Truvada 200 mg/245 mg comprimidos recubiertos con pelicula
Introduction
Label: information for the user
Truvada 200 mg/245 mg film-coated tablets
Emtricitabine/tenofovir disoproxil
Read this label carefully before starting to take this medicine, as it contains important information for you.
- Keep this label, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
1. What is Truvada and how is it used
Truvada contains two active ingredients, emtricitabine and tenofovir disoproxil.Both active ingredients are antiretroviral drugs used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor analog and tenofovir is a nucleotide reverse transcriptase inhibitor. They are commonly known as NRTIs and act by interfering with the normal functioning of an enzyme (reverse transcriptase) essential for the virus to replicate.
- Truvada is used to treat type 1 Human Immunodeficiency Virus (HIV-1) infection in adults.
- It is also used to treat HIV in adolescents aged 12 to less than 18 years with a weight of at least 35 kgwho have already been treated with other HIV medications that are no longer effective or have caused adverse effects.
- Truvada should always be used in combination with other medications to treat HIV infection.
- Truvada can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
People infected with HIV can still transmit HIV to others while taking this medication, although effective antiretroviral treatment reduces the risk.Consult your doctor about the necessary precautions to avoid infecting others.
This medication is not a cure for HIV infection.While you are taking Truvada, you may still experience infections or other diseases 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 with a weight of at least 35 kgwhen taken daily, in combination with safer sex practices:
See section 2 for a list of precautions to consider against HIV infection.
2. What you need to know before starting 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 components of this medication (listed in section 6).
If this happens, 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 should not be infected with HIV before starting to take Truvada to reduce the risk of getting HIV. You should have a test to ensure that 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 with HIV should take Truvada in combination with other medications.
- Many HIV tests may not detect a recent infection. If you get an illness similar to the flu, 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 illness similar to the flu, either in the month before starting treatment with 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 infection. Do not forget any doses of Truvada or stop taking it. Missed doses can increase the risk of getting HIV infection.
- Regular HIV detection tests should be performed.
- If you think you have become infected with HIV, see your doctor immediately. They may want to do more tests to make sure you are still not infected with HIV.
• Taking Truvada alone may not prevent you from getting HIV
- Always practice safe sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
- Do not share personal items that may contain blood or bodily fluids, such as toothbrushes and razor blades.
- Do not share or reuse needles or other injections or medications.
- You should have regular tests for other sexually transmitted infections such as syphilis or gonorrhea. These infections make it easier for you to get HIV.
Consult your doctor if you have any questions about how to prevent HIV transmission or transmission 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 measure the function of your kidneys. If you have had kidney disease, or if the tests have shown 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 a serious kidney disease or are on dialysis.
Bone problems (sometimes leading to fractures) may also occur due to damage to renal tubular 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) treated with antiretrovirals have a higher risk of severe 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) status before starting to take 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 essential 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 old.
- Consult your doctor if you are lactose intolerant (see Truvada contains lactose later in this section).
Children and adolescents
Truvada should not be given to children under 12 years old.
Other medications and Truvada
Do not take Truvada if you are already taking other medications that contain the components of Truvada (emtricitabine and tenofovir disoproxil) or any other antiviral medication that contains tenofovir alafenamide, lamivudine, or adefovir dipivoxil.
Taking Truvada with other medications that may harm your kidneys It is especially important to tell your doctor if you are taking any of these medications. Includes:
- 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)
- nonsteroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain)
If you are taking another antiviral medication called a protease inhibitor to treat HIV, your doctor may ask you to have blood tests to closely monitor your kidney function.
Also, inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Taking Truvada with other medications that contain didanosine (to treat HIV infection): Taking Truvada with other antiviral medications that contain didanosine may increase the levels of didanosine in your blood and may reduce the CD4 cell count. When taken together, medications containing tenofovir disoproxil and didanosine have been associated with rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) in some cases. 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 medications. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Taking Truvada with food and drinks
- When possible, Truvada should be taken with food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
- Although there are few 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 your pregnancy, your doctor may ask you to have periodic blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took ITIs during pregnancy, the benefit of HIV protection outweighed the risk of side effects.
- Do not breastfeed your child during treatment with Truvada. This is because the active ingredients of this medication pass into breast milk.
