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DALFAMPRIDINE tablet, extended release


  1. Dalfampridine Extended-release Tablets?
  2. , Tell Your Doctor If You:
  3. Serious Allergic Reactions. Stop Taking Dalfampridine Extended-release Tablets And Call Your Doctor Right Away Or Get Emergency Medical Help If You Have:
  4. Active Ingredient:
  5. Inactive Ingredients:
  6. Manufactured By:
  7. Manufactured For:
  8. Patient Information

Dalfampridine Extended-release Tablets? 


Dalfampridine extended-release tablets can cause seizures.

  • You could have a seizure even if you never had a seizure before.
  • Your chance of having a seizure is higher if you take too much dalfampridine extended-release tablets or if your kidneys have a mild decrease of function, which is common after age 50.
  • 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 extended-release tablets.
  • Do not take dalfampridine extended-release tablets if you have ever had a seizure.
  • Before taking dalfampridine extended-release tablets tell your doctor if you have kidney problems.
  • Take dalfampridine extended-release tablets exactly as prescribed by your doctor.

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

    Who should not take

, Tell Your Doctor If You: 

  • have any other medical conditions
  • are taking compounded 4-aminopyridine (fampridine, 4-AP)
  • are taking any other medicines, including over-the-counter medicines such as cimetidine
  • are pregnant or plan to become pregnant. It is not known if dalfampridine will harm your unborn baby. You and your doctor will decide if you should take dalfampridine extended-release tablets while you are pregnant
  • are breast-feeding or plan to breast-feed. It is not known if dalfampridine passes into your breast milk. You and your doctor should decide if you will take dalfampridine extended-release tablets or breast-feed. You should not do both.

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 takedalfampridine extended-release tablets?

  • Take dalfampridine extended-release tablets exactly as your doctor tells you to take it. Do not change your dose of dalfampridine extended-release tablets.
  • Take one dalfampridine extended-release tablets 2 times each day about 12 hours apart. Do not take more than 2 tablets of dalfampridine extended-release tablets in a 24-hour period.
  • Takedalfampridine extended-release tabletswhole. Do not break, crush, chew or dissolvedalfampridine extended-release tabletsbefore swallowing. If you cannot swallowdalfampridine extended-release tabletswhole, tell your doctor.
  • Dalfampridine extended-release tablet 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.
  • Dalfampridine extended release tablets can be taken with or without food.
  • If you miss a dose of dalfampridine extended-release tablets, 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.
  • If you take too much dalfampridine extended-release tablet, call your doctor or go to the nearest hospital emergency room right away.
  • Do not take dalfampridine extended-release tablets together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine, fampridine).

What are the possible side effects ofdalfampridine extended-release tablets?

Dalfampridine extended-release tablets

Serious Allergic Reactions. Stop Taking Dalfampridine Extended-release Tablets And Call Your Doctor Right Away Or Get Emergency Medical Help If You Have: 

  • shortness of breath or trouble breathing
  • swelling of your throat or tongue
  • hives

    • Store dalfampridine extended-release tablets at 59 F to 86 F (15 C to 30 C).
    • Safely throw away a dalfampridine extended-release tablets that are out of date or no longer needed.

    Keepdalfampridine extended-release tabletsand all medicines out of the reach of children.

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


    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dalfampridine extended-release tabletsfor 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 1-855-839-8195

    What are the ingredients indalfampridine extended-release tablets?

    Active Ingredient: 

    dalfampridine

    Inactive Ingredients: 

    hypromelloses, magnesium stearate, microcrystalline cellulose, polyethylene glycols, silicon dioxide and titanium dioxide.


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

    Manufactured By: 

    Micro Labs Limited

    Goa-403722, INDIA.

    Manufactured For: 

    Micro Labs USA Inc.


    Revised: April2018

    Patient Information 

    Advise the patient to read the FDA-approved patient labeling (Medication Guide).

    Risk of Seizures


    Inform patients that dalfampridine can cause seizures, and that they must discontinue use of dalfampridine if they experience a seizure[seeWarnings and Precautions (5.1)].


    Dalfampridinedosing


    Instruct patients to take dalfampridineexactly as prescribed. Instruct patients not to take a double dose after they miss a dose, as this would increase their risk of seizure. Instruct patients not to take more than 2 tablets in a 24-hour period and to make sure that there is an approximate 12 hour interval between doses[seeDosage and Administration (2.1,2.2)].


    Anaphylaxis


    Advise patients to discontinue dalfampridine and seek medical care if they develop signs and symptoms of anaphylaxis[seeWarnings and Precautions (5.4)].


    Drug Interactions


    Instruct patients to notify their healthcare provider prior to starting any new medication, including over-the-counter drugs.

    Storage

    Advise patients to store dalfampridine extended- release tablets at 25 C (77 F), with excursions permitted to 15 C to 30 C (59 F to 86 F). Advise patients to safely throw away dalfampridine extended- release tablets that is out of date or no longer needed.



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