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DALFAMPRIDINE tablet, film coated, extended release


  1. What Is The Most Important Information I Should Know About Dalfampridine Extended-release Tablets?
  2. Do Not Take Dalfampridine Extended-release Tablets If You:
  3. Before You Take Dalfampridine Extended-release Tablets, Tell Your Doctor If You:
  4. How Should I Take Dalfampridine Extended-release Tablets?
  5. Dalfampridine Extended-release Tablets May Cause Serious Side Effects, Including:
  6. Store At 25 C (77 F); Excursions Permitted Between 15 C To 30 C (59 F To 86 F) [active Ingredient:
  7. Alkem Laboratories Limitedmumbai 400 013, Indiadistributed By:
  8. What Is The Most Important Information I Should Know About Dalfampridine?
  9. Who Should Not Take Dalfampridine?
  10. Before You Take Dalfampridine, Tell Your Doctor If You:
  11. How Should I Take Dalfampridine?
  12. Serious Allergic Reactions. Stop Taking Dalfampridine And Call Your Doctor Right Away Or Get Emergency Medical Help If You Have:
  13. Active Ingredient:
  14. What Is The Most Important Information I Should Know About Dalfampridine Extended-release Tablets?
  15. Do Not Take Dalfampridine Extended-release Tablets If You:
  16. Before You Take Dalfampridine Extended-release Tablets, Tell Your Doctor If You:
  17. How Should I Take Dalfampridine Extended-release Tablets?
  18. Dalfampridine Extended-release Tablets May Cause Serious Side Effects, Including:
  19. Inactive Ingredients:
  20. Patient Information

What Is The Most Important Information I Should Know About 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.

Do Not Take Dalfampridine Extended-release Tablets If You: 



  • have ever had a seizure
  • have certain types of kidney problems
  • are allergic to dalfampridine (4-aminopyridine), the active ingredient in Dalfampridine Extended-release Tablets

Before You Take Dalfampridine Extended-release Tablets, 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 Extended-release Tablets 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 Extended-release Tablets 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 Take Dalfampridine 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 tablet of Dalfampridine Extended-release Tablets 2 times each day about 12 hours apart. Do not take more than 2 Dalfampridine Extended-release Tablets in a 24hour period.
  • Take Dalfampridine Extended-release Tablets whole. Do not break, crush, chew or dissolve Dalfampridine Extended-release Tablets before swallowing. If you cannot swallow Dalfampridine Extended-release Tablets whole, tell your doctor.
  • Dalfampridine Extended-release Tablets are 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 Dalfapridine-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 Tablets, 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).

Dalfampridine Extended-release Tablets May Cause Serious Side Effects, Including: 


  • 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 At 25 C (77 F); Excursions Permitted Between 15 C To 30 C (59 F To 86 F) [active Ingredient: 

dalfampridine (previously called fampridine)

Alkem Laboratories Limitedmumbai 400 013, Indiadistributed By: 


Ascend Laboratories, LLC
Parsippany, NJ 07054
Revised: June, 2018
PT 2221

What Is The Most Important Information I Should Know About Dalfampridine? 

Dalfampridine 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 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.
Do not take Dalfampridine if you have ever had a seizure.
Before taking Dalfampridine tell your doctor if you have kidney problems.
Take Dalfampridine exactly as prescribed by your doctor.

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:

have ever had a seizure
have certain types of kidney problems
are allergic to dalfampridine (4-aminopyridine), the active ingredient in Dalfampridine

Before You Take Dalfampridine, 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 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 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 Take Dalfampridine? 

Take Dalfampridine exactly as your doctor tells you to take it. Do not change your dose of Dalfampridine.
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.
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.
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.
Dalfampridine can be taken with or without food.
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.
If you take too much Dalfampridine, call your doctor or go to the nearest hospital emergency room right away.
Do not take Dalfampridine together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine, fampridine).

Serious Allergic Reactions. Stop Taking Dalfampridine 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 20 to 25 C (68 to 77 F). [

Active Ingredient: 

dalfampridine USP (previously called fampridine)

What Is The Most Important Information I Should Know About 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 many 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 tablets are safe or effective in children less than 18 years of age.

Do Not Take Dalfampridine Extended-release Tablets If You: 

have ever had a seizure
have certain types of kidney problems
are allergic to dalfampridine (4-aminopyridine), the active ingredient in dalfampridine extended-release tablets

Before You Take Dalfampridine Extended-release Tablets, 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 Take Dalfampridine Extended-release Tablets? 

Take dalfampridine extended-release tablets exactly as your doctor tells you to take them. Do not change your dose of dalfampridine extended-release tablets.
Take one tablet of 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.
Take dalfampridine extended-release tablets whole. Do not break, crush, chew or dissolve dalfampridine extended-release tablets before swallowing. If you cannot swallow dalfampridine extended-release tablets whole, tell your doctor.
Dalfampridine extended-release tablets are 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 many dalfampridine extended-release tablets, 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).

Dalfampridine Extended-release Tablets May Cause Serious Side Effects, Including: 

serious allergic reactions. Stop taking dalfampridine extended-release tablets and call your doctor right away or get emergency medical help if you have:
o
shortness of breath or trouble breathing
o
swelling of your throat or tongue
o
hives

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

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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

Inactive Ingredients: 

colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

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

Distributed by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured for Acorda Therapeutics, Inc., Ardsley, NY under license from Alkermes Pharma Ireland Limited (APIL), Athlone, Ireland, utilizing APIL s MatriX Drug Absorption System (MXDAS) technology.

MXDASis a registered trademark of Alkermes Pharma Ireland Limited (APIL).

Revised: 7/2018
ACT:DALFER:R1

121042

Patient Information 

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

Risk of Seizures

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

Dalfampridine Extended-Release TabletsDosing

Instruct patients to take dalfampridine extended-release tablets exactly 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 extended-release tablets 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 are out of date or no longer needed.



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