Efavirenz-Emtric-Tenofov Disop

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

If you have hepatitis B infection, your hepatitis symptoms may get worse or become very serious if you stop taking this medication. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop efavirenz/emtricitabine/tenofovir. Tell your doctor right away if you develop symptoms of worsening liver problems.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.

Read the Patient Information Leaflet if available from your pharmacist before you start taking efavirenz/emtricitabine/tenofovir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach as directed by your doctor, usually once daily at bedtime. Taking this medication at bedtime helps to decrease some of the side effects. See Side Effects section.

Because this combination product has fixed doses of efavirenz, emtricitabine, and tenofovir, you should only use it if your doctor has determined that the doses of all 3 medications in this product are right for you.

It is very important to keep taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

Before taking efavirenz/emtricitabine/tenofovir, tell your doctor or pharmacist if you are allergic to any of the ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), mental/mood conditions (such as depression, thoughts of suicide, psychosis), drug/substance/alcohol abuse, seizures, high cholesterol/triglyceride levels, bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), disease of the pancreas (pancreatitis).

Efavirenz/emtricitabine/tenofovir may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using efavirenz/emtricitabine/tenofovir, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics "water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using efavirenz/emtricitabine/tenofovir safely.

This drug may make you dizzy or drowsy or cause trouble concentrating. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages because they may also worsen the side effects of this medication (such as liver problems, pancreatitis, mental/mood symptoms). Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

A rash may be more common and serious in children taking this medication. Report any rash right away. The doctor may prescribe an antihistamine for your child to take before this medication is started. Consult the doctor for more information.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and efavirenz/emtricitabine/tenofovir may be part of that treatment. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, test for hepatitis B virus, viral load, T-cell counts, cholesterol and triglyceride levels, blood mineral levels, bone density tests, urine glucose/protein) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: orlistat, other drugs that may affect the kidneys (including adefovir, cidofovir, aminoglycosides such as amikacin/ gentamicin).

Do not take this medication with other products that contain emtricitabine or tenofovir. Do not take this medication with another efavirenz product unless specifically directed by your doctor. Also, lamivudine is similar to emtricitabine and should not be taken with this medication.

Other medications can affect the removal of efavirenz/emtricitabine/tenofovir from your body, which may affect how this product works. Examples include some drugs used to treat seizures (such as carbamazepine), among others.

Efavirenz/emtricitabine/tenofovir can speed up the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include atazanavir, atovaquone/proguanil, azole antifungals (such as voriconazole), bedaquiline, cabotegravir, cobicistat, elbasvir/grazoprevir, elvitegravir, macrolide antibiotics (such as clarithromycin), rilpivirine, sofosbuvir/velpatasvir, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain lab tests (such as urine cannabinoid tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.