Tenofovir disoproxil Macleods 245 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tenofovir disoproxil Macleods 245 mg film-coated tablets EFG

tenofovir disoproxil

Read the entire 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, consult 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

This medicine 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; in hepatitis B, DNA polymerase) that are essential for viruses to replicate. For the treatment of HIV infection, tenofovir disoproxil must always be used in combination with other medicines.

Tenofovir Disoproxil Macleods 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 anti-HIV medicines that are no longer fully effective due to the development of resistance, or that have caused adverse effects.

Tenofovir Disoproxil Macleods 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 in order to be treated with this medicine for HBV.

This medicine is not a cure for HIV infection. While taking tenofovir disoproxil, 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 Disoproxil Macleods

Do not take Tenofovir Disoproxil Macleods:

• 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 Macleods.

Warnings and precautions

Tenofovir 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 starting Tenofovir Disoproxil Macleods.

• If you have had kidney disease or if your blood tests have shown kidney problems. This medicine should not be given to adolescents with pre-existing kidney problems. Before starting treatment, your doctor may request blood tests to assess how well your kidneys are working. Tenofovir disoproxil may affect your kidneys during treatment. Your doctor may request regular 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.

This medicine is generally not taken together with other medicines that may harm your kidneys (see Other medicines and Tenofovir Disoproxil Macleods). If this is unavoidable, your doctor will monitor your kidney function once a week.

• If you have osteoporosis, a history of bone fractures, or bone problems.

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 side effects). Inform your doctor if you experience bone pain or fractures.

Tenofovir disoproxil may also cause loss of bone mineral density. The most 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 uncertain.

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, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include stiffness in the joints, pain, discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, inform your doctor.

• 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 cautious about 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 this medicine. These symptoms may indicate that your improved immune system is fighting the infection. Be alert for signs of inflammation or infection after starting this medicine. 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 medications for your 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, weakness starting in the hands and feet and moving upward 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 disoproxil has not been studied in patients over 65 years of age. If you are older than this and have been prescribed this medicine, your doctor will monitor you closely.

Children and adolescents

This medicine is suitable for:

• HIV-1 infected adolescents aged 12 to less than 18 years weighing at least 35 kg 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.
• HBV infected adolescents aged 12 to less than 18 years weighing at least 35 kg.

This medicine is not suitable for the following groups:

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

For dosage information, see section 3, How to take Tenofovir Disoproxil Macleods.

Other medicines and Tenofovir Disoproxil Macleods

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 treatment with this medicine if you have HBV and HIV.

• Do not take Tenofovir Disoproxil Macleods if you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take this medicine 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 suppress the immune system),

• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).

• Other medicines containing didanosine (for HIV infection): Taking this medicine 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 medicines containing 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 Disoproxil Macleods with food and drinks

Take this medicine 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.

• If you have been taking this medicine during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took ITIAN during pregnancy, the benefit of protection against HIV outweighed the risk of adverse effects occurring.

• 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 first talk to your doctor for further advice.

• If you are a mother with HIV infection, do not breastfeed your child to avoid passing the virus through breast milk. If you are breastfeeding or planning to do so, consult your doctor immediately.

Driving and using machines

This medicine may cause dizziness. If you experience dizziness during treatment with this medicine, do not drive or ride a bicycle and do not use tools or machinery.

Tenofovir Disoproxil Macleods contains lactose

Consult your doctor before starting Tenofovir Disoproxil Macleods. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Tenofovir Disoproxil Macleods contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take Tenofovir Disoproxil Macleods

Follow exactly the instructions for use of this medicine as 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 weighing 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 (half a glass) of water, orange juice, or grape juice and drink immediately.

• Always take the dose prescribed by your doctor. This is to ensure that your medicine remains 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 with kidney problems, your doctor may advise you to take this medicine 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 other antiretrovirals for instructions on how to take those medicines.

If you take more Tenofovir Disoproxil Macleods than you should

If you have accidentally taken too many tenofovir disoproxil 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 pharmacist, go to the nearest emergency department, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount taken. Bring the medicine packaging and leaflet with you so you can easily describe what you have taken.

If you forget to take Tenofovir Disoproxil Macleods

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

• If it is less than 12 hours after your usual dosing time, 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 a missed dose.

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

If you stop taking Tenofovir Disoproxil Macleods

Do not stop taking this medicine without first talking to your doctor. Stopping treatment with this medicine may reduce the effectiveness of the treatment prescribed by your doctor.

If you have hepatitis B, or both HIV and hepatitis B (coinfection), it is very important not to stop treatment with this medicine without first discussing it with your doctor. After stopping treatment with this medicine, some patients have experienced blood test results or symptoms indicating that their hepatitis has 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 hepatitis.

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

If you have any further questions about 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 in blood glucose and lipid levels. This may be partly related to improved health, lifestyle, and, in the case of blood lipids, sometimes to HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Possible serious adverse effects: inform your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare adverse effect (may affect up to 1 in 1,000 patients) but serious and potentially fatal. The following adverse effects may be signs of lactic acidosis:

  • deep, rapid breathing,
  • drowsiness,
  • feeling dizzy (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 caused by inflammation of the pancreas,
• damage to renal tubular cells.

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

• inflammation of the kidney, increased urine volume and thirst,

• changes in urine and back pain due to kidney problems, including renal failure,

• weakening of the bones (with bone pain and sometimes leading to fractures), which may occur due to damage to renal tubular cells,

• fatty liver

• If you think you may be experiencing any of these serious adverse effects, consult your doctor.

More frequent adverse effects

The following adverse effects are very common (may affect at least 10 out of 100 patients):

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

Blood tests may also show:

• decreased 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, bloating, flatulence, loss of bone mass.

Blood tests may also show:

• liver problems.

The following adverse 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, bone weakening (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 tubular cells.

The following adverse 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 adverse effects

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

5. Storage of Tenofovir Disoproxil Macleods

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.

Do not store above 30°C.

Use this medicine within 30 days after opening the container.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tenofovir disoproxil Macleods

• The active substance is tenofovir. Each tablet contains 245 mg of tenofovir disoproxil (as fumarate).
• The other components are: lactose monohydrate (E473), microcrystalline cellulose (E460), pregelatinized corn starch (modified corn starch), sodium croscarmellose (E468), and magnesium stearate (E572) which constitute the tablet core; and lactose monohydrate (E473), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), and indigo carmine aluminium lake (E132) which constitute the film coating of the tablet. See section 2 Tenofovir disoproxil Macleods contains lactose.

Nature of the product and pack sizes

Blue, oval-shaped, biconvex film-coated tablets, marked “CL 77” on one side and plain on the other.

High-density polyethylene (HDPE) bottles with child-resistant safety closures, containing pulp and a thermally sealed rayon liner, holding 30 film-coated tablets and a silica gel desiccant.

Available pack sizes: carton containing 1 bottle of 30 film-coated tablets, carton containing 60 (2 bottles of 30) film-coated tablets, and carton containing 90 (3 bottles of 30) film-coated tablets.

This medicine is also available in packaging with OPA/aluminum/PVC/aluminum blisters.

Blister pack – 30, 60, and 90 film-coated tablets

Unit-dose blister pack – 30, 60, and 90 film-coated tablets

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

or

HEUMANN PHARMA

GmbH & Co. Generica KG

Südwestpark 50, 90449 Germany

Date of the most recent revision of this package leaflet: May 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)