EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR

(em trye SYE ta been, RIL pi VIR een, and ten OF oh vir) Brand: Complera

What is the most significant information I must know about emtricitabine, rilpivirine, and tenofovir?

• Some people develop lactic acidosis while taking tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get abnormal medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cool feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, quick or uneven heart course, dizziness, or feeling very weak or weary.

Some medicines can interact with Complera and must not be used at the same time, including: dexamethasone, St. John's wort, tuberculosis medicine (rifabutin, rifampin, rifapentine), seizure medication (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), or stomach acid reducers (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole).

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for different months after you stop using Complera.

What is emtricitabine, rilpivirine, and tenofovir?

Emtricitabine, rilpivirine, and tenofovir are antiviral drugs that prevent HIV (human immunodeficiency virus) cells from multiplying in the body. HIV causes acquired immunodeficiency syndrome (AIDS).

Emtricitabine, rilpivirine, and tenofovir (Complera) is a combination medication used to treat HIV in adults who have never taken HIV medicines till. Emtricitabine, rilpivirine, and tenofovir is not a cure for HIV or AIDS.

Complera must not be taken together with another antiviral medications to treat HIV or AIDS.

Emtricitabine, rilpivirine, and tenofovir may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking emtricitabine, rilpivirine, and tenofovir?

• You must not take this medication if you are allergic to emtricitabine, rilpivirine, or tenofovir.

Do not take Complera with another medicines that also contain emtricitabine, rilpivirine, or tenofovir (Atripla, Edurant, Emtriva, Stribild, Truvada, Viread), or adefovir or lamivudine (Combivir, Epivir, Epzicom, Hepsera, or Trizivir).

• There are much another drugs that can create rilpivirine smaller effective. The next drugs must not be used together with Complera:

· dexamethasone;

· St. John's wort;

· tuberculosis medication--rifabutin, rifampin, rifapentine;

· seizure medicine--carbamazepine, oxcarbazepine, phenobarbital, phenytoin; or

· stomach acid reducers--dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.

• To create certain you can safely take Complera, speak your doctor if you have any of these another conditions:

· kidney disease;

· liver malady (including hepatitis B or C);

· a history of mental illness;

· a private or family history of Long QT syndrome; or

· osteopenia (low bone mineral density).

• Some people taking tenofovir develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver malady, and in people who have taken HIV/AIDS medicine for a long time. Conversation with your doctor about your risk.

• HIV can be passed to your child if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Speak your doctor if you become pregnant during treatment.

• Women with HIV or AIDS must not breast-feed a child. Even if your child is born without HIV, the virus may be passed to the child in your breast milk.

• Do not give this medication to anyone under 18 without the advice of a doctor.

How must I take emtricitabine, rilpivirine, and tenofovir?

• Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• Complera is generally taken once for day with a meal.

• While using Complera, you may need frequent blood trials at your doctor's office. Your bone density may also need to be tested.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for different months after you stop using Complera.

• HIV/AIDS is generally treated with a combination of drugs. Use all medications as directed by your doctor. Read the medicine manual or patient instructions provided with every medicine. Do not change your doses or medicine schedule without your doctor's advice. Every face with HIV or AIDS must stay under the care of a doctor.

• Store in original container at room temperature away from moisture and heat. Hold the bottle tightly closed when not in use.

What happens if I miss a dose?

• If you are smaller than 12 hours late in taking your medication, take the missed doze as soon as you remember. Be certain to take the medication with a meal. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking emtricitabine, rilpivirine, and tenofovir?

If you also take an antacid, take it at least 2 hours till or 4 hours after taking Complera.

If you also take a heartburn or GERD medicine (such as Tagamet, Pepcid, Axid, or Zantac), take it at least 12 hours till or 4 hours after taking Complera.

• Taking this medicine will not prevent you from passing HIV to another people. Avoid having unprotected sex or sharing razors or toothbrushes. Conversation with your doctor about safety ways to prevent HIV transmission during sex. Sharing drug or medication needles is never safety, even for a healthy person.

What are the possible side effects of emtricitabine, rilpivirine, and tenofovir?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Some people develop lactic acidosis while taking Complera. Early symptoms may get worse over time and this condition can be fatal. Get abnormal medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cool feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, quick or uneven heart course, dizziness, or feeling very weak or weary.

• Call your doctor at once if you have:

· upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

· confusion, severe depression, unusual thoughts or behavior, suicidal thoughts or actions;

· swelling, rapid weight gain, few or no urinating; or

· heighten thirst and urination, weakness, constipation.

• Complera may magnify your risk of determined infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Complera. Speak your doctor if you have:

· signs of a new infection--fever, night sweats, swollen glands, diarrhea, weight loss;

· chest pain (especially when you breathe), dry cough, wheezing;

· cool sores, sores on your genital or anal area;

· feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

· trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

· swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

• General side effects may include:

· headache, mild weary feeling;

· sleep problems (insomnia), strange dreams;

· mild nausea; or

· changes in the shape or location of body thick (especially in your arms, legs, person, neck, breasts, and waist).

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect emtricitabine, rilpivirine, and tenofovir?

Complera can harm your kidneys. This effect is heighten when you also use determined another medicines, including: antivirals, chemotherapy, injected antibiotics, medication for bowel disorders, medication to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

• Much drugs can interact with Complera. Not all possible interactions are listed here. Speak your doctor about all your medications and any you start or stop using during treatment with Complera, especially:

· antibiotics or antifungal medications;

· an antidepressant;

· anti-malaria medication;

· heart or blood pressure medication;

· medicines to treat narcolepsy;

· medication to prevent or treat nausea and vomiting;

· medicines to treat psychiatric disorders;

· much another HIV medicines;

· migraine headache medicine; or

· narcotic medication.

This list is not complete and much another drugs can interact with Complera. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about emtricitabine, rilpivirine, and tenofovir.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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