October 25, 2014
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Drug Factsheets

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Complera

(emtricitabine - rilpivirine - tenofovir)

DIN (Drug Identification Number)

02374129 COMPLERA TABLET

What side effects are possible with Complera?

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.

  • diarrhea
  • dizziness
  • fatigue
  • gas
  • headache
  • heartburn
  • loss of appetite
  • nausea
  • skin discolouration (e.g., freckles or small spots)
  • sleep problems, such as trouble sleeping or sleepiness
  • stomach pain or discomfort
  • unusual dreams
  • 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:

  • anxiety
  • bone pain or fractures
  • changes in fat distribution (e.g., increased fat in the upper back and neck, breasts, and trunk; and loss of fat from the arms, legs, and face)
  • fever
  • joint pain
  • muscle aches or pain
  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual tiredness, dizziness, rapid heart rate)
  • signs of liver problems (e.g., yellowing of skin or eyes, darkened urine, light-coloured stools, loss of appetite, nausea, vomiting, lower stomach pain)
  • skin rash
  • symptoms of heart rhythm disturbance, such as abnormal heart rhythms (e.g., fast or slow heart rate, palpitations), fainting, or seizures

Seek immediate medical attention if any of the following occur:

  • signs of an allergic reaction (e.g., skin rash; redness; irritation; swelling of the face, lips, tongue, or throat)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

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.





Are there any other precautions or warnings for Complera?

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.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, pimozide, gatifloxacin, moxifloxacin, mefloquine, dolasetron mesylate, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with emtricitabine - rilpivirine - tenofovir.

If you have heart disease and abnormal heart rhythms, or are taking certain medications that can affect heart rhythm, 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.

Bone loss/osteoporosis: This medication may cause increased breakdown of bone by the body. If this happens, bones lose strength and bone fractures may occur.

If you have osteoporosis or bone loss, 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.

Depression: Antiretroviral medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, 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.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Fat redistribution: Over time, this medication may change how fat is distributed in your body and may change your body shape. You may notice increased fat in the upper back and neck, breast, around the back, chest, and stomach area; or loss of fat from the legs, arms, and face. The long-term effects of this are not known.

Hepatitis B: There have been reports of serious liver problems while taking emtricitabine or tenofovir, two of the ingredients in this medication. If you are also infected with hepatitis B, you may experience flare-ups of hepatitis B when you stop taking this medication. Do not stop taking this medication without first consulting with your doctor. The safety and effectiveness of this medication when used by people with hepatitis B has not been determined.

Immune reconstitution 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 or tuberculosis). Report any new symptoms to your doctor immediately.

Kidney function: Kidney failure and severe kidney damage has been reported by people using tenofovir. Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects.

If you have reduced kidney function, 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.

People with severely reduced kidney function should not take this medication.

Lactic acidosis and enlarged fatty liver: Tenofovir, an ingredient in this medication, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) together with an enlarged fatty liver. This tends to occur more often in women, especially if they are overweight. If you experience any of the following symptoms, call your doctor immediately:

  • abdominal pain, swelling, bloating, or discomfort
  • diarrhea
  • dizziness or lightheadedness
  • fatigue
  • feeling cold
  • feeling unwell
  • nausea
  • slow or irregular heartbeat
  • shortness of breath
  • vomiting
  • weakness
  • weight loss
  • yellowing of the skin or eyes

Your doctor will monitor your liver function periodically by ordering laboratory tests.

Liver function: Rilpivirine, one of the ingredients in this medication, is largely removed from the body by the liver and may cause liver problems. If you have liver disease or decreased liver function, 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.

This medication should not be used by people with severely reduced liver function.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Other HIV medications: Emtricitabine - rilpivirine - tenofovir is a combination medication that should not be taken at the same time as any other medication that contains the same active ingredients. This medication should also not be taken at the same time as medications containing lamivudine or adefovir.

Pancreatitis (inflammation of the pancreas): Tenofovir may cause or worsen 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.

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.

If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.

Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: This 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 - rilpivirine - tenofovir passes into breast milk. Women who have HIV infection should not breast-feed because of the risk of passing HIV to a baby who does not have the infection.

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

Seniors: The effects of this medication on seniors have not been well studied. It is likely that people over the age of 65 will experience more side effects and should report any unusual effects to their doctor as soon as possible.

What other drugs could interact with Complera?

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

  • acyclovir
  • adefovir
  • amphoteracin B
  • antacids (e.g., aluminum hydroxide, calcium carbonate)
  • "azole" antibiotics (e.g., itraconazole, ketoconazole, voriconazole)
  • carbamazepine
  • corticosteroids (high dose; hydrocortisone, prednisone)
  • dexamethasone
  • didanosine
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide)
  • fosphenytoin
  • ganciclovir
  • H2 antagonists (e.g., cimetidine, famotidine, ranitidine)
  • lamivudine
  • macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin)
  • methadone
  • nefazodone
  • non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, etravirine, nevirapine)
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • primidone
  • protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir, saquinavir)
  • proton pump inhibitors (e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)
  • ribavirin
  • rifabutin
  • rifampin
  • rifapentine
  • St. John's wort
  • valacyclovir
  • valganciclovir

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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