CAFERGOT

INDICATIONS

Cafergot is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants, or so-called “histaminic cephalalgia.” Cafergot is a combination of 2 vasoconstrictors. It works by constricting blood vessels in the lining of the brain, which helps to decrease the pain from migraine headaches.

INSTRUCTIONS

Use Cafergot as directed by your doctor.

• Cafergot may be taken with or without food.
• Eating grapefruit or drinking grapefruit juice may affect the amount of Cafergot in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• Cafergot is only to be used as needed for a migraine attack.
• Take Cafergot at the first sign of a headache. If the initial dose does not relieve your headache, additional doses may be needed according to your doctor’s instructions. Do not take a dose of Cafergot within 30 minutes of your last dose.
• Do not take more than 6 tablets for a single migraine headache or more than 10 tablets during any 7-day period without first checking with your doctor.
• If you miss a dose of Cafergot and you still have a headache, take it as soon as you remember. Do not take a dose of Cafergot within 30 minutes of your last dose. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cafergot.

STORAGE

Store Cafergot at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cafergot out of the reach of children and away from pets.

MORE INFO:

Active Ingredients: Ergotamine tartrate and Caffeine.

Do NOT use Cafergot if:

• you are allergic to any ingredient in Cafergot
• you are pregnant or may become pregnant
• you are in labor
• you have blood vessel problems (eg, peripheral vascular disease), coronary heart disease, high blood pressure, liver or kidney problems, or severe infection (eg, sepsis)
• you are taking an azole antifungal (eg, itraconazole, ketoconazole, voriconazole), delavirdine, HIV protease inhibitors (eg, delavirdine, indinavir, nelfinavir, ritonavir), efavirenz, a ketolide antibiotic (eg, telithromycin), a macrolide antibiotic (eg, clarithromycin, erythromycin), or selective 5-HT agonists (eg, sumatriptan, eletriptan).

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Cafergot. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of blood problems (eg, porphyria), stroke, anxiety, trouble sleeping, or heart problems
• if you smoke.

Some medicines may interact with Cafergot. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Clotrimazole, fluconazole, fluoxetine, fluvoxamine, , metronidazole, nefazodone, saquinavir, or zileuton because side effects of Cafergot may be increased
• Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), beta-blockers (eg, propranolol), delavirdine, HIV protease inhibitors (eg, delavirdine, indinavir, nelfinavir, ritonavir), efavirenz, ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin, clarithromycin), or selective 5-HT agonists (eg, sumatriptan , eletriptan) because the risk of severe side effects, including irregular heartbeat or decreased oxygen to the extremities (eg, hands, feet) or brain, may be increased
• Pressor agents (eg, norepinephrine) or sympathomimetics (eg, pseudoephedrine, albuterol) because risk of side effects, including severe high blood pressure, may be increased
• Quinolones (eg, levofloxacin) because risk of side effects, such as nervousness, sleeplessness, and fast heartbeat, may be increased
• Theophylline because actions and side effects may be increased by Cafergot.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cafergot may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Do NOT exceed the recommended dose or take Cafergot for longer than prescribed without checking with your doctor. Cafergot is not for long-term daily use.
• Use of nicotine may increase the risk of severe side effects with Cafergot. Talk to you doctor before using Cafergot if you smoke or use any other kind of nicotine.
• Use Cafergot with extreme caution in children. Safety and effectiveness have not been confirmed.
• Pregnancy and breast-feeding: Do not use Cafergot if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Cafergot should not be taken during labor and delivery. Cafergot is excreted in breast milk. If you are or will be breast-feeding while you are using Cafergot, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Cafergot. This is known as dependence or addiction. It is important that you take Cafergot as instructed by your doctor. Cafergot is not for long-term daily use.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Nausea.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue color of the fingers or toes; chest pain or tightness; cold or pale fingers or toes; diarrhea; dizziness; hallucinations; headache; irregular heartbeat; leg cramps or weakness; mental or mood changes; muscle pain; numbness or tingling of the hands, feet, or skin; ringing in the ears; seizure; severe or persistent nausea or vomiting; shortness of breath; swelling; temporary fast or slow heartbeat; vomiting; weak pulse.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.