This combination medication is used to treat or prevent a certain type of headache (vascular headaches such as migraine headaches and cluster headaches). Ergotamine helps narrow widened blood vessels in the head, which reduces the throbbing effects of vascular headaches. Caffeine increases the effects of ergotamine by also narrowing the widened blood vessels in the head.

The suppository form is used when medications cannot be taken by mouth (for example, due to nausea and vomiting).

Unwrap and insert one suppository rectally as directed by your doctor. Remain lying down for a few minutes, and avoid having a bowel movement for an hour or longer so the drug will be absorbed. The suppository is for rectal use only.

If the suppository is exposed to heat and softens, chill in ice-cold water before unwrapping and using the suppository.

The dosage is based on your medical condition and response to treatment. 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.

This medication usually should be used only as needed. It is not meant for long-term daily use. The maximum dose is 2 suppositories for a single headache attack and 5 suppositories in any 7-day period.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as rebound headaches). This headache may be different from your original headache and may last a few days. To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time (more than a few weeks) or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

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, restlessness, trouble sleeping, and 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:

• rectal pain/bleeding
• slow/fast/irregular heartbeat
• tingling/pain/coldness in the fingers/toes
• whitish fingers/toes/nails
• loss of feeling in the fingers/toes
• bluish 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 pain
• vision changes
• confusion
• trouble speaking

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 www.fda.gov/medwatch.

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 this medication, tell your doctor or pharmacist if you are allergic to ergotamine or caffeine; or to other ergot alkaloids (such as dihydroergotamine) or to other xanthine drugs (such as theophylline); 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 of:

• blood circulation disease (for example, peripheral vascular disease such as arteriosclerosis, thrombophlebitis, Raynaud's disease)
• high blood pressure
• nutrient deficiency (malnutrition)
• heart/blood vessel disease (such as coronary artery disease, stroke, heart attack, abnormal heart rhythm)
• liver disease
• kidney disease
• severe infection
• severe itching
• smoking/tobacco use
• diarrhea
• diabetes
• stomach problems (such as ulcers)

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 be a cause of headaches.

Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems (including chest pain, fast/slow/irregular heartbeat) 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 may pass into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

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 reduce the risk 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 levels, urine 5-HIAA levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

This medicine may be harmful if swallowed. 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 dizziness/drowsiness, loss of feeling in the fingers/toes, rapid/weak heartbeat, bluish hands/feet, seizures.

Do not share this medication with others.

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.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. 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.