Medication Guide

MEDICATION GUIDE

Dalfampridine Extended-Release Tablets

(dal fam’ pri deen)

Rx only

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?

Dalfampridine can cause seizures.

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You could have a seizure even if you never had a seizure before.

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Your chance of having a seizure is higher if you take too much Dalfampridine or if your kidneys have a mild decrease of function, which is common after age 50.

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Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking Dalfampridine.

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Do not take Dalfampridine if you have ever had a seizure.

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Before taking Dalfampridine tell your doctor if you have kidney problems.

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Take Dalfampridine exactly as prescribed by your doctor. See "How should I take Dalfampridine?"

Stop taking Dalfampridine and call your doctor right away if you have a seizure while taking Dalfampridine.

What is Dalfampridine?

Dalfampridine is 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 is safe or effective in children less than 18 years of age.

Who should not take Dalfampridine?

Do not take Dalfampridineif you:

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have ever had a seizure

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have certain types of kidney problems

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are allergic to dalfampridine (4-aminopyridine), the active ingredient in Dalfampridine

What should I tell my doctor before taking Dalfampridine?

Before you take Dalfampridine, tell your doctor if you:

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have any other medical conditions

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are taking compounded 4-aminopyridine (fampridine, 4-AP)

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are taking any other medicines, including over-the-counter medicines such as cimetidine

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are pregnant or plan to become pregnant. It is not known if Dalfampridine will harm your unborn baby.

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are breast-feeding or plan to breast-feed. It is not known if Dalfampridine passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take dalfampridine.

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?

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Take Dalfampridine exactly as your doctor tells you to take it. Do not change your dose of Dalfampridine.

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Take one tablet of Dalfampridine 2 times each day about 12 hours apart. Do not take more than 2 tablets of Dalfampridine in a 24-hour period.

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Take Dalfampridine tablets whole. Do not break, crush, chew or dissolve Dalfampridine tablets before swallowing. If you cannot swallow Dalfampridine tablets whole, tell your doctor.

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Dalfampridine is released slowly over time. If the tablet is broken, the medicine may be released too fast. This can raise your chance of having a seizure.

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Dalfampridine can be taken with or without food.

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If you miss a dose of Dalfampridine, do not make up the missed dose. Do not take 2 doses at the same time. Take your next dose at your regular scheduled time.

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If you take too much Dalfampridine, call your doctor or go to the nearest hospital emergency room right away.

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Do not take Dalfampridine together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine, fampridine).

What should I avoid while taking Dalfampridine?

Dalfampridine 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?

Dalfampridine may cause serious side effects, including:

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serious allergic reactions. Stop taking Dalfampridine and call your doctor right away or get emergency medical help if you have:

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shortness of breath or trouble breathing

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swelling of your throat or tongue

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hives

See "What is the most important information I should know about Dalfampridine?"

The most common side effects of Dalfampridine include:

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urinary tract infection

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trouble sleeping (insomnia)

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dizziness

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headache

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nausea

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weakness

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back pain

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problems with balance

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multiple sclerosis relapse

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burning, tingling or itching of your skin

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irritation in your nose and throat

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constipation

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indigestion

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pain in your throat

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. 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?

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Store Dalfampridine Extended-Release Tablets at 20˚ to 25˚C (68˚ to 77˚F). [See USP Controlled Room Temperature.]

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Safely throw away Dalfampridine Extended-Release Tablets that are out of date or no longer needed.

Keep Dalfampridine and all medicines out of the reach of children.

General Information about the safe and effective use of Dalfampridine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dalfampridine for a condition for which it was not prescribed. Do not give Dalfampridine 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. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Dalfampridine that is written for health professionals.

For more information, please call Hikma Pharmaceuticals USA Inc. at 1-800-962-8364.

What are the ingredients in Dalfampridine Extended-Release Tablets?

Active ingredient: dalfampridine, USP (previously called fampridine)

Inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, mannitol and microcrystalline cellulose. In addition to the ingredients listed above, each extended-release tablet contains Opadry (White). Opadry (White) contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.

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

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

C50000461/03

Revised May 2023