Tenofovir disoproxil Sandoz

Package leaflet: Information for the patient

Tenofovir disoproxil Sandoz 245 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

If Tenofovir disoproxil Sandoz has been prescribed for a child, all the information in this package leaflet refers to the child (in this case, “the child” instead of “you”).

1. What is Tenofovir disoproxil Sandoz and what is it used for?

Tenofovir disoproxil Sandoz 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), commonly known as an NRTI, and works by interfering with the normal activity of certain enzymes (reverse transcriptase in HIV; DNA polymerase in hepatitis B) that are essential for viruses to replicate. Tenofovir disoproxil Sandoz must always be used in combination with other medicines when treating HIV infection.
Tenofovir disoproxil Sandoz 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 HIV medicines that are no longer fully effective due to the development of resistance, or that have caused undesirable side effects.

Tenofovir disoproxil Sandoz is also used to treat 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 Sandoz for HBV.
This medicine is not a cure for HIV infection. While taking Tenofovir disoproxil Sandoz, you may still develop infections or other diseases 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 Sandoz

Do not take Tenofovir disoproxil Sandoz

• 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 Sandoz.

Warnings and precautions

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

• Be careful not to transmit the infection to others. You can still transmit HIV while taking this medicine, although the risk is reduced due to the effect of antiretroviral therapy. Discuss with your doctor the necessary precautions to avoid transmitting the infection to others. Tenofovir disoproxil Sandoz does not reduce the risk of transmitting HBV to others through sexual contact or blood contamination. You must continue to take precautions to prevent this.

• Inform your doctor or pharmacist if you have had kidney disease, or if blood tests have shown kidney problems. Tenofovir disoproxil Sandoz 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 Sandoz 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 Sandoz should not be taken with other medicines that may damage the kidneys (see Other medicines and Tenofovir disoproxil Sandoz). If this is unavoidable, your doctor will monitor your kidney function once a week.

• Bone problems. 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.
  Bone problems (sometimes resulting in fractures) may also occur due to damage to renal tubular cells (see section 4, Possible side effects).

• 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, you may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when you start treatment with Tenofovir disoproxil Sandoz. 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 Sandoz. If you notice signs of inflammation or infection, inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of HIV infection. Autoimmune disorders may occur many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet progressing towards 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 Sandoz has not been studied in patients over 65 years of age. If you are over this age and have been prescribed Tenofovir disoproxil Sandoz, your doctor will monitor you closely.

Children and adolescents

Tenofovir disoproxil Sandoz is indicated for:

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

Tenofovir disoproxil Sandoz 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 Sandoz.

Other medicines and Tenofovir disoproxil Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• When starting therapy with Tenofovir disoproxil Sandoz, 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 Sandoz if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Sandoz 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 (for cancer treatment)
• adefovir dipivoxil (for HBV)
• 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 Sandoz 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, cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have rarely 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 Sandoz with food and drink

Tenofovir disoproxil Sandoz must be taken with food (e.g., a meal or a snack).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Do not take Tenofovir disoproxil Sandoz during pregnancy unless you have specifically discussed it with your doctor. Although there are limited clinical data on the use of Tenofovir disoproxil Sandoz in pregnant women, it is generally not used unless strictly necessary.
• If you know you are pregnant or intend to become pregnant, ask your doctor about the potential benefits and risks of antiretroviral therapy for you and your baby.
• If you have already taken Tenofovir disoproxil Sandoz during pregnancy, your doctor may request regular 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.
• Do not breastfeed during treatment with Tenofovir disoproxil Sandoz. The active substance of this medicine is excreted in human breast milk.
• If you are a woman infected with HIV or HBV, you must not breastfeed, to avoid transmitting the viruses to the newborn through breast milk.

Driving and using machines

Tenofovir disoproxil Sandoz may cause dizziness. If dizziness occurs while taking Tenofovir disoproxil Sandoz, do not drive or ride a bicycle and do not use tools or machinery.

Tenofovir disoproxil Sandoz contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Tenofovir disoproxil Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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 treatment resistance. Do not change your dose unless your doctor tells you to.
• If you are an adult and have kidney problems, your doctor may prescribe Tenofovir disoproxil Sandoz to be taken 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 antiretrovirals for guidance on how to take these medicines.
If you take more Tenofovir disoproxil Sandoz than you should
If you accidentally take too many Tenofovir disoproxil Sandoz tablets, you may increase the 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 tablet pack with you so that you can easily describe what you have taken.
If you forget to take Tenofovir disoproxil Sandoz
It is important not to miss any dose of Tenofovir disoproxil Sandoz. 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 it 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 the forgotten tablet.

