Label:information for the user

Emtricitabina/Tenofovir disoproxiloMacleods 200 mg/245 mgfilm-coated tablets EFG

Emtricitabina/Tenofovir disoproxilo

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

• Keep this label, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.
• This medicine has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist,evenif they are not listed in this label. See section 4.

1.What is Emtricitabina/Tenofovir disoproxiloand for what it is used

2.What you need to knowbeforestarting totake Emtricitabina/Tenofovir disoproxilo

3.How to take Emtricitabina/Tenofovir disoproxilo

4.Possible side effects

5Storage of Emtricitabina/Tenofovir disoproxilo

6.Contents of the package and additional information

Emtricitabina/Tenofovir disoproxilocontains two active principles,emtricitabinaandtenofovir disoproxilo.Both active principles are antiretroviral drugsthat are used to treat HIV infection.Emtricitabina is anucleoside reverse transcriptase inhibitor analogueand tenofovir is anucleotide reverse transcriptase inhibitor analogue.They are generally known as ITIANs and act by interfering with the normal work of an enzyme (reverse transcriptase) that is essential for the virus to reproduce.

• Emtricitabina/Tenofovir disoproxilois used to treat Human Immunodeficiency Virus type 1 (HIV-1) infection in adults.
• It is also used to treat HIV in adolescents aged 12 to less than 18 years with a weight of at least 35 kgwho have already been treated with other HIV medications that are no longer effective or have caused adverse effects.

• Emtricitabina/Tenofovir disoproxilo should always be used in combination with other medications to treat HIV infection.

• Emtricitabina/Tenofovir disoproxilocan be administered in place of emtricitabina and tenofovir disoproxilo used separately at the same doses.

This medication is not a cure for HIV infection. While you are takingthis medicationyou may still experience infections or other diseases associated with HIV infection.

• This medication is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 to less than 18 years with a weight of at least 35 kgwhen taken daily, in combination with safer sex practices:

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

Do not takeEmtricitabina/Tenofovir disoproxilto treat HIV or reduce the risk of contracting HIV:if you are allergicto emtricitabine, tenofovir, tenofovir disoproxil, or to any of the other components of this medication (listed in section 6).

→If this happens, call your doctor immediately.

Before taking Emtricitabina/Tenofovir disoproxil to reduce the risk of contracting HIV:

Emtricitabina/Tenofovir disoproxil can only help reduce the risk of contracting HIVbeforeyou are infected.

• You must not be infected with HIV before starting to take Emtricitabina/Tenofovir disoproxil to reduce the risk of contracting HIV.You must have a test to ensure that you are not infected with HIV. Do not take this medication unless you have been confirmed not to be infected with HIV. People with HIV must take this medication in combination with other medications.

• Many HIV tests may not detect a recent infection.If you contract a similar illness to the flu, it could mean that you have recently become infected with HIV.

These may be signs of HIV infection:

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

→Inform your doctor about any illness similar to the flu, either in the month before starting treatment with Emtricitabina/Tenofovir disoproxil or at any time while taking Emtricitabina/Tenofovir disoproxil.

Warnings and precautions

When taking Emtricitabina/Tenofovir disoproxil to reduce the risk of contracting HIV:

• Take this medication every dayto reduce your risk, not just when you think you have been at risk of contracting HIV infection.Do not forget any doses of this medication or stop taking it. Missed doses can increase the risk of HIV infection.

• You must have regular HIV detection tests.

• If you think you have become infected with HIV, consult your doctor immediately. Your doctor may want to do more tests to ensure that you are still not infected with HIV.

• Using Emtricitabina/Tenofovir disoproxil alone may not prevent you from contracting HIV.
• • Always practice safe 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 and razors.
  • Do not share or reuse needles or other injections or medications.
  • You must have tests for other sexually transmitted infections such as syphilis or gonorrhea. These infections make it easier for you to contract HIV.

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

When taking Emtricitabina/Tenofovir disoproxil to treat HIV or reduce the risk of contracting HIV:

• Emtricitabina/Tenofovir disoproxil may affect your kidneys.Your doctor may ask you to have blood tests to measure your kidney function before and during treatment. If you have had kidney disease, or if the tests have shown kidney problems, tell your doctor. This medication should not be given to adolescents with existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking this medication or, if you already have HIV, take this medication less frequently. This medication is not recommended if you have a serious kidney disease or are on dialysis.

