Ergotamine and caffeine are used together to treat migraine headache with or without aura. Ergotamine works by constricting blood vessel walls in the head, relieving dilation that causes the pain of migraine headaches. Caffeine helps the ergotamine to be absorbed into the bloodstream more effectively.

The tablets are most effective if taken at the first sign of a migraine headache. They are not effective for other types of headache. Relief is often obtained within one-half hour of taking the medication. Extra medication may be required if relief is not obtained within one-half hour (see maximum doses).

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Tablets - adults and adolescents 12 years and over: The recommended initial adult dose is 2 tablets at the first sign of a headache followed by 1 tablet after each one-half hour that the headache is not relieved. If it is found that more that 2 tablets are needed to relieve the headache, 3 tablets can be used as an initial dose for the next headache. Do not take more than 6 tablets within 24 hours or 10 tablets within 7 days.

Tablets - children 6 to 12 years: The recommended initial children's dose is 1 tablet at the first sign of a headache followed by 1 tablet after each one-half hour that the headache is not relieved. Do not take more than 3 tablets within 24 hours or 5 tablets within 7 days.

Do not use this medication to prevent migraines.

If a different medication for migraine is required, wait at least six to eight hours before the using any ergotamine- or dihydroergotamine-containing medications. Wait at least 24 hours before using almotriptan, eletriptan, frovatriptan, sumatriptan, naratriptan, rizatriptan, or zolmitriptan.

Store tablets at room temperature below 25°C.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Ergotamine - caffeine should not be taken by anyone who:

• is allergic to ergotamine, caffeine, or to any of the ingredients of the medication
• is a breast-feeding mother
• is less than 6 years old
• is or may become pregnant
• is taking the following medications:
  • antifungal agents (e.g., ketoconazole, itraconazole)
  • macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin)
  • protease inhibitors (e.g., ritonavir, nelfinavir, indinavir)
• has a history of coronary artery disease
• has a septic (internal infection) condition
• has blood circulation disorders
• has reduced liver or kidney function
• has severe high blood pressure

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• diarrhea, nausea, or vomiting (occurring without other signs of overdose or problems with blood circulation)
• dizziness or drowsiness (occurring without other signs of overdose or problems with blood circulation)
• dry mouth
• nervousness or restlessness

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• swelling of the face, fingers, feet, or lower legs

Check with your doctor immediately if any of the following side effects occur:

• coldness, numbness, or tingling in the fingers, toes, or face
• itching of the skin
• weakness in the legs

Side effects that may mean you are developing blood circulation problems:

• anxiety or confusion (severe)
• change in vision
• chest pain
• increase in blood pressure
• pain in the arms, legs, or lower back, especially if the pain occurs in your calves or heels while you walk
• pale, bluish-coloured, or cold hands or feet (not caused by cold temperatures and occurring together with other side effects listed)
• red or violet-coloured blisters on the skin of the hands or feet

Signs of overdose:

• convulsions (seizures)
• diarrhea, nausea, vomiting, or stomach pain or bloating (severe) occurring together with other signs of overdose or blood circulation problems
• dizziness, drowsiness, or weakness (severe), occurring together with other signs of overdose or blood circulation problems
• dry mouth (excessive)
• fast or slow heartbeat
• headaches, more often or more severe than before
• shortness of breath
• unusual excitement
• vision changes

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Dependence: People who take ergotamine - caffeine for extended periods of time may become dependent upon it and require progressively increasing doses for relief of vascular headaches or to prevent the increasing unpleasant effects which may follow withdrawal of the medication.

Drowsiness/reduced alertness: Do not undertake activities requiring mental alertness, such as driving or operating equipment, until you determine your response and sensitivity to ergotamine - caffeine.

Overdose/continuous use: It is important to stay within the limits of the recommended dosage and avoid excessive or prolonged use.

Excessive dryness of the mouth and visual disturbances are signs of overdose or of sensitivity to belladonna alkaloids. In such cases, your doctor may recommend reducing the dose.

If an overdose is suspected, seek medical help immediately.

Pregnancy: Ergotamine - caffeine may cause harm when taken by a pregnant woman. It should not be taken by women who are or may become pregnant.

Breast-feeding: This medication passes into breast milk and may cause symptoms of vomiting, diarrhea, weak pulse, and unstable blood pressure in nursing infants. Breast-feeding mothers should not use this medication.

There may be an interaction between ergotamine - caffeine and any of the following:

• almotriptan
• antifungal agents (e.g., ketoconazole, itraconazole)
• beta-blockers (e.g., propranolol, sotalol, timolol)
• eletriptan
• frovatriptan
• macrolide antibiotics (e.g., erythromycin, clarithromycin, telithromycin)
• naratriptan
• nitrates (e.g., nitroglycerin, isosorbide)
• nicotine
• other ergot medications (e.g., methysergide, dihydroergotamine, ergonovine, ergoloid mesylates)
• protease inhibitors (e.g., ritonavir, nelfinavir, indinavir)
• rizatriptan
• sumatriptan
• zolmitriptan

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.