Leaflet:information for the patient

Tenofovir disoproxil Macleods 245 mg film-coated tablets EFG

tenofovir disoproxil

Read 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Tenofovir disoproxil Macleods

3.How to take Tenofovir disoproxil Macleods

4.Possible side effects

5Storage of Tenofovir disoproxil Macleods

6.Contents of the pack and additional information

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

This medication contains the active ingredienttenofovir disoproxil. This active ingredient is anantiretroviralor antiviral drugused to treat HIV infection, or HVB, or both.Tenofovir isanucleotide reverse transcriptase inhibitor analogue,commonly knownasITIAN and acts by interfering with the normal function of certain enzymes (in the case of HIV thereverse transcriptaseand in hepatitis B theDNA polymerase) essential for viruses toreproduce. Forthe treatment of HIV infection, tenofovir disoproxil must be used always in combination withother medications.

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

• adults,
• adolescents between 12 and less than 18 years who have already been treatedwithothermedications against HIV that are no longer fully effective due to the developmentofresistances, or that have caused adverseeffects.

Tenofovir disoproxil Macleods is also used to treat chronic hepatitis B, ainfectioncaused by the HVB(hepatitis B virus). The tablets are suitable for:

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

No HIV infection is required to be treated with this medication for HVB.

This medication is not a cure for HIV infection. While taking tenofovir disoproxil, you maystillbe able to have infections or other diseases associated with HIV infection. You may alsocontinue to transmit HVB to others. Therefore, it is essential to take precautionstoavoid infectingothers.

Do not takeTenofovir disoproxil Macleods:

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

• If this is the case,inform your doctor immediately and do not takeTenofovir disoproxil Macleods.

Warnings andprecautions

Tenofovirdoes not reduce the risk of transmission of HBV to other people by sexual contact or blood contamination. You should continue to take precautions to avoid it.

Consult your doctor or pharmacist before starting to takeTenofovir disoproxil Macleods.

• If you have had kidney disease or if your blood tests have shown kidney problems.This medicine should not be administered to adolescents with existing kidney problems. Before starting treatment, your doctor may request that you have some blood tests to evaluate the function of your kidneys. Tenofovir disoproxil may affect your kidneys during treatment. Your doctor may request that you have some blood tests during treatment to control the function of your kidneys. 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 told you to.

This medicine is usually not taken with other medicines that may damage yourkidneys(seeOther medicines and Tenofovir disoproxil Macleods). If this is unavoidable, your doctor will monitor the function of your kidneys once a week.

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

You may also experience bone problems (which manifest as persistent bone pain or that worsen and sometimes end in fractures) due to damage to renal tubular cells (see section 4,Undesirable effects). Inform your doctor if you have bone pain or fractures.

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

The long-term effects of tenofovir disoproxil on bone health and the future risk of fractures in adult and pediatric patients are imprecise.

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

• Speak to your doctor if you have a history of liver disease, includinghepatitis.

Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals have a higher risk of severe 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 request blood tests to monitor your liver function.

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

• If you are over 65 years old, inform your doctor or pharmacist.

Children andadolescents

This medicine isappropriatefor:

• Adolescents infected with HIV-1 aged 12 and under 18 years who weigh at least 35 kg and who have already been treatedwith other HIV medicines that are no longer fully effective due to the development of resistance, or that have causedside effects.
• Adolescents infected with HBVaged 12 and under 18 years who weigh at least 35kg.

This medicineis notappropriate for the followinggroups:

• Not for children infected with HIV-1under 12years old.
• Not for children infected with HBVunder 12years old.

To know the dose, see section 3,How to take Tenofovir disoproxil Macleods.

Other medicines andTenofovir Disoproxil Macleods

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any othermedicine.

• Do not stop taking any HIV medicine prescribed by your doctor when you start treatment with this medicine if you have HBV andVIH.

• Do not take Tenofovir disoproxil Macleodsif you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take this medicine with medicines that containadefovirdipivoxil (a medicine used to treat chronic hepatitis B).

• It is very important that you tell your doctor if you are taking other medicinesthatmay damage yourkidneys.

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 treatcancer),
• adefovir dipivoxil (used to treat HBV infection),
• tacrolimus (used to produce immune suppression),
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

• Other medicines that contain didanosine (for HIV infection):When you takethis medicinewith other antiviral medicines that contain didanosine, it may increase the levels of didanosine in your blood and may reduce the CD4 cell count. When taken together, medicines that contain tenofovir disoproxil and didanosine have been reported in rare cases to cause inflammation of the pancreas and lactic acidosis (excess of lactic acid in the blood), 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 inform your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevirto treat hepatitis C infection.

Taking Tenofovir disoproxil Macleods with food anddrinks

Take this medicinewith food(for example, a meal or anappetizer).

Tenofovir disoproxil Macleods contains lactose

Consult your doctor before starting to take Tenofovir disoproxil Macleods.If your doctor has told you that yousuffer from an intolerance to certainsugars,consult with him before taking this medicine.

