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Complera (Generic Emtricitabine, Rilpivirine, and Tenofovir)

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WARNING

Hepatitis B virus infection should not be treated with emtricitabine, rilpivirine, or tenofovir (HBV; an ongoing liver infection). If you suspect you may have HBV, let your doctor know. Before you start taking emtricitabine, rilpivirine, and tenofovir for your condition, your doctor may do a test to determine whether you have HBV. If you are taking emtricitabine, rilpivirine, and tenofovir and have HBV, your condition could abruptly go worse if you stop taking them. For several months after you stop taking emtricitabine, rilpivirine, and tenofovir, your doctor will check on you and place lab tests to see if your HBV has gotten worse.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to emtricitabine, rilpivirine, and tenofovir, your doctor will prescribe specific tests both before and during your therapy.

The dangers of using emtricitabine, rilpivirine, and tenofovir should be discussed with your doctor.

Why is this medication prescribed?

Emtricitabine, rilpivirine, and tenofovir are taken in combination to treat HIV in adults and kids who weigh at least 77 pounds (35 kilograms). Nucleoside and nucleotide reverse transcriptase inhibitors are a class of medicines that includes emtricitabine, rilpivirine, and tenofovir (NRTIs). They function by containing the spread of HIV within the body. Despite the fact that emtricitabine, rilpivirine, and tenofovir do not treat HIV, they may lessen your risk of getting AIDS and other HIV-related conditions such serious infections or cancer. The risk of contracting or spreading the HIV virus to others may be reduced by taking these medications, engaging in safer sexual behaviour, and changing other aspects of one’s lifestyle.

How should this medicine be used?

Emtricitabine, rilpivirine, and tenofovir are available as a tablet for oral use. Once a day, it is often taken together with a meal (not just a protein drink). Emtricitabine, rilpivirine, and tenofovir should be taken every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Emtricitabine, rilpivirine, and tenofovir must all be taken exactly as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Throughout your treatment, your doctor might advise or prescribe a calcium and vitamin D supplement. These supplements should be taken daily as prescribed by your doctor.

Even if you feel good, keep taking emtricitabine, rilpivirine, and tenofovir. Without consulting your doctor, do not discontinue taking emtricitabine, rilpivirine, or tenofovir.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking emtricitabine, rilpivirine, and tenofovir,

  • If you have an allergy to emtricitabine, rilpivirine, tenofovir, any other medications, or any of the ingredients in emtricitabine, rilpivirine, and tenofovir tablets, inform your doctor and pharmacist right away. Get a list of the components from your pharmacist.
  • You should let your doctor know if you’re taking any of the following medications: carbamazepine (Carbatrol, Equetro, Tegretol, and others), dexamethasone, dexlansoprazole (Dexilant), esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, in Zegerid), oxcarba Emtricitabine, rilpivirine, and tenofovir should not be taken if you are taking one or more of these drugs, according to your doctor.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: antibiotics such as adefovir (Hepsera), amiodarone (Nexterone, Pacerone), erythromycin (E.E.S., Ery-Tab, Erythrocin, and others), gentamicin, and telithromycin (Ketek); medications for treating fungal infections including fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole, posaconazole (Noxafil), and voriconazole (Vfend); drugs for treating tuberculosis (anti-TB) include rifabutin (Mycobutin) and rilpivirine (Edurant); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and cidofovir (Cytovene), ganciclovir (Cytovir), valacyclovir (Valtrex), and valganciclovir (Valcyte), cyclosporine (Gengraf, Neoral, Sandimmune); other HIV drugs including emtricitabine, rilpivirine, or tenofovir (Atripla, Descovy, Edurant, Emtriva, Genvoya, Odefsey, Stribild, Truvada, Vemlidy, Viread); methadone; and lamivudine (Epivir, Epivir-HBV, in Combivir, Epzicom, Triumeq, Trizivir); (Dolophine). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Emtricitabine, rilpivirine, and tenofovir should be taken at least 2 hours before or at least 4 hours after taking antacids containing calcium, magnesium, or aluminium (Maalox, Mylanta, Tums, etc.).
  • Use cimetidine (Tagamet), famotidine (Pepcid, in Duexis), nizatidine (Axid), or ranitidine (Zantac) or any other indigestion, heartburn, or ulcer medication at least 12 hours before or at least 4 hours after taking emtricitabine, rilpivirine, or tenofovir.
  • Inform your doctor if you have or have ever had any of the conditions listed in the IMPORTANT WARNING section, depression or other mental illness, bone issues such as osteoporosis or bone fractures, or any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in individuals with weasel-like symptoms).
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor right away if you get pregnant while taking emtricitabine, rilpivirine, or tenofovir. If you have HIV or are taking emtricitabine, rilpivirine, or tenofovir, you shouldn’t breastfeed.
  • Emtricitabine, rilpivirine, and tenofovir may alter your ideas, behaviour, or mental health, so you should be aware of this. If you experience any of the following signs while taking emtricitabine, rilpivirine, or tenofovir, call your doctor right away: Feeling down, despairing, worried, or restless; thinking about suicide; planning; or really trying to commit suicide.
  • You should be aware that when you take HIV medicine, your immune system could become stronger and start to fight other infections that were already present in your body. You might begin to exhibit signs of those infections as a result of this. Tell your doctor right away if you experience any new or worsening symptoms while taking emtricitabine, rilpivirine, or tenofovir.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

As soon as you recall, take the missed dose with food. Skip the missed dose and carry on with your regular dosing plan if it has been more than 12 hours since your last dose. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There could be negative effects with emtricitabine, rilpivirine, and tenofovir. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Having trouble falling or staying asleep
  • Strange dreams
  • Alteration in skin tone
  • Hands or feet may experience tingling, burning, or aching
  • Headache
  • Diarrhea
  • Slight rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

  • Edoema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Persistent or escalating bone pain
  • Aching or weakened muscles
  • Less urinations
  • Stomach’s upper right corner hurts
  • Nausea
  • Vomiting
  • Reduced appetite
  • Flu-like signs
  • Extreme fatigue
  • Uncommon bruising or bleeding
  • Weakness
  • Dizziness
  • Lightheadedness
  • Rapid or erratic heartbeat
  • Having trouble breathing
  • Urine that is dark yellow or brown.
  • Colored-light bowel motions
  • Eyes or skin that have a yellow tint
  • Experience coldness, especially in your arms or legs

Emtricitabine, rilpivirine, and tenofovir should be stopped immediately if you experience any of the following symptoms along with a severe rash, and you should seek emergency medical attention if necessary:

  • Face, lips, mouth, tongue, or throat swelling
  • Breathing or swallowing challenges
  • Mouth ulcers or body blisters
  • Rosy and enlarged eyes
  • Fever
  • Dark faeces
  • Right side of the stomach hurts
  • Eyes or skin that have a yellow tint

Rilpivirine, tenofovir, and emtricitabine could also have additional side effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

Emtricitabine, rilpivirine, and tenofovir should always be available. Do not put off getting a refill on your prescription until you are out of medicine.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Complera® (as a combination product containing Emtricitabine, Rilpivirine, Tenofovir)
  • Odefsey® (as a combination product containing Emtricitabine, Rilpivirine, Tenofovir)
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