TENOFOVIR DISOPROXIL QILU 245 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Tenofovir Disoproxil Qilu 245 mg film-coated tablets EFG

tenofovir disoproxil

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 Qilu and what is it used for
2. What you need to know before you take Tenofovir Disoproxil Qilu
3. How to take Tenofovir Disoproxil Qilu
4. Possible side effects

5 Storage of Tenofovir Disoproxil Qilu

1. Contents of the pack and other information

If Tenofovir Disoproxil Qilu has been prescribed to your child,please note that all the information in this leaflet is intended for your child (so when you read “you”, this will mean “your child”).

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

Tenofovir Disoproxil Qilu contains the active substance tenofovir disoproxil. This active substance is an antiretroviralor antiviral medicine used to treat HIV infection, HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, also known as NtRTI, which works by interfering with the normal functioning of enzymes (reverse transcriptase in the case of HIV infection and DNA polymerase in the case of hepatitis B), which are essential for the viruses to reproduce. For the treatment of HIV infection, Tenofovir Disoproxil Qilu should always be used in combination with other medicines indicated for the treatment of HIV.

Tenofovir Disoproxil Qilu is a medicine used to treat HIV infection(Human Immunodeficiency Virus). The tablets are indicated for:

• Adults.
• Adolescents from 12 to less than 18 yearswho have already been treated with other HIV medicines that are no longer fully effective due to the development of resistance or that have caused side effects.

Tenofovir Disoproxil Qilu is also a treatment for chronic hepatitis B, which is an infection caused by the HBV(hepatitis B virus). The tablets are indicated for:

• Adults.
• Adolescents from 12 to less than 18 years.

You do not have to have HIV infection to be treated with Tenofovir Disoproxil Qilu for HBV infection.

This medicine is not a cure for HIV infection. While taking Tenofovir Disoproxil Qilu, you may still have infections or other illnesses associated with HIV infection. You can also continue to transmit HIV or HBV to others. Therefore, it is essential that you take precautions to avoid infecting others.

2. What you need to know before you take Tenofovir Disoproxil Qilu

Do not takeTenofovir Disoproxil Qilu

• if 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 take Tenofovir Disoproxil Qilu.

Warnings and precautions

Tenofovir Disoproxil Qilu does not reduce the risk of transmission of HBV to others through sexual contact or blood contamination. You must continue to take precautions to avoid this.

Talk to your doctor or pharmacist before starting Tenofovir Disoproxil Qilu.

• If you have had kidney disease or if your blood tests have shown kidney problems.Tenofovir Disoproxil Qilu should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may ask you to have blood tests to assess your kidney function. Tenofovir Disoproxil Qilu can 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 recommend that you take these tablets less frequently. Do not reduce the dose prescribed by your doctor unless your doctor tells you to.

Tenofovir Disoproxil Qilu is not normally taken with other medicines that can harm your kidneys (see Taking Tenofovir Disoproxil Qilu with other medicines); if it is unavoidable, your doctor will monitor your kidney function once a week.

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

There may also be bone problems (which manifest as persistent or worsening bone pain and sometimes end in fractures) 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 can also cause bone mass loss. The most significant 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 uncertain.

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

• Tell your doctor if you have a history of liver disease, such as hepatitis.Patients with liver disease, such as 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 Qilu. These symptoms may indicate that your immune system is improving and fighting the infection. Be aware of signs of inflammation or infection soon after starting Tenofovir Disoproxil Qilu. 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 starting treatment with medicines for the treatment of your HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms, such as muscle weakness, weakness that starts in the hands and feet and moves up to the torso, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

• If you are over 65 years, talk to your doctor or pharmacist. Tenofovir Disoproxil Qilu has not been studied in patients over 65 years. If you are older and are prescribed Tenofovir Disoproxil Qilu, your doctor will monitor you closely.

Children and adolescents

Tenofovir Disoproxil Qilu is suitable for:

• Adolescents infected with HIV-1 aged between 12 and 18 years who weigh at least 35 kg and have already been treated with 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 aged between 12 and 18 years who weigh at least 35 kg.

Tenofovir Disoproxil Qilu is not suitable for the following groups:

• Children under 12 years of age infected with HIV-1.
• Children under 12 years of age infected with HBV.

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

Other medicines and Tenofovir Disoproxil Qilu

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• If you have both HIV and HBV infection,do not stop taking any anti-HIV medicinesthat your doctor has prescribed for you when you start taking Tenofovir Disoproxil Qilu.

• Do not take Tenofovir Disoproxil Qiluif you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Disoproxil Qilu with 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 Disoproxil Qilu with other antiviral medicines that contain didanosine can increase the levels of didanosine in the blood and may reduce the CD4 cell count. When medicines containing tenofovir disoproxil and didanosine are taken together, pancreatitis and lactic acidosis (excess lactic acid in the blood) have been rarely reported, in some cases fatal. Your doctor will carefully consider whether you should be treated with combinations of tenofovir and didanosine.

• It is also important that you tell your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

Taking Tenofovir Disoproxil Qilu with food and drinks

Take Tenofovir Disoproxil Qilu with food (e.g., a meal or 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.

