EMTRICITABINE/TENOFOVIR DISOPROXIL MACLEODS 200 mg/245 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Emtricitabine/Tenofovir disoproxilMacleods 200 mg/245 mgfilm-coated tablets EFG

Emtricitabine/Tenofovir disoproxil

Read all of 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 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 symptoms are the same as yours.
• If you experience 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 and other information

1. What is Emtricitabine/Tenofovir disoproxil and what is it used for
2. What you need to know before you take Emtricitabine/Tenofovir disoproxil
3. How to take Emtricitabine/Tenofovir disoproxil
4. Possible side effects

5 Storage of Emtricitabine/Tenofovir disoproxil

1. Contents of the pack and other information

1. What is Emtricitabine/Tenofovir disoproxil and what is it used for

Emtricitabine/Tenofovir disoproxilcontains two active substances, emtricitabineand tenofovir disoproxil. Both active substances are antiretroviralmedicines used to treat HIV infection. Emtricitabine is a nucleoside analogue reverse transcriptase inhibitorand tenofovir is a nucleotide analogue reverse transcriptase inhibitor. They are generally known as NRTIs and work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce.

• Emtricitabine/Tenofovir disoproxilis used to treat HIV-1 infection in adults.
• It is also used to treat HIV in adolescents from 12 to less than 18 years of age with a body weight of at least 35 kgand who have already been treated with other HIV medicines that are no longer effective or have caused side effects.

• Emtricitabine/Tenofovir disoproxil must always be used in combination with other medicines to treat HIV infection.

• Emtricitabine/Tenofovir disoproxil can be taken instead of emtricitabine and tenofovir disoproxil taken separately at the same doses.

This medicine is not a cure for HIV infection. While you are taking this medicine, you may still develop infections or other illnesses associated with HIV.

• This medicine is also used to reduce the risk of becoming infected with HIV-1 in adults and adolescents from 12 to less than 18 years of age with a body weight of at least 35 kgwhen taken daily, in combination with safer sex practices:

See section 2 for a list of precautions to take against HIV infection.

2. What you need to know before you take Emtricitabine/Tenofovir disoproxil

Do not takeEmtricitabine/Tenofovir disoproxilto treat HIV or reduce the risk of becoming infected with HIV:if you are allergicto emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).

→ Ifthis happens, contact your doctor immediately.

Before taking Emtricitabine/Tenofovir disoproxil to reduce the risk of becoming infected with HIV:

Emtricitabine/Tenofovir disoproxil can only help reduce the risk of becoming infected with HIV beforeyou become infected.

• You must not be infected with HIV before starting Emtricitabine/Tenofovir disoproxil to reduce the risk of becoming infected with HIV. You will need to have an HIV test to make sure you are not already infected with HIV. Do not take this medicine to reduce the risk of infection unless you have been confirmed to be free of HIV. People with HIV should take this medicine in combination with other medicines.

• Many HIV tests can miss a recent infection.If you get a flu-like illness, it could be a sign that you have recently become infected with HIV.

These can be signs of HIV infection:

• fatigue
• fever
• joint or muscle pain
• headache
• vomiting or diarrhea
• rash
• night sweats
• enlarged lymph nodes in the neck or groin

→ Tell your doctor about any flu-like illness, either in the month before starting Emtricitabine/Tenofovir disoproxil or at any time while taking Emtricitabine/Tenofovir disoproxil.

Warnings and precautions

When taking Emtricitabine/Tenofovir disoproxil to reduce the risk of becoming infected with HIV:

• Take this medicine every day to reduce your risk, not just when you think you have been at risk of becoming infected with HIV. Do not miss any doses of this medicine or stop taking it. Missed doses can increase the risk of becoming infected with HIV.

• You should have regular HIV tests.

• If you think you have become infected with HIV, contact your doctor immediately. They may want to do more tests to make sure you are still not infected with HIV.

• TakingEmtricitabine/Tenofovir disoproxilon its own may not prevent you from becoming infected with HIV.
• • Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
  • Do not share personal items that may contain blood or bodily fluids, such as toothbrushes or razors.
  • Do not share or reuse needles or injections or medicines.
  • You should have tests for other sexually transmitted infections like syphilis or gonorrhea. These infections make it easier for you to become infected with HIV.

Talk to your doctor if you have any questions about how to prevent getting HIV or passing it on to others.

