Emtricitabine/tenofovir disoproxil Glenmark 200 mg/245 mg film-coated tablets EFG

Package leaflet: Information for the user

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, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

3. How to take Emtricitabine/Tenofovir disoproxil Glenmark

4. Possible side effects

   1. How to store Emtricitabine/Tenofovir disoproxil Glenmark

5. Contents of the pack and other information

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

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

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

Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor.

They are generally known as NRTIs and work by interfering with the normal function of an enzyme (reverse transcriptase) that is essential for the virus to replicate.

• Emtricitabine/tenofovir disoproxil is 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 weighing at least 35 kg who have previously been treated with other HIV medicines that are no longer effective or have caused adverse effects.

  • Emtricitabine/tenofovir disoproxil must always be used in combination with other medicines for the treatment of HIV infection.
  • Emtricitabine/tenofovir disoproxil may be administered instead of emtricitabine and tenofovir disoproxil given 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 infection.

• Emtricitabine/tenofovir disoproxil is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 to less than 18 years weighing at least 35 kg when taken daily in combination with safer sexual practices.

See section 2 for a list of precautions to consider regarding HIV infection.

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

Do not take emtricitabine/tenofovir disoproxil to treat HIV or to reduce the risk of getting HIV:

• if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil fumarate, or any of the other components of this medicine (listed in section 6).

?If any of this applies to you, 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 before you are infected.

• You must not be infected with HIV before starting emtricitabine/tenofovir disoproxil to reduce the risk of getting HIV. You must be tested to ensure you are not infected with HIV. Do not take this medicine to reduce the risk unless it has been confirmed that you are not infected with HIV. People who have HIV must take emtricitabine/tenofovir disoproxil in combination with other medicines.

• Many HIV tests may not detect a recent infection. If you develop a flu-like illness, it could mean you have recently become infected with HIV.

These may 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, whether occurring in the month before starting treatment with 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 only when you think you may have been exposed to HIV infection. Do not miss any doses or stop taking it. Missed doses may increase the risk of acquiring HIV infection.

• You must have regular HIV testing.

• If you think you may have become infected with HIV, consult your doctor immediately. Additional tests may be needed to confirm you remain uninfected with HIV.

• Taking emtricitabine/tenofovir disoproxil alone 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 may contain blood or body fluids, such as toothbrushes and razors.

• Do not share or reuse needles or other injection equipment or medications.

• You should be tested regularly for other sexually transmitted infections such as syphilis or gonorrhea. These infections can make it easier for you to acquire HIV.

Talk to your doctor if you have further questions about preventing HIV infection or transmission to others.

When taking emtricitabine/tenofovir disoproxil to treat HIV or to reduce the risk of getting HIV:

• Emtricitabine/Tenofovir disoproxil may affect your kidneys. Before and during treatment, your doctor may request blood tests to monitor your kidney function. If you have had kidney disease or if blood tests have shown 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. If you already have HIV, your doctor may recommend a less frequent dosing schedule. Emtricitabine/tenofovir disoproxil is not recommended if you have severe kidney disease or are on dialysis.

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

Bone problems (manifested as persistent or worsening bone pain and sometimes leading to fractures) may also occur due to damage to renal tubule cells (see section 4, Possible side effects). Inform your doctor if you experience bone pain or fractures.

Tenofovir disoproxil may also cause loss of bone mineral density. The greatest bone loss was observed in clinical studies when patients received tenofovir disoproxil in combination with a boosted protease inhibitor for HIV treatment.

In general, the long-term effects of tenofovir disoproxil on bone health and the future risk of fractures in adult and pediatric patients are uncertain.

• Talk to your doctor if you have a history of liver disease, including hepatitis. HIV-infected patients who also have liver disease (including chronic hepatitis B or C) and are treated with antiretrovirals have an increased risk of serious 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) status before starting this medicine. 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 consulting your doctor: see section 3, Do not interrupt treatment with Emtricitabina/Tenofovir disoproxilo Glenmark.

