir Disoproxil Teva 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 Teva.

If you have had kidney disease, or if blood tests have shown kidney problems. Tenofovir Disoproxil Teva must not be administered to adolescents who already have kidney problems. Before starting treatment, your doctor may order blood tests to assess kidney function. Tenofovir Disoproxil Teva may have effects on the kidneys during treatment. Your doctor may order 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 your doctor has instructed you to do so.

Tenofovir Disoproxil Teva should not be taken with other medicines that may damage the kidneys
(see Other medicines and Tenofovir Disoproxil Teva). 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 you or your child experience bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mineral density. The greatest 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 caused by reduced blood supply to the bone). Duration of combination antiretroviral therapy, use of corticosteroids, 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 the 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 best 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, when you start treatment with Tenofovir Disoproxil Teva you may develop symptoms of infection and inflammation or a worsening of symptoms from an existing infection. These symptoms may
indicate that the body's immune system is fighting the infection. Monitor for signs of inflammation or infection soon after starting Tenofovir Disoproxil Teva.
If you notice signs of inflammation or infection, inform your doctor immediately.
After starting treatment for HIV infection, in addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur. 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, tremor, or hyperactivity, inform your doctor immediately to receive necessary treatment.
Inform your doctor or pharmacist if you are over 65 years old. Tenofovir Disoproxil Teva has not been studied in patients over 65 years of age. If you are older than this and have been prescribed Tenofovir Disoproxil Teva, your doctor will monitor you closely.

Children and adolescents
Tenofovir Disoproxil Teva tablets are indicated for:

HIV-1 infected adolescents aged 12 to under 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 under 18 years with body weight of at least 35 kg.

Tenofovir Disoproxil Teva 245 mg tablets are 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 Teva.

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

When starting therapy with Tenofovir Disoproxil Teva, do not stop taking any anti-HIV medicines prescribed by your doctor if you are co-infected with both HBV and HIV.
Do not take Tenofovir Disoproxil Teva if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Disoproxil Teva 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 immune system suppression),
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).
Other medicines containing didanosine (for HIV infection): Taking Tenofovir

Disoproxil Teva with other antiviral medicines containing didanosina may increase levels of didanosine 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, which in some cases have led to death. Your doctor must consider very carefully 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 Teva with food and drink
Tenofovir Disoproxil Teva must be taken with food (e.g., a meal or snack).
Pregnancy and breastfeeding
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 taken Tenofovir Disoproxil Teva during pregnancy, your doctor may regularly request blood tests and other diagnostic examinations to monitor the baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.

For adult patients

If you are an HBV-positive mother and your newborn received treatment to prevent transmission of hepatitis B at birth, you may be able to breastfeed your baby, but you must discuss this with your doctor first to receive further information.
Breastfeeding is not recommended for HIV-positive women because HIV infection can be transmitted to the child through breast milk. If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

For adolescents:

If the girl has HBV and the newborn received treatment to prevent transmission of hepatitis B at birth, the girl may be able to breastfeed the newborn, but she must discuss this with her doctor first to receive further information.
Breastfeeding is not recommended for HIV-positive mothers because HIV infection can be transmitted to the child through breast milk. If the girl is breastfeeding or considering breastfeeding, she must discuss this with her doctor as soon as possible.

Driving and using machines
Tenofovir Disoproxil Teva may cause dizziness. If dizziness occurs while taking Tenofovir Disoproxil Teva, do not drive or ride a bicycle and do not use tools or machinery.
Tenofovir Disoproxil Teva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Tenofovir Disoproxil Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, 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 weighing 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 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 important to ensure that the medicines are fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to do so.
If you are an adult and have kidney problems, your doctor may prescribe Tenofovir Disoproxil Teva less frequently.
If you have HBV, your doctor may suggest an HIV test to determine whether you have both HBV and HIV.

