Zomig-ZMT

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

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

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Zomig^®
• Zomig-ZMT^®

• It is used to treat migraine headaches.

• If you have an allergy to zolmitriptan or any other part of Zomig ZMT (zolmitriptan orally disintegrating tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: High blood pressure or some types of migraine headaches like hemiplegic or basilar migraine.
• If you have liver disease.
• If you have ever had any of these health problems: Chest pain or pressure; diseased arteries going to the legs or arms; heart attack; heart disease; poor blood flow in the heart, brain, bowel, or kidney; stroke; or a heartbeat that is not normal like Wolff-Parkinson-White syndrome.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you have taken almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or sumatriptan in the last 24 hours.
• If you have taken ergotamine, methysergide, dihydroergotamine, or any drug like them in the last 24 hours.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Zomig ZMT.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Dizziness.
• Feeling sleepy.
• Feeling of warmth.
• Feeling of heaviness or pressure.
• Dry mouth.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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

Zolmitriptan is used to treat migraine headaches in adults.

Zolmitriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Zolmitriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Zolmitriptan may also be used for purposes not listed in this medication guide.

Zolmitriptan is used to treat acute migraine headaches in adults. It is not used to prevent migraine headaches and is not used for cluster headaches. Zolmitriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans.

Many people find that their headaches go away completely after they take zolmitriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Zolmitriptan often relieves symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Zolmitriptan is not an ordinary pain reliever. It should not be used to relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Zolmitriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the benefits that it can do.

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chest pain (severe)
• heaviness, tightness, or pressure in the chest or neck
• sensation of burning, warmth, heat, numbness, tightness, or tingling

• Abdominal or stomach pain (severe)
• changes in facial skin color
• cough or hoarseness
• diarrhea
• fast or irregular heartbeat
• fever or chills
• hives, itching, or skin rash
• itching
• loss of appetite
• lower back or side pain
• nausea
• painful or difficult urination
• puffiness or swelling of the eyelids or around the eyes, face, or lips
• tightness in the chest
• trouble breathing
• weakness

• Blurred vision
• confusion
• difficulty swallowing
• dizziness
• fainting
• frequent strong or increased urge to urinate
• headache
• increased volume of pale, dilute urine
• nervousness
• pounding in the ears
• severe numbness, especially on one side of the face or body
• slow heartbeat
• unusual tiredness or weakness

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Lack or loss of strength
• sleepiness or unusual drowsiness
• warm or cold sensation

• Dizziness or lightheadedness
• dry mouth
• feeling of constant movement of self or surroundings
• sensation of spinning

• Anxiety
• crying
• depersonalization
• depression
• dysphoria
• euphoria
• hyperventilation
• irritability
• loss of memory
• paranoia
• problems with memory
• quick to react or overreact emotionally
• rapidly changing moods
• redness of the skin
• seeing, hearing, or feeling things that are not there
• shaking
• trouble sleeping
• welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to zolmitriptan: oral tablet, oral tablet disintegrating

Other dosage forms:

• nasal spray

Along with its needed effects, zolmitriptan (the active ingredient contained in Zomig-ZMT) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zolmitriptan:

• Chest pain (severe)
• heaviness, tightness, or pressure in the chest or neck
• sensation of burning, warmth, heat, numbness, tightness, or tingling

• Abdominal or stomach pain (severe)
• changes in facial skin color
• cough or hoarseness
• diarrhea
• fast or irregular heartbeat
• fever or chills
• hives, itching, or skin rash
• itching
• loss of appetite
• lower back or side pain
• nausea
• painful or difficult urination
• puffiness or swelling of the eyelids or around the eyes, face, or lips
• tightness in the chest
• trouble breathing
• weakness

• Blurred vision
• confusion
• difficulty swallowing
• dizziness
• fainting
• frequent strong or increased urge to urinate
• headache
• increased volume of pale, dilute urine
• nervousness
• pounding in the ears
• severe numbness, especially on one side of the face or body
• slow heartbeat
• unusual tiredness or weakness

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of zolmitriptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Lack or loss of strength
• sleepiness or unusual drowsiness
• warm or cold sensation

• Dizziness or lightheadedness
• dry mouth
• feeling of constant movement of self or surroundings
• sensation of spinning

• Anxiety
• crying
• depersonalization
• depression
• dysphoria
• euphoria
• hyperventilation
• irritability
• loss of memory
• paranoia
• problems with memory
• quick to react or overreact emotionally
• rapidly changing moods
• redness of the skin
• seeing, hearing, or feeling things that are not there
• shaking
• trouble sleeping
• welts

Applies to zolmitriptan: nasal spray, oral tablet, oral tablet disintegrating

Cardiovascular

Common (1% to 10%): Chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, palpitations
Uncommon (0.1% to 1%): Arrhythmias, hypertension, syncope, tachycardia
Rare (less than 0.1%): Angina pectoris, myocardial infarct, coronary vasospasm, QT prolongation, thrombophlebitis[Ref]

Rare reports of serious cardiac adverse events have been reported including acute myocardial infarction within a few hours following administration of this drug.

