Truvada
emtricitabine, tenofovir disoproxil
emtricitabine/tenofovir disoproxil
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.
What Truvada is and what it is used for
What you need to know before you take Truvada
How to take Truvada
Possible side effects
How to store Truvada
Contents of the pack and other information
Truvada contains two active substances, emtricitabine and tenofovir disoproxil. Both of these active substances are antiretroviral medicines which are used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.
Truvada should always be used combined with other medicines to treat HIV infection.
Truvada can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
See section 2 for a list of precautions to take against HIV infection.
If this applies to you, tell your doctor immediately. Before taking Truvada to reduce the risk of getting HIV:
Truvada can only help reduce your risk of getting HIV before you are infected.
These may be signs of HIV infection:
tiredness
fever
joint or muscle aches
headache
vomiting or diarrhoea
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.
Take Truvada every day to reduce your risk, not just when you think you have been at risk of HIV infection. Do not miss any doses of Truvada, or stop taking it. Missing doses may increase your risk of getting HIV infection.
Get tested for HIV regularly.
If you think you were infected with HIV, tell your doctor straight away. They may want to do more tests to make sure you are still HIV negative.
Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
Do not share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.
Do not share or re-use needles or other injection or drug equipment.
Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
These infections make it easier for HIV to infect you.
Ask your doctor if you have any more questions about how to prevent getting HIV or spreading HIV to other people.
Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mass. The most pronounced bone loss was seen in clinical studies 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 adult and paediatric patients are uncertain.
Tell your doctor if you know you suffer from osteoporosis. Patients with osteoporosis are at a higher risk of fractures.
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, 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.
Truvada is not for use in children under 12 years of age.
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 pains)
If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may order blood tests to closely monitor your kidney function.
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.
Whenever possible, Truvada should be taken with food. Pregnancy and breast-feeding
If you have taken Truvada during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of
side effects.
If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.
Truvada can cause dizziness. If you feel dizzy while taking Truvada, do not drive and do not use any tools or machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then mix the powder with about 100 mL (half a glass) of water, orange juice or grape juice, and drink immediately.
Ask your doctor if you have any questions about how to prevent getting HIV or prevent spreading HIV to other people.
If you accidentally take more than the recommended dose of Truvada, contact your doctor or nearest emergency department for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.
It is important not to miss a dose of Truvada.
Do not stop taking Truvada without contacting your doctor.
Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
deep rapid breathing
drowsiness
feeling sick (nausea), being sick (vomiting)
stomach pain
If you think you may have lactic acidosis, get medical help immediately.
muscle weakness
weakness beginning in the hands and feet and moving up towards the trunk of the body
palpitations, tremor or hyperactivity
If you notice these or any symptoms of inflammation or infection, get medical help immediately.
(may affect more than 1 in 10 people)
diarrhoea, being sick (vomiting), feeling sick (nausea)
dizziness, headache
rash
feeling weak
Tests may also show:
decreases in phosphate in the blood
increased creatine kinase
(may affect up to 1 in 10 people)
pain, stomach pain
difficulty sleeping, abnormal dreams
problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
other allergic reactions, such as wheezing, swelling or feeling light-headed
Tests may also show:
low white blood cell count (a reduced white blood cell count can make you more prone to infection)
increased triglycerides (fatty acids), bile or sugar in the blood
liver and pancreas problems
(may affect up to 1 in 100 people)
pain in the abdomen (tummy) caused by inflammation of the pancreas
swelling of the face, lips, tongue or throat
anaemia (low red blood cell count)
breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells
Tests may also show:
decreases in potassium in the blood
increased creatinine in your blood
changes to your urine
(may affect up to 1 in 1,000 people)
Lactic acidosis (see Possible serious side effects)
fatty liver
yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver
inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells
softening of the bones (with bone pain and sometimes resulting in fractures)
back pain caused by kidney problems
Damage to kidney tubule cells may be associated with breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood.
If you notice any of the side effects listed above or if any of the side effects get serious, talk to your doctor or pharmacist.
The frequency of the following side effects is not known.
Bone problems. Some patients taking combination antiretroviral medicines such as 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 medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
joint stiffness
joint aches and pains (especially of the hip, knee and shoulder)
difficulty with movement
If you notice any of these symptoms tell your doctor.
During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Children given emtricitabine very commonly experienced changes in skin colour including
darkening of the skin in patches
Children commonly experienced low red blood cell count (anaemia).
this may cause the child to be tired or breathless
If you notice any of these symptoms tell your doctor.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton after {EXP}. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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 136 mg of tenofovir).
Truvada film-coated tablets are blue, capsule-shaped tablets, engraved on one side with the word “GILEAD” and on the other side with the number “701”. Truvada comes in bottles of 30 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister 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.
County Cork, T45 DP77 Ireland
Gilead Sciences Ireland UC
IDA Business & Technology Park Carrigtohill
County Cork Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
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Gilead Sciences Poland Sp. z o.o. Tel.: + 48 22 262 8702
Gilead Sciences
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Gilead Sciences, Lda. Tel: + 351 21 7928790
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
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Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
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Gilead Sciences Ελλάς Μ.ΕΠΕ. Τηλ: + 30 210 8930 100
Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1849
Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
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