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

Introduction

Package Leaflet: Information for the User

Emtricitabine/Tenofovir Disoproxil Glenmark 200 mg/245 mg Film-Coated Tablets EFG

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 and other information

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

1. Contents of the pack and other information

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

Emtricitabine/Tenofovir Disoproxil Glenmark contains two active substances, emtricitabine and tenofovir disoproxil.

Both active substances are antiretroviral medicines used to treat HIV infection.

Emtricitabine is a nucleoside analogue reverse transcriptase inhibitor and 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 Disoproxil is used to treat HIV-1 infection in adults.

• It is also used to treat HIV-1 in adolescents from 12 to less than 18 years of age, weighing at least 35 kg, and 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 Emtricitabine/Tenofovir Disoproxil, you may still develop infections or other illnesses associated with HIV.

• Emtricitabine/Tenofovir Disoproxil is also used to reduce the risk of getting HIV-1 infection in adults and adolescents from 12 to less than 18 years of age, weighing at least 35 kg, when 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 Glenmark

Do not take Emtricitabine/Tenofovir Disoproxil to treat HIV or reduce the risk of getting HIV:if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil fumarate, or any of the other ingredients of this medicine (listed in section 6).

If this happens, call your doctor immediately.

Before taking Emtricitabine/Tenofovir Disoproxil to reduce the risk of getting HIV:

Emtricitabine/Tenofovir Disoproxil can only help reduce the risk of getting HIV beforeyou are infected.

• You must not be infected with HIV before you start taking Emtricitabine/Tenofovir Disoproxil to reduce the risk of getting 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 getting HIV unless you have been confirmed to be free of HIV infection. People with HIV should take Emtricitabine/Tenofovir Disoproxil in combination with other medicines.

• Many HIV tests can miss a recent infection.If you get a flu-like illness, it could mean that you have been recently 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 this medicine.

Warnings and precautions

When taking Emtricitabine/Tenofovir Disoproxil to reduce the risk of getting HIV:

• Take Emtricitabine/Tenofovir Disoproxil every day to reduce your risk, not just when you think you have been at risk of getting HIV.Do not miss any doses or stop taking it. Missed doses can increase your risk of getting HIV.

• You will need to have regular HIV tests.

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

• Using Emtricitabine/Tenofovir Disoproxil on its own may not prevent you from getting HIV.

• Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
• Do not share personal items that can contain blood or bodily fluids, such as toothbrushes or razor blades.
• Do not share or reuse needles or other injections or medicines.
• You should be tested for other sexually transmitted infections like syphilis or gonorrhea. These infections can increase your risk of getting HIV.

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

When taking Emtricitabine/Tenofovir Disoproxil to treat HIV or reduce the risk of getting 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 your blood tests show kidney problems, tell your doctor. Emtricitabine/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 medicine, or if you already have HIV, to take it less often. Emtricitabine/Tenofovir Disoproxil is not recommended if you have severe kidney disease or are on dialysis.

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

Bone problems (which show up as persistent or worsening bone pain and sometimes result 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 most pronounced bone loss was seen in clinical studies when patients received treatment for HIV with tenofovir disoproxil in combination with a boosted protease inhibitor.

Generally, 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 a history of liver disease, including hepatitis.Patients with HIV who also have liver disease (including chronic hepatitis B or C), treated with antiretrovirals, have a higher risk of serious and potentially life-threatening liver problems. If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.

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

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

• Consult your doctor if you are lactose intolerant(see Emtricitabine/Tenofovir Disoproxil Glenmark contains lactosebelow).

Children and adolescents

Emtricitabine/Tenofovir Disoproxil is not for use in 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 any of the ingredients of this medicine, or any other antiviral medicine that contains tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

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

Taking Emtricitabine/Tenofovir Disoproxil with 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, and sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Emtricitabine/Tenofovir Disoproxil with other medicines that contain didanosine (for HIV treatment):Taking Emtricitabine/Tenofovir Disoproxil with other antiviral medicines that contain didanosine can increase the levels of didanosine in your blood and may reduce your 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 Disoproxil with food and drinks

• When possible, take it 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 been taking Emtricitabine/Tenofovir Disoproxil during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV outweighed the risk of side effects.