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

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

4. Possible side effects

During HIV therapy, an increase in weight and 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 also to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Possible serious 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 patients) 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 patients):

• abdominal pain caused by inflammation of the pancreas
• damage to renal tubular cells

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

• inflammation of the kidneys, 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 at least 10 out of 100 patients):

• diarrhoea, vomiting, nausea, dizziness, rash, feeling of weakness

Laboratory tests have also shown:

• reduced phosphate levels in the blood

Other possible side effects

The following side effects are common (may affect up to 10 out of 100 patients):

• headache, stomach pain, fatigue, feeling of fullness, flatulence

Laboratory tests have also shown:

• liver problems

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

• muscle weakness, muscle pain or muscle weakness

Laboratory tests have also shown:

• reduced potassium levels in the blood
• increased creatinine levels in the blood
• problems with the pancreas

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 patients):

• 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 at the following website: https://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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle, the carton,
and the blister after Exp.. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening of the bottle, use within 30 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tenofovir disoproxil Sandoz contains

• The active substance is tenofovir disoproxil. Each film-coated tablet contains 245 mg of tenofovir disoproxil.
• The other components are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, crospovidone (type B), magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E171), polyethylene glycol 400, polysorbate 80. See section 2 “Tenofovir disoproxil Sandoz contains lactose”.

Description of the appearance of Tenofovir disoproxil Sandoz and package contents
Film-coated white, almond-shaped, biconvex tablets, 16 mm x 10 mm in size, marked on one side with “H” and “T11” on the other side.
Single-dose push-through blisters OPA-Al-PVC/Al.
Pack sizes: 30x1, 60x1 and 90x1 film-coated tablets.
White opaque HDPE bottle containing a silica gel desiccant container and a sterile cotton plug, with a white opaque polypropylene child-resistant screw cap.
Pack sizes: 30, 60 (2x30) and 90 (3x30) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Sachsen-Anhalt, 39179 Barleben
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA 3000
Malta

This medicinal product is authorized in the European Economic Area Member States under the following names:
Finland: Tenofovir disoproxil Sandoz 245 mg kalvopäällysteiset tabletit
Austria: Tenofovir Sandoz 245 mg - Filmtabletten
Belgium: Tenofovir disoproxil Sandoz 245 mg filmomhulde tabletten
Bulgaria: Тенофовир Сандоз Tenofovir Sandoz
Cyprus: Tenofovir disoproxil Sandoz
Czech Republic: Tenofovir disoproxil Sandoz 245 mg
Germany: Tenofovirdisoproxil - 1 A Pharma 245 mg Filmtabletten
Denmark: Tenofovir disoproxil Sandoz
Estonia: Tenofovir disoproxil Sandoz
Spain: Tenofovir Sandoz 245 mg comprimidos recubiertos con película EFG
France: TENOFOVIR DISOPROXIL SANDOZ 245 mg, comprimé pelliculé
Croatia: Tenofovirdizoproksil Sandoz 245 mg filmom obložene tablete
Hungary: Tenofovir disoproxil Sandoz 245 mg filmtabletta
Ireland: Tenofovir disoproxil Rowex 245 mg Film-coated tablets
Italy: Tenofovir Disoproxil Sandoz
Lithuania: Tenofovir disoproxil Sandoz 245 mg plėvele dengtos tabletės
Latvia: Tenofovir disoproxil Sandoz 245 mg apvalkotās tabletes
Netherlands: Tenofovir disoproxil Sandoz 245 mg, filmomhulde tabletten
Norway: Tenofovir disoproxil Sandoz
Poland: Tenofovir disoproxil Sandoz
Portugal: Tenofovir Sandoz
Romania: Tenofovir disoproxil Sandoz 245 mg comprimate flmate
Sweden: Tenofovir disoproxil Sandoz 245 mg filmdragerade tabletter
Slovenia: Dizoproksiltenofovirat Sandoz 245 mg filmsko obložene tablete
United Kingdom: Tenofovir disoproxil Sandoz 245mg film-coated tablets