IMPORTANT SAFETY INFORMATION
What is the most important information I should know about Ergomar® (ergotamine tartrate sublingual tablets)?
Serious and/or life-threatening reductions in blood flow to the brain or extremities have been reported due to interactions between the active ingredient in Ergomar (ergotamine tartrate) and protease inhibitors and macrolide antibiotics. These medications should not be taken together.
Before starting Ergomar, you should know that:
Ergomar is a prescription medicine used in adults for treating or preventing a migraine headache. Ergomar is not a pain medicine and should not be used to treat other types of headaches.
Do not take Ergomar if you are taking medicines called CYP 3A4 inhibitors (such as certain medicines for infections, certain HIV medicines, and some antibiotics). Serious side effects may occur when these kinds of medicines are used at the same time as Ergomar.
There have been a few reports of patients on ergotamine tartrate (the active ingredient of Ergomar) and caffeine therapy experiencing a buildup of excess tissue in the space behind the stomach and intestine or in the lungs. In rare cases, long-term use of ergotamine tartrate plus caffeine has caused thickening of the valves of the heart. Do not take Ergomar on a daily basis.
Do not take Ergomar with other medicines that cause the blood vessels to become narrow (vasoconstrictors).
Do not smoke if you take Ergomar.
Do not take more Ergomar than your healthcare professional recommends. (see How to take Ergomar)
In rare cases, patients have experienced withdrawal symptoms (including rebound headache) when stopping ergotamine, particularly after taking it over long periods of time.
There have been reports of drug abuse and psychological dependence in patients who take ergotamine tartrate.
Do not take Ergomar if you:
- Are taking certain anti-HIV medications known as protease inhibitors such as ritonavir, nelfinavir
- Are taking a macrolide antibiotic such as erythromycin, clarithromycin or troleandomycin
- Are taking anti-fungal medications such as ketoconazole or itraconazole
- Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
- Have high blood pressure or if you have any disease affecting your heart, arteries, or blood circulation
- Have liver or kidney disease
- Are allergic to any of the ingredients in Ergomar
How to take Ergomar:
- For best results, Ergomar should be taken at the first sign of a migraine attack
- One Ergomar 2 mg tablet should be placed under the tongue. If needed, another tablet may be taken at no sooner than 30 minutes following the first dose
- You should not take more than three tablets in any 24-hour period
- You should not take more than five tablets (10 mg) in any one week
- Ergomar should not be used on a daily basis
There are possible side effects when taking Ergomar. Contact your healthcare professional immediately if you experience:
- Blue-colored skin, numbness or tingling in the fingers or toes
- Muscle pain in the arms and legs
- Weakness in the legs
- Chest pain
- Temporary speeding or slowing of the heart rate
- Swelling or itching
Other side effects of Ergomar may include nausea, vomiting, and dizziness. This is not a complete list of all possible side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
This is the most important information to know about Ergomar. Ask your healthcare professional if you have any questions or want more information.
Please see the Prescribing Information, including Boxed Warning, for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact TerSera Therapeutics at 1-888-374-6627 or firstname.lastname@example.org.
Do you suffer
- Are you dissatisfied with the therapies you have been prescribed to treat your migraines?
- Have you been told to avoid caffeine?
- Have you been told to avoid the sweetener aspartame?
- Do you have trouble swallowing pills or capsules?
If you answered yes to one or more of these questions, ask your healthcare provider if Ergomar might be right for you.
Please see Important Safety Information and Full Prescribing Information, including Boxed Warning.