• If you are over 65 years old, 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 Emtricitabina/Tenofovir disoproxilo Glenmark contains lactose later in this section).

Children and adolescents

Emtricitabine/tenofovir disoproxil is not intended for use in children under 12 years of age.

Other medicines and emtricitabine/tenofovir disoproxil

Do not take emtricitabine/tenofovir disoproxil if you are already taking other medicines that contain the components of this medicine, or any other antiviral medicine containing tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

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

Taking emtricitabine/tenofovir disoproxil with other medicines that may harm your kidneys: It is especially important that you tell your doctor if you are taking any of the following medicines:

• 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 relief of bone or muscle pain)

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

It is also important to inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir for the treatment of hepatitis C virus infection.

Taking emtricitabine/tenofovir disoproxil with other medicines containing didanosine (for treatment of HIV infection): Taking emtricitabine/tenofovir disoproxil with other antiviral medicines containing didanosine may increase levels of didanosine in your blood and may reduce CD4 cell count. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal, have been reported when tenofovir disoproxil and didanosine are taken together. Your doctor will carefully consider whether to treat you with a combination of tenofovir and didanosine.

? Tell your doctor if you are taking any of these medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Taking emtricitabine/tenofovir disoproxil with food and drinks

• This medicine should be taken with food whenever possible.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If you have taken emtricitabine/tenofovir disoproxil during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV outweighed the risk of side effects.

• Do not breastfeed while taking emtricitabine/tenofovir disoproxil. This is because the active substances in this medicine pass into breast milk.
• Women living with HIV are not recommended to breastfeed because HIV infection can be transmitted to the baby through breast milk.
• If you are breastfeeding or planning to breastfeed, you should consult your doctor as soon as possible.

Driving and using machines

The combination of emtricitabine and tenofovir disoproxil may cause dizziness. If you experience dizziness during treatment with this medicine, do not drive and do not operate tools or machinery.

Emtricitabina/Tenofovir disoproxilo Glenmark contains lactose

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

Emtricitabina/Tenofovir disoproxilo Glenmark contains phosphate

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

Emtricitabina/Tenofovir disoproxilo 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 exactly your doctor's instructions on how to take this medicine. If in doubt, consult your doctor or pharmacist again.

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

• Adults: one tablet daily. Emtricitabine/tenofovir disoproxil should be taken with food whenever possible.
• Adolescents aged 12 to under 18 years weighing at least 35 kg: one tablet daily, preferably taken with food.

If you have difficulty swallowing, you may 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 dose prescribed by your doctor. This is to ensure that your medicine is fully effective and to reduce the risk of developing treatment resistance. 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 together with other antiretroviral medicines. Please refer to the package leaflets of the other antiretrovirals for instructions on how to take them.

• If you are taking emtricitabine/tenofovir disoproxil to reduce the risk of acquiring HIV, take the medicine every day, not only when you believe you may have been exposed to HIV infection.

Consult your doctor if you have any questions about how to prevent HIV infection or prevent 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, contact your doctor or go to the nearest emergency department. Take the tablet bottle with you so you can clearly describe what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget a dose

It is important not to miss a dose of this medicine.

• If you remember within 12 hours of your usual time for taking emtricitabine/tenofovir disoproxil, take the tablet as soon as possible, preferably with food, and then take your next dose at the usual time.

• If 12 hours or more have passed since your usual dosing time, do not take the missed dose. Wait and take the next dose at your usual time, preferably with food.

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 stop treatment with emtricitabine/tenofovir disoproxil

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

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

?Do not stop treatment with emtricitabine/tenofovir disoproxil without consulting your doctor.

If you have hepatitis B, it is especially important not to stop 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, stopping treatment is not recommended, as this may lead to worsening of hepatitis, which could potentially be fatal.