- If you are a woman with HIV, it is recommended that you do not breastfeed to avoid passing the virus to the child through breast milk.
Driving and using machines
Truvada may cause dizziness. If you experience dizziness during treatment with Truvada, do not drive or operate tools or machines.
Truvada contains lactose
If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medication.
3. How to Take Truvada
- Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
The recommended dose of Truvada for treating HIV is:
- Adults: one tablet a day, preferably with food.
- Adolescents aged 12 to less than 18 years with a weight of at least 35 kg:one tablet a day, preferably with food.
The recommended dose of Truvada for reducing the risk of contracting HIV is:
- Adults: one tablet a day, preferably with food.
- Adolescents aged 12 to less than 18 years with a weight of at least 35 kg: one tablet a day, preferably 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 or grapefruit juice, and drink it immediately.
- Always take the recommended dose prescribed by your doctor. This is to ensure that your medication is completely 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 Truvada with other antiretroviral medications. Consult the prospectuses of the other antiretrovirals to know how to take these medications.
- If you are taking Truvada to reduce the risk of contracting HIV,take Truvada every day, not just when you think you have been at risk of contracting HIV.
Consult your doctor if you have any questions about how to prevent HIV transmission or prevent transmission to other people.
If you take more Truvada than you should
If you accidentally took more than the recommended dose of Truvada, consult your doctor or go to the nearest emergency service. Bring the tablet container with you so that you can easily describe what you have taken.
If you forget a dose
It is essential not to forget a dose of Truvada.
- If you realize within 12 hoursfrom the time you take Truvada regularly, take the tablet as soon as possible, preferably with food, and then take the next dose at your regular time.
- If more than 12 hourshave passed since the time you take Truvada regularly, do not take the missed dose. Wait and take the next dose, preferably with food, at your regular time.
If you vomit within 1 hour of taking Truvada, take another tablet. You do not need to take another tablet if you vomited more than an hour after taking Truvada.
Do not interrupt Truvada treatment
- If you are taking Truvada for HIV treatment,suspending treatment may reduce the effectiveness of the recommended HIV therapy prescribed by your doctor.
- If you are taking Truvada to reduce the risk of contracting HIV, do not stop taking Truvada or miss any doses. Suspending Truvada treatment or missing doses may increase the risk of HIV infection.
Do not interrupt Truvada treatment without consulting your doctor.
- If you have hepatitis B, it is especially important not to suspend your Truvada treatment without first talking to your doctor. You may need to have blood tests for several months after suspending treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to suspend treatment as this may lead to a worsening of hepatitis, which can be potentially fatal.
Talk to your doctor immediatelyabout new or unusual symptoms after suspending treatment, particularly symptoms associated with hepatitis B virus infection.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Possible serious side effects:
- Lactic acidosis (excess of lactic acid in the blood)is a rare but potentially fatal side effect. Lactic acidosis is more common 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
- abdominal 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 shortly 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 off infections that may be present without apparent symptoms.
- They may also appearautoimmune disorders, when the immune system attacks healthy body tissue, after starting to take medications to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms such as:
- muscle weakness
- weakness starting in the hands and feet and ascending to the body 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
(may affect more than 1 in 10 people)
- diarrhea, vomiting, nausea
- dizziness, headache
- skin rash
- feeling weak
The tests may also show:
- decreased phosphate levels in the blood
- increased creatine kinase
Common side effects
(may affect up to 1 in 10 people)
- abdominal pain, stomach pain
- difficulty sleeping, abnormal dreams
- digestive problems with discomfort after meals, feeling bloated (gas), flatulence
- skin eruptions (including red patches or spots sometimes with blisters and swelling of the skin), 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
The tests may also show:
- low white blood cell count (a reduced white blood cell count may make you more prone to infections)
- increased triglycerides (fats), bile, or sugar in the blood
- problems with the liver and pancreas
Uncommon side effects
(may affect up to 1 in 100 people)
- abdominal pain caused by pancreatitis inflammation
- swelling of the face, lips, tongue, or throat
- anemia (low red blood cell count)
- muscle rupture, muscle pain, or muscle weakness that may occur due to damage to the renal tubular cells
The tests may also show:
- decreased potassium levels in the blood
- increased creatinine in the blood
- changes in urine
Rare side effects
(may affect up to 1 in 1,000 people)
- lactic acidosis (see Possible serious side effects)
- fatty liver
- yellowing of the skin or eyes, itching, or abdominal pain caused by liver inflammation
- kidney inflammation, increased urine volume, and feeling thirsty, renal failure, damage to the renal tubular cells
- bone weakening (with bone pain and sometimes leading to fractures)
- back pain due to kidney problems
Damage to the renal tubular cells may be associated with muscle rupture, bone weakening (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased levels of potassium or phosphate in the blood.
