tafero-logo-pack Emtricitabine 200mg Tablets
tafero-logo-pack Emtricitabine 200mg Tablets

HUMAN

IMMUNODEFICIENCY

VIRUS

HIV (Human Immunodeficiency Virus) is a virus that attacks the body’s immune system. If HIV is not treated, it can lead to AIDS (acquired immunodeficiency syndrome).

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What Is HIV?

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HIV (human immunodeficiency virus) is a virus that attacks cells that help the body fight infection, making a person more vulnerable to other infections and diseases. It is spread by contact with certain bodily fluids of a person with HIV, most commonly during unprotected sex (sex without a condom or HIV medicine to prevent or treat HIV), or through sharing injection drug equipment.

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  • TAFERO-EM/TAFERO-EM 10

    • Read 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.

  • What is in this leaflet

    1. What TAFERO-EM/TAFERO-EM 10 is and what it is used for
    2. What you need to know before you take TAFERO-EM/TAFERO-EM 10
    3. How to take TAFERO-EM/TAFERO-EM 10
    4. Possible side effects
    5. How to store TAFERO-EM/TAFERO-EM 10
    6. Contents of the pack and other information

  • 1. What TAFERO-EM/TAFERO-EM 10 is and what it is used for?

  • TAFERO-EM/TAFERO-EM 10 contains two active substances
    • Emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
    • Tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)

  • Emtricitabine and tenofovir alafenamide blocks the action of the reverse transcriptase enzyme, which is essential for the virus to multiply. Emtricitabine and tenofovir alafenamide, therefore, reduces the amount of HIV in your body.

  • Emtricitabine and tenofovir alafenamide in combination with other medicines is for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults and adolescents 12 years of age and older, who weigh at least 35 kg.

  • 2. What you need to know before you take TAFERO-EM/TAFERO-EM 10?

  • Do not take TAFERO-EM/TAFERO-EM 10
    • If you are allergic to emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

  • Warnings and Precautions

  • You must remain under the care of your doctor while taking emtricitabine and tenofovir alafenamide.

  • You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people. This medicine is not a cure for HIV infection. While taking Emtricitabine and tenofovir alafenamide you may still develop infections or other illnesses associated with HIV infection.

  • Talk to your doctor before taking Emtricitabine and tenofovir alafenamide

    • If you have liver problems or have suffered liver disease, including hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
    • If you have hepatitis B liver infections, problems may become worse after you stop taking Emtricitabine and tenofovir alafenamide. Do not stop taking emtricitabine and tenofovir alafenamide without talking to your doctor.
    • Your doctor may choose to not prescribe Emtricitabine and tenofovir alafenamide to you if your virus has a certain resistance mutation, as Emtricitabine and tenofovir alafenamide may not be able to reduce the amount of HIV in your body as effectively.
    • If you have had kidney disease or if tests have shown problems with your kidneys. Your doctor may order blood tests to monitor how your kidneys work when starting and during treatment with Emtricitabine and tenofovir alafenamide.

  • Once you start taking Emtricitabine and tenofovir alafenamide, look out for

    • Signs of inflammation or infection
    • Joint pain, stiffness or bone problems

  • If you notice any of these symptoms, tell your doctor immediately.

  • Although kidney problems have not been observed with Emtricitabine and Tenofovir alafenamide, there is a possibility that you may experience kidney problems when taking Emtricitabine and Tenofovir alafenamide over a long period of time (see Warnings and precautions).

  • Children and Adolescents

  • Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg. The use of Emtricitabine and tenofovir alafenamide in children aged 11 years or under has not yet been studied.

  • Other medicines and Emtricitabine and Tenofovir alafenamide

  • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. TAFERO-EM/TAFERO-EM 10 may interact with other medicines. As a result, the amounts of TAFERO-EM/TAFERO-EM 10 or other medicines in your blood may change. This may stop your medicines from working properly, or may make any side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels.