When taking Emtricitabine/Tenofovir disoproxil to treat HIV or reduce the risk of becoming infected with HIV:

• Emtricitabine/Tenofovir disoproxil can affect your kidneys.Before and during treatment, your doctor may ask you to have blood tests to check your kidney function. If you have had kidney disease, or if the tests have shown kidney problems, tell your doctor. This medicine must not be given to adolescents with existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking this medicine or, if you already have HIV, take this medicine less often. This medicine is not recommended if you have severe kidney disease or are on dialysis.

• Talk to your doctor if you have a history of bone problems or osteoporosis.

Bone problems

For adult patients:

Bone problems (shown as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to the kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.

Tenofovir disoproxil can also cause bone loss. The greatest bone loss was seen in clinical studies when patients were treated for HIV with tenofovir disoproxil in combination with a boosted protease inhibitor.

The long-term effect of tenofovir disoproxil on bone health and the risk of future fractures in adult and pediatric patients is not known.

For adolescent/pediatric patients:

Bone problems (shown as persistent or worsening bone pain and sometimes resulting in fractures) due to damage to the kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.

Tenofovir disoproxil can also cause bone loss. The greatest bone loss was seen in clinical studies when patients were treated for HIV with tenofovir disoproxil in combination with a boosted protease inhibitor.

The long-term effect of tenofovir disoproxil on bone health and the risk of future fractures in adult and pediatric patients is not known.

Tell your doctor if you have osteoporosis. Patients with osteoporosis are at a greater risk of fractures.

• Talk to your doctor if you have a history of liver disease, including hepatitis.Patients with HIV who are also infected with liver disease (including chronic hepatitis B or C) and are treated with antiretrovirals have a greater risk of serious and potentially life-threatening liver complications. If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.

• Know your hepatitis B virus (HBV) statusbefore starting Emtricitabine/Tenofovir disoproxil. If you have HBV, there is a serious risk of liver problems when you stop taking this medicine, whether you also have HIV or not. It is important not to stop taking this medicine without talking to your doctor: see section 3, Do not stop takingEmtricitabine/Tenofovir disoproxil.

• If you are over 65 years of age, tell your doctor.Emtricitabine/Tenofovir disoproxil has not been studied in patients over 65 years of age.

• Consult your doctor if you are intolerant to lactose(see Emtricitabine/Tenofovir disoproxil contains lactose below).

Children and adolescents

Emtricitabine/Tenofovir disoproxil should not be given to children under 12 years of age.

Other medicines and Emtricitabine/Tenofovir disoproxil

Do not take Emtricitabine/Tenofovir disoproxilif you are already taking other medicines that contain the components of Emtricitabine/Tenofovir disoproxil (emtricitabine and tenofovir disoproxil) or any other antiviral medicine that contains tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Taking Emtricitabine/Tenofovir disoproxilwith other medicines that can harm your kidneys:it is especially important that you tell your doctor if you are taking any of these medicines. These include:

• aminoglycosides (for bacterial infection)
• amphotericin B (for fungal infection)
• foscarnet (for viral infection)
• ganciclovir (for viral infection)
• pentamidine (for infections)
• vancomycin (for bacterial infection)
• interleukin-2 (for cancer treatment)
• cidofovir (for viral infection)
• non-steroidal anti-inflammatory drugs (NSAIDs, for pain relief or to reduce inflammation)

If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may ask you to have blood tests to closely monitor your kidney function.

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

Taking Emtricitabine/Tenofovir disoproxilwith other medicines that contain didanosine (for HIV treatment):

Taking this medicine with other antiviral medicines that contain didanosine can increase the levels of didanosine in your blood and may reduce the CD4 cell count. When medicines containing tenofovir disoproxil and didanosine are taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, sometimes causing death. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

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

Taking Emtricitabine/Tenofovir disoproxilwith food and drinks

• Whenever possible, Emtricitabine/Tenofovir disoproxil should be taken with food.

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 taken this medicine during 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 NRTIs during pregnancy, the benefits of protection against HIV outweighed the risks of side effects.

For adult patients:

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

• If you are a mother with HIV, it is recommended that you do not breastfeed your baby to avoid passing the virus to your baby through breast milk.

• If you are breastfeeding or thinking of breastfeeding, consult your doctor as soon as possible.

For adolescent/pediatric patients:

• If the girl has HBV and her baby is receiving treatment to prevent hepatitis B transmission at birth, she may be able to breastfeed her baby, but first talk to her doctor for more information.

• If the girl has HIV, she must not breastfeed to avoid passing the virus to her baby through breast milk.

