Meloxicam and Rizatriptan

IMPORTANT WARNING:

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as the combination of meloxicam and rizatriptan may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as meloxicam if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, angina (chest pain), irregular heartbeats, a stroke, diabetes, if you smoke, and if you have or have ever had high cholesterol or high blood pressure. Get emergency medical help right away if you experience any of the following symptoms: pain in the chest, arms, back, neck, jaw, or stomach; breaking out in cold sweat; lightheadedness shortness of breath; nausea or vomiting; weakness in one part or side of the body; slurred speech; sudden severe headache; problems walking; dizziness; loss of balance or coordination; or changes in vision.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart bypass surgery), you should not take meloxicam and rizatriptan right before or right after the surgery.

NSAIDs such as meloxicam may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, if you smoke, drink large amounts of alcohol, or have liver disease. Tell your doctor if you have or have ever had ulcers or bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking meloxicam and rizatriptan and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Tell your doctor and pharmacist what prescription and nonprescriptionmedications, vitamins, nutritional supplements, and herbal products you are taking orplan to take while taking meloxicam and rizatriptan. Make sure you tell your doctor if you are taking medications that may increase your risk of bleeding. Your doctor may need to change the doses of yourmedications or monitor you carefully for side effects.

You will be given the Medication Guide when you begin treatment with meloxicam and rizatriptan and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visithttps://www.fda.gov/Drugs/DrugSafety/ucm085729.htmto obtain the Medication Guide.

WHY is this medicine prescribed?

Meloxicam and rizatriptan is used to treat the symptoms of migraine headaches. Meloxicam is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain and inflammation. Rizatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Meloxicam and rizatriptan does not prevent migraine attacks or reduce the number of headaches you have.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Meloxicam and rizatriptan comes as a tablet to take by mouth. Take with or without food as a single dose at the first sign of a migraine headache. Call your doctor if your symptoms do not improve after you take meloxicam and rizatriptan. Do not take a second tablet.

Swallow the tablets whole; do not split, chew, or crush them.

Call your doctor if your headaches do not get better or occur more frequently after taking meloxicam and rizatriptan.

If you take meloxicam and rizatriptan more often or for longer than the recommended period of time, your headaches may get worse or may occur more frequently. You should not take meloxicam and rizatriptan or any other headache medication for more than 10 days per month. Call your doctor if you need to take meloxicam and rizatriptan to treat more than 7 headaches in a 1-month period.

What SPECIAL PRECAUTIONS should I follow?

Before taking meloxicam and rizatriptan,

• tell your doctor and pharmacist if you are allergic to this drug combination, any part of this drug combination, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• some medications should not be taken with meloxicam and rizatriptan. Make sure you have discussed any medications you are currently taking or plan to take before starting meloxicam and rizatriptan with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking meloxicam and rizatriptan, please get the advice of your doctor or pharmacist.

• tell your doctor pharmacist if you are taking the following medications or have taken them in the past 24 hours: other selective serotonin receptor agonists such as almotriptan, eletriptan (Relpax), naratriptan, rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), or zolmitriptan (Zomig); or ergot-type medications such as bromocriptine (Cycloset, Parlodel), cabergoline, dihydroergotamine (Ergomar, Migranal, Trudhesa), ergonovine, ergotamine (Ergomar, in Migergot), and methylergonovine.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase A (MAO-A) inhibitor such as isocarboxazid (Marplan), phenelzine (Parnate), or tranylcypromine (Nardil).

• the following nonprescription or herbal products may interact with meloxicam and rizatriptan: aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking meloxicam. Do not start any of these medications while taking meloxicam without discussing with your healthcare provider.

• tell your doctor if you have or ever had ischemic bowel disease (bloody diarrhea and stomach pain caused by decreased blood flow to the intestines) or kidney problems. Your doctor may tell you not to take meloxicam and rizatriptan.

• tell your doctor if you have or have ever had circulation problems such as varicose veins, blood clots in the legs, or Raynaud's disease (problems with blood flow to the fingers, toes, ears, and nose); asthma, especially if you have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); or any other medical condition.

• tell your doctor if you are pregnant, plan to become pregnant; or are breast-feeding. Meloxicam may harm the fetus and cause problems with delivery if it is taken around 20 weeks or later during pregnancy. Do not take meloxicam and rizatriptan around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while taking meloxicam and rizatriptan, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking meloxicam and rizatriptan.

• you should know that meloxicam and rizatriptan may make you drowsy, dizzy, or feel weak. Do not drive a car or operate machinery until you know how this medication affects you.

• talk to your doctor about your headache symptoms to make sure they are caused by migraine. Meloxicam and rizatriptan should not be used to treat hemiplegic or basilar migraine or headaches caused by other conditions (such as cluster headaches).

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Meloxicam and rizatriptan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• gas or bloating
• dizziness
• drowsiness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking meloxicam and rizatriptan and call your doctor immediately or get emergency medical treatment:

• rash; blistering, peeling, or bleeding skin;hives;itching;swelling of the eyes, face, tongue, lips, or throatdifficulty; breathing or swallowing; or hoarseness
• pain, burning, numbness, tingling or weakness in the legs or feet; or paleness or blue color of the legs, feet, or toes
• fast, slow, or irregular heartbeat; chest pain; pale skin; unusual tiredness or weakness; or cold hands and feet
• shortness of breath or difficulty breathing; unexplained weight gain; or swelling in the abdomen, ankles, feet, or legs
• nausea, excessive tiredness, lack of energy, yellowing of the skin or eyes, pain in the right upper part of the stomach, diarrhea, itching, and flu-like symptoms
• cloudy, discolored, or bloody urine; back pain; or decreased, difficult, or painful urination

Meloxicam and rizatriptan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reachhttps://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• lack of energy
• drowsiness
• dizziness or faintness
• nausea,vomiting, orstomach pain
• bloody, black, or tarry stools; or vomit that is bloody or looks like coffee grounds
• difficulty breathing
• rapid, pounding, or irregular heartbeat
• tightness, pain, pressure, or heaviness in the chest, throat, neck, and/or jaw

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly.

You should keep a headache diary by writing down when you have headaches and when you take meloxicam and rizatriptan.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.