Dalfampridine is used to improve walking in patients with multiple sclerosis (MS).

Dalfampridine may also be used for purposes not listed in this medication guide.

Dalfampridine can cause a seizure, even if you never had one before. Taking too much dalfampridine may increase your risk of seizure. Your risk may also be higher if you have kidney problems or are older than 50.

Your kidney function may need to be tested before you start taking dalfampridine.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Taking too much dalfampridine may increase your risk of seizure. Space your doses 12 hours apart. Do not take more than 2 tablets in 24 hours.

You may take dalfampridine with or without food.

Swallow the tablet whole and do not crush, chew, or break it. Breaking the pill may cause too much of the drug to be released at one time which can increase your risk of a seizure.

Do not use a tablet that has been crushed or broken.

Store at room temperature away from moisture and heat. Do not use past the expiration date on the label.

Usual Adult Dose for Multiple Sclerosis:

Maximum dose: 10 mg orally every 12 hours

Comments:
-This drug may be taken with or without food.
-Tablets should be swallowed whole, and not divided, crushed, chewed, or dissolved.
-Patients should not take double or extra doses if a dose is missed.

Use: To improve walking in adult patients with multiple sclerosis (MS) demonstrated by an increase in walking speed

You should not use this medicine if you are allergic to dalfampridine or 4-aminopyridine, or if you have:

• moderate to severe kidney disease; or

• if you've ever had a seizure.

Dalfampridine can cause a seizure, even if you never had one before. Your risk may also be higher if you have kidney problems or are older than 50.

Tell your doctor if you have ever had:

• kidney disease; or

• if you also take a form of this medicine obtained from a compounding pharmacy (fampridine, or 4-aminopyridine).

Older adults may be more sensitive to the effects of this medication.

It is not known if dalfampridine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 18 years old.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause confusion or seizures.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

Dalfampridine may cause serious side effects. Call your doctor at once if you have:

• pain or burning when you urinate; or

• relapse or worsening of MS symptoms.

Common side effects of dalfampridine may include:

• weakness, MS relapse;

• painful urination;

• dizziness, balance problems;

• numbness or tingling;

• sleep problems (insomnia);

• nausea, constipation, upset stomach;

• stuffy nose, sinus pain, sore throat; or

• headache, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• cimetidine.

This list is not complete. Other drugs may affect dalfampridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to dalfampridine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.