Tenofovir disoproxil Accorpharma 245 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Tenofovir Disoproxil Accordpharma 245 mg film-coated tablets EFG

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, since 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 the leaflet

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

If Tenofovir Disoproxil Accordpharma 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 Accordpharma is and what it is used for

Tenofovir Disoproxil 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 (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 viruses to replicate. For the treatment of HIV infection, tenofovir disoproxil must always be used in combination with other antiretroviral medicines.

Tenofovir Disoproxil Accordpharma tablets are a medicine used to treat HIV infection (human immunodeficiency virus). The tablets are suitable for:

• adults
• adolescents aged 12 to under 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 Disoproxil Accordpharma tablets are 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 under 18 years.

You do not need to have HIV in order to be treated with tenofovir disoproxil 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 starting Tenofovir Disoproxilo Accordpharma

Do not take Tenofovir Disoproxilo Accordpharma:

• 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 Disoproxilo Accordpharma.

Warnings and precautions

Tenofovir disoproxil does 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 disoproxil must not be administered to adolescents with pre-existing kidney problems. Before starting treatment, your doctor may request blood tests to assess your kidney function. Tenofovir disoproxil 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 your doctor has instructed you to do so.

Tenofovir disoproxil is generally not taken together with other medicines that may damage your kidneys (see Taking Tenofovir Disoproxilo Accordpharma with other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.

• If you have osteoporosis, a history of bone fracture, 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 tubule 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. More 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 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). Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, and others may be among the numerous risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, pain (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.

• 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 disoproxil. These symptoms may indicate that your improved immune system is fighting the infection. Be alert for signs of inflammation or infection after starting tenofovir disoproxil. If you notice signs of inflammation or infection, inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition where the immune system attacks healthy body tissue) may also occur after you have started taking medicines 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 up toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary 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 tenofovir disoproxil, your doctor will monitor you closely.

Children and adolescents

Tenofovir Disoproxilo Accordpharma is suitable for:

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

Tenofovir Disoproxilo Accordpharma 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 Disoproxilo Accordpharma.

Taking Tenofovir Disoproxilo Accordpharma 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 treatment with Tenofovir Disoproxilo Accordpharma, if you have both HBV and HIV.
• Do not take Tenofovir Disoproxilo Accordpharma if you are already using medicines that contain tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Disoproxilo Accordpharma 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 damage 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 induce 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 disoproxil with other antiviral medicines containing didanosine may increase didanosine levels in your blood and may reduce CD4 cell count. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), some fatal, have been reported when medicines containing tenofovir disoproxil and didanosine are taken together. Your doctor will carefully consider whether to treat you with a combination of tenofovir and didanosine.

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

Taking Tenofovir Disoproxilo Accordpharma with food and drink

Take tenofovir disoproxil with food (e.g., a meal or a snack).

Pregnancy and breastfeeding

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

• If you have been taking Tenofovir Disoproxilo Accordpharma during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took tenofovir disoproxil (NRTIs) during pregnancy, the benefit of protection against the virus 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 first discuss this with 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 considering breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

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

This medicine contains lactose

Inform 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, i.e., essentially “sodium-free”.

3. How to take Tenofovir Disoproxil Accordpharma

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 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 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 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 disoproxil 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 to learn how to take those medicines.

If you take more Tenofovir Disoproxil than you should

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

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

If you forget to take Tenofovir 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 were supposed to take it.

• If it is less than 12 hours after your usual 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 your usual time. Do not take a double dose to make up for missed doses.

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

If you stop taking Tenofovir Disoproxil

Do not stop taking tenofovir disoproxil without your doctor's advice. Stopping treatment with tenofovir disoproxil 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 disoproxil without first talking to your doctor. After stopping treatment with tenofovir disoproxil, some patients have had 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, stopping treatment is not recommended, as this may lead to a worsening of hepatitis.

• Talk to your doctor before stopping tenofovir disoproxil for any reason, especially if you are experiencing 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 you associate with hepatitis B virus infection.

• Contact your doctor before restarting tenofovir disoproxil 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 the recovery of health, lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your child's doctor will monitor these changes.

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

Possible serious adverse effects: tell 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 side effect that can be life-threatening. The following side effects may be signs of lactic acidosis:

• deep, 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 caused by inflammation of the pancreas
• damage to renal tubule cells

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

• inflammation of the kidney, increased urine volume and feeling thirsty, damage to renal tubule cells
• 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 be experiencing any of these serious adverse effects, consult your doctor.

More frequent adverse effects

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

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

Blood tests may also show:

• decreased 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

Blood tests may also show:

• liver problems

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

• muscle rupture, muscle pain or weakness

Blood tests may also show:

• decreased blood potassium levels
• increased blood creatinine
• problems with the pancreas

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.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tenofovir Disoproxil Accordpharma

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 30 °C.

Medicines must not be disposed of via wastewater or household waste. 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 Accordpharma

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

The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized starch (corn), sodium croscarmellose (E 468), and magnesium stearate (E470b), which constitute the tablet core; and hypromellose (E464), lactose monohydrate, titanium dioxide (E171), and triacetin (E 1518), which constitute the tablet coating. See section 2 “Tenofovir disoproxil Accordpharma contains lactose”.

Appearance of the medicinal product and contents of the pack

Tenofovir disoproxil Accordpharma 245 mg are film-coated white tablets, almond-shaped, with approximate dimensions 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 blister packs 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, 6th floor

08039 Barcelona

Manufacturer

Pharmadox healthcare Ltd

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

Or

Laboratori Fundació DAU

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

08040 Barcelona

Spain

Date of the latest revision of this leaflet: August 2024

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