The combination of ergotamine and caffeine prevents and treats migraine headaches. Ergotamine is in a class of medications called ergot alkaloids. It works with caffeine by preventing blood vessels in the head from expanding and causing headaches.

The combination of ergotamine and caffeine is a tablet to take by mouth and a suppository to insert rectally. It is usually taken at the first sign of a migraine headache. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ergotamine and caffeine precisely as directed. Please do not take more or less of it or more often than your doctor prescribes.

To use the tablets, follow these steps:

• Take two tablets at the first sign of a migraine.
• Lie down and relax in a quiet, dark room for at least 2 hours.
• If the headache pain does not stop within 30 minutes, take one or two more tablets.
• Take one or two tablets every 30 minutes until the headache pain stops, or you have taken six pills.
• Call your doctor if the headache continues after you have taken six tablets. Do not take more than six tablets for one headache unless your doctor specifically tells you to do so.
• Do not take more than six tablets in 24 hours or ten tablets in 1 week. If you need more, call your doctor.

To use the suppositories, follow these steps:

• If the suppository feels soft, place it in ice-cold water (before removing the foil wrapper) until it hardens.
• Remove the wrapper and dip the tip of the suppository in water.
• Lie down on your left side and raise your right knee to your chest. (A left-handed person should lie on the right side and raise the left knee.)
• Using your finger, insert the suppository into the rectum, about 1/2 to 1 inch (1.25 to 2.5 centimeters) in children and 1 inch (2.5 centimeters) in adults. Hold it in place for a few moments.
• Wash your hands thoroughly; then lie down and relax in a dark, quiet room for at least 2 hours.
• If the headache pain does not stop within 1 hour, insert another suppository.
• If the headache pain continues after you have inserted two suppositories, call your doctor. Do not use more than two suppositories for one headache unless your doctor specifically tells you to do so.
• Do not use more than five suppositories in 1 week. If you need more, call your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking ergotamine and caffeine,

• Tell your doctor and pharmacist if you are allergic to ergotamine, caffeine, or any other medications.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: clotrimazole, fluconazole (Diflucan), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), medications for asthma and colds, metronidazole (Flagyl), nefazodone (Serzone), propranolol (Inderal), saquinavir (Invirase, Fortovase), and zileuton (Zyflo). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have had high blood pressure, problems with circulation; coronary artery disease; a severe blood infection; or kidney or liver disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Call your doctor immediately if you become pregnant while taking ergotamine and caffeine. Ergotamine and caffeine may harm the fetus.

Talk to your doctor about drinking grapefruit juice while taking this medicine.

Ergotamine and caffeine may cause side effects. Tell your doctor if either of these symptoms is severe or does not go away:

• nausea
• vomiting

Some side effects can be severe. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• leg weakness
• chest pain
• rapid heartbeat
• slow heartbeat
• dizziness
• muscle pain in the legs or arms
• blue hands and feet
• swelling
• itching
• pain, burning, or tingling in the fingers and toes

Ergotamine and caffeine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a severe side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light and excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant, and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• vomiting
• numbness
• tingling sensation
• pain
• blue hands and feet
• lack of pulse
• dizziness or lightheadedness
• fainting
• drowsiness
• unconsciousness
• coma
• seizures

Keep all appointments with your doctor.

If you take large doses of this medication for a long time, you may have a severe headache for a few days after stopping the medication. Call your doctor if the headache lasts more than a few days.

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

You need to keep a written list of all the prescription and nonprescription (over-the-counter) medicines you are taking and 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.