Migranal

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Patient Information Leaflet or Medication Guide provided by your pharmacist before you start using dihydroergotamine and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist.

This medication comes in individual nasal spray vials. Each vial contains enough medication to treat a single migraine attack. Do not use more than 4 sprays for a single attack. Before using each nasal spray vial, prime the pump by spraying 4 times into the air, away from the face.

At the first sign of a migraine, spray this medication into the nostrils. Do not inject this medication. Use 1 spray into each nostril. Do not tilt your head back, sniff through your nose, or blow your nose while spraying or immediately after. Use another spray into each nostril 15 minutes after the first sprays, or use as directed by your doctor. After using the medication, you should lie down and relax in a quiet, darkened room. The maximum number of sprays you can use for a single attack is 4 sprays (two in each nostril). You should feel some relief within 30 minutes of using this medication.

The dosage is based on your medical condition and response to treatment. Ask your doctor how often you can use this medication to treat your migraine headaches. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

This medication works best if it is used as the first signs of the headache occur. If you wait until the headache has worsened, the medication may not work as well. Use only as needed to treat migraine attacks when they occur. It is not meant for long-term daily use.

If you have never used this medication before and you have risk factors for heart disease (see Precautions), you may need to be monitored for rare but serious side effects (such as chest pain) when you take the first dose. Your doctor may ask you to take the first dose in the office.

If you also take "triptan" or other ergot medications (such as sumatriptan, methysergide), wait 24 hours before and after taking dihydroergotamine. Consult your doctor or pharmacist for more details and for advice on how to time your doses of these medications.

If you are using drugs for migraine attacks on 10 or more days each month, the drugs may actually make your headaches worse (medication overuse headache). Do not use medications more often or for longer than directed. Tell your doctor if you need to use this medication more often, or if the medication is not working as well, or if your headaches get worse.

See also Warning section.

Sore nose/throat, stuffy/runny nose, changes in taste, dizziness, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause a very serious lack of blood flow. Stop using dihydroergotamine and tell your doctor right away if you have any serious side effects, including: slow/fast heartbeat, weakness in the legs, muscle pain in the arms/legs, tingling/numbness, feeling of coldness in the hands/feet, blue fingers/toes, severe stomach/abdominal pain.

Get medical help right away if you have any very serious side effects, including: jaw/left arm pain, chest pain/pressure, sudden tiredness, weakness on one side of the body, trouble speaking, vision changes, mental/mood changes (such as confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using dihydroergotamine, tell your doctor or pharmacist if you are allergic to it; or to other ergot alkaloids (such as ergotamine, methysergide, bromocriptine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially: heart disease (such as chest pain/angina, heart attack), stroke, high blood pressure, blood circulation disease (such as peripheral arterial disease, Raynaud's syndrome), a certain severe blood infection (sepsis), bowel disease (such as ischemic bowel syndrome), kidney disease, liver disease, headaches with unusual symptoms or certain types of headache (hemiplegic/basilar), recent blood vessel surgery, nasal problems (such as chronic congestion, nasal allergies).

Tell your doctor if you have the following risk factors for heart disease: high blood pressure, high blood cholesterol, obesity, diabetes, smoking/tobacco use, family history of heart disease.

If you are at high risk for heart disease, your doctor may want to check your heart before prescribing dihydroergotamine and give your first dose in the office.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems (such as chest pain, fast/slow/irregular heartbeat) and decreased blood supply to the brain/hands/feet. Do not use tobacco while taking this medication. If you smoke, talk to your doctor about how to stop smoking.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using dihydroergotamine. Dihydroergotamine may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This drug may pass into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 3 days after the last dose. Consult your doctor before breastfeeding.

See also Warning and How to Use sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: bronchodilators/decongestants/stimulants (such as epinephrine, pseudoephedrine, methylphenidate, amphetamine).

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or other migraine medications).

Do not share this medication with others.

Lab and/or medical tests (such as EKG) may need to be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Certain foods/beverages or food additives (such as red wine, cheese, chocolate, monosodium glutamate, alcohol) as well as some lifestyle patterns (such as irregular eating/sleeping habits, stress) may bring about a migraine headache. Avoiding these "triggers" may help decrease the frequency of migraine headaches. Consult your doctor for more details.

Take this medication only as needed when a migraine occurs, as directed by your doctor. This medication is not taken on a regular schedule.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe/sudden numbness, blue or purple hands/feet, slow/difficult breathing, confusion, seizures.

Store at room temperature away from heat and light. Do not freeze or refrigerate. Once the nasal spray vial is opened, this medication expires after 8 hours. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.