Driving and using machines

Emtricitabine/Tenofovir disoproxil can cause dizziness. If you feel dizzy while taking this medicine, do not driveor operate tools or machines.

Emtricitabine/Tenofovir disoproxil contains lactose

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

Emtricitabine/Tenofovir disoproxil contains sodium

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

3. How to Take Emtricitabine/Tenofovir Disoproxil

Follow your doctor's instructions for taking this medication exactly.

Your doctor.If in doubt, consult your doctor or pharmacist again.

The recommended dose of Emtricitabine/Tenofovir Disoproxil for treating HIV is:

• Adults:one tablet a day, preferably with food.

• Adolescents from 12 to less than 18 years of age with a weight of at least 35 kg:one tablet a day, preferably with food.

The recommended dose of Emtricitabine/Tenofovir Disoproxil for reducing the risk of contracting HIV is:

• Adults:one tablet a day, preferably with food.

• Adolescents from 12 to less than 18 years of age with a weight of at least 35 kg:one tablet a day, preferably with food.

If you have 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 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 do so.

• If you are receiving treatment for HIV infection,your doctor will prescribe Emtricitabine/Tenofovir Disoproxil with other antiretroviral medications. Consult the leaflets of the other antiretrovirals to know how to take these medications.

• If you are taking Emtricitabine/Tenofovir Disoproxil to reduce the risk of contracting HIV,take Emtricitabine/Tenofovir Disoproxil every day, not just when you think you have been at risk of contracting HIV infection.

Consult your doctor if you have any questions about how to prevent HIV transmission or prevent its transmission to other people.

If you take more Emtricitabine/Tenofovir Disoproxil than you should

If you accidentally took more than the recommended dose of Emtricitabine/Tenofovir Disoproxil, consult your doctor or go to the nearest emergency department. Bring the bottle of tablets 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Emtricitabine/Tenofovir Disoproxil

It is essential that you do not forget a dose of Emtricitabine/Tenofovir Disoproxil.

• If you realize within 12 hoursfrom the time you usually take Emtricitabine/Tenofovir Disoproxil, take the tablet as soon as possible, preferably with food, and then take the next dose at your usual time.

• If 12 hours or more have passedsince the time you usually take Emtricitabine/Tenofovir Disoproxil, do not take the missed dose. Wait and take the next dose, preferably with food, at your usual time.

If you vomit before 1 hour has passed after taking Emtricitabine/Tenofovir Disoproxil,take another tablet. You do not need to take another tablet if you vomited more than an hour after taking Emtricitabine/Tenofovir Disoproxil.

Do not interrupt treatment with Emtricitabine/Tenofovir Disoproxil

• If you are taking Emtricitabine/Tenofovir Disoproxil for the treatment of HIV infection,suspending treatment may reduce the effectiveness of the recommended HIV therapy by your doctor.

• If you are taking Emtricitabine/Tenofovir Disoproxil to reduce the risk of contracting HIV,do not stop taking this medication or miss any doses. Suspending treatment with this medication, or missing doses, may increase the risk of contracting HIV infection.

Do not interrupt treatment with Emtricitabine/Tenofovir Disoproxil without consulting your doctor.

• If you have hepatitis B,it is especially important not to suspend your treatment with Emtricitabine/Tenofovir Disoproxil without first talking to your doctor. You may need to have blood tests for several months after suspending treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to suspend treatment as this may cause worsening of hepatitis, which can be potentially fatal.

Talk to your doctor immediatelyabout new or unusual symptoms after suspending your treatment, particularly symptoms that you associate with hepatitis B virus infection.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Possible Serious Side Effects:

• Lactic acidosis(excess lactic acid in the blood) is a rare but potentially fatal side effect. Lactic acidosis is more common in women, especially if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:
• • deep and rapid breathing
  • drowsiness
  • nausea, vomiting
  • stomach pain

→ If you think you may have lactic acidosis, seek medical attention immediately.

• Any sign of inflammation or infection.In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of inflammation of previous infections may appear shortly after starting HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows the body to fight against infections that may be present without any apparent symptoms.

• Autoimmune disorders may also appear, when the immune system attacks healthy body tissue,after starting to take medications for HIV treatment. Autoimmune disorders can occur many months after starting treatment. Pay attention to 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

→ If you notice these or any symptoms of inflammation or infection, seek medical attention immediately.

