200 mg/245 mg film-coated tablets
What Truvada is and what it is used for
Truvada contains two active substances, emtricitabine and tenofovir disoproxil. Both of these active substances are antiretroviral drugs used to treat HIV infection. Emtricitabine is a nucleoside-type reverse transcriptase inhibitor and tenofovir is a nucleotide-type reverse transcriptase inhibitor. However, both are generally called NRTIs and work by affecting the normal function of an enzyme (reverse transcriptase) that the virus needs for its reproduction (propagation).
- Truvada is a treatment for human immunodeficiency virus 1 ( HIV -1 ) infection in adults.
- The medicine is also used to treat HIV in young people aged 12 to under 18 who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer effective or which have caused side effects.
– Truvada must always be taken in combination with other medicines against HIV .- Truvada can be used instead of the separate administration of emtricitabine and tenofovir disoproxil at the same dose.
People who are HIV -positive can still transmit HIV when taking this medicine, even though the risk is reduced with effective antiretroviral therapy. Discuss the necessary measures to avoid infecting others with your doctor.
This medicine does not cure HIV infection. While taking Truvada, you may still develop an infection or other illnesses associated with HIV infection.
- Truvada is also used to reduce the risk of becoming infected with HIV – 1 in adults and adolescents aged 12 years and up to less than 18 years who weigh at least 35 kg, when taken daily along with safe sex:
See Section 2 for a list of precautions that can be taken against HIV infection.
What you need to know before you take Truvada
Do not take Truvada
Do not take Truvada to treat HIV or to reduce the risk of contracting 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, inform your doctor immediately.
Before taking Truvada to reduce your risk of getting HIV:
Truvada can only help reduce your risk of getting HIV before you are infected.
- To reduce your risk of getting HIV, you must be HIV -negative before starting Truvada. You must be tested to ensure that you do not already have an HIV infection. Do not take Truvada to reduce your risk of infection unless it has been confirmed that you are HIV-negative. People with HIV must take Truvada in combination with other medicines.
- Many HIV tests can miss a recent infection. If you get a flu-like illness, it may mean that you have recently been infected with HIV.
These can be signs of HIV infection:
- joint or muscle pain
- vomiting or diarrhea
- night sweats
- enlarged lymph nodes in the neck or groin.
→ Tell the doctor about any flu-like symptoms – either in the month before starting treatment with Truvada or at any time while taking Truvada.
Warnings and precautions
While you are taking Truvada to reduce your risk of getting HIV:
- Take Truvada every day to reduce your risk, not just when you think you have been exposed to the risk of getting HIV infection. Do not miss any doses of Truvada or stop taking it. If you miss a dose, your risk of contracting HIV infection may increase.
- Get tested regularly for HIV.
- If you think you have been infected with HIV, tell your doctor immediately. The doctor may want to perform several tests to make sure you are still HIV-negative.
- Taking Truvada alone may not prevent you from getting HIV.
- Always practice safe sex. Use a condom to reduce contact with semen, vaginal fluids, or blood.
- Do not share personal items that may contain blood or body fluids, e.g. toothbrushes and razor blades.
- Do not share or reuse needles or other injection or drug equipment.
- Get tested for other sexually transmitted infections such as syphilis and gonorrhea. These infections make it easier for you to become infected with HIV.
Ask your doctor if you have more questions about how to prevent getting HIV or passing HIV to other people.
While you are taking Truvada to treat HIV or to reduce your risk of getting HIV:
- Truvada can affect your kidneys. Before and during treatment, your doctor may order some blood tests to measure kidney function. Inform your doctor if you have had kidney disease in the past or if tests have shown that you have kidney problems. 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, to take the tablets less often. Truvada is not recommended if you have severe kidney disease or if you are receiving dialysis.
Bone problems (manifesting 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 ). Tell your doctor if you have bone pain or a fracture.
Tenofovir disoproxil can also cause loss of bone mass. The most pronounced bone loss was seen in clinical trials when patients were treated for HIV with tenofovir disoproxil in combination with a boosted protease inhibitor.
Overall, the effects of tenofovir disoproxil on long-term bone health and future fracture risk in adults and children are uncertain.
Tell your doctor if you suffer from osteoporosis. Patients with osteoporosis are at higher risk of fracture.
- Inform your doctor if you already have or have had liver disease, including hepatitis. HIV patients with liver disease (including chronic hepatitis B or C) treated with antiretroviral agents are at increased risk of severe and potentially fatal liver complications. If you have hepatitis B or C, your doctor will carefully choose the best treatment for you.