  • Medicines used in treating hepatitis B infection

  • You should not take Emtricitabine and tenofovir alafenamide with medicines containing

    • tenofovir alafenamide
    • tenofovir disoproxil
    • lamivudine
    • adefovir dipivoxil

  • → Tell your doctor if you are taking any of these medicines.

  • Other types of medicine

  • Talk to your doctor if you are taking

    • Antibiotics, used to treat bacterial infections including tuberculosis, containing: - rifabutin, rifampicin, and rifapentine
    • Antiviral medicines used to treat HIV
      - emtricitabine and tipranavir
    • Anticonvulsants, used to treat epilepsy, such as
      - carbamazepine, oxcarbazepine, phenobarbital and phenytoin
    • Herbal remedies used to treat depression and anxiety containing:
      - St. John’s wort (Hypericum perforatum)

  • Tell your doctor if you are taking these or any other medicines. Do not stop your treatment without contacting your doctor.

  • Pregnancy and breast-feeding

    • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
    • Tell your doctor immediately if you become pregnant and ask about the potential benefits and risks of your antiretroviral therapy to you and your child.

  • If you have taken Emtricitabine and Tenofovir alafenamide 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.

  • Do not breast-feed during treatment with Emtricitabine and tenofovir alafenamide. This is because one of the active substances in this medicine passes into breast milk. It is recommended that you do not breast-feed to avoid passing the virus to the baby through breast milk.

  • Driving and using machines

  • Emtricitabine and tenofovir alafenamide can cause dizziness. If you feel dizzy when taking Emtricitabine and tenofovir alafenamide, do not drive and do not use any tools or machines.

  • 3. How to take TAFERO-EM/TAFERO-EM 10 ?

  • 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 is

  • Adults: one tablet each day, with or without food

  • Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with or without food

  • It is recommended not to chew or crush the tablet due to the bitter taste.

  • If you have difficulty swallowing the tablet whole, you can split it in half. Take both halves of the tablet one after the other to get the full dose. Do not store the split tablet.

  • Always take the dose recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to.

  • If you are on dialysis, take your daily dose of Emtricitabine and tenofovir alafenamide following completion of dialysis.

  • If you take more Emtricitabine and tenofovir alafenamide than you should

  • If you take more than the recommended dose of Emtricitabine and tenofovir alafenamide you may be at higher risk of side effects of this medicine (see section 4, Possible side effects).

  • Contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can show what you have taken.

  • If you forget to take TAFERO-EM/TAFERO-EM 10

  • It is important not to miss a dose of TAFERO-EM/TAFERO-EM 10.

  • If you do miss a dose

    • If you notice within 18 hours of the time you usually take TAFERO-EM/TAFERO-EM 10, you must take the tablet as soon as possible. Then take the next dose as usual.
    • If you notice 18 hours or more after the time you usually take TAFERO-EM/TAFERO-EM 10, then do not take the missed dose. Wait and take the next dose at your usual time.

  • If you vomit less than 1 hour after taking TAFERO-EM/TAFERO-EM 10, take another tablet.

  • Do not stop taking TAFERO-EM/TAFERO-EM 10

  • Do not stop taking TAFERO-EM/TAFERO-EM 10 without talking to your doctor. Stopping TAFERO-EM/TAFERO-EM 10 can seriously affect how well future treatment works. If TAFERO-EM/TAFERO-EM 10 is stopped for any reason, speak to your doctor before you restart taking TAFERO-EM/TAFERO-EM 10 tablets.

  • When your supply of TAFERO-EM/TAFERO-EM 10 starts to run low,get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a few days. The disease may then become harder to treat.

  • If you have both HIV infection and hepatitis B, it is very important not to stop taking Emtricitabine and tenofovir alafenamide without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which may be life-threatening.

  • 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.

  • 4. Possible side effects

  • Like all medicines, this medicine can cause side effects, although not everybody gets them.

  • Possible serious side effects

    • Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and who have had opportunistic infections in the past (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after antiretroviral treatment is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
    • Autoimmune disorders (the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
      - 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 the side effects described above, tell your doctor immediately.

