Uses of Ergotamine and Caffeine Tablets:

• It is used to treat migraine headaches.

What do I need to tell my doctor BEFORE I take Ergotamine and Caffeine Tablets?

• If you have an allergy to ergotamine, caffeine, or any other part of this medicine (ergotamine and caffeine tablets).
• If you are allergic to this medicine (ergotamine and caffeine tablets); any part of this medicine (ergotamine and caffeine tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Blood vessel disease, heart disease, high blood pressure, kidney disease, liver disease, or a very bad infection.
• If you have taken almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, or zolmitriptan in the last 24 hours.
• If you are pregnant or may be pregnant. Do not take this medicine (ergotamine and caffeine tablets) if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine (ergotamine and caffeine tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (ergotamine and caffeine tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ergotamine and Caffeine Tablets?

For all patients taking this medicine (ergotamine and caffeine tablets):

• Tell all of your health care providers that you take this medicine (ergotamine and caffeine tablets). This includes your doctors, nurses, pharmacists, and dentists.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine is not meant for regular, daily use. Talk with the doctor.
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• Use care if you have risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, man older than 40 years of age, other family members with early heart disease, woman after change of life). Talk with your doctor.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this medicine (ergotamine and caffeine tablets) may cause nervousness, shakiness, and a fast heartbeat.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine (ergotamine and caffeine tablets), call your doctor right away.

Children:

• This medicine is not approved for use in children. However, the doctor may decide the benefits of taking this medicine (ergotamine and caffeine tablets) outweigh the risks. If your child has been given this medicine (ergotamine and caffeine tablets), ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this medicine (ergotamine and caffeine tablets) to your child.

How is this medicine (Ergotamine and Caffeine Tablets) best taken?

Use this medicine (ergotamine and caffeine tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take at the first sign of a migraine headache.
• Take with or without food.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain or pressure.
• Slow heartbeat.
• Swelling.
• Dizziness or passing out.
• Muscle pain or weakness.
• Change in color of hands or feet from pale to blue or red.
• Numbness, pain, tingling, or cold feeling of the hands or feet.
• Any sores or wounds on the fingers or toes.
• Rarely, heart valve problems have happened with this medicine (ergotamine and caffeine tablets). Call your doctor right away if you have a fast or abnormal heartbeat, shortness of breath, swelling in the arms or legs, or a big weight gain.

What are some other side effects of Ergotamine and Caffeine Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ergotamine and Caffeine Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (ergotamine and caffeine tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.