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ALMOTRIPTAN tablet, film coated


  1. Patient Information
  2. Tablets Can Cause Serious Side Effects, Including:
  3. Stop Taking Almotriptan Tablets And Get Emergency Medical Help Right Away If You Have Any Of The Following Symptoms Of A Heart Attack:
  4. Almotriptan Tablets Are Not For People With Risk Factors For Heart Disease Unless A Heart Exam Is Done And Shows No Problem. You Have A Higher Risk For Heart Disease If You:
  5. Almotriptan Tablets?
  6. Almotriptan Tablets If You:
  7. What Should I Avoid While Taking Almotriptan Tablets?
  8. Almotriptan Tablets May Cause Serious Side Effects, Including:
  9. Symptoms Of Gastrointestinal And Colonic Ischemic Events Include:
  10. Symptoms Of Peripheral Vascular Ischemia Include:
  11. Active Ingredient:
  12. Inactive Ingredients:
  13. Marketed By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).


Drug Interactions

Advise patients to talk with their physician or pharmacist before taking any new medicines, including prescription and non-prescription drugs and supplements[

Almotriptan

Tablets Can Cause Serious Side Effects, Including: 

Heart attack and other heart problems. Heart problems may lead to death.

Stop Taking Almotriptan Tablets And Get Emergency Medical Help Right Away If You Have Any Of The Following Symptoms Of A Heart Attack: 

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Almotriptan Tablets Are Not For People With Risk Factors For Heart Disease Unless A Heart Exam Is Done And Shows No Problem. You Have A Higher Risk For Heart Disease If You: 

  • have high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease
  • are past menopause
  • are a man over 40 years old

What are

Almotriptan Tablets? 

  • Almotriptan tablets are a prescription medicine that belongs to a class of medicines called Triptans. Almotriptan tablets are used:
    • to treat acute migraine attacks in adults with a history of migraine with or without aura.
    • to treat acute migraine headache pain in children 12 to 17 years of age with a history of migraine with or without aura, and who have migraine attacks that last 4 hours or more when not treated.
  • It is not known if almotriptan tablets are safe and effective in children 12 to 17 years of age with migraine related symptoms (nausea; light sensitivity; sound sensitivity).
  • Almotriptan tablets are not to be used to prevent migraine attacks.
  • Almotriptan tablets are not for the treatment of hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
  • It is not known if almotriptan tablets are safe and effective for the treatment of cluster headaches.
  • It is not known if almotriptan tablets are safe and effective in children under 12 years of age.

Do not take

Almotriptan Tablets If You: 

  • have or have had heart problems
  • have or have had a stroke or transient ischemic attack (TIA)
  • have or have had blood vessel problems including ischemic bowel disease
  • have uncontrolled high blood pressure
  • have hemiplegic or basilar migraine. If you are not sure if you have these types of migraines, ask your health care provider.
  • have taken any of the following medicines in the last 24 hours:
    • ergotamines
    • dihydroergotamines
    • methysergide
    • sumatriptan
    • eletriptan
    • frovatriptan
    • naratriptan
    • rizatriptan
    • sumatriptan and naproxen
    • zolmitriptan
  • are allergic to almotriptan malate or any of the ingredients in almotriptan tablets.

    • Take almotriptan tablets exactly as your doctor tells you to take it.
    • If your headache comes back after your first dose, you may take a second dose 2 hours or more after the first dose. If your pain continues after the first dose, do not take a second dose without first checking with your doctor.
    • Do not take more than 2 almotriptan tablets in a 24-hour period.
    • If you take too much almotriptan tablets, call your doctor or go to the nearest hospital emergency room right away.

What Should I Avoid While Taking Almotriptan Tablets? 

Almotriptan tablets may cause dizziness, sleepiness, and problems

Almotriptan Tablets May Cause Serious Side Effects, Including: 

  • changesin color or sensation in your fingers and toes (Raynaud's syndrome)
  • stomachand 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
  • problemswith 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
  • serotoninsyndrome.Serotonin syndrome is a rare but serious problem that can happen in people using almotriptan tablets, especially if almotriptan tablets are used with antidepressant medicines called SSRIs or SNRIs. Call your doctor if you have any of the following symptoms of serotonin syndrome:
    • mental changes such as

      • Store almotriptan tablets at room temperature between 68 F to 77 F (20 C to 25 C).
      • Safely throw away medicine that is out of date or no longer needed.

      Keep almotriptan tablets and all medicines out of the reach of children.

      General information about the safe and effective use of almotriptan tablets.

      Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use almotriptan tablets for a condition for which it was not prescribed. Do not give almotriptan tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about almotriptan tablets that is written for health professionals.

Active Ingredient: 

almotriptan malate

Inactive Ingredients: 

mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, sodium stearyl fumarate, polyethylene glycol, titanium dioxide and hypromellose.

Marketed By: 

Ajanta Pharma USA Inc.

Bridgewater, NJ 08807.

Made in India.


This Patient Information has been approved by the U.S. Food and Drug Administration


Revised: 12/2017





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