QMIIZ ODT- meloxicam tablet, orally disintegrating 
TerSera Therapeutics LLC

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This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: 07/2019

Medication Guide for
QMIIZODT (kew'-miz oh dee tee)
(meloxicam) Orally Disintegrating Tablet

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:

  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
    • with increasing doses of NSAIDs
    • with longer use of NSAIDs

    Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

    Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
    • anytime during use
    • without warning symptoms
    • that may cause death

    The risk of getting an ulcer or bleeding increases with:

    • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
    • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
  • increasing doses of NSAIDs
  • longer use of NSAIDs
  • smoking
  • drinking alcohol
  • older age
  • poor health
  • advanced liver disease
  • bleeding problems
NSAIDs should only be used:
  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.
Who should not take QMIIZ ODT?
Do not take QMIIZ ODT:
  • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • right before or after heart bypass surgery.
  • if you have phenylketonuria (PKU). QMIIZ ODT contains phenylalanine (a component of aspartame).
Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:
  • have liver or kidney problems
  • have high blood pressure
  • have asthma
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
  • are breastfeeding or plan to breast feed.
Tell your healthcare provider about all the medicines you take, including prescription or over-the- counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.
How should I take QMIIZ ODT Orally Disintegrating Tablet (ODT)?
  • Take QMIIZ ODT exactly as prescribed.
  • Leave QMIIZ ODT in the package it comes in until you are ready to take it.
  • When you are ready to take your dose
    • Be sure your hands are dry
    • Open the carton and peel back the foil on the blister. Do not push the tablet through the foil.
    • As soon as you open the blister, remove the tablet and put it onto your tongue.
    • The tablet will disintegrate quickly in your saliva so that you can easily swallow it with or without drinking liquid.
What are the possible side effects of NSAIDs?
NSAIDs can cause serious side effects, including:
See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Get emergency help right away if you get any of the following symptoms:
  • shortness of breath
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat
Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms, legs hands and feet
If you take too much of your NSAID, call your healthcare provider or get medical help right away.
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other information about NSAIDs
  • Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
How should I store QMIIZ ODT?
  • Store QMIIZ ODT at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Excursions permitted between 59 °F to 86 °F (15 °C to 30 °C).
  • Keep QMIIZ ODT dry and away from moisture. Avoid high humidity and excessive heat above 104 °F (40 °C)
Keep QMIIZ ODT and all medicines out of the reach of children.
General information about the safe and effective use of NSAIDs.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.
Manufactured for: TerSera Therapeutics LLC, Lake Forest, IL 60045
Manufactured by: Catalent Pharma Solutions, Limited, Swindon, Wilshire, SN5 8RU, UK

QMIIZ ODT is a trademark of TerSera Therapeutics LLC.
© 2019 TerSera Therapeutics LLC
For more information, go to www.QMIIZODT.com or call 1- (844) 334-4035.
Revised: 7/2019
TerSera Therapeutics LLC