Refer to the package leaflet of other antiretroviral medicines for guidance on how to take them.
If you take more Tenofovir Disoproxil Teva than you should
→ If you accidentally take too many Tenofovir Disoproxil Teva tablets, 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. Take the bottle of tablets, the blister pack or the carton with you so that you can easily describe what you have taken.
If you forget to take Tenofovir Disoproxil Teva
It is important that you do not miss any doses of Tenofovir Disoproxil Teva. If you forget a dose, consider how much time has passed since you were supposed to take the medicine.

If less than 12 hours have passed since your usual dosing time, 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 your usual dosing time, 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 Teva, take another tablet. You should not take another tablet if you vomit more than 1 hour after taking Tenofovir Disoproxil Teva.
If you stop taking Tenofovir Disoproxil Teva
Do not stop taking Tenofovir Disoproxil Teva without consulting your doctor. Stopping Tenofovir Disoproxil Teva 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 Teva without first contacting your doctor. Some patients have experienced worsening of their hepatitis, as shown by symptoms or blood tests, after stopping Tenofovir Disoproxil Teva. 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 Teva 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 Teva tablets.

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

4. Possible side effects

During HIV therapy, an increase in weight and in blood levels of lipids and glucose 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 everyone 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 uncommon (may affect up to 1 in 100 people treated):

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 treated):

kidney inflammation, excessive urination and thirst
changes in urine 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 have 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 more than 1 in 10 people):

headache, stomach pain, fatigue, bloating sensation, flatulence, loss of bone mass

Laboratory tests have also shown:

liver problems

The following side effects are uncommon (may affect more than 1 in 100 people):

muscle breakdown, muscle pain, or muscle weakness

Laboratory tests have also shown:

decreased potassium levels in the blood
increased creatinine levels in the blood
problems with the pancreas

Muscle breakdown, 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 more than 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 get 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 at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tenofovir Disoproxil Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or bottle and outer carton after {Exp.}. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Teva 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: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, hydrogenated vegetable oil, and sodium lauryl sulfate.
Coating: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), indigo carmine aluminium lake (E132), carmine acid (E120).
See section 2 “Tenofovir Disoproxil Teva contains lactose”.

Description of the appearance of Tenofovir Disoproxil Teva and the contents of the pack
Tenofovir Disoproxil Teva are film-coated tablets, blue to light blue in colour, oval-shaped, 16.6 mm long and 8.9 mm wide, imprinted on one side with the letter “T” and smooth on the other side.
Tenofovir Disoproxil Teva is available in blisters containing 30 or 90 tablets, in unit dose blisters containing 30x1 or 90x1 tablets, in hospital packs of 10x1 tablets, and in bottles containing 30 or 90 tablets (3x30). Each bottle contains one or two silica gel desiccant canisters, which must not be ingested.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Teva Italia S.r.l., Piazzale Luigi Cadorna, 4, 20123 - Milan, Italy

Manufacturers:
TEVA Gyógyszergyár Zrt., Debrecen, Pallagi út 13, H-4042 (Hungary)
Merckle GmbH, Ludwig-Merckle-Straße 3, Blaubeuren, 89143 (Germany)
Teva Operations Poland Sp. z o.o., Ul. Mogilska 80, 31-546 Kraków, Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Tenofovir ratiopharm 245mg Filmtabletten
Germany: Tenofovirdisoproxil-ratiopharm 245 mg Filmtabletten
Denmark: Tenofovir disoproxil Teva
Spain: Tenofovir Disoproxilo Teva 245 mg comprimidos recubiertos con película EFG
France: Tenofovir disoproxil Teva 245 mg, comprimé pelliculé
Ireland: Tenofovir Disoproxil Teva 245 mg Film-coated Tablets
Italy: Tenofovir Disoproxil Teva 245 mg compresse rivestite con film
Luxembourg: Tenofovirdisoproxil-ratiopharm 245 mg Filmtabletten
Lithuania: Tenofovir Disoproxil Teva 245 mg apvalkotās tabletes
Netherlands: Tenofovirdisoproxil Teva 245 mg, filmomhulde tabletten
Portugal: Tenofovir Teva, 245 mg Comprimidos revestidos por película
Sweden: Tenofovir disoproxil Teva