DALFAMPRIDINE - dalfampridine tablet, film coated, extended release 
Aurobindo Pharma Limited

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MEDICATION GUIDE

Dalfampridine Extended-Release Tablets

[Dalfampridine (dal FAM pri deen)]


Read this Medication Guide before you start taking dalfampridine extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.


What is the most important information I should know about dalfampridine extended-release tablets?


Dalfampridine extended-release tablets can cause seizures.


Stop taking dalfampridine extended-release tablets and call your doctor right away if you have a seizure while taking dalfampridine extended-release tablets.


What are dalfampridine extended-release tablets?


Dalfampridine extended-release tablets are a prescription medicine used to help improve walking in adults with multiple sclerosis (MS). This was shown by an increase in walking speed.


It is not known if dalfampridine extended-release tablets are safe or effective in children less than 18 years of age.


Who should not take dalfampridine extended-release tablets?


Do not take dalfampridine extended-release tablets if you:



What should I tell my doctor before taking dalfampridine extended-release tablets?

Before you take dalfampridine extended-release tablets, tell your doctor if you:


Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.


Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.


How should I take dalfampridine extended-release tablets?

What should I avoid while taking dalfampridine extended-release tablets?

Dalfampridine extended-release tablets may cause dizziness or vertigo. If you have these symptoms, do not drive, operate machinery, or do other dangerous activities.

What are the possible side effects of dalfampridine extended-release tablets?


Dalfampridine extended-release tablets may cause serious side effects, including:



See “What is the most important information I should know about dalfampridine extended-release tablets?”


The most common side effects of dalfampridine extended-release tablets include:



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 dalfampridine extended-release 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.


How should I store dalfampridine extended-release tablets?


Keep dalfampridine extended-release tablets and all medicines out of the reach of children.


General Information about the safe and effective use of dalfampridine extended-release tablets


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dalfampridine extended-release tablets for a condition for which it was not prescribed. Do not give dalfampridine extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them.


This Medication Guide summarizes the most important information about dalfampridine extended-release tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about dalfampridine extended-release tablets that is written for health professionals.

For more information call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


What are the ingredients in dalfampridine extended-release tablets?


Active ingredient: dalfampridine (previously called fampridine)


Inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.


This Medication Guide has been approved by the U.S. Food and Drug Administration.

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Revised: 12/2021

Revised: 12/2021
Aurobindo Pharma Limited