TENOFOVIR DISOPROXIL CIPLA 245 MG FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Tenofovir disoproxil Cipla 245 mg film-coated tablets EFG

Tenofovir disoproxil fumarate

Read all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tenofovir disoproxil Cipla and what is it used for
2. What you need to know before you take Tenofovir disoproxil Cipla
3. How to take Tenofovir disoproxil Cipla
4. Possible side effects

5 Storage of Tenofovir disoproxil Cipla

1. Contents of the pack and other information

If Tenofovir has been prescribed to your child, note that all the information in this leafletis intended for your child (in this case, read “your child” instead of “you”).

1. What is Tenofovir disoproxil Cipla and what is it used for

Tenofovir contains the active substance tenofovir disoproxil. This active substance is an antiretroviralor antiviral medicine used to treat HIV infection, or HBV, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, also known as NtRTI, which works by interfering with the normal function of enzymes (in the case of HIV, reverse transcriptase, and in hepatitis B, DNA polymerase) that are essential for the viruses to reproduce. For the treatment of HIV infection, tenofovir must always be used in combination with other medicines.

Tenofovir is a medicine used to treat HIV infection(Human Immunodeficiency Virus). The tablets are suitable for:

• adults,
• adolescents between 12 and less than 18 years who have already been treated with other HIV medicines which are no longer fully effective due to the development of resistance, or which have caused side effects.

Tenofovir is also used to treat chronic hepatitis B, an infection caused by the hepatitis B virus (HBV). The tablets are suitable for:

• adults,
• adolescents between 12 and less than 18 years.

You do not need to have HIV to be treated with tenofovir for HBV.

This medicine is not a cure for HIV infection. While you are taking tenofovir, you may still develop infections or other illnesses associated with HIV. You may also continue to transmit HBV to others. Therefore, it is important that you take precautions to avoid infecting others.

2. What you need to know before you take Tenofovir disoproxil Cipla

Do not takeTenofovir disoproxil Cipla

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

If this is the case, tell your doctor immediately and do not takethis medicine.

Warnings andprecautions

Talk to your doctor or pharmacist before you start taking Tenofovir disoproxil Cipla.

• Tenofovir does not reduce the risk of transmission of HBV through sexual contact or blood contamination. You must continue to take precautions to avoid this.

• If you have had kidney disease or if your blood tests have shown kidney problems, talk to your doctor or pharmacist. Tenofovir should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may ask you to have blood tests to check your kidney function. Tenofovir can affect your kidneys during treatment. Your doctor may ask you to have blood tests during treatment to check your kidney function. If you are an adult, your doctor may advise you to take the tablets less frequently. Do not reduce the dose prescribed by your doctor unless your doctor has told you to.

Tenofovir is not normally taken with other medicines that can harm your kidneys (see Taking Tenofovir disoproxil Cipla with other medicines). If this is unavoidable, your doctor will check your kidney function once a week.

• Bone problems. Some adult patients with HIV who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by lack of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. The symptoms of osteonecrosis are: stiffness in the joints, pain, and discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, tell your doctor.

Bone problems (which manifest as persistent or worsening bone pain and sometimes end in fractures) may also occur due to damage to the renal tubular cells (see section 4, Possible side effects).

Tell your doctor or your child's doctor if you have bone pain or fractures.

Tenofovir disoproxil can also cause bone mass loss. The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a protease inhibitor.

In general, the effects of tenofovir disoproxil on long-term bone health and the risk of future fractures in adult and pediatric patients are unclear.

Tell your doctor or your child's doctor if you know you have osteoporosis, a history of bone fractures, or if you have bone problems.

• Talk to your doctor if you have a history of liver disease, including hepatitis.

Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretrovirals have a higher risk of serious and potentially life-threatening liver complications. If you have a hepatitis B infection, your doctor will carefully consider the best treatment for you. If you have a history of liver disease or chronic hepatitis B infection, your doctor may perform blood tests to check your liver function.

