Caffeine, Ergotamine Tartrate Oral tablet

What is this medicine?

CAFFEINE; ERGOTAMINE (KAF een; er GOT a meen) is part of a group of medicines called ergot alkaloids. It is used to treat or prevent migraine and cluster headaches.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart or blood vessel disease
• high blood pressure
• infection
• kidney disease
• liver disease
• poor circulation
• an unusual or allergic reaction to caffeine, ergotamine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. You should only take this medicine at the first sign of an attack. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• antifungal drugs like fluconazole, itraconazole, ketoconazole or voriconazole
• certain antibiotics like erythromycin, clarithromycin, and troleandomycin
• cocaine
• conivaptan
• dexfenfluramine
• ephedrine
• feverfew
• grapefruit juice
• imatinib
• isoproterenol
• medicines called nitrates like isosorbide and nitroglycerin
• medicines for colds, flu, or breathing difficulties like phenylephrine and pseudoephedrine
• medicines for HIV or AIDS called protease inhibitors, delavirdine, efavirenz, nelfinavir
• medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan
• midodrine
• nefazodone
• other ergot alkaloids like bromocriptine, cabergoline, dihydroergotamine, ergoloid mesylates, ergonovine, methylergonovine, and methysergide

This medicine may also interact with the following medications:

• clotrimazole
• fluoxetine
• fluvoxamine
• medicines for high blood pressure, especially beta-blockers
• metronidazole
• nicotine
• zileuton

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Check with your doctor or health care professional if you do not get relief from your headaches after using this medicine. You may need to be changed to a different kind of medicine to treat your migraines.

This medicine decreases the circulation of blood to your skin, fingers, and toes. You may get more sensitive to the cold. Elderly patients are more likely to feel this effect. Dress warmly and avoid long exposure to the cold.

This medicine contains caffeine. Limit your intake of caffeinated beverages on the days that you use this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain or tightness
• cold hands or feet
• confusion
• fast, slow, or pounding heartbeat
• itching
• leg or arm pain or cramps
• rectal discomfort or sores
• seizure
• stomach pain
• swelling of hands, ankles, or feet
• tingling, pain or numbness in feet or hands
• vomiting
• weakness

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• increased urination
• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.