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Zomig Nasal Spray

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Zomig Nasal Spray

PATIENT INFORMATION

ZOMIG®
(Zo-mig)
(zolmitriptan) Nasal Spray

Please read this information before you start taking ZOMIG Nasal Spray and each time you renew your prescription just in case anything has changed. Remember, this summary does not take the place of discussions with your doctor. You and your doctor should discuss ZOMIG Nasal Spray when you start taking your medication and at regular checkups.

What is ZOMIG Nasal Spray?

ZOMIG Nasal Spray is a prescription medicine used to treat migraine headaches with or without aura in adults.

ZOMIG Nasal Spray is not for other types of headaches

ZOMIG Nasal Spray is not for the prevention of migraine headaches.

It is not known if ZOMIG Nasal Spray is safe and effective to treat cluster headaches.

ZOMIG Nasal Spray is not for people with moderate or severe liver problems (hepatic impairment.)

It is not known if ZOMIG Nasal Spray is safe and effective in children.

Who should not use ZOMIG Nasal Spray?

Do not use ZOMIG Nasal Spray if you have:

  • heart problems, a history of heart problems, or problems with the electrical system of your heart
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
  • narrowing of blood vessels to your legs, arms, or stomach (peripheral vascular disease)
  • uncontrolled high blood pressure
  • used certain medicines called 5-HT1 agonists (“triptans”) such as almotriptan (AXERT®), eletriptan (RELPAX®), frovatriptan (FROVA®), naratriptan (AMERGE®), rizatriptan (MAXALT®), sumatriptan (IMITREX®), sumatriptan/naproxen (TREXIMET®); medicines that contain ergotamine, or ergot medicines such as BELLERGAL-S®, CAFERGOT®, ERGOMAR®, WIGRAINE®; dihydroergotamine like D.H.E. 45® or MIGRANAL®; or methysergide (SANSERT®) in the last 24 hours. Ask your doctor or pharmacist for a list of these medicines if you are not sure.
  • are taking a monoamine oxidase A inhibitor (MAO-A inhibitor) or you stopped taking a MAO-A inhibitor in the last 14 days. Ask your doctor if you are not sure if you take an MAO-A inhibitor such as phenelzine sulfate (NARDIL®) or tranylcypromine sulfate (PARNATE®).
  • are allergic to zolmitriptan of any of the ingredients in ZOMIG Nasal Spray. See the end of this leaflet for a complete list of ingredients in ZOMIG Nasal Spray.

What should I tell my doctor before using ZOMIG Nasal Spray?

Before using ZOMIG Nasal Spray, tell your doctor about all your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • are a female who has gone through menopause
  • have heart disease or a family history of heart disease or stroke
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if ZOMIG Nasal Spray will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ZOMIG Nasal Spray passes into your breast milk. You and your doctor should decide if you will use ZOMIG Nasal Spray or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

  • medicines used to treat mood disorders, including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors (MAOIs).
  • cimetidine

How should I use ZOMIG NASAL Spray?

For detailed instructions, see the step-by-step instructions for using ZOMIG Nasal Spray at the end of this Patient Information.

  • Certain people should take their first dose of ZOMIG Nasal Spray in their doctor's office or in another medical setting. Ask your doctor if you should take your first dose in a medical setting.
  • Use ZOMIG Nasal Spray exactly as your doctor tells you to use it.
  • Your doctor may change your dose. Do not change your dose without first talking with your doctor.
  • If your headache comes back after using one nasal spray or you only get some relief from your headache, you can use another nasal spray 2 hours after the previous nasal spray.
  • Do not use more than a total of 10 mg of ZOMIG Nasal Spray in any 24-hour period.
  • It is not known if it is safe and effective to use ZOMIG Nasal Spray for more than 4 headaches in 30 days.
  • Some people who use too much ZOMIG Nasal Spray may have worse headaches (medication overuse headaches). If your headaches get worse, your doctor may decide to stop your treatment with ZOMIG Nasal Spray.
  • If you use too much ZOMIG Nasal Spray, call your doctor or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take ZOMIG Nasal Spray so you can talk to your doctor about how ZOMIG Nasal Spray is working for you.

What should I avoid while using ZOMIG Nasal Spray?

ZOMIG Nasal Spray can cause dizziness, weakness, or drowsiness. If you have these symptoms do not drive a car, use machinery, or do anything that needs you to be alert.

What are the possible side effects of ZOMIG Nasal Spray?

ZOMIG Nasal Spray can cause serious side effects.

