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ALMOTRIPTAN MALATE tablet, film coated


  1. Patient Information
  2. Distributed 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[see Contraindications(4.5) and (4.6) and Drug Interactions (7)].

Hypersensitivity

Inform patients to tell their physician if they develop a rash, itching, or breathing difficulties after taking almotriptan malate[see Warnings and Precautions (5.8)].

Risk of Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, Other Vasospasm-Related Events, and Cerebrovascular Events

Inform patients that almotriptan malate may cause serious cardiovascular side effects such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative signs or symptoms. Apprise the patient of the importance of this follow-up[see Warnings and Precautions (5.1), (5.2), (5.3), (5.4)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with the use of almotriptan malate or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)[see Warnings and Precautions (5.5)].

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary)[see Warnings and Precautions (5.6)].

Pregnancy

Advise patients to notify their physician if they become pregnant during treatment or intend to become pregnant[see Use in Specific Populations (8.1)].

Nursing Mothers

Advise patients to notify their physician if they are breastfeeding or plan to breastfeed[see Use in Specific Populations (8.3)].

Ability to Operate Machinery or Vehicles

Counsel patients that almotriptan malate may cause dizziness, somnolence, visual disturbances, and other CNS symptoms that can interfere with driving or operating machinery. Accordingly, advise the patient not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience with almotriptan malate to gauge whether it affects their mental or visual performance adversely.

Distributed By: 

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. C 5/2017



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