Metaxalone

Metaxalone comes as a tablet to take by mouth. It usually is taken three or four times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take metaxalone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking metaxalone,

• tell your doctor and pharmacist if you are allergic to metaxalone, any other medications, or any of the ingredients in metaxalone tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking metaxolone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had anemia (a condition with an abnormally low number of red blood cells), kidney disease, or liver disease, Your doctor may tell you not to take metaxalone.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking metaxalone, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking metaxalone.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how metaxalone affects you.
• remember that alcohol can add to the drowsiness caused by this drug.

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• drowsiness
• dizziness
• headache
• nervousness

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• agitation, hallucinations, coma, fever, sweating, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• rash; itching; swelling of the lips, face, or tongue; shortness of breath; difficulty breathing or swallowing
• yellowing of the skin or eyes

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).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, 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 reach. https://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.

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:

• drowsiness
• extreme tiredness
• agitation
• difficulty breathing
• seizures
• fast heart rate
• hallucinations (seeing things or hearing voices that do not exist)
• delusions (having strange thoughts or beliefs that have no basis in reality)
• coma
• high body temperature
• muscle twitching or loss of muscle control

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking metaxolone.

Do not let anyone else take your medications. 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.