Possible Side Effects:

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

• diarrhea, vomiting, nausea
• dizziness, headache
• rash
• feeling of weakness

Lab tests may also show:

• decreased phosphate levels in the blood
• elevated creatine kinase

Common Side Effects(may affect up to 1 in 10 people)

• pain, stomach pain
• difficulty sleeping, abnormal dreams
• digestive problems with discomfort after meals, feeling bloated (gas), flatulence
• rash (including red spots or pimples, sometimes with blisters and swelling of the skin), which can be allergic reactions, itching, changes in skin color such as darkening of the skin in patches
• other allergic reactions, such as difficulty breathing, swelling, or feeling slightly dizzy
• bone loss

Lab tests may also show:

• low white blood cell count (a reduced number of white blood cells can make you more prone to infections)
• increased triglycerides (fatty acids), bile, or sugar in the blood
• liver and pancreas problems

Uncommon Side Effects(may affect up to 1 in 100 people)

• abdominal pain (stomach) caused by pancreas inflammation
• swelling of the face, lips, tongue, or throat
• anemia (low red blood cell count)
• muscle rupture, muscle pain, or muscle weakness that can occur in case of damage to
• renal tubular cells

Lab tests may also show:

• decreased potassium levels in the blood
• increased creatinine in the blood
• changes in your urine

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

• lactic acidosis (see Possible Serious Side Effects)
• fatty liver
• yellowing of the skin or eyes, itching, or stomach pain caused by liver inflammation
• kidney inflammation, increased urine volume, and feeling of thirst, kidney failure, damage to renal tubular cells
• weakening of the bones (with bone pain and which sometimes ends in fractures)
• back pain due to kidney problems

Damage to renal tubular cells can be associated with muscle rupture, weakening of the bones (with bone pain and which sometimes ends in fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood.

→ If you notice any of the above side effects or if any of the side effects worsen,talk to your doctor or pharmacist.

The frequency of the following side effects is unknown.

• Bone problems. Some patients taking combined antiretroviral medications

like Emtricitabine/Tenofovir Disoproxil may develop a bone disease called osteonecrosis(death of bone tissue caused by loss of blood supply to the bone). Taking this type of medication for a long time, taking corticosteroids, consuming alcohol, having a very weakened immune system, and being overweight can be some of the many risk factors for developing this disease. Signs of osteonecrosis are:

• joint stiffness
• joint pain or discomfort (especially in the hip, knee, and shoulder)
• difficulty moving

→ If you notice any of these symptoms, talk to your doctor.

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 to HIV medications themselves. Your doctor will monitor these changes.

Other Side Effects in Children

• Children who receive emtricitabine often experience changes in skin color, including dark spots on the skin
• Children frequently have a low number of red blood cells (anemia), which can cause fatigue or shortness of breath

→ If you notice any of these symptoms, talk to your doctor.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Emtricitabine/Tenofovir Disoproxil

Keep this medication out of sight and reach of children.

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

Do not store above 30°C. Keep in the original packaging to protect it from moisture.

Validity period once the bottle is opened: 90 days

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Emtricitabine/Tenofovir Disoproxil

The active ingredients areemtricitabineand tenofovir disoproxil. Each film-coated tablet of Emtricitabine/Tenofovir Disoproxil contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).

The other ingredients arelactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate (E572), coating material [hypromellose (E464), lactose monohydrate, triacetin (E1518), titanium dioxide (E171), aluminum lake crimson lake (E132)]

Appearance of the Product and Package Contents

Emtricitabine/Tenofovir Disoproxil Macleods film-coated tablets are blue, capsule-shaped, biconvex, marked with "L 24" on one side and smooth on the other.

Emtricitabine/Tenofovir Disoproxil Macleods is available in bottles of 30 and 90 tablets. Each bottle contains a silica gel desiccant in a separate bag or container and should not be swallowed. The bottles are packaged in a box together with the leaflet.

The available package sizes are: 30 (1 bottle of 30) and 90 [(1 bottle of 90) or (3 bottles of 30)] film-coated tablets.

Emtricitabine/Tenofovir Disoproxil Macleods is also available in blister packaging:

Blister packaging – 30 and 90 film-coated tablets

Single-dose blister packaging – 30 and 90 film-coated tablets

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, España

Manufacturer

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, 62-020

Swarzedz, Polonia

O

HEUMANN PHARMA

GmbH & Co. Generica KG

Südwestpark 50, 90449

Nürnberg, Alemania

O

Pharmadox Healthcare Ltd.

KW20A, Kordin Industrial Park,

Paola , PLA3000

Malta

Date of the Last Revision of this Leaflet:September 2024

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