If you notice any of the above side effects or if any of the side effects worsen, speak with your doctor or pharmacist.
The frequency of the following side effects is unknown.
- Bone problems.Some patients taking combined antiretroviral medications like Truvada may develop a bone disease called osteonecrosis (bone tissue death 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 may 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, speak with your doctor.
During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.
Other side effects in children
- Children receiving emtricitabine often experience frequent changes in skin color, including
- dark skin patches
- Children frequently have a low red blood cell count (anemia)
- this may cause fatigue or shortness of breath
If you notice any of these symptoms, inform your doctor.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Truvada Storage
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the bottle and the box after {CAD}. The expiration date is the last day of the month indicated.
Store in the original packaging to protect it from moisture. Keep the bottle perfectly closed.
Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Truvada
• The active principles areemtricitabina and tenofovir disoproxilo. Each film-coated tablet of Truvada contains 200 mg of emtricitabina and 245 mg of tenofovir disoproxilo (equivalent to 300 mg of tenofovir disoproxilo fumarate or to 136 mg of tenofovir).
• The other components arecroscarmelosa sódica, triacetato de glicerol (E1518), hipromelosa (E464), laca de aluminio índigo carmín (E132), lactosa monohidrato, estearato magnésico (E572), celulosa microcristalina (E460), almidón pregelatinizado (sin gluten), dióxido de titanio (E171).
Aspect of the product and content of the package
The film-coated tablets of Truvada are blue tablets, in capsule shape, marked on one face 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 must be kept inside the bottle to protect the tablets. The silica gel desiccant is contained in a separate sachet or container, and should not be taken.
This medicine is available in packages of 1 bottle of 30 film-coated tablets and in packages of 90 (3 bottles of 30) film-coated tablets. Only some package sizes may be marketed.
Holder of the marketing authorization:
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Irlanda
Responsible for manufacturing:
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Irlanda
For more information about this medicine, please contact the local representative of the marketing authorization holder:
België/Belgique/Belgien Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0)24 01 35 50 | Lietuva Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702 |
???? Gilead Sciences Ireland UC ???: + 353 (0) 1 686 1888 | Luxembourg/Luxemburg Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 24 01 35 50 |
Ceská republika Gilead Sciences s.r.o. Tel: + 420 (0) 910 871 986 | Magyarország Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 |
Danmark Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849 | Malta Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 |
Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0 | Nederland Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98 |
Eesti Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702 | Norge Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849 |
Ελλ?da Gilead Sciences Ελλ?ς Μ.ΕΠΕ. Τηλ: + 30 (0) 210 8930 100 | Österreich Gilead Sciences GesmbH Tel: + 43 (0) 1 260 830 |
España Gilead Sciences, S.L. Tel: + 34 (0) 91 378 98 30 | Polska Gilead Sciences PolandSp. z o.o. Tel: + 48 22 262 8702 |
France Gilead Sciences Tél: + 33 (0) 1 46 09 41 00 | Portugal Gilead Sciences, Lda. Tel: + 351 (0) 21 7928790 |
Hrvatska Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 | România Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 |
Ireland Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 999 | Slovenija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 |
Ísland Gilead Sciences Sweden AB Sími: + 46 (0) 8 5057 1849 | Slovenská republika Gilead Sciences Slovakia s.r.o. Tel: + 421 (0) 232 121 210 |
Italia Gilead Sciences S.r.l. Tel: + 39 (0) 02 439201 | Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849 |
Κ?pρος Gilead Sciences Ελλ?ς Μ.ΕΠΕ. Τηλ: + 30 (0) 210 8930 100 | Sverige Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1849 |
Latvija Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702 | United Kingdom Gilead Sciences Ltd. Tel: + 44 (0) 8000 113 700 |
Last review date of this leaflet:
The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
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