Ergomar

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

This medication has rarely caused a very serious lack of blood flow to the hands and feet (peripheral ischemia) or to the brain, which could cause a stroke. The risk is increased when this medication is taken with other drugs that can affect the removal of ergotamine from your body. Examples include azole antifungals (such as ketoconazole, itraconazole), cobicistat, mifepristone, certain antidepressants (such as nefazodone), macrolide antibiotics (such as clarithromycin, erythromycin, troleandomycin), HIV protease inhibitors (such as nelfinavir, indinavir), ritonavir, SSRIs (such as fluoxetine, paroxetine, fluvoxamine), among others.

Nausea, vomiting, and dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: slow/fast/irregular heartbeat, tingling/pain/coldness in the fingers/toes, whitish fingers/toes/nails, loss of feeling in the fingers/toes, bluish hands/feet, muscle pain/weakness, severe stomach/abdominal pain, lower back pain, signs of kidney problems (such as change in the amount of urine).

Get medical help right away if you have any very serious side effects, including: chest pain, vision changes, confusion, trouble speaking.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to ergotamine; or to other ergot alkaloids (such as dihydroergotamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation disease (such as peripheral vascular disease such as arteriosclerosis, thrombophlebitis, Raynaud's disease), high blood pressure, nutrient deficiency (malnutrition), heart/blood vessel disease (such as coronary artery disease, stroke, recent heart attack), liver disease, kidney disease, severe infection, severe itching, smoking/tobacco use, diabetes.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Remember that alcohol may be a cause of headaches.

Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems (including chest pain, fast/slow/irregular heartbeat) and decreased blood flow to the brain/hands/feet. Do not use tobacco while taking this medication. If you smoke, talk to your doctor about how to stop smoking.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If you also take "triptan" migraine drugs (such as sumatriptan, rizatriptan), you will need to separate your "triptan" dose from your dose of this medication to reduce the risk of serious side effects. Ask your doctor how long you should wait between your doses of these drugs.

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or other migraine medications).

Do not share this medication with others.

Certain foods/beverages or food additives (such as red wine, cheese, chocolate, monosodium glutamate, alcohol) as well as some lifestyle patterns (such as irregular eating/sleeping habits, stress) may bring about a migraine headache. Avoiding these "triggers" may help decrease the frequency of migraine headaches. Consult your doctor for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness/drowsiness, loss of feeling in the fingers/toes, rapid/weak heartbeat, bluish hands/feet, seizures.

Place one tablet under the tongue, allowing it to dissolve as directed by your doctor. Do not chew or swallow the tablet. Do not eat or drink while the tablet is dissolving in your mouth.

The dosage is based on your medical condition and response to treatment. This medication works best if it is taken as the first signs of the headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication usually should be taken only as needed. It is not meant for long-term daily use. The maximum dose is 3 tablets in any 24-hour period and 5 tablets in any 7-day period.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as rebound headaches). This headache may be different from your original headache and may last a few days. To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used ergotamine for a long time (more than a few weeks) or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

If you are using drugs for migraine attacks on 10 or more days each month, the drugs may actually make your headaches worse (medication overuse headache). Do not use medications more often or for longer than directed. Tell your doctor if you need to use this medication more often, or if the medication is not working as well, or if your headaches get worse.