Eletriptan

What it is used for

Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks.

Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.

The most important thing to know

" These serious side effects include: changes in color or sensation in your fingers and toes (Raynaud's syndrome) s tomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain stomach pain after meals weight loss nausea or vomiting constipation or diarrhea bloody diarrhea fever p roblems with blood circulation to your legs and feet (peripheral vascular ischemia ).

Symptoms of peripheral vascular ischemia include: cramping and pain in your legs or hips feeling of heaviness or tightness in your leg muscles burning or aching pain in your feet or toes while resting numbness, tingling, or weakness in your legs cold feeling or color changes in 1 or both legs or feet m edication overuse headaches.

Some people who take too many eletriptan hydrobromide tablets may have worse headaches (medication overuse headache). If your headaches get worse, your doctor may decide to stop your treatment with eletriptan hydrobromide tablets. The most common side effects of eletriptan hydrobromide tablets include: dizziness nausea weakness tiredness drowsiness Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of eletriptan hydrobromide tablets. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800 FDA-1088. Ho w should I store eletriptan hydrobromide tablets? Store eletriptan hydrobromide tablets at 20° to 25°C (68° to 77°F) G e n e r a l information about the safe and effective use of eletriptan hydrobromide tablets Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not use eletriptan hydrobromide tablets for a condition for which it was not prescribed. Do not give eletriptan hydrobromide tablets to other people, even if they have the same symptoms you have. It may harm them. This Patient Information summarizes the most important information about eletriptan hydrobromide tablets.

If you would like more information about eletriptan hydrobromide tablets, talk with your doctor. You can ask your doctor or pharmacist for information on eletriptan hydrobromide tablets that is written for health professionals. Please address medical inquiries to, [email protected] or Tel.: 1-877-993-8779. Wh a t are the ingredients in eletriptan hydrobromide tablet?

Active ingredient: eletriptan hydrobromide Inactive ingredients: anhydrous lactose, croscarmellose sodium, FD & C Yellow No. #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, titanium dioxide and triacetin. Additionally, each 20 mg tablet contains D & C Yellow #10 aluminum lake and FD & C Blue #2 aluminum lake and each 40 mg tablet contains ferric oxide yellow and ferric oxide red.

* All Product/Brand names are the trademarks of their respective owners. This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 12/22

Who should not take it

do not take a second tablet without first talking with your doctor. If your headache comes back or you only get some relief from your headache, you can take a second tablet 2 hours after the first tablet. Do not take more than a total of 80 mg of eletriptan hydrobromide tablets in a 24-hour period. If you take too much eletriptan hydrobromide tablets, call your doctor or go to the nearest hospital emergency room right away.

You should write down when you have headaches and when you take eletriptan hydrobromide tablets so you can talk to your doctor about how well eletriptan hydrobromide tablets is working for you. Wh a t should I avoid while taking eletriptan hydrobromide tablets? Eletriptan hydrobromide tablets can cause dizziness, weakness, or drowsiness.

If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert. Wh a t are the possible side effects of eletriptan hydrobromide tablets? Eletriptan hydrobromide tablets m a y cause serious side effects. See "