Package Leaflet: Information for the User

Emtricitabina/Tenofovir disoproxilo Glenmark 200 mg/245 mg Film-Coated Tablets EFG

Read 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 questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1.What Emtricitabina/Tenofovir disoproxilo Glenmark is and what it is used for

2.What you need to know before you start taking Emtricitabina/Tenofovir disoproxilo Glenmark

3.How to take Emtricitabina/Tenofovir disoproxilo Glenmark

4.Possible side effects

1. Storage of Emtricitabina/Tenofovir disoproxilo Glenmark

6.Contents of the pack and additional information

Emtricitabina/Tenofovir disoproxilo Glenmark contains two active principles, emtricitabina and tenofovir disoproxilo.Emtricitabina and tenofovir disoproxilo are both antiretroviral drugs

Both active principles are used to treat HIV infection.

Emtricitabina is aninhibitor of reverse transcriptase analog of nucleosideand tenofovir is aninhibitor of reverse transcriptase analog of nucleotide.

They are commonly known as ITIAN and act by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce.

• Emtricitabina/tenofovir disoproxilo is used to treat type I Human Immunodeficiency Virus (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 disoproxilo can 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 taking emtricitabina/tenofovir disoproxilo, you will still be able to contract infections or other diseases associated with HIV infection.

• Emtricitabina/tenofovir disoproxilo is also used to reduce the risk of contracting 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 take emtricitabina/tenofovir disoproxil to treat HIV or reduce the risk of getting HIV:if you are allergic to emtricitabina, tenofovir, tenofovir disoproxil fosfate, or any of the other components of this medication (listed in section 6).

?Call your doctor immediately if this happens.

Before taking emtricitabina/tenofovir disoproxil to reduce the risk of getting HIV:

Emtricitabina/tenofovir disoproxil can only help reduce the risk of getting HIVbeforeyou are infected.

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

• Many HIV tests may not detect a recent infection. If you get 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 flu-like illness, either in the month before starting treatment with emtricitabina/tenofovir disoproxil or at any time while taking this medication.

Warnings and precautions

When taking emtricitabina/tenofovir disoproxil to reduce the risk of getting HIV:

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

• You should have regular HIV detection tests.

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

• Using emtricitabina/tenofovir disoproxil alone may not prevent you from getting 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 should have regular tests for other sexually transmitted infections such as syphilis or gonorrhea. These infections make it easier for you to get HIV.

Consult your doctor if you have more questions about preventing HIV transmission or transmission to others.

When taking emtricitabina/tenofovir disoproxil to treat HIV or reduce the risk of getting 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. Emtricitabina/tenofovir disoproxil 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. If you have HIV, you should take it less frequently. Emtricitabina/tenofovir disoproxil is not recommended if you have severe kidney disease or are on dialysis.

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

You may also experiencebone problems(which manifest as persistent or worsening bone pain and sometimes leading to fractures) due to damage to renal tubular cells (see section 4, Possible side effects).

Tenofovir disoproxil can also cause bone loss. The most pronounced bone loss was observed in clinical studies when patients received HIV treatment 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.

• 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 this medication. If you have HBV, there is a serious risk of liver problems when you stop taking emtricitabina/tenofovir disoproxil, 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 interrupt treatment with Emtricitabina/Tenofovir disoproxil Glenmark.

• If you are over 65 years old, tell your doctor.The combination of emtricitabina and tenofovir disoproxil has not been studied in patients over 65 years old.

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

Children and adolescents

Emtricitabina/tenofovir disoproxil is not for use in 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 this medication, or any other antiviral medication that contains tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking emtricitabina/tenofovir disoproxil with other medications that can damage your kidneys:It is especially important to tell your doctor if you are taking any of these medications. Includes:

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 renal function.

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

Taking emtricitabina/tenofovir disoproxil with other medications that contain didanosine (for HIV treatment):When taking emtricitabina/tenofovir disoproxil with other antiviral medications that contain didanosine, the levels of didanosine in your blood may increase and reduce CD4 cell count. Rarely, taking these medications together has been associated with pancreatitis and lactic acidosis (excess lactic acid in the blood) in some cases. 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 need to take any other medication.

Taking emtricitabina/tenofovir disoproxil with food and drinks

• When possible, take it 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 been taking emtricitabina/tenofovir disoproxil during your pregnancy, your doctor may ask you to have periodic blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took ITIANs during pregnancy, the benefit of HIV protection outweighed the risk of side effects.

• Do not breastfeed your child during treatment with emtricitabina/tenofovir disoproxil. This is because the active ingredients in this medication pass into breast milk.
• Do not recommend breastfeeding to women with HIV because the infection can be transmitted to the baby through breast milk.
• Consult your doctor as soon as possible if you are breastfeeding or plan to breastfeed.

Driving and using machines

The combination of emtricitabina and tenofovir disoproxil can cause dizziness. If you experience dizziness during treatment with this medication,do not driveor operate tools or machines.

Emtricitabina/Tenofovir disoproxil Glenmark 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 Glenmark contains phosphate

Consult your doctor if you are following a low-phosphate diet. Each tablet contains 46 mg of phosphate.

Emtricitabina/Tenofovir disoproxil Glenmark contains sodium

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

Consult your doctor if you are lactose intolerant or intolerant to other sugars.

• Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of emtricitabina/tenofovir disoproxil for treating HIV or reducing the risk of contracting HIV is:

• Adults: one tablet per day.When possible, emtricitabina/tenofovir disoproxil should be taken with food.
• Adolescents aged 12 to less than 18 years with a weight of at least 35 kg: one tablet per day, when possible 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 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.