• Be aware of infections. If you have advanced HIV infection (AIDS) and you have another type of infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection when you start treatment with tenofovir. These symptoms may indicate that your immune system is improving and fighting the infection. Be aware of signs of inflammation or infection after starting tenofovir. If you notice signs of inflammation or infection, tell 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 have started taking medicines for the treatment of your HIV infection. Autoimmune disorders can occur many months after starting treatment. If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves up towards the trunk of the body, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

• If you are over 65 years old, tell your doctor or pharmacist. Tenofovir has not been studied in patients over 65 years old. If you are over this age and have been prescribed tenofovir, your doctor will monitor you closely.

Children and adolescents

Tenofovir is suitablefor:

• adolescents infected with HIV-1 between 12 and less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer fully effective due to the development of resistance, or which have caused side effects.
• adolescents infected with HBV between 12 and less than 18 years who weigh at least 35 kg.

Tenofovir is notsuitable for the following groups:

• not for children infected with HIV-1 under 12 years.
• not for children infected with HBV under 12 years.

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

Taking Tenofovir disoproxil Cipla with other medicines

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

• Do not stop taking any anti-HIV medicines prescribed by your doctor when you start treatment with tenofovir if you have HBV and HIV.

• Do not take tenofovir if you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take tenofovir with medicines that contain adefovir dipivoxil (a medicine used to treat chronic hepatitis B).

• It is very important that you tell your doctor if you are taking other medicines that can harm your kidneys.

These medicines 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 infection),
• tacrolimus (used to produce immune system suppression),
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

• Other medicines that contain didanosine (for HIV infection): Taking tenofovir with other antiviral medicines that contain didanosine can increase the levels of didanosine in your blood and may reduce the CD4 cell count. When medicines containing tenofovir disoproxil and didanosine are taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, in some cases fatal. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

• It is also important that you tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

Taking Tenofovir disoproxil Cipla with food and drinks

Take tenofovir with food (e.g., a meal or a 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 before taking this medicine.

For adults:

• If you have been taking tenofovir during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NtRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

• If you are a mother and have a hepatitis B infection, and your baby has been treated to prevent hepatitis B transmission at birth, you may be able to breastfeed your infant, but first talk to your doctor for more information.

• It is not recommended that women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or think about breastfeeding, you must consult your doctor as soon as possible.

For adolescents:

• If your child has HBV, and your baby has been treated to prevent hepatitis B transmission at birth, your child may be able to breastfeed the infant, but first talk to your child's doctor for more information.

• It is not recommended that women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or think about breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

Tenofovir can cause dizziness. If you feel dizzy during treatment with tenofovir, do not driveor ride a bicycleor operate tools or machines.

Tenofovir disoproxil Cipla contains lactose

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Tenofovir disoproxil Cipla contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this is, essentially “sodium-free”.

3. How to take Tenofovir disoproxil Cipla

Always take this medicine exactly as your doctor or pharmacist has told you to.

The recommended doseis:

• Adults: 1 tablet a day with food (e.g., a meal or a snack).
• Adolescents between 12 and less than 18 years who weigh at least 35 kg: 1 tablet a day with food (e.g., a meal or a snack).

If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then, mix the powder with approximately 100 ml of water (half a glass), orange juice, or grape juice, and drink it immediately.

• Always take the dose recommended by your doctor. This is to ensure that your medicine is completely effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.

• If you are an adult and have kidney problems, your doctor may advise you to take tenofovir less frequently.

• If you have HBV, your doctor may offer you an HIV test to see if you have HBV and HIV.

Consult the package leaflets of the other antiretrovirals to know how to take these medicines.

If you take moreTenofovir disoproxil Ciplathan you should

If you accidentally took too many tenofovir tablets, you may be at a higher risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Talk to your doctor or go to the nearest emergency department.

If you have taken more tenofovir than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

Take the pack of tablets with you so that you can easily describe what you have taken.

If you forget to takeTenofovir Disoproxil Cipla

It is important that you do not miss a dose of tenofovir. If you miss a dose, determine how long it has been since you should have taken it.

• If it is less than 12 hours since you normally take it, take it as soon as you can, and then take your next dose at the usual time.

