Ergotamine-Caffeine

Store at room temperature away from light and moisture. Do not store in the bathroom. 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.

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.

Take this medication by mouth with or without food as directed by your doctor, usually 2 tablets at the first sign of headache, followed by 1 tablet every half hour until the headache is relieved. Do not take more than 6 tablets per headache attack or 10 tablets in a 7-day period.

If your doctor has prescribed this medication to help prevent certain types of headaches (such as cluster headaches), take this medication exactly as directed by your doctor, usually for short-term treatment (2 to 3 weeks).

The dosage is based on your medical condition and response to treatment. This medication works best if it is taken at the first sign of the headache. If you wait until the headache has worsened, the medication may not work as well.

If you have a higher risk for heart problems (see Precautions), your doctor may perform a heart exam before you start taking this medication. He/she may also direct you to take your first dose of this medication in the office/clinic to monitor for serious side effects (such as chest pain). Talk to your doctor for details.

This medication is usually taken only as needed. It is not meant for long-term daily use.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

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.

Nausea, vomiting, upset stomach, restlessness, trouble sleeping, or dizziness 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.

Tell your doctor right away if you have any serious side effects, including: slow/fast/irregular heartbeat, numbness/tingling in fingers/toes, blue fingers/toes/nails, cold hands/feet, muscle pain/weakness, severe stomach/abdominal pain, lower back pain, signs of kidney problems (such as change in the amount of urine).

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, confusion, trouble speaking, vision changes, weakness on one side of the body.

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.

See also Warning section.

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.

If you also take "triptan" migraine drugs (such as sumatriptan, rizatriptan), you will need to separate your triptan dose from your dose of this medication to lessen the chance of serious side effects. Ask your doctor how long you should wait between your doses of these drugs.

Some products may contain caffeine or ingredients that could raise your heart rate or blood pressure. Certain beverages (such as coffee, colas, energy drinks) may also contain caffeine. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or other headache products).

This medication may interfere with certain medical/lab tests (such as dipyridamole-thallium imaging tests, urine catecholamine/5-HIAA levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Do not share this medication with others.

Certain foods, beverages, or food additives (such as red wine, cheese, chocolate, monosodium glutamate) as well as lifestyle patterns such as irregular eating/sleeping habits or stress may bring on a migraine headache. Avoiding these "triggers" may help lessen migraine attacks. Consult your doctor for more details.

Not applicable.

Before taking this medication, tell your doctor or pharmacist if you are allergic to ergotamine or caffeine; or to other ergot alkaloids (such as dihydroergotamine); or if you have any other allergies. This product may contain inactive ingredients (such as tartrazine found in some brands), 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 of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), kidney disease, liver disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stroke or "mini-stroke" (transient ischemic attack).

Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions, including: high blood pressure, high cholesterol, diabetes, family history of heart disease, overweight, postmenopausal (women), age more than 40 years (men).

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). Remember that alcohol may cause headaches.

Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems and decreased blood flow 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 or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

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: nausea/vomiting, numbness/tingling in the fingers/toes, chest pain, muscle pain/weakness.