Prospect: information for the patient

Tenofovir disoproxil Accordpharma245 mgfilm-coated tablets

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isTenofovir Disoproxil Accordpharmaand what it is used for

2. What you need to know before starting to takeTenofovir Disoproxil Accordpharma

3. How to takeTenofovir Disoproxil Accordpharma

4. Possible adverse effects

5. Storage ofTenofovir Disoproxil Accordpharma

6. Contents of the pack and additional information

IfTenofovir Disoproxil Accordpharmahas been prescribed to your child, note that all the information in this prospect is directed at your child (in this case, read “your child” instead of “you”).

Tenofovir Disoproxilo contains the active ingredienttenofovir disoproxil. This active ingredient is anantiretroviralor antiviral medication that is used to treat HIV infection, or HBV, or both. Tenofovir is anucleotide reverse transcriptase inhibitor,commonly known as NRTI, which acts by interfering with the normal function of certain enzymes (in the case of HIV thereverse transcriptaseand in hepatitis B theDNA polymerase) that are essential for viruses to replicate. For the treatment of HIV infection,tenofovir disoproxil must be used always in combination with other medications.

Tenofovir Disoproxilo Accordpharmatablets are a medication 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 treatedwith other HIV medications that are no longer fully effective due to the development of resistance, or that have caused adverse effects.

Tenofovir Disoproxilo Accordpharmatablets are also used to treat chronic hepatitis B, a HBV infection. The tablets are suitable for:

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

It is not necessary to have HIV to be treated withtenofovir disoproxilfor HBV.

This medication is not a cure for HIV infection. While takingtenofovir disoproxil, you may still get infections or other diseases associated with HIV infection. You may also continue to transmit HBV to others. Therefore, it is essential to take precautions to avoid infecting others.

Do not takeTenofovir Disoproxilo Accordpharma:

-if you are allergicto tenofovir, tenofovir disoproxilor 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 Disoproxilo Accordpharma.

Warnings and precautions

Tenofovir disoproxildoes not reduce the risk of transmission of VHB by sexual contact or blood contamination. You should continue to take precautions to avoid it.

• If you have had kidney disease or if your tests have shown kidney problems, consult your doctor or pharmacist.This medicine should not be administeredto adolescents with existing kidney problems.Before starting treatment, your doctor may request that some blood tests be done to evaluate the functioning of your kidneys.Tenofovir disoproxilmay affect your kidneys during treatment. Your doctor may request that some blood tests be done during treatment to monitor the functioning 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 do so.

Tenofovir disoproxilis usually not taken with other medicines that may damage your kidneys (seeTakingTenofovir Disoproxilo Accordpharmawith other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.

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

You may also experience bone problems (which manifest as persistent bone pain or worsening and sometimes leading to 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 boosted protease inhibitor.

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

Some adult patients with HIV who take combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by loss of blood supply to the bone). The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and a higher body mass index, among others, may be some of the numerous risk factors for developing this disease. The signs of osteonecrosis are joint stiffness, pain (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, including hepatitis.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 perform blood tests to monitor your liver function.

• Infections.If you have advanced HIV infection (AIDS) and develop another type of infection, you may experience symptoms of infection and inflammation or worsening of symptoms of an existing infection when you start treatment withTenofovir disoproxil. 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 taketenofovir disoproxil. 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 HIV treatment. 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.Tenofovir disoproxilhas not been studied in patients over 65 years old. If you are over this age and have been prescribedtenofovir disoproxil, your doctor will monitor you closely.

Children and adolescents.

Tenofovir Disoproxilo Accordpharmaisappropriatefor:

• adolescents infected with HIV-1 between 12 and less than 18 years old 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 caused side effects.
• adolescents infected with HVB between 12 and less than 18 years old who weigh at least 35 kg.

Tenofovir Disoproxilo Accordpharmais notappropriate for the following groups:

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

To know the dose, see section 3,How to takeTenofovir Disoproxilo Accordpharma.

TakingTenofovir Disoproxilo Accordpharmawith other medicines

Inform your doctor or pharmacist if you are taking,have takenrecentlyor mayhave to take any other medicine.

• Do not stop taking any HIV medicineprescribed by your doctor when you start treatment withTenofovir Disoproxilo Accordpharmaif you have HVB and HIV.
• Do not takeTenofovir Disoproxilo Accordpharmaif you are using medicines that already contain disoproxil of tenofovir or tenofovir alafenamide. Do not takeTenofovir Disoproxilo Accordpharmawith medicines that contain dipivoxil of adefovir (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 damage 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),
• dipivoxil of adefovir (used to treat HVB 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):Takingtenofovir disoproxilwith other antiviral medicines that contain didanosine may increase the levels of didanosine in your blood and may reduce the CD4 cell count. When taken together, medicines that contain disoproxil of tenofovir and didanosine have been associated with rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), in some cases fatal. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

• You should also inform your doctorif your child is taking ledipasvir/sofosbuvir,sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

TakingTenofovir Disoproxilo Accordpharmawith food and drinks

Taketenofovir disoproxil with food(e.g. a meal or a snack).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

• If you have been takingTenofovir Disoproxilo Accordpharmaduring your pregnancy, your doctor may request that some blood tests be done periodically and other diagnostic tests to monitor the development of your baby. In children whose mothers tooktenofovir disoproxil(NRTIs) during pregnancy, the benefit of protection against the virus was greater than the risk of adverse effects.