• If it is more than 12 hours since you should have taken it, 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 missed doses.

If you vomit within 1 hour of taking tenofovir,take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking tenofovir.

If you stop takingTenofovir disoproxil Cipla

Do not stop taking tenofovir without your doctor telling you to. Stopping treatment with tenofovir may reduce the effectiveness of the treatment recommended by your doctor.

If you have hepatitis B, or HIV and hepatitis B (co-infection),it is very important that you do not stop your treatment with tenofovir without first talking to your doctor. After stopping treatment with tenofovir, some patients have had blood tests or symptoms indicating that their hepatitis had worsened. You may need to have blood tests for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment as this may lead to worsening of hepatitis.

• Talk to your doctor before stopping tenofovir for any reason, especially if you are experiencing any side effects or if you have another illness.
• Talk to your doctor immediately if you experience any new or unusual symptoms after stopping your treatment, especially those symptoms that you associate with hepatitis B virus infection.
• Contact your doctor before restarting tenofovir tablets.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

During HIV treatment, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Possible Serious Adverse 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 adverse effect that can be fatal. The following adverse effects may be signs of lactic acidosis:
• deep and rapid breathing,
• drowsiness,
• nausea, vomiting, and stomach pain.

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

Other Possible Serious Adverse Effects

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

• abdominal pain (stomach pain) caused by pancreas inflammation,
• damage to renal tubular cells.

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

• kidney inflammation, increased urine volume, and feeling of thirst,
• changes in urine and back pain due to kidney problems, including kidney failure,
• weakening of bones (with bone pain and sometimes resulting in fractures), which may occur due to damage to renal tubular cells,
• fatty liver.

If you think you may have any of these serious adverse effects, consult your doctor.

More Frequent Adverse Effects

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

• diarrhea, vomiting, nausea, dizziness, rash, feeling weak.

Lab tests may alsoshow:

• decrease in blood phosphate levels.

Other Possible Adverse Effects

The following adverse effects are common(may affect up to 1 in 10 patients):

• headache, stomach pain, feeling tired, feeling bloated, flatulence, loss of bone mass.

Lab tests may alsoshow:

• liver problems.

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

• muscle rupture, muscle pain or weakness.

Lab tests may alsoshow:

• decrease in blood potassium levels,
• increase in blood creatinine,
• pancreas problems.

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tenofovir Disoproxil Cipla

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle, packaging, or blister pack after CAD. The expiration date is the last day of the month indicated.

Blister pack

Do not store above 25°C.

Bottle

Store below 30°C.

Keep in the original bottle to protect from moisture.

Keep the bottle properly closed.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tenofovir Disoproxil Cipla

-The active ingredientis tenofovir disoproxil. Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).

• The other ingredients are:

Tablet core:lactose monohydrate, sodium croscarmellose (E468), cornstarch, polysorbate 80 (E433), microcrystalline cellulose (E460), and magnesium stearate (E572).

Tablet coating:lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, aluminum lake blue #2 FD&C/indigo carmine Al (E132).

Appearance and Package Contents

Tenofovir Cipla tablets are film-coated, blue in color, capsule-shaped, biconvex, 17.20 ± 0.30 mm in length, and 8.20 ± 0.30 mm in thickness, with the mark "TNV" on one side and smooth on the other.

High-density polyethylene (HDPE) bottle with a child-resistant polypropylene cap containing 30 film-coated tablets and a silica gel desiccant

Aluminum blister pack with a 3-layer laminated aluminum film

The following package sizes are available: cardboard boxes with a 30-tablet bottle and cardboard boxes with 90 (3 bottles of 30) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp

Belgium

Manufacturer:

Cipla (EU) Limited

Dixcart House,

Addlestone Road,

Bourne Business Park,

Addlestone, Surrey, KT15 2LE,

United Kingdom

Or

Cipla Europe NV

De Keyserlei 58-60,

Box-19, 2018 Antwerp,

Belgium

Or

S&D Pharma CZ, spol. S.r.o,

Theodor 28, 273 08 Pchery (Pharmos a.s. facility), Czech Republic

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet: November 2024

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).