TENOFOVIR DISOPROXIL ACCORPHARMA 245 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tenofovir Disoproxil Accordpharma245 mgfilm-coated tablets EFG

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

• Keep this leaflet, 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 get 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 Accordpharma and what is it used for
2. What you need to know before you take Tenofovir Disoproxil Accordpharma
3. How to take Tenofovir Disoproxil Accordpharma
4. Possible side effects
5. Storage of Tenofovir Disoproxil Accordpharma
6. Contents of the pack and other information

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

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

Tenofovir Disoproxil 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 functioning 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 disoproxil must always be used in combination with other medicines.

Tenofovir Disoproxil Accordpharmatablets are 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 treatedwith other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused side effects.

Tenofovir Disoproxil Accordpharmatablets are also used to treat chronic hepatitis B, an infection caused by the HBV(hepatitis B virus). 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 disoproxil for HBV.

This medicine is not a cure for HIV infection. While you are taking tenofovir disoproxil, 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 Accordpharma

Do not takeTenofovir Disoproxil Accordpharmaif:

• 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 takeTenofovir Disoproxil Accordpharma.

Warnings and precautions

Tenofovir disoproxildoes 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, consult your doctor or pharmacist.Tenofovir Disoproxilshould not be administered to adolescents with existing kidney problems. Before starting treatment, your doctor may ask you to have blood tests to assess your kidney function. Tenofovir disoproxilmay affect your kidneys during treatment. Your doctor may ask you to have blood tests during treatment to monitor your 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 told you to.

Tenofovir disoproxilis not normally taken with other medicines that can harm your kidneys (see TakingTenofovir Disoproxil Accordpharmawith other medicines). 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 (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 if you have bone pain or fractures.

Tenofovir disoproxil may 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 boosted 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.

Some adult patients with HIV who take combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue 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 many risk factors for developing this disease. The signs of osteonecrosis are joint stiffness, pain (especially in the hips, knees, and shoulders), and difficulty moving. If you notice any of these symptoms, tell your doctor.

• Tell 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 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 monitor your liver function.

• 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 the symptoms of an existing infection when you start treatment with Tenofovir Disoproxil. These symptoms may indicate that your immune system is improving and fighting the infection. Be aware of the signs of inflammation or infection after starting to take tenofovir disoproxil. 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 the start of 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 disoproxilhas not been studied in patients over 65 years old. If you are over this age and have been prescribed tenofovir disoproxil, your doctor will monitor you closely.

Children and adolescents.

Tenofovir Disoproxil Accordpharmais suitablefor:

• adolescents infected with HIV-1 between 12 and less than 18 years who weigh at least 35 kg and 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 HBV between 12 and less than 18 years who weigh at least 35 kg.

Tenofovir Disoproxil Accordpharmais notsuitable for the following groups:

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

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

TakingTenofovir Disoproxil Accordpharmawith 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 medicinesprescribed by your doctor when you start treatment with Tenofovir Disoproxil Accordpharmaif you have HBV and HIV.
• Do not takeTenofovir Disoproxil Accordpharmaif you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Disoproxil Accordpharmawith 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 disoproxilwith other antiviral medicines that contain didanosine may increase the levels of didanosine in your blood and may reduce the CD4 cell count. When medicines that contain 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 doctorif your child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

TakingTenofovir Disoproxil Accordpharmawith food and drinks

Taketenofovir disoproxil with food(for example, 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.

• If you have been takingTenofovir Disoproxil Accordpharmaduring 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 tenofovir disoproxilduring pregnancy (HIV-positive mothers), the benefit of protection against the virus was greater than the risk of adverse 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, but first talk to your doctor for more information.

• It is not recommended that women with HIV breastfeedbecause HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or thinking of breastfeeding, consult your doctor as soon as possible.

Driving and using machines

Tenofovir Disoproxil Accordpharmamay cause dizziness. If you feel dizzy during treatment with Tenofovir Disoproxil Accordpharma, do not drive or ride a bicycleor operate tools or machines.

This medicinecontainslactose

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

This medicine contains sodium

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

3. How to take Tenofovir Disoproxil Accordpharma

Always take this medicine exactly as your doctor or pharmacist has told you.If you are not sure, ask your doctor or pharmacist again.

The recommended dose is:

• Adults:1 tablet a day with food (for example, 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 (for example, a meal or a snack).

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 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 disoproxilless 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 Disoproxilthan you should

If you have accidentally taken too many tenofovir disoproxiltablets, you may be at a higher risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Consult your doctor or go to the nearest emergency department. Take the package with you so that you can easily describe what you have taken.

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

If you forget to takeTenofovir Disoproxil

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

• If it is less than 12 hourssince 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 hourssince 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 the missed doses.

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

If you stop takingTenofovir Disoproxil

Do not stop taking tenofovir disoproxilwithout your doctor telling you to. Stopping treatment with tenofovir disoproxilmay 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 disoproxilwithout first talking to your doctor. After stopping treatment with tenofovir disoproxil, some patients have presented with blood tests 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, it is not recommended to stop treatment as this may lead to worsening of hepatitis.

• Talk to your doctor before stopping tenofovir disoproxilfor any reason, especially if you experience any side effects or 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 resuming tenofovir disoproxiltablets.

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. The child's doctor will monitor these changes.

Like all medications, this medication may 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 people) 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

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

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

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

• kidney inflammation, increased urine volume and feeling of thirst,damage to renal tubular cells
• changes inyour urineand back paindue to kidney problems, including kidney failure
• weakening of bones (with bone painand 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

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

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

Lab tests may also show:

• decrease in blood phosphate levels

Other Possible Adverse Effects

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

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

Lab tests may also show:

• liver problems

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

• muscle rupture, muscle pain or weakness

Lab tests may also show:

• 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.

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

• 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 Pharmacovigilance System for human use medications: 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 Accordpharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. 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 ofTenofovir Disoproxil Accordpharma

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

The other excipients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized corn starch, sodium croscarmellose (E468), and magnesium stearate (E470b) that make up the tablet core, and hypromellose (E464), lactose monohydrate, titanium dioxide (E171), and triacetin (E1518) that make up the tablet coating. See section 2 "Tenofovir disoproxil Accordpharma contains lactose".

Appearance of the Product and Package Contents

Tenofovir disoproxil Accordpharma 245 mg are film-coated tablets, white in color, almond-shaped, with an approximate size of 16.9 mm in length and 10.4 mm in width, marked on one side with 'H' and on the other side with '123'.

Tenofovir disoproxil Accordpharma 245 mg film-coated tablets are available in aluminum/PVC/Aluminum/OPA (unit dose) blisters containing 30x1 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Manufacturer

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 Revision of this Leaflet:August 2024

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