Apo-Emtricitabine/Tenofovir

**For treating HIV infection, **the usual recommended adult dose is 1 tablet by mouth once daily. It should be taken with other anti-HIV medications. Emtricitabine - tenofovir can be taken with or without food.

It is important to use this medication exactly as prescribed by your doctor. If you do not, the amount of HIV virus in your blood may increase and the virus may develop resistance to this medication. Do not stop taking this medication without telling your doctor. Your HIV infection may get worse if you stop this medication.

For pre-exposure prevention, the usual recommended adult dose is **1 tablet by mouth once daily. **Emtricitabine - tenofovir can be taken with or without food. The medication must be taken regularly on a daily basis, not just when you are engaging in high-risk sexual activities.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take more than 1 dose of emtricitabine - tenofovir in 1 day. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, in its original container, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each blue, capsule-shaped, biconvex, film-coated tablet, engraved "APO" on one side, "E-T" on the other side, contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil). *Nonmedicinal ingredients: *anhydrous lactose, colloidal silicon dioxide, crospovidone, FD&C Blue No. 2, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Do not use this medication if you:

• are allergic to emtricitabine, tenofovir, or any ingredients of the medication

• are using this medication for pre-exposure prophylaxis and you already have HIV or you do not know your HIV status

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abnormal or unusual dreams

• diarrhea

• dizziness

• gas

• headache

• indigestion

• nausea

• pain

• rash

• skin discolouration

• stomach pain

• trouble sleeping

• vomiting

• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bone breaks or fractures

• muscle pain or weakness

• shortness of breath

• signs of kidney problems (e.g., increased thirst, changes in urination patterns, swelling of the legs and feet, feeling listless and tired)

• signs of liver problems (e.g., yellowing of skin and eyes, dark urine, light-coloured bowel movements)

• symptoms of pancreatitis (upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

Seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (i.e., swelling of face or throat, hives, or difficulty breathing)

• signs of lactic acidosis (e.g., dizziness, fatigue, unusual muscle pain, nausea, vomiting, stomach pain, feeling cold in legs and arms, fast heartbeat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bones: Emtricitabine - tenofovir may weaken bones. Your doctor may monitor your bone mass while you are taking this medication, especially if you are at risk for bone fracture or for disease of the bone. If you experience unexplained bone pain or break a bone, contact your doctor. Your doctor may want you to start taking vitamin D and calcium supplements.

Cholesterol: Emtricitabine - tenofovir can cause increased levels of lipids in the bloodstream. If you are at risk of developing high cholesterol or you have high cholesterol levels, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Diabetes: **This medication may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hepatitis B: The safe use of this medication has not been established for people who are also infected with hepatitis B. Your doctor may test you for hepatitis B infection before you start taking this medication. If this medication is used to treat HIV by people who have hepatitis B, worsening of hepatitis B may occur when the medication is stopped. If you also have hepatitis B and stop using this medication, your doctor will monitor your liver function closely for several months.

Immune reconstitution inflammatory syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes, hepatitis, or tuberculosis). Report any new symptoms to your doctor immediately.

Kidney function: Kidney disease or reduced kidney function may cause emtricitabine - tenofovir to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may also need to change the dosing schedule of this medication if you have existing kidney problems.

Tenofovir can cause kidney problems, including severe kidney damage and kidney failure. Your doctor may monitor your kidney function with blood tests while you are taking this medication. Additional tests may be needed if you have a history of kidney problems or if you need to take another medication that can cause kidney problems.

If you experience signs of reduced kidney function, such as decreased urination, nausea, vomiting, or swelling of the feet and ankles, contact your doctor as soon as possible.

**Lactic acidosis and enlarged liver: **This medication can cause a rare but serious condition called lactic acidosis (buildup of lactic acid), together with an enlarged fatty liver. Your doctor will periodically monitor you and perform laboratory tests to check your liver function. Seek immediate medical attention if you notice any symptoms of this condition, such as:

• dizziness

• feeling cold

• irregular heartbeat

• lightheadedness

• nausea

• stomach pain

• tiredness

• vomiting

• weakness

Liver problems: This medication can cause liver problems. Your doctor may monitor your liver function while you are taking this medication, especially if you have risk factors for liver problems. Tell your doctor immediately about any signs of liver problems, such as:

• dark urine

• diarrhea

• loss of appetite

• nausea

• pale stools

• vomiting

• weight loss

• yellowing of the skin or whites of the eyes

Pancreatitis: This medication may cause inflammation of the pancreas (pancreatitis). If you have a history of or are at risk for developing pancreatitis, you should be closely monitored by your doctor while taking this medication. Contact your doctor if you develop signs of pancreatitis, such as:

• back pain

• chills

• fever

• nausea

• rapid heartbeat

• swollen abdomen

• upper left abdominal pain

**Pre-exposure prophylaxis: **If you are using this medication for PrEP you will need to undergo screening for HIV before starting this medication and every 3 months while taking this medication. Discuss with your doctor if develop any symptoms of a flu-like illness, such as tiredness, fever, night sweats, rash, vomiting, diarrhea, joint or muscle pain, headache, sore throat, or enlarged lymph nodes in the neck or groin. These symptoms may be signs of an HIV infection.

While you are taking emtricitabine - tenofovir, it is very important to practice safer sex at all times. Do not have any kind of sex without protection. Latex condoms should be used in addition to this medication.

Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if emtricitabine or tenofovir pass into breast milk. Because HIV can be transmitted by breast milk, women who have HIV should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between emtricitabine - tenofovir and any of the following:

• acyclovir

• adefovir

• aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)

• amiodarone

• "azole" antifungals (e.g., itraconazole, ketoconazole, posaconazole)

• carvedilol

• celecoxib

• cladribine

• cobicistat

• cyclosporine

• dronedarone

• elagolix

• eliglustat

• eltrombopag

• enzalutamide

• flibanserin

• ganciclovir

• hepatitis C virus protease inhibitors (e.g., ledipasvir, velpatasvir, voxilaprevir)

• HIV protease inhibitors (e.g., atazanavir, lopinavir, ritonavir)

• ivacaftor

• lamivudine

• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)

• non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)

• orlistat

• paramomycin

• propafenone

• protein kinase inhibitors (e.g., cabozantinib, lapatinib, osimertinib)

• quinidine

• quinine

• ranolazine

• ribavirin

• teriflunomide

• valacyclovir

• valganciclovir

• verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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