Tenofovir disoproxil Cipla 245 mg film-coated tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

If tenofovir has been prescribed for your child, please note that all the information in this leaflet is directed to your child (in this case, read “your child” instead of “you”).

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

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

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

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

• adults,
• adolescents aged 12 to 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 taking tenofovir, you may still develop infections or other illnesses associated with HIV infection. You may also continue to transmit HBV to others. Therefore, it is important that you take precautions to avoid infecting other people.

2. What you need to know before taking Tenofovir disoproxilo Cipla

Do not take Tenofovir disoproxilo Cipla

• 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 this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tenofovir disoproxilo Cipla.

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

• If you have had kidney disease or if your blood tests have shown kidney problems, consult your doctor or pharmacist. Tenofovir should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may request blood tests to assess your kidney function. Tenofovir may affect your kidneys during treatment. Your doctor may request periodic 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 is generally not taken together with other medicines that may harm your kidneys (see Taking Tenofovir disoproxilo Cipla with other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.

• Bone problems. Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Numerous risk factors for developing this condition include duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include: joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you experience any of these symptoms, inform your doctor.

Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures) may also occur due to damage to renal tubular cells (see section 4, Possible adverse effects).

Inform your doctor or your child’s doctor if you or your child experience bone pain or fractures.

Tenofovir disoproxil may also cause loss of bone mineral density. More pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

Overall, the long-term effects of tenofovir disoproxil on bone health and the future risk of fractures in adult and pediatric patients are not fully known.

Inform your doctor or your child’s doctor if you or your child have osteoporosis, a history of bone fractures, or bone-related 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, treated with antiretrovirals, have an increased risk of serious and potentially fatal liver complications. If you have 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 monitor your liver function.

• Be aware of infections. If you have advanced HIV infection (AIDS) and have another type of infection, you may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when you start treatment with tenofovir. These symptoms may indicate that your improved immune system is fighting the infection. Be alert for signs of inflammation or infection after starting tenofovir. 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 you have started taking medicines for HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, ascending weakness starting in the hands and feet and moving toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive appropriate treatment.

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

Children and adolescents

Tenofovir is suitable for:

• Adolescents infected with HIV-1 aged 12 to less than 18 years who weigh at least 35 kg and who have previously been treated with other HIV medicines that are no longer fully effective due to resistance development or that have caused adverse effects.
• Adolescents infected with HBV aged 12 to less than 18 years who weigh at least 35 kg.

Tenofovir is not suitable for the following groups:

• Not for children infected with HIV-1 under 12 years of age.
• Not for children infected with HBV under 12 years of age.

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

Taking Tenofovir disoproxilo Cipla with other medicines

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

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

• Do not take tenofovir if you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take tenofovir together with medicines containing 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 may harm your 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 infection),

• Tacrolimus (used to produce 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 with other antiviral medicines containing didanosine may increase levels of didanosine in your blood and may reduce CD4 cell count. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal, have been reported when tenofovir disoproxil and didanosine are taken together. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

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

Taking Tenofovir disoproxilo Cipla with food and drink

Take tenofovir with food (for example, a meal or a snack).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

For adults:

• If you have taken tenofovir during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your baby’s development. In babies whose mothers took ITIAN during pregnancy, the benefit of protection against HIV outweighed the risk of adverse effects.

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

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

For adolescents:

• If your child has HBV, and their baby has been treated to prevent transmission of hepatitis B at birth, your child may be able to breastfeed, but you should first talk to your child’s doctor for further information.

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

Driving and using machines

Tenofovir may cause dizziness. If you experience dizziness during treatment with tenofovir, do not drive or ride a bicycle and do not operate tools or machinery.

Tenofovir disoproxilo Cipla contains lactose

This medicine contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Tenofovir disoproxilo Cipla contains sodium

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

3. How to take Tenofovir disoproxil Cipla

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

If you have particular difficulty swallowing, you may 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 immediately.

• Always take the dose recommended by your doctor. This is to ensure that your medicine is fully effective and to reduce the risk of developing treatment resistance. 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 advise you to take tenofovir less frequently.

• If you have HBV, your doctor may offer you an HIV test to determine whether you have both HBV and HIV.

Refer to the package leaflets of the other antiretrovirals to find out how to take those medicines.

If you take more Tenofovir disoproxil Cipla than you should

If you have accidentally taken too many tenofovir tablets, you may be at increased risk of experiencing possible adverse effects with this medicine (see section 4, Possible adverse effects). Contact your doctor or go to the nearest emergency department.

If you have taken more tenofovir than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

Take the tablet packaging with you so you can easily describe what you have taken.

If you forget to take Tenofovir disoproxil Cipla

It is important not to miss a dose of tenofovir. If you forget a dose, determine how long it has been since you were supposed to take it.

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

• If it is more than 12 hours since you were supposed to take 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 after taking tenofovir, take another tablet. You do not need to take another tablet if you vomited more than 1 hour after taking tenofovir.

If you stop taking Tenofovir disoproxil Cipla

Do not stop taking tenofovir unless your doctor tells you to do so. 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 (coinfection), it is very important not to 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, stopping treatment is not recommended, as this may lead to a worsening of your hepatitis.

• Talk to your doctor before stopping tenofovir for any reason, particularly if you experience any adverse effects or have another illness.
• Contact your doctor immediately if you experience any new or unusual symptoms after stopping your treatment, particularly symptoms related to hepatitis B virus infection.
• Contact your doctor before restarting treatment with tenofovir tablets.

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

4. Possible side effects

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health 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: tell your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare side effect (may affect up to 1 in 1,000 patients) but serious and potentially life-threatening. The following side effects may be signs of lactic acidosis:
• deep or rapid breathing,
• drowsiness,
• nausea, vomiting, and stomach pain.

If you think you may 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 (stomach) pain caused by inflammation of the pancreas,
• damage to renal tubule cells.

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

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

If you think you may 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 patients):

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

Blood tests may also show:

• decreased blood phosphate levels.

Other possible side effects

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

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

Blood tests may also show:

• liver problems.

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

• muscle rupture, muscle pain or weakness.

Blood tests may also show:

• decreased blood potassium levels,
• increased blood creatinine,
• pancreas problems.

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

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tenofovir disoproxil Cipla

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle, packaging, or blister after EXP. The expiry date refers to the last day of the month indicated.

Blister pack

Do not store above 25°C.

Bottle container

Store below 30°C.

Keep in the original bottle to protect from moisture.

Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tenofovir Disoproxil Cipla

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

• The other components are:

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

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

Appearance of the product and contents of the pack

Tenofovir Cipla tablets are film-coated, blue, capsule-shaped, biconvex tablets, 17.20 ± 0.30 mm in length and 8.20 ± 0.30 mm in thickness, marked "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 three-layer laminated aluminum foil.

The following pack sizes are available: cardboard packs containing one bottle of 30 film-coated tablets, and cardboard packs containing 90 film-coated tablets (3 bottles of 30).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

Manufacturer

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

S&D Pharma CZ, spol. s.r.o.,
Theodor 28, 273 08 Pchery (Pharmos a.s. facility),
Czech Republic

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: November 2024

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