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ALMOTRIPTAN MALATE- almotriptan tablet, film coated


  1. Patient Information
  2. Almotriptan 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. What Are Almotriptan Tablets?
  6. Do Not Take Almotriptan Tablets If You:
  7. What Should I Avoid While Taking Almotriptan Tablets?
  8. Almotriptan Tablets May Cause Serious Side Effects, Including:
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. Manufactured For:
  12. Manufactured By:
  13. Drug Interactions:
  14. Hypersensitivity:
  15. Risk Of Myocardial Ischemia And/or Infarction, Other Adverse Cardiac Events, Other Vasospasm-related Events, And Cerebrovascular Events:
  16. Serotonin Syndrome:
  17. Medication Overuse Headache:
  18. Pregnancy:
  19. Nursing Mothers:
  20. Ability To Operate Machinery Or Vehicles:

Patient Information 

Almotriptan Tablets, USP
(al moe trip tan)

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 belong to a class of medicines called Triptans. Almotriptan tablets are used:
o
to treat acute migraine attacks in adults with a history of migraine with or without aura.
o
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:
o
ergotamines
o
dihydroergotamines
o
methysergide
o
sumatriptan
o
eletriptan
o
frovatriptan
o
naratriptan
o
rizatriptan
o
sumatriptan and naproxen
o
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 them.
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 many 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: 

Store almotriptan tablets at room temperature between 20 C to 25 C (68 F to 77 F).
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 they were not prescribed. Do not give almotriptan tablets to other people, even if they have the same symptoms you have. They 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: 

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

Manufactured For: 

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Manufactured By: 

Mylan Laboratories Limited Hyderabad 500 096, India

For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

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

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad 500 096, India
Code No.: MH/DRUGS/25/NKD/89

75061692

Revised: 5/2017
MX:ALMT:R3U

Drug Interactions: 

Advise patients to talk with their physician or pharmacist before taking any new medicines, including prescription and non-prescription drugs and supplements[seeContraindications (4.5)and(4.6)andDrug Interactions (7)].

Hypersensitivity: 

Inform patients to tell their physician if they develop a rash, itching, or breathing difficulties after taking almotriptan tablets[seeWarnings 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 tablets 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, or 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[seeWarnings and Precautions (5.1),(5.2),(5.3), and(5.4)].

Serotonin Syndrome: 

Caution patients about the risk of serotonin syndrome with the use of almotriptan tablets or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)[seeWarnings 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)[seeWarnings and Precautions (5.6)].

Pregnancy: 

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

Nursing Mothers: 

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

Ability To Operate Machinery Or Vehicles: 

Counsel patients that almotriptan tablets 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 tablets to gauge whether they affect their mental or visual performance adversely.



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