Safety Profile

Conducting a great camping trip: Dave

Relieving migraine fast^a: SYMBRAVO

Bravo SYMBRAVO!

^aSome patients experienced migraine relief at 2 hours.

Demonstrated safety and tolerability

In clinical studies, SYMBRAVO was well tolerated. The most common side effects were dizziness (2%) and tiredness (2%) in single-dose migraine treatment studies.

Dizziness and tiredness are not the only possible side effects of SYMBRAVO. For more information, talk to your doctor and refer to the Medication Guide.

During a study of over 700 patients that lasted up to 12 months with ~19,000 doses of SYMBRAVO, 2% of patients left due to side effects.

Tell your HCP about all your medical conditions, including if you:

Have or have had heart problems, high blood pressure, chest pain, or shortness of breath
Have any risk factors for heart or blood vessel problems
Have kidney or liver problems
Have asthma

IMPORTANT SAFETY INFORMATION

INDICATION

What is SYMBRAVO (sim-BRAH-voh)? SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a triptan). SYMBRAVO is an oral prescription medicine used to treat acute migraine headaches with or without aura in adults.

SYMBRAVO is not used to prevent or decrease the number of migraine headaches you have or for treatment of hemiplegic or basilar migraines. SYMBRAVO is not indicated as a treatment for cluster headaches or for use in children.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMBRAVO?

SYMBRAVO may increase the 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, and longer use, of NSAIDs.

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

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

Stop taking SYMBRAVO and get emergency help right away if you have any of the following symptoms which can be indicative of a heart attack or stroke:

discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
weakness in one part or one side of your body
slurred speech

People with risk factors for heart disease should not take SYMBRAVO unless a heart exam is done and shows no problem. You have higher risk for heart disease if you:

have high blood pressure
have high cholesterol
smoke
are overweight
have diabetes or a family history of diabetes

SYMBRAVO can increase the risk of potentially life-threatening bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines that can occur anytime during use and without warning symptoms.

SYMBRAVO may cause serious allergic or skin reactions which can be life-threatening. Stop taking SYMBRAVO and get emergency help right away if you develop:

sudden wheezing or problems breathing or swallowing
rash or reddening of your skin with blisters or peeling
blisters or bleeding of your lips, eye lids, mouth, nose, or genitals
swelling of your lips, tongue, throat or body
fainting

SYMBRAVO already contains an NSAID (meloxicam). Do not use SYMBRAVO with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your HCP first, because they may contain an NSAID also.

Do not take SYMBRAVO if you:

have or had heart problems or right before or after heart bypass surgery
have or had a stroke or transient ischemic attack (TIA)
have or had blood vessel problems of your legs and arms, stomach (ischemic bowel disease), or kidneys
have or had hemiplegic or basilar migraines
have uncontrolled high blood pressure
take propranolol containing medicines
have taken other triptan or ergot-containing medicines within the last 24 hours
take an antidepressant medicine called monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the last 2 weeks
are allergic to meloxicam, rizatriptan, NSAIDs, or any of the ingredients in SYMBRAVO
have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs
have moderate to severe kidney problems and are at risk of kidney failure or if you are on dialysis

SYMBRAVO may cause serious side effects. These serious side effects include:

heartbeats that are too fast or too slow (arrhythmias)
new or worse high blood pressure
heart failure
life-threatening skin reactions
liver or kidney problems including organ failure
low red blood cell count (anemia)
asthma attacks in people who have asthma

Medication Overuse Headaches: Some people who use too many SYMBRAVO tablets may have worse headaches. If your headaches get worse, your HCP may decide to stop your treatment with SYMBRAVO.

Stop taking SYMBRAVO and get emergency help right away if you have any of the following:

Stomach and intestinal problems. Symptoms of gastrointestinal and colonic ischemic events may include sudden or severe stomach pains even after meals; sudden weight loss; severe nausea, vomiting, constipation, diarrhea; and bloody diarrhea.
Circulation problems to legs and feet. Symptoms of peripheral vascular ischemia may include cramping and pain in your legs and hips; heaviness or tightness in leg muscles; burning, aching, numbness, tingling, or weakness in your legs, feet, or toes; cold feelings or color changes in one or both legs or feet.
Serotonin syndrome. Can happen when taking SYMBRAVO with antidepressant medicines called SSRIs or SNRIs. Stop taking SYMBRAVO and call your doctor right away if you have any of the following symptoms:

mental status changes including agitation, hallucinations, or coma
fast heartbeat
changes in your blood pressure
increased body temperature
tight muscles
trouble walking

Stop taking SYMBRAVO and call your healthcare provider right away if you have any of the following symptoms:

nausea
vomiting blood
more tired or weaker than usual
blood in your bowel movement or it is black and sticky like tar
diarrhea
itching, skin rash, or blisters with fever
unusual weight gain
your skin or eyes look yellow
indigestion or stomach pain
swelling of the arms, legs, hands, or feet
flu-like symptoms
tenderness in your right upper side
vision problems

COMMON SIDE EFFECTS

The most common side effects of SYMBRAVO include dizziness and tiredness.

These are not all the possible side effects of SYMBRAVO. Tell your doctor if you have any side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

BEFORE USING

Tell your HCP about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements.
It is important to tell your HCP if you are taking:
- Propranolol containing medicines such as Inderal^® LA or Innopran^® XL
- Aspirin or other anti-coagulants (blood thinners)
- Medicines to help your mood including SSRIs and SNRIs
If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take SYMBRAVO with your other medicines.
Tell your HCP if you are pregnant or plan to become pregnant. SYMBRAVO is not recommended during pregnancy. Taking NSAIDs, including SYMBRAVO, at about 20 weeks of pregnancy or later may harm your unborn baby. NSAIDs, including SYMBRAVO, should not be taken after about 30 weeks of pregnancy.
Tell your HCP if you are breastfeeding or plan to breastfeed.

Tell your HCP about all your medical conditions, including if you:

have or have had heart problems, high blood pressure, chest pain, or shortness of breath
have any risk factors for heart or blood vessel problems
have kidney or liver problems
have asthma

Review the list below with your HCP. SYMBRAVO may not be right for you if:

take daily preventative aspirin
you are pregnant or plan to become pregnant
you are breastfeeding or plan to breastfeed

HOW TO TAKE

SYMBRAVO is available by prescription only.
Take SYMBRAVO exactly as instructed by your HCP.
The maximum daily dose of SYMBRAVO is 1 tablet. Talk to your HCP about what to do if your headache does not go away or comes back.
Take SYMBRAVO for the shortest time needed.
Swallow SYMBRAVO tablets whole. Do not crush, chew, or divide the tablets.
SYMBRAVO can be taken with or without food.
Do not give SYMBRAVO to other people.
If you take too much SYMBRAVO call your poison control center at 1‑800‑222‑1222 or go to the nearest hospital emergency room right away.

LEARN MORE

For more information about SYMBRAVO, call 866‑496‑2976 or visit SYMBRAVO.com.

This summary provides basic information about SYMBRAVO but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about SYMBRAVO and how to take it. Your HCP is the best person to help you decide if SYMBRAVO is right for you.

SYM CON BS 01/2025

Please see full Prescribing Information, including Boxed Warning, for risk of serious cardiovascular and gastrointestinal events, and Medication Guide.

Safety Profile

Demonstrated safety and tolerability

Medical conditions

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