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

Bone problems

For adult patients:

Bone problems (which manifest as persistent bone pain or worsening and sometimes ending in fractures) may occur due to damage to renal tubular cells (see section 4, Possible side 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 for HIV with tenofovir disoproxil in combination with a protease inhibitor.

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

For pediatric patients/adolescents:

Bone problems (which manifest as persistent bone pain or worsening and sometimes ending in fractures) due to damage to renal tubular cells (see section 4, Possible side effects).Inform your child's doctor if they 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 for HIV with tenofovir disoproxil in combination with a protease inhibitor.

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

Inform your child's doctor if they have osteoporosis. Patients with osteoporosis have a higher risk of fractures.

• Talk to your doctor if you have a history of liver disease, including hepatitis.Patients infected with HIV, who also have 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 or C, your doctor will carefully consider the best treatment regimen for you.

• Know your hepatitis B virus (HBV) statusbefore starting to takeEmtricitabina/Tenofovir disoproxil. If you have HBV, there is a serious risk of liver problems when you stop taking this medication, regardless of whether you also have HIV. It is essential not to stop taking this medication without consulting your doctor: see section 3, Do not stop taking Emtricitabina/Tenofovir disoproxil.

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

• Consult your doctor if you are lactose intolerant(see Emtricitabina/Tenofovir disoproxil contains lactose later in this section).

Children and adolescents

Emtricitabina/Tenofovir disoproxil should not be administered to children under 12 years old.

Other medications and Emtricitabina/Tenofovir disoproxil

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

Taking Emtricitabina/Tenofovir disoproxil with other medications that may damage your kidneys:it is especially important to tell your doctor if you are taking any of these medications. This includes:

• 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)
• nonsteroidal anti-inflammatory drugs (NSAIDs, for relieving bone or muscle pain)

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

Also, inform your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Emtricitabina/Tenofovir disoproxil with other medications that contain didanosine (for HIV treatment):

Taking this medicationwith other antiviral medications that contain didanosine may increase didanosine levels in your blood and may reduce CD4 cell count. When taken together, medications containing tenofovir disoproxil 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.

→Inform your doctorif you are taking any of these medications. Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Taking Emtricitabina/Tenofovir disoproxil with food and drinks

• When possible, Emtricitabina/Tenofovir disoproxil should be taken with food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you have takenthis medicationduring your pregnancy, your doctor may ask you to have periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took ITIANs during pregnancy, the benefit of HIV protection outweighed the risk of side effects.

For adult patients:

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

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

• If you are breastfeeding or plan to breastfeed, you mustconsult your doctor as soon as possible.

For pediatric patients/adolescents:

• If the girl has HBV and her baby is receiving treatment to prevent HBV transmission at birth, it may be possible for the girl to breastfeed her infant, but first talk to the girl's doctor for more information.

• If the girl has HIV, she should not breastfeed to avoid passing the virus to the child through breast milk.

Driving and using machines

Emtricitabina/Tenofovir disoproxil may cause dizziness. If you experience dizziness during treatment with this medication,do not driveor operate tools or machines.

Emtricitabina/Tenofovir disoproxil contains lactose

If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medication.

Emtricitabina/Tenofovir disoproxil contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor.

Consult your doctor or pharmacist again if you are unsure.In case of doubt, consult your doctor or pharmacist again.

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

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

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

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

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

• Adolescents aged 12 to less than 18 years with a weight of at least 35 kg:one tablet per 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 or grapefruit 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 receiving treatment for HIV infection,your doctor will prescribe Emtricitabine/Tenofovir disoproxil with other antiretroviral medications. Consult the prospectuses of the other antiretrovirals to know how to take these medications.

• If you are takingEmtricitabine/Tenofovir disoproxilto reduce the risk of contracting HIV,take Emtricitabine/Tenofovir disoproxilevery 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 the transmission of HIV or prevent its transmission to other people.

If you take moreEmtricitabine/Tenofovir disoproxilthan you should

If you accidentally took more than the recommended dose of Emtricitabine/Tenofovir disoproxil, consult your doctor or go to the nearest emergency service. Bring the tablet container 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 takeEmtricitabine/Tenofovir disoproxil

It is essential not to forget a dose of Emtricitabine/Tenofovir disoproxil.