  • Very common side effects

  • (May affect more than 1 in 10 people)

    • Feeling sick (nausea)

  • Common side effects

  • (May affect up to 1 in 10 people)

    • abnormal dreams
    • headache
    • dizziness
    • diarrhoea
    • vomiting
    • stomach pain
    • wind (flatulence)
    • rash
    • tiredness (fatigue)

  • Uncommon side effects

  • (May affect up to 1 in 100 people)

    • low red blood cell count (anaemia)
    • problems with digestion resulting in discomfort after meals (dyspepsia)
    • swelling of the face, lips, tongue or throat (angioedema)
    • itching (pruritus)
    • hives (urticaria)
    • joint pain (arthralgia)

  • If any of the side effects get serious tell your doctor.

  • Other effects that may be seen during HIV treatment

  • The frequency of the following side effects is not known (frequency cannot be estimated from the available data).

    • Bone problems. Some patients taking combination antiretroviral medicines such as Emtricitabine and tenofovir alafenamide 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 HIV therapy 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.

  • Reporting of side effects

  • Health care professionals, patients/consumers are advised to closely monitor the possibility of the above ADRs associated with the use of the above drugs. If such reactions are encountered, please report to the Hetero either by filling of Suspect Adverse Drug Reactions Reporting Form (form.heteroworld.com) or by Hetero Helpline No. 1800-120-8689. Also for all India safety cases and complaints, please write to drugsafetyindia@heterodrugs.com.

  • 5. How to store TAFERO-EM/TAFERO-EM 10 ?

  • 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 carton and bottle 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..

Frequently Asked Questions

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faq

HIV stands for human immunodeficiency virus, which is the virus that causes HIV infection. AIDS stands for acquired immunodeficiency syndrome. AIDS is the most advanced stage of HIV infection.

HIV attacks and destroys the infection-fighting CD4 cells (CD4 T lymphocyte) of the immune system. The loss of CD4 cells makes it difficult for the body to fight off infections, illnesses, and certain cancers. Without treatment, HIV can gradually destroy the immune system, causing health decline and the onset of AIDS. With treatment, the immune system can recover.

HIV can be transmitted from one person to another when certain bodily fluids are shared between people. Bodily fluids that can transmit HIV include blood, semen, vaginal fluids, rectal fluids, and breast milk.

HIV can be transmitted during vaginal or anal sex, through sharing needles for injecting drugs or tattooing, by getting stuck with a needle that has the blood of someone with HIV on it, through pregnancy, and through breastfeeding.

The transmission of HIV from a birthing parent with HIV to their child during pregnancy, childbirth, or breastfeeding is called perinatal transmission of HIV.

You cannot get HIV by shaking hands or hugging a person who has HIV. You also cannot get HIV from contact with objects, such as dishes, toilet seats, or doorknobs, used by a person with HIV. HIV is not spread through the air or water or by mosquitoes, ticks, or other insects.

Within 2 to 4 weeks after infection with HIV, some people may have flu-like symptoms, such as fever, chills, or rash. The symptoms may last for a few days to several weeks. Other possible symptoms of HIV include night sweats, muscle pain, sore throat, extreme tiredness, swollen lymph nodes, and mouth ulcers. Having these symptoms does not mean you have HIV. Other illnesses can cause the same symptoms. Some people may not feel sick during early HIV infection (called acute HIV). During this earliest stage of HIV infection, the virus multiplies rapidly. After the initial stage of infection, HIV continues to multiply but at lower levels.

More severe symptoms of HIV infection for persons not on ART may not appear for many years until HIV has developed into AIDS. People with AIDS have weakened immune systems that make them prone to opportunistic infections. Opportunistic infections are infections and infection-related cancers that occur more frequently or are more severe in people with weakened immune systems than in people with healthy immune systems.

Without treatment, HIV transmission is possible at any stage of HIV infection—even if a person with HIV has no symptoms of HIV.