- Find out your hepatitis B virus (HBV) status before 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 ”.
- Talk to your doctor if you are over 65. Truvada has not been studied in patients over 65 years of age.
- Talk to your doctor if you are lactose intolerant (see “Truvada contains lactose” later in this section.
Taking Truvada with food and drink
- Whenever possible, Truvada should be taken with food.
Children and young people
Truvada should not be used in children under 12 years of age.
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 using this medicine.
If you have taken Truvada during your pregnancy, the doctor may ask the baby to have regular blood tests and other tests to check the baby’s development. For children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV is greater than the risk of side effects.
- Do not breastfeed during treatment with Truvada. This is because the active substances in this medicine are excreted in human breast milk.
- If you are an HIV-infected woman, you should not breastfeed your infant to avoid transmission of HIV to the baby through breast milk.
Driving ability and use of machinery
Truvada can cause dizziness. Do not drive or use tools or machines if you feel dizzy while taking Truvada.
Truvada contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
Truvada contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Truvada
- Always take Truvada as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Truvada for HIV treatment is:
- Adults: one tablet daily, if possible with food.
- Young people aged 12 to under 18 years weighing at least 35 kg: one tablet daily, if possible with food.
The recommended dose of Truvada to reduce the risk of getting HIV is:
- Adults: one tablet daily, if possible with food.
- Adolescents 12 years and up to less than 18 years weighing at least 35 kg: one tablet daily, if possible with food.
If you have difficulty swallowing, you can crush the tablet with the tip of a spoon. Then mix the powder with about 100 ml (half a glass) of water, orange juice, or grape juice and drink immediately.
- Always take the dose prescribed by the doctor to ensure that the medicine is effective and to reduce the development of resistance to the treatment. Do not change the dose unless your doctor tells you to.
- If you are being treated for HIV infection, your doctor will prescribe Truvada along with other antiretroviral medicines. Read the leaflets for these medicines for guidance on how to take them.
- If you are taking Truvada to reduce your risk of getting HIV, take Truvada every day, not just when you think you have been exposed to the risk of being infected with HIV.
Ask your doctor if you have any questions about how to prevent getting HIV or passing HIV to other people.
If you have taken too much Truvada
If you accidentally take more than the prescribed dose of Truvada, contact your doctor or nearest emergency department for advice. Save the jar so you can easily describe what you have taken.
If you miss a dose
You mustn’t miss a dose of Truvada.
- If you notice within 12 hours of the time you usually take Truvada, take the tablet, preferably with food, as soon as possible. Then take the next dose at the usual time.
- If you notice it 12 hours or more after the time you usually take Truvada, ignore the missed dose. Wait and take the next dose, preferably with food, at the usual time.
If you vomit less than 1 hour after a dose of 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 the treatment of HIV infection, if you stop taking the tablets, the effect of the anti- HIV treatment the doctor has recommended may be reduced.
- If you are taking Truvada to reduce your risk of getting HIV, do not stop taking Truvada or miss any doses. If you stop using Truvada or miss a dose, your risk of getting HIV infection may increase.
→ Do not stop taking Truvada without first talking to your doctor.
- If you have chronic hepatitis B, you mustn’t stop Truvada treatment without first talking to your doctor. You may need to provide blood samples for several months after the end of treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to the worsening of hepatitis A, which can be life-threatening.
→ Inform your doctor immediately of any new and unexpected symptoms that appear after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any serious side effects are
- Lactic acidosis (excess lactic acid in the blood) is a rare condition with potentially life-threatening side effects. Lactic acidosis occurs more often in women, especially if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:
- deep, rapid breathing
- nausea, vomiting
- abdominal pain
→ If you think you may have lactic acidosis, seek medical attention immediately.
- Any signs of inflammation or infection. In some patients with advanced HIV infection ( AIDS ) and previous opportunistic infections ( infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune system and enable the body to fight infections that may have existed without any visible symptoms.
- Autoimmune disorders, when the immune system attacks healthy body tissue, can also occur after you start taking medicines to treat HIV infection. Autoimmune disorders may occur many months after treatment has begun. Pay attention to any signs of infection or other symptoms such as:
- muscle weakness
- weakness that starts in the hands and feet and moves up the trunk
- palpitations, tremors or hyperactivity.
