Zolmitriptan Oral (patient information)

Why is this medication prescribed

Zolmitriptan is used to treat the symptoms of migraine headache (severe throbbing headache that sometimes is experienced with other symptoms such as upset stomach and sensitivity to sound and light). Zolmitriptan is in a class of medications called selective serotonin (5-HT) receptor agonists. It works by reducing swelling of blood vessels around the brain and blocking the release of certain natural substances that cause pain, upset stomach, and other symptoms of migraine. Zolmitriptan does not prevent migraine attacks.

How should this medicine be used

Zolmitriptan comes as a tablet and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken during a migraine attack. If your symptoms improve after you take zolmitriptan but return after 2 hours or longer, you may take a second dose. However, if your symptoms do not improve after you take zolmitriptan, do not take a second dose without calling your doctor. Your doctor will tell you the maximum number of tablets or orally disintegrating tablets you may take in a 24 hour period.Call your doctor if you need to take zolmitriptan to treat more than 3 headaches in one month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take zolmitriptan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not take zolmitriptan to treat a headache that feels different than your usual migraine attacks. Call your doctor to find out what you should do.

If you have certain risk factors for heart disease, your doctor may ask you to take your first dose of zolmitriptan in the doctor's office or other medical facility where you can be monitored for serious reactions.

If your doctor has prescribed a dose lower than 2.5 mg, you may use your fingers to break the 2.5 mg tablet on the line that divides it in half. However, you should not break or split the orally disintegrating tablet.

To take the orally disintegrating tablet, use dry hands to peel back the foil packaging. Immediately take out the tablet and place it on your tongue. The tablet will quickly dissolve and can be swallowed with saliva. No water is needed to swallow disintegrating tablets.Do not open the foil packaging or remove the orally disintegrating tablet until just before you are ready to take it.

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

Other uses for this medicine

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

What special precautions should I follow

Before taking zolmitriptan

• tell your doctor and pharmacist if you are allergic to zolmitriptan or any other medications.
• do not take zolmitriptan if you have taken any of the following medications in the past 24 hours: other selective serotonin receptor (5-HT) agonists such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), or sumatriptan (Imitrex); or ergot-type medications such as bromocriptine (Parlodel), cabergoline (Dostinex), dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Germinal, Hydergine), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), methylergonovine (Methergine), methysergide (Sansert), and pergolide (Permax).
• do not take zolmitriptan if you are taking a monoamine oxidase A (MAO-A) inhibitor such as isocarboxazid (Marplan), phenelzine (Parnate), or tranylcypromine (Nardil) or if you have taken one of these medications in the past 2 weeks.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention any of the following: acetaminophen (Tylenol), cimetidine (Tagamet), oral contraceptives ('birth control pills'), propranolol (Inderal), and selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you smoke, if you or any family members have or have ever had heart disease, if you have gone through menopause (change of life), and if you have or have ever had a heart attack; angina (chest pain); pounding or irregular heartbeat; shortness of breath; a stroke or 'mini-stroke'; high blood pressure; high cholesterol; diabetes; seizures;circulation problems such as varicose veins, blood clots in the legs, Raynaud's disease (problems with blood flow to the fingers, toes, ears, and nose), or ischemic bowel disease (bloody diarrhea and stomach pain caused by decreased blood flow to the intestines);or liveror kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you plan to be sexually active while you are taking this medication, talk to your doctor about effective methods of birth control. If you become pregnant while taking zolmitriptan, call your doctor.
• you should know that this medication may cause drowsiness and dizziness. Do not drive a car or operate machinery until you know how zolmitriptan affects you.
• talk to your doctor about your headache symptoms. Zolmitriptan should not be used to treat certain types of migraine headaches (hemiplegic or basilar) or other types of headaches (such as cluster headaches).
• if you have phenylketonuria (PKU, a inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the orally disintegrating tablets contain phenylalanine.

What special dietary instructions should I follow

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

Side Effects

Mild side effects

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

• burning or tingling feeling
• feeling warm or cold
• drowsiness
• dry mouth
• upset stomach
• heartburn
• sweating
• weakness

Severe side effects

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

• pain, tightness, pressure, or heaviness in the chest, throat, or jaw
• muscle aches
• slow or difficult speech
• dizziness or faintness
• weakness or numbness of an arm or leg
• fast, pounding, or irregular heartbeat
• bloody diarrhea
• stomach pain
• paleness or blue color of the fingers and toes
• shortness of breath
• swelling of the eyes, face, lips, tongue, or throat,
• difficulty swallowing
• hoarseness
• rash or lumps on the skin

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 [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

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). Throw away any medication that is outdated or no longer needed and any orally disintegrating tablets that you removed from the blister pack but did not use immediately. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• sleepy, quiet state.

What other information should I know

Keep all appointments with your doctor and the laboratory.

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

Brand names

• Zomig®
• Zomig-ZMT®