Truvada Film-Coated Tablets

    Truvada Film-Coated Tablets

    S4


    1. What TRUVADA is and what it is used for.

    TRUVADA is a type of medicine called an HIV (human immunodeficiency virus) nucleoside analogue reverse transcriptase inhibitor (NRTI). TRUVADA contains 2 medicines, emtricitabine (200 mg) and tenofovir disoproxil fumarate (or tenofovir DF) (300 mg) combined in one pill.

    Treatment for HIV Infection

    TRUVADA is used in adults in combination with other anti-HIV medicines to treat people with HIV infection.

    Treatment for Pre-Exposure Prophylaxis (PrEP)

    To reduce the risk of getting HIV-1 in adults, TRUVADA is to be used in combination with safer sex practices and rigorous use at all times. This is called Pre-Exposure Prophylaxis or PrEP.

    2. What you need to know before you take TRUVADA.

    Do not take TRUVADA:

    • If you are hypersensitive (allergic) to emtricitabine or tenofovir disoproxil fumarate or any of the other ingredients of TRUVADA (see WHAT TRUVADA CONTAINS).
    • If you are pregnant or breastfeeding.
    • If you have kidney problems or are on dialysis.
    • If you are already taking any other tenofovir or emtricitabine containing medicines or medicines containing lamivudine because these medicines contain the same or similar active ingredients.
    • If you are a female who is taking TRUVADA to prevent HIV infection and you become pregnant while taking TRUVADA.
    • If you are HIV positive or if your HIV status is not known, when using TRUVADA to prevent HIV infection.
    • If you are not fully committed to use TRUVADA every day for Pre-Exposure Prophylaxis.

    Take special care with TRUVADA:

    • If you have bone problems.
    • If you have liver problems including Hepatitis B Virus infection.
    • If you have had kidney problems in the past or take other medicines that can cause kidney problems.
    • If you are taking other medicines as TRUVADA may interact with these other medicines.
    • If you are also infected with the Hepatitis B Virus (HBV), you need close medical follow up for several months after stopping treatment with TRUVADA. Follow-up includes medical examinations and blood tests to check for HBV that could be getting worse.
    • Patients with Hepatitis B Virus who take TRUVADA and then stop it, may get “flare-ups” of their hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. TRUVADA is not approved for the treatment of Hepatitis B Virus infection.
    • You should read the patient information leaflet of the other HIV medicines that you will be taking in combination with TRUVADA.
    • Changes in body fat have been seen in some patients taking TRUVADA and other anti-HIV medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions are not known at this time.
    • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking TRUVADA and other HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.

    3. How to take TRUVADA.

    Do not share medicines prescribed for you with any other person. Always take TRUVADA tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

    Recommended dosage of TRUVADA tablets:

    The usual dose of TRUVADA is one (1) tablet once a day. Take TRUVADA at the same time each day.

    Treatment of HIV

    If you take TRUVADA for the treatment of HIV infection, it should be used in combination with other anti-HIV medicines.

    Prevention of HIV

    If you take TRUVADA to reduce the risk of getting HIV-1, you must also use other methods to reduce your risk of getting HIV. See “Take special care with TRUVADA”. Your doctor will tell you how long your treatment with TRUVADA will last. Do not stop treatment early.

    If you have the impression that the effect of TRUVADA tablets is too strong or too weak, talk to your doctor or pharmacist.

    If you take more TRUVADA than you should

    In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

    If you forget to take/missed a dose of TRUVADA

    It is important that you do not miss any doses. If you miss a dose of TRUVADA, take it as soon as possible that day and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take 2 doses at the same time. Contact your healthcare provider or pharmacist if you are not sure what to do. Do not take more than one dose of TRUVADA in a day.

    Effects when treatment with TRUVADA is stopped

    You should not stop treatment unless your doctor instructs you to. When your TRUVADA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood will increase if the medicine is stopped for even a short time. The virus may develop resistance to TRUVADA and become difficult to treat.

    4. Possible side effects.

    TRUVADA can have side effects. NOTE: Not all side effects reported for TRUVADA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

    If any of the following happens, stop taking TRUVADA and tell your doctor immediately or go to the casualty department at your nearest hospital:

    • Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing (angioedema);
    • rash or itching;
    • fainting.

    These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TRUVADA. You may need urgent medical attention or hospitalisation.

    Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

    • Difficulty breathing;
    • less urine than is normal for you;
    • signs or symptoms of lactic acidosis (build-up of acid in the blood) e.g. feeling weak or tired, having unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold (especially in your arms and legs), feeling dizzy and lightheaded and having a fast or irregular heartbeat;
    • signs or symptoms of serious liver problems e.g. skin or white part of the eye turns yellow (jaundice), urine turns dark, stools turn light in colour, feeling sick to your stomach (nausea), have lower stomach area pain (abdominal pain) and not feeling like eating food for several days or longer;
    • signs of softening of the bones (bone pain and sometimes resulting in fractures).

    These are all serious side effects. You may need urgent medical attention.

    Tell your doctor if you notice any of the following:

    The following side effects have been frequently reported:

    • Stomach pain;
    • pain;
    • abnormal physical weakness or lack of energy;
    • diarrhoea;
    • headache;
    • nausea (feeling sick), vomiting;
    • dizziness;
    • 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 e.g. wheezing, swelling or feeling lightheaded.

    Blood 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;
    • increased creatine kinase (an enzyme resulting from breakdown of your muscles);
    • increased amylase or lipase in the blood;
    • increased liver enzymes.

    The following side effects have been reported with unknown frequency:

    • Back pain caused by kidney problems;
    • anaemia (low red blood cell count), which may include symptoms e.g. fatigue, skin pallor, shortness of breath, light-headedness, dizziness, or a fast heartbeat;
    • breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells;
    • inflammation of the pancreas which most commonly begins with abdominal pain in the middle or upper left part of the abdomen and may increase after eating or lying flat the back.

    Blood and urine tests may also show:

    • Decreases in potassium in the blood;
    • decreases in phosphate in the blood;
    • increased creatinine in your blood;
    • changes to your urine.

    This list of side effects is not complete. If you have questions about side effects, ask your healthcare provider. You should report any new or continuing symptoms to your healthcare provider right away. Your healthcare provider may be able to help you manage these side effects. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

    5. How to store TRUVADA.

    Store TRUVADA at or below room temperature (at or below 30 °C). It should remain stable until the expiration date printed on the label.

    Do not keep your medicine in places that are too hot or cold.

    Do not store in a bathroom.

    Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.

    Do not use if seal over bottle opening is broken or missing. Do not remove from carton until required for use.

    Keep TRUVADA in its original container and keep the container tightly closed.

    Return all unused medicine to your pharmacist.

    Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

    STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

    Important Disclaimer

    The Truvada Film-Coated Tablets professional information leaflet below is the property of Aspen Pharmacare and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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