Maxalt-MLT

Maxalt-MLT is a headache medicine that narrows the blood vessels around the brain. This medicine also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Maxalt-MLT is used to treat migraine headaches. This medicine will only treat a headache that has already started. It will not prevent headaches or decrease the number of attacks.

Maxalt-MLT should not be used to treat a common tension headache, or a headache that causes loss of movement on one side of your body. Use Maxalt-MLT only if your doctor has confirmed that you have migraine headaches.

Maxalt-MLT may also be used for purposes not listed in this medication guide.

You should not use Maxalt-MLT if you have uncontrolled high blood pressure, heart problems, a history of heart attack or stroke, or circulation problems that cause a lack of blood supply within the body.

Do not take Maxalt-MLT within 24 hours before or after using another migraine headache medicine.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

You should not use Maxalt-MLT if you are allergic to it, or if you have:

• heart problems, or a stroke (including "mini-stroke");
• coronary artery disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;
• circulation problems affecting your legs, arms, stomach, intestines, or kidneys;
• uncontrolled high blood pressure;
• severe liver disease; or
• a headache that seems different from your usual migraine headaches.

Do not use Maxalt-MLT if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have ever had:

• liver or kidney disease;
• heart problems, chest pain;
• shortness of breath; or
• risk factors for coronary artery disease (such as high blood pressure, high cholesterol, diabetes, menopause, smoking, a family history of coronary artery disease, being overweight, or being older than 40 and a man).

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with Maxalt-MLT and cause a serious condition called serotonin syndrome.

Maxalt-MLT disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant or breastfeeding.

Maxalt-MLT is not approved for use by anyone younger than 6 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Maxalt-MLT may lead to serious side effects. Stop using Maxalt-MLT and call your doctor immediately if you experience:

• sudden and severe stomach pain and bloody diarrhea;
• cold feeling or numbness in your feet and hands;
• severe headache, blurred vision, pounding in your neck or ears;
• heart attack symptoms—chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• high levels of serotonin in the body—agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea; or
• signs of a stroke—sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects of Maxalt-MLT may include:

• dizziness, drowsiness, feeling tired; or
• pain or a feeling of pressure in your throat or chest.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take Maxalt-MLT as soon as you notice headache symptoms. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Take the regular tablet whole with a full glass of water.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

After taking a tablet (for adults): If your headache does not completely go away, or goes away and comes back, take a second tablet 2 hours after the first. If your symptoms have not improved, contact your doctor before taking any more tablets.

After taking a tablet (for children ages 6 to 17): If your headache does not completely go away, or goes away and comes back, contact your doctor before taking any more tablets.

Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Call your doctor if your symptoms do not improve, or if you have more than 4 headaches in one month (30 days).

Maxalt-MLT can raise blood pressure to dangerous levels. Your blood pressure may need to be checked often while you are using Maxalt-MLT. If you use this medicine long-term, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture and heat.

Since Maxalt-MLT is taken only as needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not get better after using this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not take Maxalt-MLT within 24 hours before or after using another migraine headache medicine, including:

• almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, zolmitriptan; or
• ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine.

Avoid driving or doing anything dangerous until you know how Maxalt-MLT will affect you. Your reactions could be impaired.

Tell your doctor about all your other medicines, especially:

• propranolol;
• an antidepressant; or
• medicine to treat a mood disorder.

This list is not complete. Other drugs may affect Maxalt-MLT, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Tell your doctor about all your other medicines, especially any type of antidepressant.

Other drugs may affect Maxalt-MLT, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.