Consumer Information for: MYLAN-EMTRICITABINE/TENOFOVIR DISOPROXIL

Do NOT take Mylan-Emtricitabine/Tenofovir Disoproxil if:

• you are on other medications that may affect your kidneys and have not discussed this with your healthcare professional.
• you have or are at known risk for any type of bone disease or bone related problems and have not discussed this with your healthcare professional.
• you are allergic to Mylan-Emtricitabine/Tenofovir Disoproxil or any of its ingredients. The medicinal ingredients are emtricitabine and tenofovir DF (see: What the important nonmedicinal ingredients are).
• you are already taking 3TC®, ATRIPLA® Combivir®, COMPLERA®, DESCOVY®, EMTRIVA®, GENVOYA®, ODEFSEYTM, Heptovir®, Kivexa®, STRIBILD®, Triumeq®, Trizivir®, VEMLIDYTM or VIREAD® because these medicines contain the same or similar active ingredients
• you are also taking HEPSERA® to treat your HBV infection

Changes in your immune system (Immune Reconstitution Syndrome) can happen when an HIV-1 infected person starts taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body [e.g. Grave's disease (which affects the thyroid gland), GuillainBarré syndrome (which affects the nervous system) or polymyositis (which affects the muscles)] and it may develop at any time, sometimes months later after the start of HIV therapy. Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling or fatigue, or any new symptoms, contact your healthcare professional right away.

Before taking Mylan-Emtricitabine/Tenofovir Disoproxil to reduce your risk of getting HIV-1 infection (PrEP indication):

• You must get tested to be sure you are HIV-negative. It is important that you also get tested at least every 3 months as recommended by your healthcare provider while taking Mylan-Emtricitabine/Tenofovir Disoproxil. Do not take Mylan-Emtricitabine/Tenofovir Disoproxil to reduce the risk of getting HIV (PrEP) unless you are confirmed to be HIV-negative.
• Tell your healthcare provider if you have any of the following symptoms within the last month before you start taking Mylan-Emtricitabine/Tenofovir Disoproxil or at any time while taking Mylan-Emtricitabine/Tenofovir Disoproxil:
• tiredness
• fever
• sweating a lot (especially at night)
• rash
• vomiting or diarrhea
• joint or muscle aches
• headache
• sore throat
• enlarged lymph nodes in the neck or groin

These may be signs of HIV infection and you may need to have a different kind of test to diagnose HIV. If you are already taking Mylan-Emtricitabine/Tenofovir Disoproxil to prevent HIV-1 infection (PrEP), your healthcare provider may tell you to stop taking Mylan-Emtricitabine/Tenofovir Disoproxil until an HIV test confirms that you do not have HIV-1 infection.

Just taking Mylan-Emtricitabine/Tenofovir Disoproxil may not keep you from getting HIV. MylanEmtricitabine/Tenofovir Disoproxil does NOT always prevent HIV.

You must still practice safer sex at all times. Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

You must also use other prevention methods to keep from getting HIV.

• Know your HIV-1 status and the HIV-1 status of your partners.
• While taking Mylan-Emtricitabine/Tenofovir Disoproxil, get tested at least every 3 months for HIV, as recommended by your healthcare provider. Ask your partners to get tested.
• If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you are still HIV-negative.
• Get tested for other sexually transmitted infections such as syphilis and gonorrhea. These infections make it easier for HIV to infect you.
• Get information and support to help reduce risky sexual behavior.
• Have fewer sex partners.
• Do not miss any doses of Mylan-Emtricitabine/Tenofovir Disoproxil. Missing doses may increase your risk of getting HIV-1 infection.

BEFORE you use Mylan-Emtricitabine/Tenofovir Disoproxil (emtricitabine / tenofovir disoproxil fumarate) talk to your healthcare professional:

If you are pregnant or planning to become pregnant: Pregnant mothers should not take Mylan-Emtricitabine/Tenofovir Disoproxil unless specifically directed by the healthcare professional.

If you are a female who is taking MylanEmtricitabine/Tenofovir Disoproxil to prevent HIV infection (PrEP) and you become pregnant while taking MylanEmtricitabine/Tenofovir Disoproxil, talk to your healthcare provider about whether you should continue taking MylanEmtricitabine/Tenofovir Disoproxil.

Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this Antiretroviral Pregnancy Registry.

If you are breast-feeding or planning to breastfeed: Do not breastfeed if you are taking Mylan-Emtricitabine/Tenofovir Disoproxil or have HIV. Emtricitabine and tenofovir DF, the two components of Mylan-Emtricitabine/Tenofovir Disoproxil, pass to your baby in your breast milk. You should not breastfeed because of the risk of passing HIV to your baby. Talk to your healthcare professional about the best way to feed your baby.

If you have other medical conditions: Let your healthcare professional know if you have other medical conditions, especially liver, bone and kidney problems.

If you are taking other medicines: Some medicines can interact when taken together, including prescription and nonprescription medicines and dietary supplements (see INTERACTIONS WITH THIS MEDICATION).

If you are taking didanosine: Taking didanosine and Mylan-Emtricitabine/Tenofovir Disoproxil may cause serious reactions including lactic acidosis (too much acid in the blood), pancreatitis (inflamed pancreas) and nerve damage (neuropathy) (see INTERACTIONS WITH THIS MEDICATION and SIDE EFFECTS AND WHAT TO DO ABOUT THEM).

Mylan-Emtricitabine/Tenofovir Disoproxil should not be used with or soon after cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides, or nonsteroidal antiinflammatory drugs (NSAIDS), due to potential harm to the kidneys.

It is a good idea to keep a complete list of all the medicines that you take. Make a new list when medicines are added or stopped. Give copies of this list to all of your healthcare providers every time you visit your healthcare professional or fill a prescription.

Other Special Warnings:
Your blood sugar levels (glucose) or levels of fats (lipids) in your blood may increase with HIV treatment. Your doctor may order blood tests for you.