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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Emtricitabine/Tenofovir disoproxil Macleods 200 mg/245 mg film-coated tablets EFG

Emtricitabine/Tenofovir disoproxil

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Emtricitabine/Tenofovir disoproxil is and what it is used for
2. What you need to know before taking Emtricitabine/Tenofovir disoproxil
3. How to take Emtricitabine/Tenofovir disoproxil
4. Possible side effects
5. How to store Emtricitabine/Tenofovir disoproxil
6. Contents of the pack and other information

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

Emtricitabine/Tenofovir disoproxil 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 commonly 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 infection with Human Immunodeficiency Virus type 1 (HIV-1) in adults.

• It is also used to treat HIV in adolescents aged 12 to less than 18 years with a body weight of 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 should always be used in combination with other medicines to treat 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 this medicine, you may still develop infections or other illnesses associated with HIV infection.

• This medicine 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 body weight of at least 35 kg, when taken daily in combination with safer sexual practices:

See section 2 for a list of precautions to help prevent HIV infection.

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

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, or any of the other ingredients of this medicine (listed in section 6).

→ If 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 become 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 this medicine in combination with other medicines.

• Many HIV tests may not detect a recent infection. If you develop 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 you are taking Emtricitabine/Tenofovir disoproxil.

Warnings and precautions

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

• Take this medicine every day to reduce your risk, not only when you think you have been exposed to HIV infection. Do not miss any doses of this medicine or stop taking it. Missed doses may increase the risk of acquiring HIV infection.

• You must have regular HIV screening tests.

• If you think you have become infected with HIV, consult your doctor immediately. They may want to perform further tests to confirm you remain uninfected with HIV.

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

Talk to your doctor if you have further questions about how to prevent 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 ask you to have blood tests to monitor kidney function. If you have had kidney disease, or if blood tests have shown kidney problems, tell your doctor. This medicine 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 this medicine less frequently. This medicine 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 fractures, or bone problems.

Bone problems

For adult patients:

Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures) may 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 most pronounced bone loss was observed in clinical studies when patients were treated for HIV with tenofovir disoproxil in combination with a boosted protease inhibitor.

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.

For adolescent/pediatric patients:

Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures) due to damage to renal tubule cells (see section 4, Possible side effects). Inform the child’s doctor if the child experiences bone pain or fractures.

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

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.

Inform the child’s doctor if the child has osteoporosis. Patients with osteoporosis have an increased risk of fractures.

• 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 a higher 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) infection status before starting Emtricitabine/Tenofovir disoproxil. If you have HBV, there is a serious risk of liver problems when you stop taking this medicine, 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 stop taking Emtricitabine/Tenofovir disoproxil.

• If you are over 65 years old, tell your doctor. Emtricitabine/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 contains lactose below in this section).

Children and adolescents

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

Other medicines and Emtricitabine/Tenofovir disoproxil

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

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 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 relief of bone or muscle pain)

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

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

Taking Emtricitabine/Tenofovir disoproxil with other medicines containing didanosine (for treatment of HIV infection):

Taking this medicine with other antiviral medicines containing didanosine may increase didanosine levels 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 combinations 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 medicines.

Taking Emtricitabine/Tenofovir disoproxil with food and drink

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

Pregnancy and breastfeeding

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

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

For adult patients:

• If you have HBV infection and your baby has been treated to prevent transmission of hepatitis B at birth, you may be able to breastfeed, but first talk to your doctor for further advice.

• If you have HIV infection, you are advised not to breastfeed, to avoid passing the virus to the child through breast milk.

• If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

For adolescent/pediatric patients:

• If the girl has HBV infection and her baby is receiving treatment to prevent transmission of hepatitis B at birth, she may be able to breastfeed, but first talk to the girl’s doctor for further advice.

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

Driving and using machines

Emtricitabine/Tenofovir disoproxil may cause dizziness. If you experience dizziness during treatment with this medicine, do not drive or operate tools or machinery.

Emtricitabine/Tenofovir disoproxil contains lactose

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

Emtricitabine/Tenofovir disoproxil contains sodium

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

3. How to take Emtricitabine/Tenofovir disoproxil

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

• Adults: one tablet daily, preferably taken with food.

• Adolescents aged 12 to less than 18 years weighing at least 35 kg: one tablet daily, preferably taken with food.

The recommended dose of Emtricitabine/Tenofovir disoproxil to reduce the risk of acquiring HIV is:

• Adults: one tablet daily, preferably taken with food.

• Adolescents aged 12 to less than 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 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 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 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 Emtricitabine/Tenofovir disoproxil every day, not only when you think you may have been exposed to the risk of HIV infection.

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

If you take more Emtricitabine/Tenofovir disoproxil than you should

If you have accidentally taken 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, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Emtricitabine/Tenofovir disoproxil

It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil.

• 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 time for taking Emtricitabine/Tenofovir disoproxil, do not take the missed dose. Wait and take the next dose at the 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 the 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 this medicine or miss any doses. Stopping treatment with this medicine 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 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, stopping treatment is not recommended, as it may lead to a worsening of hepatitis, which could be potentially fatal.

Contact your doctor immediately if you experience any new or unusual symptoms after stopping your 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 experiences 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 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 that occur in people with a weakened immune system), 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 apparent symptoms.

• Autoimmune disorders may also occur, in which 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, tremors, 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 that 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)
• fatty liver
• yellowing of the skin or eyes, itching, or abdominal (stomach) pain caused by liver inflammation
• kidney inflammation, increased urine volume and feeling thirsty, 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 (death of bone tissue caused by reduced blood supply to the bone). Long-term use of such medicines, taking corticosteroids, alcohol consumption, having a very weak immune system, and being overweight may be some of 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 and lifestyle, 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 frequently experience changes in skin pigmentation, including dark spots on the skin
• Children frequently develop a low red blood cell count (anemia), which may cause fatigue or shortness of breath

→ If you notice any of these symptoms, speak with your doctor.

Reporting of adverse effects

If you experience any adverse effect, consult 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

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 container and blister pack after EXP. The expiry date refers to the last day of the month indicated.

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

Validity period after opening the bottle: 90 days

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Emtricitabine/Tenofovir disoproxil

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

The other components are monohydrate lactose, microcrystalline cellulose (E460), pregelatinized corn starch, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate (E572), coating material [hypromellose (E464), monohydrate lactose, glycerol triacetate (E1518), titanium dioxide (E171), indigo carmine aluminium lake (E132)].

Appearance of the product and contents of the pack

The film-coated tablets of Emtricitabine/Tenofovir disoproxil Macleods are blue, capsule-shaped, biconvex tablets, marked on one side with “L 24” and smooth on the other.

Emtricitabine/Tenofovir disoproxil Macleods is available in bottles of 30 and 90 film-coated tablets. Each bottle contains a silica gel desiccant in a separate sachet or container, which must not be swallowed. The bottles are packaged in a carton together with the package leaflet.

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

Emtricitabine/Tenofovir disoproxil Macleods is also available in blister packs:

Blister pack – 30 and 90 film-coated tablets

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, 62-020

Swarzedz, Poland

Or

HEUMANN PHARMA

GmbH & Co. Generica KG

Südwestpark 50, 90449

Nuremberg, Germany

Or

Pharmadox Healthcare Ltd.

KW20A, Kordin Industrial Park,

Paola, PLA3000

Malta

Date of the most recent review of this package leaflet: September 2024

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/)