• If you are receiving treatment for HIV infection,your doctor will prescribe emtricitabina/tenofovir disoproxil with other antiretroviral medications. Consult the prospectuses of the other antiretrovirals to know how to take these medications.

• If you are taking emtricitabina/tenofovir disoproxil to reduce the risk of contracting HIV,take the medication 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 the transmission of HIV or prevent its transmission to other people.

If you take more Emtricitabina/Tenofovir disoproxil Glenmark than you should

If you accidentally take more than the recommended dose of emtricitabina/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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget a dose

It is essential not to forget a dose of this medication.

• If you realize within 12 hoursfrom the time you normally take emtricitabina/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 hours have passedsince the time you normally take emtricitabina/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 of taking emtricitabina/tenofovir disoproxil, take another tablet. You do not need to take another tablet if you vomited more than an hour after taking emtricitabina/tenofovir disoproxil.

Do not interrupt treatment with emtricitabina/tenofovir disoproxil

• If you are taking emtricitabina/tenofovir disoproxil for HIV treatment,suspending treatment may reduce the effectiveness of the recommended HIV therapy by your doctor.

• If you are taking emtricitabina/tenofovir disoproxil to reduce the risk of contracting HIV,do not stop taking emtricitabina/tenofovir disoproxil or miss any doses. Stopping treatment with emtricitabina/tenofovir disoproxil or missing doses may increase the risk of contracting HIV infection.

?Do not interrupt treatment with emtricitabina/tenofovir disoproxil without consulting your doctor.

If you have hepatitis B,it is especially important not to suspend your treatment with emtricitabina/tenofovir disoproxil without first talking to your doctor. You mayneed 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 can be potentially fatal.

?Consult your doctor immediately about new or unusual symptoms aftersuspending treatment, particularly symptoms associated with hepatitis B virus infection.

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

Like all medicines, this medicine 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 side effects may be signs of lactic acidosis:

• deep and rapid breathing
• drowsiness
• nausea, vomiting
• abdominal pain

?If you think you may be experiencing 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 the body's improved immune response, which allows 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 medicines 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

Frequent side effects

(may affect more than 1 in 10 people)

• diarrhea, vomiting, nausea,
• vertigo, headache,
• eruption.
• feeling of weakness

Tests may also show:

• decreased phosphate levels in the blood.
• increased creatine kinase

Common side effects

(may affect up to 1 in 10 people)

• dizziness, abdominal pain
• difficulty sleeping, abnormal dreams
• digestive problems with discomfort after meals, feeling bloated (gas), flatulence
• 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

Tests may also show:

• blood white cell count decreased (a reduced white 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 100 people):

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

• anemia (low red blood cell count)
• muscle rupture, muscle pain, or muscle weakness that may occur in cases of kidney tubule cell damage

Tests may also show:

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

Uncommon side effects

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

• acidosis lactic (seePossible serious side effects)
• steatosis (fatty liver)
• yellowing of the skin or eyes, itching, or abdominal pain (stomach) caused by liver inflammation
• kidney inflammation, increased urine volume, and feeling thirsty, renal failure, kidney tubule cell damage
• bone weakening (with bone pain and sometimes leading to fractures)

• back pain due to kidney problems

Kidney tubule cell damage may be associated with muscle rupture, bone weakening (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood.

??If you notice any of these side effects or if any of the side effects worsen, speak with your doctor or pharmacist.

The frequency of the following side effects is unknown.

• Bone problems. Some patients taking combined antiretroviral medications such as Emtricitabine/Tenofovir disoproxil may develop a bone disease called osteonecrosis (bone tissue death 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, speak with your doctor.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Other side effects in children

• Children receiving emtricitabine often experience frequent changes in skin color, including:
• Dark skin patches
• Children frequently present with a low number of red blood cells (anemia)
• This may cause fatigue or shortness of breath

• If you notice any of these symptoms, inform your doctor.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directlythrough the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

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

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Emtricitabine/Tenofovir disoproxil Glenmark

• The active ingredients are emtricitabine and tenofovir disoproxil (as phosphate).

Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir).

• The other components are microcrystalline cellulose (E460), mannitol (E421), sodium croscarmellose, anhydrous colloidal silica, stearic acid E570), lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), andlaca of aluminium carmine(E132).

Appearance of the product and contents of the package

Blue, oval, biconvex, smooth on both faces, 18.6 mm x 9.5 mm film-coated tablets.

Emtricitabine/Tenofovir disoproxil Glenmark is presented in white plastic bottles.

Each bottle contains one (in a pack of 20) or three (in a pack of 90) silica gel desiccant bags depending on the format. The bags should be kept in the bottle to protect the tablets and should not be swallowed.

The following formats are available:

• 30 film-coated tablets
• 90 (3 packs of 30) film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer

Glenmark Pharmaceuticals s.r.o.

Fibichova 143 566 17

Vysoké Mýto

Czech Republic

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate, Paola,

PLA 3000, Malta

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Panta

28045 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Denmark:Emtricitabine/Tenofovir disoproxil Glenmark 200 mg/245 mg film-coated tablets

Spain:Emtricitabine/Tenofovir disoproxil Glenmark 200 mg/245 mg film-coated tablets EFG

Netherlands:Emtricitabine/Tenofovir disoproxil Glenmark 200 mg/245 mg film-coated tablets

Sweden:Emtricitabine/Tenofovir disoproxil Glenmark 200 mg/245 mg film-coated tablets

Last review date of this leaflet:January 2025.

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