• If you are a mother and have HVB infection, and your baby has been treated to prevent transmission of hepatitis B at birth, it is possible that you may breastfeed your infant, but first speak with your doctor to get more information.

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

Driving and operating machines

Tenofovir disoproxil Accordpharmamay cause dizziness. If you experience dizziness during treatment withTenofovir disoproxilo Accordpharma,do not drive or ride a bikeor operate tools or machines.

This medicinecontainslactose

Inform your doctor before taking this medicine. Patients with hereditary galactose intolerance, total lactase deficiency or glucose or galactose malabsorption should not take this medicine.

This medicine contains sodium

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

Followexactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of 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 of water (half a glass), orange 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 taketenofovir disoproxilless frequently.

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

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

If you take moreTenofovir Disoproxilthan you should

If you accidentally took too many tablets oftenofovir disoproxil, you may be at a higher risk of experiencing possible side effects with this medication (see section 4,possible side effects). Consult your doctor or go to the nearest emergency service. Bring the packaging with you so that they can easily describe what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeTenofovir Disoproxil

It is essential that you do not forget a dose oftenofovir disoproxil. 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 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 takenTenofovir Disoproxil,take another tablet. You do not need to take another tablet if you vomited more than an hour after takingtenofovir disoproxil.

If you interrupt the treatment withTenofovir Disoproxil

Do not stop takingtenofovir disoproxilwithout your doctor's permission. Stopping treatment withtenofovir disoproxilmay reduce the effectiveness of the recommended treatment by your doctor.

If you have hepatitis B, or HIV and hepatitis B (coinfection),it is very important that you do not interrupt your treatment withtenofovir disoproxilwithout first talking to your doctor. After interrupting treatment withtenofovir disoproxil,some patients have presented blood test results or symptoms indicating that their hepatitis had worsened. You may need to have blood tests for several months after interrupting 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 takingtenofovir disoproxilfor any reason, particularly if you experience any side effect or have another disease.

• Talk to your doctor immediately if you experience any new or unusual symptoms after interrupting treatment, particularly those symptoms related to hepatitis B infection.

• Contact your doctor before restarting the tablets oftenofovir disoproxil.

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 health recovery and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The child's doctor will monitor these changes.

Like all medications, this medication may produce side effects, although not everyone will experience them.

Severe side effects: report to your doctor immediately

• Lactic acidosis(excess 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
• Nausea, vomiting, and stomach pain

If you think you may havelactic acidosis, contact your doctor immediately.

Other possible severe side effects

Infrequent(may affect up to 1 in 100 people):

• Abdominal pain(belly pain) caused by pancreatitis inflammation
• Damage to kidney tubular cells

Rare(may affect up to 1 in 1,000 people):

• Kidney inflammation,increased urine volume and sensation of thirst,damage to kidney tubular cells
• Changes inyoururineandback paindue to kidney problems, including renal failure
• Weakening of bones (withbone painand sometimes ending in fractures), which may occur due to damage to kidney tubular cells.
• Fatty liver

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

More frequent side effects

Very frequent(may affect more than 1 in 10 people):

• Diarrhea, vomiting, nausea, dizziness, rash, feeling weak

Lab tests may also show:

• Decreased phosphate levels in the blood

Other possible side effects

Frequent(may affect up to 1 in 10 people):

• Headache, stomach pain, feeling tired, feeling bloated, flatulence, bone loss

Lab tests may also show:

• Liver problems

Infrequent(may affect up to 1 in 100 people):

• Muscle rupture, muscle pain or weakness

Lab tests may also show:

• Decreased potassium levels in the blood
• Increased creatinine levels in the blood
• Pancreas problems

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

Rare(may affect up to 1 in 1,000 people):

• Abdominal pain (belly pain) caused by liver inflammation
• Swelling of the face, lips, tongue, or throat

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it's apossibleside effect that doesn't appear in this prospectus.You can also report them directlythrough the Spanish System for Pharmacovigilance of human use medicines: https://www.notificaram.es.By reporting side effects, you can contribute toproviding more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging afterCAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Tenofovir Disoproxilo Accordpharma

The active ingredient is tenofovir. Each tablet contains 245 mg of disoproxil of tenofovir (as fumarate).

The other excipients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized cornstarch, sodium croscarmellose (E 468) and magnesium stearate (E470b) that make up the core of the tablet, and hypromellose (E464), lactose monohydrate, titanium dioxide (E171), and triacetin (E 1518) that make up the coating of the tablet. See section 2 “ Tenofovir disoproxilo Accordpharma contains lactose ”.

Appearance of the product and content of the container

Tenofovir disoproxilo Accordpharma 245 mg are film-coated tablets with a white film coating, almond-shaped, with an approximate dimension of 16.9 mm in length and 10.4 mm in width, marked on one face with ‘H’ and on the other face with ‘123’.

Tenofovir disoproxilo Accordpharma 245 mg are film-coated tablets available in aluminum/PVC/aluminum/OPA blister packs (single-dose) containing 30x1 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Responsible for manufacturing

Pharmadox healthcare Ltd

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

O

Laboratori Fundació DAU

C/ C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona

Spain

Date of the last review of this leaflet: August 2024

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