?Contact your doctor immediately if you experience any new or unusual symptoms after stopping treatment, particularly symptoms you associate with hepatitis B virus infection.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Possible serious adverse effects:

• Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening adverse effect. Lactic acidosis occurs more frequently in women, especially those who are overweight, and in people with liver disease. The following adverse effects may be signs of lactic acidosis:

• deep, 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 occurring in people with weakened immune systems), signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, allowing the body to fight infections that may have been present without any apparent symptoms.

• Autoimmune disorders may also occur when the immune system attacks healthy body tissue, after starting medications to treat HIV infection. Autoimmune disorders may occur many months after starting treatment. Watch for any symptoms of infection or other symptoms such as:

• muscle weakness

• weakness starting in the hands and feet and moving upward toward the trunk

• palpitations, tremor, or hyperactivity

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

Possible adverse effects

Very common adverse effects

(may affect more than 1 in 10 people)

• diarrhea, vomiting, feeling sick (nausea)
• dizziness, headache
• rash
• feeling weak

Blood tests may also show:

• decreased phosphate levels in blood
• elevated creatine kinase

Common adverse effects

(may affect up to 1 in 10 people)

• pain, stomach ache
• difficulty sleeping, abnormal dreams
• digestive problems with discomfort after meals, bloating (gas), flatulence
• rashes (including red spots or pimples, sometimes with blisters and skin swelling), 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
• Loss of bone mass

Blood tests may also show:

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

Uncommon adverse effects

(may affect up to 1 in 100 people)

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

Blood tests may also show:

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

Rare adverse effects

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

• lactic acidosis (see Possible serious adverse effects above)

• fatty liver

• yellowing of the skin or eyes, itching, or abdominal (stomach) pain caused by liver inflammation

• kidney inflammation, increased urine volume and sensation of thirst, kidney failure, damage to renal tubule cells

• weakening of the bones (with bone pain and sometimes leading to fractures)

• back pain due to kidney problems

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

??If you notice any of the adverse effects listed above or if any of the adverse effects worsen, speak with your doctor or pharmacist.

The frequency of the following adverse effects is unknown.

• Bone problems. Some patients taking combined antiretroviral medicines such as Emtricitabine/Tenofovir disoproxil may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Long-term use of these types of medicines, corticosteroid use, alcohol consumption, having a very weak immune system, and being overweight may be some of the many risk factors for developing this condition. Signs of osteonecrosis include:
• joint stiffness
• joint discomfort or pain (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 in blood glucose and lipid levels. This may be partly related to improved health, lifestyle factors, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Other adverse effects in children

• Children receiving emtricitabine very commonly experience changes in skin pigmentation, including:

  • Dark spots on the skin

• Children frequently develop a low number of red blood cells (anemia)

  • This may cause fatigue or dyspnea

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Emtricitabine/Tenofovir Disoproxil Glenmark

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

Do not use this medicine after the expiry date which is stated on the bottle and the outer carton after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly discard medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Emtricitabine/Tenofovir disoproxil Glenmark

• The active substances 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, colloidal anhydrous silica, stearic acid (E570), lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518) and indigo carmine aluminium lake (E132).

Description of the product and contents of the pack

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

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

Each bottle contains one (in the 20-tablet pack) or three (in the 90-tablet pack) silica gel desiccant sachets, depending on the pack size. The sachets must be kept inside the bottle to protect the tablets and must not be swallowed.

The following pack sizes are available:

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Denmark: Emtricitabine/Tenofovirdisoproxil Glenmark 200 mg/245 mg filmomhulde tabletten

Spain: Emtricitabina/Tenofovir disoproxilo Glenmark 200 mg/245 mg comprimidos recubiertos con película EFG

Netherlands: Emtricitabine/Tenofovir disoproxil Glenmark 200 mg/245 mg filmomhulde tabletten

Sweden: Emtricitabine/Tenofovir disoproxil Glenmark 200 mg/245 mg filmdragerade tabletter

Date of the most recent review of this leaflet: January 2025.

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