→ If you notice these or any symptoms of inflammation or infection, seek medical attention immediately.
Possible side effects:
Very common side effects are
(may occur in at least 1 in 10 patients) :
- diarrhea, vomiting, nausea
- dizziness, headache
- feeling of weakness
Samples may also show:
- lowering of the phosphate level in the blood
- elevated creatine kinase
Common side effects are
(may affect up to 10 in 100 patients) :
- pain, abdominal pain
- difficulty sleeping, abnormal dreams
- indigestion resulting in discomfort after meals, feeling bloated, gas
- skin rash (including red dots or patches of skin sometimes with blistering and swelling of the skin) which may be allergic reactions, itching, skin discoloration including dark spots on the skin
- other allergic reactions, such as wheezing/wheezing, swelling, or a feeling of intoxication
Samples may also show:
- low white blood cell count (a drop in white blood cell count can mean you are more likely to get an infection )
- increased levels of triglycerides (fatty acids) in the blood, increased amount of bile pigments in the blood, or increased blood sugar
- liver and pancreas problems
Less common side effects are
(may affect up to 1 in 100 patients)
- pain in the abdomen (stomach) caused by inflammation of the pancreas
- swelling of the face, lips, tongue, or throat
- anemia (low red blood cell count )
- muscle breakdown, muscle pain, or muscle weakness that may occur due to damage to kidney tubule cells
Samples may also show:
- lowered potassium levels in the blood
- increased creatinine level in the blood
- changes in urine
Rare side effects are
(may occur in 1 in 1,000 patients)
- lactic acidosis (see Possible serious side effects )
- fatty liver
- yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver
- kidney inflammation, urinating a lot and feeling thirsty, kidney failure, and damage to kidney tubule cells.
- reduced bone hardness (which causes bone pain and sometimes leads to fractures )
- back pain caused by kidney problems
Damage to kidney tubule cells can be associated with the breakdown of muscles, decreased bone hardness (which causes bone pain and sometimes leads to fracture ), muscle pain, muscle weakness, and lowered potassium or phosphate levels in the blood.
→ If you notice any of the side effects mentioned above or if any side effects become serious, talk to your doctor or pharmacist.
The frequency of the following side effects is not known.
- Skeletal problems. Some patients taking combination antiretroviral drugs such as Truvada may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone tissue). Some of the many risk factors for developing this disease are the use of this type of medicine for a long time, the use of corticosteroids, the use of alcohol, a very weak immune system, and being overweight. Signs of osteonecrosis are:
- joint stiffness
- joint aches and pains (especially in the hip joint, knee joint, and shoulder joint)
- difficulty moving.
→ Inform the doctor if you notice any of these symptoms.
During treatment against HIV, weight gain and an increase in blood fat and blood glucose levels may occur. This is partly related to improved health and lifestyle and as far as blood fats are concerned, sometimes with the HIV drugs themselves. Your doctor will take samples for this.
Other side effects in children
- Children who have been given emtricitabine have very often suffered from discoloration of the skin, including
- dark spots on the skin
- Children often suffer from too low several red blood cells ( anemia ).
- This can lead to the child becoming tired or short of breath.
– Inform your doctor if you notice any of these symptoms.
How to store Truvada
Keep this medicine out of sight and reach of children.
Use before the expiry date which is stated on the can and carton after EXP. The expiration date is the last day of the specified month.
Store in the original packaging. Moisture sensitive. Close the jar well.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substances are emtricitabine and tenofovir disoproxil. One Truvada film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate, or 136 mg of tenofovir).
- Other ingredients are croscarmellose sodium, glycerol triacetate (E1518), hypromellose (E464), indigo carmine (E132), lactose monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), pregelatinized starch (gluten-free) and titanium dioxide (E171).
Appearance and package sizes of the medicine
Truvada film-coated tablets are blue, capsule-shaped tablets. On one side they are embossed with the word “GILEAD” and on the other side with the number “701”. Truvada is supplied in cans containing 30 tablets. Each jar contains desiccant (silica gel) which must be in the jar to protect the tablets. The desiccant (silica gel) is in a separate sachet or container and should not be swallowed.
The following pack sizes are available: Outer cartons containing 1 bottle of 30 film-coated tablets and 60 (2 bottles of 30) and 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Gilead Sciences Ireland UC
County Cork, T45 DP77
Gilead Sciences Ireland UC
IDA Business & Technology Park