Tenofovir disoproxil Macleods contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.Yourdoctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults:1 tablet per day with food (for example, a meal or an appetizer).
• Adolescents between 12 and less than 18 years who weigh at least 35 kg:1 tablet per day with food (for example, a meal or an appetizer).

If you have special difficulty swallowing, you can 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 it immediately.

• Always take the recommended dose prescribed by your doctor.This is to ensure that your medication 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 this medication less frequently.

• If you have VHB, your doctor may offer you to undergo a VIH test to see if you have VHB and VIH.

Consult the prospectuses of other antiretrovirals to know how to take these medications.

If you take more Tenofovir disoproxilo Macleods than you should:

If you have taken accidentally too many tablets of tenofovir disoproxilo, you may be at a higher risk of experiencing possible adverse effects with this medication (see section 4, Possible Adverse Effects). Consult your doctor or pharmacist, go to the nearest emergency service or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.Bring with you the packaging and the medication leaflet so that you can easily describe what you have taken.

If you forgot to take Tenofovir disoproxilo Macleods:

It is essential that you do not forget a dose of this medication. If you forget a dose, determine how long it has been since you should have taken it.

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

• If it is more than 12 hourssince when you should have taken it, do not take the missed dose. Wait and take the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

If you vomit before 1 hour after having taken this medication,take another tablet.You do not need to take another tablet if you vomited more than an hour after taking this medication.

If you interrupt the treatment with Tenofovir disoproxilo Macleods:

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

If you have hepatitis B, or both VIH and hepatitis B (coinfection),it is very important that you do not interrupt your treatment with this medication without first talking to your doctor. After interrupting treatment with this medication, some patients have presented blood tests or symptoms indicative of their hepatitis having 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 interrupt treatment as this may lead to a worsening of their hepatitis.

• Talk to your doctor before stopping taking this medication for any reason, particularly if you experience any adverse effect or if you have another disease.
• Talk to your doctor immediately if you experience any new or unusual symptoms after interrupting your treatment, particularly those symptoms related to the hepatitis virus infection.
• Contact your doctor before restarting the tablets of this medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.notodasthepersonswillexperiencethem.

Severe side effects: report to your doctor immediatelyimmediately

• Lactic acidosis(excess of lactic acid in the blood) is a rare but severe side effect that can be fatal. The following side effects may be signs of lactic acidosis:
• • deep and rapid breathing,
  • drowsiness,
  • feeling dizzy (nausea), vomiting, and stomach pain.

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

Other possible severe side effectssevere

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

• Abdominal painabdominalcaused by inflammation of the pancreas,
• damage to the renal tubular cells.

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

• inflammation of the kidney,increased urine volume and sensation ofthirst,
• changes inyoururineandback paindue to kidney problems, including renal failure,
• weakening of the bones (with bone pain and sometimes ending in fractures),whichmay occur due to damage to the renal tubular cells,
• Fatty liver

• If you think you may have any of these severe side effects, consult your doctor.

More frequent side effectsfrequent

The following side effects are very frequent (may affect at least 10 in 100 patients):

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

The tests may also show:

• decrease in blood phosphate levels.

Other possible side effectsside

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

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

The tests may also show:

• liver problems.

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

• muscle rupture, muscle pain or weakness.

The tests may also show:

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

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

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe bottle, packaging or blister packafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Use this medication within 30 days after opening the packaging.

Medicines should not be disposed of through the drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection pointat the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment

Composition ofTenofovir disoproxil Macleods

• The active ingredient is tenofovir. Each tablet contains 245 mg of tenofovir disoproxil (asfumarate).
• The other componentsare:lactose monohydrate (E473),microcrystalline cellulose (E460), cornstarch (modified cornstarch),sodium croscarmellose (E468) and magnesium stearate(E572) that form the core of the tablet and lactose monohydrate (E473), hypromellose (E464). titanium dioxide (E171), triacetin (E1518) and aluminium lake of indigo carmine (E132)that form the film coating of the tablet. See section 2Tenofovir disoproxil Macleods contains lactose.

Appearance of the product and contents of the pack

Blue-coated tablets, oval-shaped and biconvex, engraved with “CL 77” on one face and smooth on the other face.

High-density polyethylene (HDPE) bottles with child-resistant safety closures and a heat-sealed paper insert with rayon, containing 30 film-coated tablets and a silica gel desiccant.

The available pack sizes are: a box containing 1 HDPE bottle of 30 film-coated tablets, a box containing 60 (2 HDPE bottles of 30) film-coated tablets and a box containing 90 (3 HDPE bottles of 30) film-coated tablets.

This medicinal product is also available in blister packs of OPA/aluminium/PVC/aluminium.

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

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

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacture

Marketing authorisation holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Responsible person for manufacture

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

or

HEUMANN PHARMA

GmbH & Co. Generica KG

Südwestpark 50, 90449Germany

Last revision date of thisleaflet:May 2024

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)