TRUVADA 200 mg/245 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Truvada 200 mg/245 mg film-coated tablets

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 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

1. What Truvada is and what it is used for
2. What you need to know before you take Truvada
3. How to take Truvada
4. Possible side effects
5. Storage of 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 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 usually called NRTIs and work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce.

• Truvada is used to treat HIV-1 infection in adults.
• It is also used to treat HIV-1 infection in adolescents from 12 to less than 18 years of age with a body weight of at least 35 kgwho have already been treated with other HIV medicines that are no longer effective or have caused side effects.

• Truvada must always be used in combination with other medicines to treat HIV infection.
• Truvada may be used instead of emtricitabine and tenofovir disoproxil taken separately at the same doses.

People infected with HIV must continue to take Truvada and other HIV medications exactly as prescribed by their healthcare providerand should remain under the care of a healthcare provider. The long-term risks and benefits of Truvada for HIV treatment are not known.

Truvada does not cure HIV infection or AIDS. You may still develop infections or other illnesses associated with HIV.

• Truvada 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 with a body weight of at least 35 kgwhen taken daily, in combination with safer sex practices:

See section 2 for a list of precautions to take to avoid HIV infection.

2. What you need to know before you take Truvada

Do not take Truvada to treat HIV or 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 happens, call your doctor right away.

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 will need to have an HIV test to make sure you are not infected with HIV. Do not take Truvada to reduce the risk of getting HIV unless you have been confirmed to not be infected with HIV. People who have HIV should take Truvada 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 recently become 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 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 just when you think you have been at risk of getting HIV.Do not miss any doses of Truvada or stop taking it. Missed doses can increase the risk of getting HIV.

• You should get tested for HIV regularly.

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

• Taking Truvada alone may not keep 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 razors.
  • Do not share or reuse needles or injections or medications.
  • You should get tested for other sexually transmitted infections like syphilis or gonorrhea. These infections make it easier for you to get HIV.

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

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

• Truvada 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. Truvada should 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, take Truvada less often. Truvada is not recommended if you have severe kidney disease or are on dialysis.

Bone problems (which can lead to fractures) can also occur due to damage to the kidney tubule cells (see section 4, Possible side effects).

• 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) and are treated with antiretrovirals have a greater 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) statusbefore starting Truvada. If you have HBV, there is a serious risk of liver problems when you stop taking Truvada, whether or not you also have HIV. It is important not to stop taking Truvada without talking to your doctor: see section 3, Do not stop taking Truvada.

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

• Ask your doctor if you are lactose intolerant(see Truvada contains lactose below).

Children and adolescents

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

Other medicines and Truvada

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

Taking Truvada with other 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 bone or muscle pain relief)

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, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Truvada with other medicines that contain didanosine (for HIV treatment):Taking Truvada with other antiviral medicines that contain didanosine can increase the levels of didanosine in your blood and may reduce the 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 doctor if 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 Truvada with food and drink

• Where possible, Truvada should be taken 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.

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

If you have taken Truvada during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your baby. 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 during treatment with Truvada.This is because the active substances of this medicine pass into breast milk.

• If you are a woman with HIV, it is recommended that you do not breastfeedto avoid passing the virus to your baby through breast milk.

Driving and using machines

Truvada can cause dizziness. If you feel dizzy while taking Truvada, do not drive or operate tools or machines.

Truvada contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Truvada

• Always take this medicine exactly as your doctor has told you.Check with your doctor or pharmacist if you are not sure.

The recommended dose of Truvada for treating HIV is:

• Adults: one tablet a day, where possible with food.

• Adolescents from 12 to less than 18 years of age with a body weight of at least 35 kg: one tablet a day, where possible with food.

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

• Adults: one tablet a day, where possible with food.
• Adolescents from 12 to less than 18 years of age with a body weight of at least 35 kg: one tablet a day, where 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 dose of Truvada recommended by your doctor. This is to make sure 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.

• If you are taking Truvada for HIV treatment, your doctor will prescribe Truvada with other antiretroviral medicines. Read the package leaflets of the other antiretrovirals to find out how to take them.

• If you are taking Truvada to reduce the risk of getting HIV, take Truvada every day, not just when you think you have been at risk of getting HIV.

Ask your doctor if you have any questions about how to prevent getting HIV or giving it 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 room. Take the pack of tablets with you so you can easily describe what you have taken.

If you forget to take Truvada

It is important that you do not miss a dose of Truvada.

• If you realize within 12 hoursof the time you usually take Truvada, take the tablet as soon as possible, preferably with food, and then take the next dose at the usual time.
• If more than 12 hours have passedsince the time you usually take Truvada, do not take the missed dose. Wait and take the next dose, preferably with food, at the usual time.

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 1 hour after taking Truvada.

Do not stop taking Truvada

• If you are taking Truvada for HIV treatment, stopping treatment can reduce the effectiveness of your HIV treatment as recommended by your doctor.

• If you are taking Truvada to reduce the risk of getting HIV, do not stop taking Truvada or miss any doses. Stopping treatment with Truvada, or missing doses, can increase the risk of getting HIV.

Do not stop taking Truvada without talking to your doctor.

• If you have hepatitis B, it is especially important not to stop your treatment with Truvada 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 can cause your hepatitis to get worse, which can be life-threatening.

Talk to your doctor right awayabout any new or unusual symptoms after stopping treatment, especially symptoms that you think may be related to hepatitis B infection.

If you have any other 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 all people suffer from them.

Possible Serious Adverse Effects:

• Lactic acidosis (excess of lactic acid in the blood)is a rare but potentially fatal adverse effect. Lactic acidosis is more frequent in women, especially if they are overweight, and in people with liver disease. The following 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 soon 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 tissue, after starting to take medicines to treat HIV infection. 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 body trunk
• palpitations, tremors, 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)

• diarrhea, vomiting, nausea
• dizziness, headache
• rash
• feeling of weakness

Lab tests may also show:

• decrease in blood phosphate levels
• increase in creatine kinase

Common Adverse 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 patches sometimes with blisters and skin swelling), 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

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 blood sugar
• liver and pancreas problems

Uncommon Adverse 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 blood potassium levels
• increase in blood creatinine
• changes in urine

Rare Adverse Effects

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

• lactic acidosis (see Possible Serious Adverse Effects)
• fatty liver
• yellow skin or 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 sometimes resulting in fractures)
• back pain due to kidney problems

Damage to the renal tubule cells can be associated with muscle breakdown, bone weakening (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness, and decreased blood potassium or phosphate levels.

If you notice any of the above adverse effects or if any of the adverse effects worsen, talk to your doctor or pharmacist.

The frequency of the following adverse effects is unknown.

• Bone problems.Some patients taking antiretroviral combination therapies like Truvada 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 Adverse Effects in Children

• Children taking emtricitabine often suffer from 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the bottle and carton after {CAD}. The expiration 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 the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Truvada

• The active ingredients are emtricitabine and tenofovir disoproxil. Each film-coated tablet of Truvada 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 ingredients are sodium croscarmellose, glycerol triacetate (E1518), hypromellose (E464), aluminum lake indigo carmine (E132), lactose monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), pregelatinized starch (gluten-free), titanium dioxide (E171).

Appearance and Package Contents

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

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

Marketing Authorization Holder:

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer:

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

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