Caffeine (KAF-een), Ergotamine Tartrate (er-GOT-a-meen TAR-trate)

Treats or prevents migraine headaches.

Brand Name(s):

Cafergot

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine works best if you take it at the first sign of a migraine headache.
• Do not use more than 6 tablets in one day or 10 tablets in one week.
• This medicine is not for long-term use.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, nelfinavir, ritonavir, or troleandomycin.
• Some foods and medicines can affect how ergotamine and caffeine works. Tell your doctor if you are using clotrimazole, fluconazole, fluoxetine, fluvoxamine, metronidazole, nefazodone, nicotine, propranolol, saquinavir, or zileuton.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• This medicine may cause the following problems:
  • Stomach problems, including retroperitoneal fibrosis
  • Lung problems, including pleuropulmonary fibrosis
• This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including asthma). Tell your doctor if you have any allergies (including an aspirin allergy)
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change or loss of consciousness, drowsiness, lightheadedness, fainting, fast, slow, or uneven heartbeat, seizures, cold, clammy skin
• Chest pain, trouble breathing
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Pain in the arms, legs, or lower back, pale, bluish color, or cold hands or feet
• Stomach pain, change in how much or how often you urinate, loss of appetite, lower back pain, nausea, vomiting, weakness
• Swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Dizziness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088