Symptoms such as fever, weakness, and weight loss may be a sign that a person’s HIV has advanced to AIDS. HIV can be diagnosed through blood or saliva testing. Tests include:

Antigen-antibody tests: These tests most often use blood from a vein. Antigens are substances on the HIV virus itself. They most often show up in the blood within a few weeks after being exposed to HIV. The immune system makes antibodies when it's exposed to HIV. It can take weeks to months for antibodies to show up in blood. You may not show a positive result on an antigen-antibody test until 2 to 6 weeks after exposure to HIV.

Antibody tests: These tests look for antibodies to HIV in blood or saliva. Most rapid HIV tests are antibody tests. This includes self-tests done at home. You may not show a positive result on an antibody test until 3 to 12 weeks after you've been exposed to HIV.

Nucleic acid tests (NATs): These tests look for the virus in the blood, called viral load. They use blood from a vein.

If someone have been exposed to HIV within the past few weeks, health care professional may suggest NAT. NAT is the first test to become positive after exposure to HIV.

If any of these tests are negative, person may need a follow-up test weeks to months later to confirm the results.

If the person has been diagnosed with HIV/AIDS, following tests can help the healthcare professional to learn the stage of the disease and the best treatment.

CD4 T cell count: CD4 T cells are white blood cells that HIV targets and destroys. Even if you have no symptoms, HIV infection becomes AIDS when your CD4 T cell count dips below 200.

Viral load also called HIV RNA: This test measures the amount of virus in your blood. After starting HIV treatment, the goal is to have a viral load so low that it doesn't show up on the test, called undetectable. This greatly reduces your chances of opportunistic infection and other HIV-related complications.

Medicine resistance: Some category of HIV virus are resistant to medicines. This test helps the healthcare professional to know if the HIV patient has the form of the virus that has produced resistance. This guides treatment decisions.

There's no cure for HIV/AIDS. Once the person is infected with HIV virus, the body can't get rid of it. But there are medicines that can control HIV and prevent complications. Antiretroviral therapy (ART) is the use of HIV medicines to treat HIV infection. People on ART take a combination of HIV medicines (called an HIV treatment regimen) every day (pills) or by schedule (injections). In many cases oral medicines may be combined into a single pill or capsule. There are newer long-acting medicines given by an injection every 2 months that may be used in some people.

ART is recommended for everyone who has HIV. ART prevents HIV from multiplying, which reduces the amount of HIV in the body (called the viral load). Having less HIV in the body protects the immune system and prevents HIV infection from advancing to AIDS. ART cannot cure HIV, but HIV medicines can help people with HIV live long, healthy lives.

ART reduces the risk of HIV transmission. ART can reduce a person’s viral load to an undetectable level. An undetectable viral load means that the level of HIV in the blood is too low to be detected by a viral load test. People with HIV who maintain an undetectable viral load have no risk of transmitting HIV to their HIV-negative partner through sex.

HIV medicines taken during pregnancy, childbirth, and breastfeeding can also reduce the risk of perinatal (parent to infant) transmission of HIV. Pregnant people with HIV can speak with their health care provider to determine what method of feeding their baby is right for them.

For people without HIV, there are several ways to reduce the risk of acquiring HIV infection. Using condoms correctly with every sexual encounter, particularly with partners that are HIV positive with a detectable viral load or with partners whose HIV status is unknown, can reduce the risk of acquiring HIV. Reducing HIV risk also involves limiting and reducing sexual partners, and avoiding sharing needles.

Pre-exposure prophylaxis (PrEP) is an HIV prevention option for people who do not have HIV but who are at risk of becoming infected with HIV. PrEP involves taking a specific HIV medicine every day or a long-acting injection.

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Disclaimer: The content mentioned in this website is based on the published literature and is for informational purposes only. Hetero Healthcare makes every effort to present accurate and reliable information, but does not warrant, or assume any legal liability or responsibility for, the accuracy or completeness of any information provided. The product prescribing information complies with drug approval for use in Indian and may not reflect regulatory approvals of other countries. The patient information is not intended to substitute professional advice and services of a qualified healthcare professional. Any advice regarding the management of the medical condition is totally in the discreet of the physician’s knowledge and expertise.

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