Pregnancy

• If you have taken Tenofovir Disoproxil Qiluduring your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your baby. In children whose mothers took NtRTIs during pregnancy, the benefit of protection against the virus was greater than the risk of side effects.

Breastfeeding

• If you are a mother and have HBV infection,and your baby has been treated to prevent the transmission of hepatitis B at birth, it may be possible for you to breastfeed your infant, but first talk to your doctor for more information.

• Mothers with HIV infection should not breastfeed their babiesbecause HIV infection can be transmitted to the baby through breast milk. If your daughter is breastfeeding or plans to breastfeed, she should consult her doctor as soon as possible.

Driving and using machines

Tenofovir Disoproxil Qilu may cause dizziness. If you feel dizzy during treatment with Tenofovir Disoproxil Qilu, do not drive or ride a bicycle, or operate tools or machines.

Tenofovir Disoproxil Qilu contains lactose.

Tell your doctor before taking Tenofovir Disoproxil.If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Tenofovir Disoproxil Qilu 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 Qilu

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

• Adults:1 tablet a day with food (e.g., a meal or snack).
• Adolescents from 12 to less than 18 yearswho weigh at least 35 kg: 1 tablet a day with food (e.g., a meal or snack).

If you have difficulty swallowing the tablet, you can use the tip of a spoon to crush it. Then, mix the powder with about 100 ml (half a glass) of water, 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 recommend that you take tenofovir disoproxil less frequently.

• If you have HBV infection, your doctor may ask you to have an HIV test to see if you are co-infected with HIV and HBV.

Consult the package leaflets of the other antiretrovirals to know how to take these medicines.

If you take more Tenofovir Disoproxil Qilu than you should

If you accidentally took too many tablets of tenofovir disoproxil, 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 bottle of tablets with you so that you can easily describe what you have taken.

You can also consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tenofovir Disoproxil Qilu

It is essential 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, you should take it as soon as possible 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 missed doses.

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

If you stop taking Tenofovir Disoproxil Qilu

Do not stop taking tenofovir disoproxil without your doctor telling you to. 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 co-infection, it is crucial that you do not 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 had 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 can lead to worsening of hepatitis.

• Talk to your doctor before stopping tenofovir disoproxil for 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 restarting Tenofovir Disoproxil Qilu tablets.

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 glucose and lipid levels in the blood. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes with HIV medications themselves. Your 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.

• The lactic acidosis(excess lactic acid in the blood) is a rare(may affect up to 1 in 1000 patients) but serious adverse effect that can be fatal. The following adverse effects may be signs of lactic acidosis:
• deep and rapid breathing
• drowsiness
• feeling of dizziness (nausea), dizziness (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 patients):

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

Rare(may affect up to 1 in 1000 patients):

• kidney inflammation, increased urine volume, and feeling of thirst
• changes in urine and back pain due to kidney problems, including kidney failure
• weakening of bones (with bone pain and 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.

Other Adverse Effects

Very Common(may affect at least 10 in 100 patients):

• diarrhea,
• nausea (vomiting),
• feeling of dizziness (nausea),
• dizziness,
• rash,
• feeling of weakness
• decrease in blood phosphate levels (observed in blood tests)

Common(may affect up to 10 in 100 patients):

• headache,
• stomach pain,
• feeling of fatigue,
• feeling of being bloated,
• flatulence
• bone mass loss
• liver problems (observed in blood tests)

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

• muscle rupture,
• muscle pain or weakness
• decrease in blood potassium levels (observed in blood tests)
• increase in blood creatinine (observed in blood tests)
• liver problems (observed in blood tests)

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

Rare(may affect up to 1 in 1000 patients):

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

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: 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 Qilu

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle and carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tenofovir Disoproxil Qilu

• The active ingredientis tenofovir. Each tablet contains 245 mg of tenofovir disoproxil (in the form of fumarate).

• Other ingredients are: lactose monohydrate, microcrystalline cellulose PH101 (E-460), pregelatinized corn starch, sodium croscarmellose, magnesium stearate (E-572), which make up the core of the tablet; and HPMC 2910/hypromellose (15 mPa s) (E-464), lactose monohydrate, titanium dioxide (E-171), triacetin, and FD&C blue No. 2/aluminum carmine indigo 3%-5%, which make up the film coating of the tablet. See section 2 Tenofovir Disoproxil Qilu contains lactose.

Appearance and Package Contents

Tenofovir Disoproxil Qilu 245 mg film-coated tablets are blue, almond-shaped film-coated tablets marked with "32" on one side. Tenofovir Disoproxil Qilu 245 mg film-coated tablets are available in bottles containing 30 tablets. Each bottle contains a silica gel desiccant that should be kept inside the bottle to protect the tablets. The silica gel desiccant is contained in a separate sachet or container and should not be swallowed.

Available presentation:

Carton box with 1 bottle of 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, Madrid-28046,

Spain

Manufacturer

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès, 08290

Barcelona,

Spain

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral 22,

Alcobendas, Madrid -28108

Spain

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet:May 2024

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