Truvada 200 mg/245 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Truvada 200 mg/245 mg film-coated tablets

Emtricitabine/tenofovir disoproxil

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Truvada is and what it is used for

Truvada 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.

• Truvada 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.

• Truvada must always be used in combination with other medicines for the treatment of HIV infection.

• Truvada may be given instead of separate emtricitabine and tenofovir disoproxil taken at the same doses.

People infected with HIV can still transmit HIV to others while taking this medicine, although effective antiretroviral treatment reduces the risk. Please consult your doctor about the precautions necessary to avoid infecting other people.

This medicine is not a cure for HIV infection. While you are taking Truvada, you may still develop infections or other illnesses associated with HIV infection.

• Truvada 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 help prevent HIV infection.

2. What you need to know before taking Truvada

Do not take Truvada 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 Truvada to reduce the risk of getting HIV:

Truvada can only help reduce the risk of getting HIV before you are infected.

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

• Many HIV tests may not detect a recent infection. If you develop flu-like illness, 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
• rash
• night sweats
• enlarged lymph nodes in the neck or groin

Inform your doctor about any flu-like illness, whether occurring in the month before starting Truvada or at any time while taking Truvada.

Warnings and precautions

When taking Truvada to reduce the risk of getting HIV:

• Take Truvada every day to reduce your risk, not only when you think you may have been exposed to HIV infection. Do not miss any doses of Truvada 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. They may want to perform additional tests to confirm that you remain uninfected with HIV.

• Using Truvada alone may not prevent you from acquiring 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 injecting 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 how to prevent acquiring or transmitting HIV.

When taking Truvada to treat HIV or to reduce the risk of getting HIV:

• Truvada 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. Truvada must not be given to adolescents with existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking Truvada or, if you already have HIV, to take Truvada less frequently. Truvada is not recommended if you have severe kidney disease or are on dialysis.

Bone problems (sometimes leading to fractures) may also occur due to damage to renal tubule cells (see section 4, Possible side effects).

• 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) 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) infection status before starting Truvada. If you have HBV, there is a serious risk of liver problems when you stop taking Truvada, regardless of whether you also have HIV. It is important not to stop taking Truvada without consulting your doctor: see section 3, Do not stop taking Truvada.

• If you are over 65 years old, tell your doctor. Truvada has not been studied in patients over 65 years of age.

• Consult your doctor if you are lactose intolerant (see Truvada contains lactose later in this section).

Children and adolescents

Truvada must not be given to children under 12 years of age.

Other medicines and Truvada

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

Taking Truvada 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 (to treat cancer)
• cidofovir (for viral infection)
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve 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 to inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

Taking Truvada with other medicines containing didanosine (for treatment of HIV infection): Taking Truvada with other antiviral medicines containing didanosine may increase the 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 medicines containing tenofovir disoproxil and didanosine are taken together. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

Inform 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 Truvada with food and drinks

• Truvada 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.

• Although there is limited clinical data on the use of Truvada in pregnant women, it is generally not used unless absolutely necessary.
• If you become pregnant or plan to become pregnant, ask your doctor about the potential risks and benefits of Truvada therapy for you and your child.

If you have taken Truvada 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.

• Do not breast-feed while taking Truvada. This is because the active substances in this medicine pass into breast milk.

• If you are a woman with HIV infection, you are advised not to breast-feed to avoid transmitting the virus to your child through breast milk.

Driving and using machines

Truvada may cause dizziness. If you experience dizziness while being treated with Truvada, do not drive or operate tools or machinery.

Truvada contains lactose

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

3. How to take Truvada

• Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Truvada for treating HIV is:

• Adults: one tablet daily, preferably with food.

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

The recommended dose of Truvada for reducing the risk of getting HIV is:

• Adults: one tablet daily, preferably with food.
• Adolescents aged 12 to less than 18 years weighing at least 35 kg: one tablet daily, preferably 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 Truvada together with other antiretroviral medicines. Refer to the package leaflets of the other antiretrovirals for instructions on how to take them.

• If you are taking Truvada to reduce the risk of getting HIV, take Truvada every day, not only when you think 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 Truvada than you should

If you accidentally take more than the recommended dose of Truvada, contact your doctor or go to the nearest emergency department. Take the medicine container with you so you can clearly describe what you have taken.

If you forget a dose

It is important not to miss a dose of Truvada.

• If you realize within 12 hours of your usual dosing time, take the tablet as soon as possible, preferably with food, and then take the next dose at your regular 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 regular time, preferably with food.

If you vomit within 1 hour after taking Truvada, take another tablet. You do not need to take another tablet if you vomit more than one hour after taking Truvada.

Do not stop treatment with Truvada

• If you are taking Truvada for the treatment of HIV infection, stopping treatment may reduce the effectiveness of your prescribed HIV therapy.

• If you are taking Truvada to reduce the risk of getting HIV, do not stop taking Truvada or miss any doses. Stopping Truvada or missing doses may increase your risk of acquiring HIV infection.

Do not stop treatment with Truvada without consulting your doctor.

• If you have hepatitis B, it is especially important not to stop treatment with Truvada without first talking to your doctor. You may need 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 a worsening of hepatitis, which could be potentially 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 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 when the immune system attacks healthy body tissue, after starting medicines 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 beginning in the hands and feet and moving up toward the trunk
  • palpitations, tremor, or hyperactivity

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

Possible adverse effects:

Very common adverse effects

(may affect more than 1 in 10 people)

• diarrhoea, 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, feeling bloated (gas), flatulence

• rashes (including red spots or pimples, sometimes with blisters and skin swelling), which may be allergic reactions, itching, changes in skin colour such as darkening of the skin in patches

• other allergic reactions such as difficulty breathing, swelling, or feeling slightly dizzy

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
• anaemia (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)
• 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 Truvada may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Long-term use of these types of medicines, taking corticosteroids, alcohol consumption, having a very weak immune system, and being overweight may be among the many risk factors for developing this disease. 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 commonly experience changes in skin pigmentation, including
  • dark spots on the skin
• Children frequently develop a low number of red blood cells (anaemia)
  • this may cause fatigue or dyspnoea

If you notice any of these symptoms, inform 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 through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Truvada

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

Do not use this medicine after the expiry date stated on the bottle and the carton after {EXP}. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture. Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Truvada

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

• The other components are croscarmellose sodium, glycerol triacetate (E1518), hypromellose (E464), indigo carmine aluminium lake (E132), lactose monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), pregelatinised starch (gluten-free), titanium dioxide (E171).

Appearance of the product and contents of the container

Truvada film-coated tablets are blue, capsule-shaped tablets, marked on one side with the word “GILEAD” and on the other side with the number “701”. Truvada is available in bottles of 30 tablets. Each bottle contains a silica gel desiccant which should be kept inside the bottle to protect the tablets. The silica gel desiccant is contained in a separate sachet or container and must not be swallowed.

This medicine is available in packs containing 1 bottle of 30 film-coated tablets and in packs containing 90 film-coated tablets (3 bottles of 30). Only certain pack sizes may be marketed.

Marketing Authorisation Holder:

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer:

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

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

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.