• Do not breastfeed your child while taking Emtricitabine/Tenofovir Disoproxil.This is because the active ingredients of this medicine pass into breast milk.
• Women with HIV should not breastfeed their babies because HIV can be passed to the baby through breast milk.
• If you are breastfeeding or thinking of breastfeeding, talk to your doctor as soon as possible.

Driving and using machines

The combination of emtricitabine and tenofovir disoproxil may cause dizziness. If you feel dizzy, do not driveor operate tools or machines.

Emtricitabine/Tenofovir Disoproxil Glenmark 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 Glenmark contains phosphate

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

Emtricitabine/Tenofovir Disoproxil Glenmark contains sodium

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

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

3. How to Take Emtricitabine/Tenofovir Disoproxil Glenmark

• Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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

• Adults: one tablet a day. When possible, emtricitabine/tenofovir disoproxil should be taken with food.
• Adolescents from 12 to less than 18 years of age with a weight of at least 35 kg: one tablet a 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 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 package inserts of the other antiretrovirals to learn how to take those medications.

• If you are taking emtricitabine/tenofovir disoproxil to reduce the risk of getting HIV, take the medication every day, not just when you think you have been at risk of getting HIV infection.

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

If you take more Emtricitabine/Tenofovir Disoproxil Glenmark than you should

If you accidentally take 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 miss a dose

It is essential that you do not miss a dose of this medication.

• 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 more than 12 hours 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 within 1 hour after taking emtricitabine/tenofovir disoproxil, take another tablet. You do not need to take another tablet if you vomited more than one 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, stopping 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 getting HIV, do not stop taking emtricitabine/tenofovir disoproxil or miss any doses. Stopping treatment with emtricitabine/tenofovir disoproxil, or missing doses, may increase the risk of getting 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 stop your treatment with emtricitabine/tenofovir disoproxil without first talking to your doctor. You may need to have blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment as this may cause worsening of hepatitis, which can be potentially fatal.

Consult your doctor immediately about new or unusual symptoms after stopping your treatment, particularly symptoms that you associate with hepatitis B virus infection.

If you have any other questions about using 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 side effects 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, allowing the body to fight infections that may be present without any apparent symptoms.

• Autoimmune disorders may also appear when the immune system attacks healthy body tissueafter 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:

• decrease in phosphate levels in the blood.
• increase in 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)
• increase in 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 (belly) caused by pancreas inflammation
• swelling of the face, lips, tongue, or throat

• anemia (low red blood cell count)
• muscle breakdown, muscle pain, or muscle weakness that can occur in case of damage to the renal tubule cells

Lab tests may also show:

• decrease in potassium levels in the blood
• increase in creatinine in the blood
• changes in 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 and eyes, itching, or abdominal pain (belly) caused by liver inflammation
• kidney inflammation, increased urine volume, and feeling of thirst, kidney failure, damage to the renal tubule cells
• bone weakening (with bone pain and which can sometimes lead to fractures)

• back pain due to kidney problems

The damage to the renal tubule cells can be associated with muscle breakdown, bone weakening (with bone pain and which can sometimes lead to fractures), muscle pain, muscle weakness, and decreased levels of potassium or phosphate 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 red blood cell count (anemia)
• • This can cause fatigue or shortness of breath

• If you notice any of these symptoms, inform 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 package insert. 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 Glenmark

Keep this medication out of sight and reach of children.

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

Store below 25°C.

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. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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 ingredients are microcrystalline cellulose (E460), mannitol (E421), croscarmellose sodium, colloidal anhydrous silica, stearic acid (E570), lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), and aluminum lake carmine indigo (E132).

Appearance of the Product and Package Contents

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

Emtricitabine/Tenofovir Disoproxil Glenmark is available in white plastic bottles.

Each bottle contains one (in a package of 20) or three (in a package of 90) silica gel desiccant sachets, depending on the format. The sachets 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 packages of 30) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

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

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

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

Spain:Emtricitabina/Tenofovir disoproxilo 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

Date of the last revision of this package insert:January 2025.

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/).