Chest pain/tightness/pressure and/or heaviness appear to be dose-related occurring in 2%, 3%, and 4% of patients receiving 1 mg, 2.5 mg, and 5 mg, respectively. Neck/throat/jaw pain/tightness/pressure occurred in 4%, 7%, and 10% of patients, respectively.[Ref]

Nervous system

Very Common (greater than 10%): Taste disturbances (up to 21%, inhaler)
Common (1% to 10%): Paresthesia, somnolence, dizziness, hyperesthesia
Rare (less than 0.1%): Cerebral ischemia, amnesia, convulsions, ataxia, dystonia, hyperkinesia, hypotonia, hypertonia
Frequency not reported: Serotonin syndrome[Ref]

Paresthesia appears to be a dose-related adverse event occurring in 5%, 7%, and 9% of patients receiving 1 mg, 2.5 mg, and 5 mg, respectively.[Ref]

Other

Common (1% to 10%): Warm/cold sensation, heaviness other than chest or neck, pressure/tightness/heaviness, vertigo, asthenia, chills
Uncommon (0.1% to 1%): Tinnitus, hyperacusis, ear pain[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dry mouth, dysphagia, dyspepsia, abdominal pain, vomiting
Uncommon (0.1% to 1%): Gastroenteritis, increased thirst
Rare (less than 0.1%): Stomatitis, constipation, hematemesis, pancreatitis, melena, ulcer
Very rare (less than 0.01%): Bloody diarrhea, gastrointestinal infarction or necrosis, gastrointestinal ischemic events, ischemic colitis, splenic infarction[Ref]

General

The most common adverse reactions included neck, throat, jaw pain; dizziness; paresthesia; asthenia; somnolence; warm and cold sensation; nausea; heaviness sensation; and dry mouth. In adolescents treated with the nasal spray, the more commonly reported adverse reactions included dysgeusia, nasal discomfort, dizziness, oropharyngeal pain, and nausea.[Ref]

Hematologic

Uncommon (0.1% to 1%): ecchymosis
Rare (less than 0.1%): Thrombocytopenia, eosinophilia, leucopenia[Ref]

Metabolic

Uncommon (0.1% to 1%): Increased appetite, thirst
Rare (less than 0.1%): Anorexia, hyperglycemia[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, muscle weakness
Uncommon (0.1% to 1%): Back pain, leg cramps, tenosynovitis
Rare (less than 0.1%): Arthritis, tetanus, twitching[Ref]

Respiratory

Common (1% to 10%): Disorder/discomfort of nasal cavity, throat pain, throat tightness, oropharyngeal pain
Uncommon (0.1% to 1%): Pharyngitis, rhinitis, dyspnea, sinusitis, bronchitis, increased cough, epistaxis, laryngeal edema, hiccup, laryngitis, yawn
Rare (less than 0.1%): Apnea, voice alteration[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Hypersensitivity reactions including angioedema, anaphylactic reactions and anaphylactic shock[Ref]

Ocular

Rare (less than 0.1%): Diplopia, dry eyes, lacrimation, conjunctivitis, eye pain, visual field defect[Ref]

Genitourinary

Uncommon (0.1% to 1%): Polyuria, urinary urgency, cystitis, hematuria
Rare (less than 0.1%): Urinary frequency, miscarriage, dysmenorrhea[Ref]

Dermatologic

Common (1% to 10%): Sweating, facial edema
Uncommon (0.1% to 1%): Urticaria, pruritus, rash, photosensitivity reaction
Rare (less than 0.1%): Angioedema[Ref]

Local

Common (1% to 10%): Local irritation or soreness at the site of administration of nasal spray

In clinical trials using the nasal spray approximately 3% (n=460) patients reported local irritation or soreness at the site of administration. Effects were severe in about 1% of patients and approximately 57% resolved in 1 hour. Nasopharyngeal examinations of a subset of patients failed to demonstrate any clinically significant changes with repeated use of the nasal spray.

Some side effects of Zomig-ZMT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.