Call your doctor right away if you have any of the following symptoms after using ZOMIG Nasal Spray:

  • Heart attack and other heart problems. Heart problems may lead to death. Stop taking ZOMIG Nasal Spray and get emergency medical help right away if you have any of the following symptoms of a heart attack or other heart problems:
    • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
    • chest pain or chest discomfort that feels like heavy pressure, squeezing, or fullness
    • pain or discomfort in your arms, back, neck, jaw, or stomach
    • shortness of breath with or without chest discomfort
    • breaking out in a cold sweat
    • feeling lightheaded
    • nausea or vomiting with any of the symptoms included above
  • stroke. Symptoms of stroke include face drooping, slurred speech, and unusual weakness or numbness.
  • changes in color or sensation in your fingers and toes (Raynaud's syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
    • sudden or severe stomach pain
    • stomach pain after meals
    • weight loss
    • nausea or vomiting
    • constipation or diarrhea
    • bloody diarrhea
    • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • feeling of heaviness or tightness in your leg muscles
    • burning or aching pain in your feet or toes while resting
    • numbness, tingling, or weakness in your legs
    • cold feeling or color changes in 1 or both legs or feet
  • serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people using ZOMIG Nasal Spray, especially if ZOMIG Nasal Spray is used with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norephinephrine reuptake inhibitors (SNRIs).
    Ask your doctor or pharmacist for a list of these medicines if you are not sure.
    Call your doctor right away if you have any of the following symptoms of serotonin syndrome:
    • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
    • fast heartbeat
    • changes in blood pressure
    • high body temperature
    • tight muscles
    • trouble walking
    • nausea, vomiting, or diarrhea
  • increased blood pressure
  • allergic reactions. Symptoms of an allergic reaction include:
    • rash
    • hives
    • itching
    • swelling of the face, mouth throat, or tongue
    • difficulty breathing

The most common side effects of ZOMIG Nasal Spray are:

  • unusual taste
  • numbness
  • dizziness
  • skin sensitivity (hyperparesthesia)

These are not all the possible side effects of ZOMIG Nasal Spray. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZOMIG Nasal Spray?

Store ZOMIG Nasal Spray at room temperature between 68°F to 77°F (20°C -25°C).

Keep ZOMIG Nasal Spray and all medicines out of the reach of children.

General information about the safe and effective use of ZOMIG Nasal Spray.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use ZOMIG Nasal Spray for a condition for which it was not prescribed. Do not give ZOMIG Nasal Spray to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about ZOMIG Nasal Spray. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about ZOMIG Nasal Spray that is written for health professionals.

For more information go to www.ZOMIG.com or call 1-877-994-6729.

What are the Ingredients in ZOMIG Nasal Spray?

Active ingredient: zolmitriptan

Inactive ingredients: anhydrous citric acid, dibasic sodium phosphate, and purified water

Instructions for Use

ZOMIG®
(Zo-mig)
(zolmitriptan) Nasal Spray

Important: For use in your nose only. Do not spray in your eyes.

Note: There is only 1 dose in the nasal sprayer. Do not try to prime the nasal sprayer or you will lose the dose. Do not press the plunger until you have put the tip into your nostril or you will lose the dose.

Steps for using ZOMIG Nasal Spray

Step 1. Remove the ZOMIG Nasal Spray unit from the single use package it comes in. Do not remove the unit until you are ready to use it. The unit contains only 1 spray.

Step 2. Blow your nose gently to clear your nasal passages before use.

Step 3. Remove the protective cap (See Figure A).

Figure A

Remove the protective cap - Illustration

Step 4. Keeping your head in an upright position, gently close 1 nostril with your index finger and breathe out gently through your mouth. (See Figure B). Either nostril can be used.

Figure B

gently close 1 nostril - Illustration

Step 5. With your other hand, hold the container with your thumb supporting the container at the bottom, and your index and middle fingers on each side of the nozzle. (See Figure C).

Figure C

Holding the container - Illustration

Insert the tip of the sprayer device into your open nostril as far as feels comfortable and tilt your head slightly (See Figure D).

Do not press the plunger yet.

Step 6. Breathe in gently through your nose and at the same time press the plunger firmly with your thumb to release your dose of ZOMIG Nasal Spray (See Figure D).

Figure D

Breathing in - Illustration

The plunger may feel stiff and you may hear a click. Keep your head slightly tilted back and remove the tip from your nose. Breathe gently through your mouth for 5 to 10 seconds. You may feel liquid in your nose or the back of your throat. This is normal.

Step 7. Dispose the Zomig Nasal Spray device after completing the full dose or as soon as it becomes outdated or no longer needed. Dispose of properly. Keep out of reach of children. Do not reuse.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 9/30/2013
This monograph has been modified to include the generic and brand name in many instances.

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Zomig Nasal Spray - User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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