• If you realize within 12 hoursfrom the time you normally 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 more than 12 hourshave passed since the time you normally 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 within 1 hour after takingEmtricitabine/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 withEmtricitabine/Tenofovir disoproxil

• If you are takingEmtricitabine/Tenofovir disoproxilfor HIV treatment,suspending treatment may reduce the effectiveness of the recommended HIV therapy prescribed by your doctor.

• If you are takingEmtricitabine/Tenofovir disoproxilto reduce the risk of contracting HIV,do not stop taking this medication or miss any doses. Stopping treatment with this medication or missing doses may increase the risk of 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 a worsening of your hepatitis, which may be potentially fatal.

Talk to your doctor immediatelyabout new or unusual symptoms after suspending treatment, particularly symptoms associated with hepatitis B infection.

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

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

Possible severe 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, vomitings
  • abdominal 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 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, allowing the body to fight off infections that may be present without apparent symptoms.

• They may also appearautoimmune disorders,when the immune system attacks healthy body tissue, after starting to take medications to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms such as:
• • muscle weakness
  • weakness starting in the hands and feet and ascending to the body trunk
  • 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
• skin rash
• feeling weak

Lab tests may also show:

• decreased phosphate levels in the blood
• increased creatine kinase

Common side effects(may affect up to 1 in 10 people)

• pain, abdominal pain
• difficulty sleeping, abnormal dreams
• digestive problems with discomfort after meals, feeling bloated (gas), flatulence
• skin eruptions (including red patches or spots sometimes with blisters and swelling of the skin), which may 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 white blood cell count may make you more prone to infections)
• increased triglycerides (fats), bile, or sugar in the blood
• problems with the liver and pancreas

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

• lactic acidosis(see Possible severe side effects)
• fatty liver
• yellowing of the skin or eyes, itching, or abdominal pain (caused by liver inflammation
• kidney inflammation, increased urine volume, and feeling thirsty, kidney failure, damage to the renal tubular cells
• bone weakening (with bone pain and sometimes leading to fractures)
• back pain due to kidney problems

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

→If you notice any of the previously mentioned 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

such as Emtricitabina/Tenofovir disoproxilomay develop a bone disease calledosteonecrosis(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 may 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 blood glucose and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Other side effects in children

• Children receiving emtricitabina often experience skin discoloration, including dark patches on the skin
• Children often have a low red blood cell count (anemia), which may cause fatigue or shortness of breath

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Shelf life once the bottle is opened: 90 days

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofEmtricitabina/Tenofovir disoproxilo

The active principles areemtricitabinaandtenofovir disoproxilo. Each film-coated tablet of Emtricitabina/Tenofovir disoproxilo contains 200 mg of emtricitabina and 245 mg of tenofovir disoproxilo (equivalent to 300 mg of tenofovir disoproxil fumarate or to 136 mg of tenofovir).

The other components arelactose monohydrate, microcrystalline cellulose (E460), pregelatinized cornstarch, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate (E572), coating material [hypromellose (E464), lactose monohydrate, triacetin (E1518), titanium dioxide (E171), indigo carmine lake (E132)]

Appearance of the product and contents of the package

The film-coated tablets of Emtricitabina/Tenofovir disoproxilo Macleods areblue, capsule-shaped, biconvex, marked on one face with “L 24” and smooth on the other.

Emtricitabina/Tenofovir disoproxilo Macleods is available in bottles of 30 and 90 tablets. Each bottle contains a silica gel desiccant in a separate sachet or container and should not be taken. The bottles are packaged in a carton together with the leaflet.

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

Emtricitabina/Tenofovir disoproxilo Macleods is also available in blister packaging:

Blister packaging – 30 and 90 film-coated tablets

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

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer responsible

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, 62-020

Swarzedz, Poland

O

HEUMANN PHARMA

GmbH & Co.Generica KG

Südwestpark 50, 90449

Nürnberg,Germany

O

Pharmadox Healthcare Ltd.

KW20A, Kordin Industrial Park,

Paola , PLA3000

Malta

Last review date of thisleaflet:September 2024

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