facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

CARBAMAZEPINE capsule, extended release


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Carbamazepine Extended-release Capsules?
  3. Carbamazepine Extended-release Capsules Can Cause Serious Side Effects, Including:
  4. Carbamazepine Extended-release Capsules Is A Medicine Used To Treat:
  5. Do Not Take Carbamazepine Extended-release Capsules If You:
  6. Before You Take Carbamazepine Extended-release Capsules, Tell Your Healthcare Provider If You:
  7. How Should I Take Carbamazepine Extended-release Capsules?
  8. What Should I Avoid While Taking Carbamazepine Extended-release Capsules?
  9. What Are The Possible Side Effects Of Carbamazepine Extended-release Capsules?
  10. What Is The Most Important Information I Should Know About Carbamazepine?
  11. Carbamazepine Can Cause Serious Side Effects, Including:
  12. Carbamazepine Is A Medicine Used To Treat:
  13. Do Not Take Carbamazepine If You:
  14. Before You Take Carbamazepine, Tell Your Healthcare Provider If You:
  15. How Should I Take Carbamazepine?
  16. What Should I Avoid While Taking Carbamazepine?
  17. What Are The Possible Side Effects Of Carbamazepine?
  18. What Are The Ingredients In Carbamazepine?
  19. In Addition:
  20. Active Ingredient(s):
  21. Inactive Ingredient(s):
  22. Revised: 2/2019document Id:

Patient Information 

Carbamazepine Extended-Release Capsules

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

What Is The Most Important Information I Should Know About Carbamazepine Extended-release Capsules? 

Do not stop taking carbamazepine extended-release capsules without first talking to your healthcare provider.

Stopping carbamazepine extended-release capsules suddenly can cause serious problems.

Carbamazepine Extended-release Capsules Can Cause Serious Side Effects, Including: 

1. Carbamazepine extended-release capsules may cause rare but serious rashes that may lead to death. These serious skin reactions are more likely to happen within the first four months of carbamazepine extended-release capsule treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent you may need a genetic blood test before you take carbamazepine extended-release capsules to

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop carbamazepine extended-release capsules without first talking to a healthcare provider.

Stopping carbamazepine extended-release capsules suddenly can cause serious problems.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Carbamazepine Extended-release Capsules Is A Medicine Used To Treat: 

  • certain types of seizures (partial, tonic-clonic, mixed)
  • certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).

Carbamazepine extended-release capsules is not a regular pain medicine and should not be used for aches or pains.

Do Not Take Carbamazepine Extended-release Capsules If You: 

  • have a history of bone marrow depression
  • are allergic to carbamazepine or any of the ingredients in carbamazepine extended-release capsules.

Before You Take Carbamazepine Extended-release Capsules, Tell Your Healthcare Provider If You: 

  • have or ever had heart problems
  • have or ever had blood problems
  • have or ever had liver or kidney problems
  • have or ever had allergic reactions to medicines
  • have or ever had increased pressure in your eye
  • have or have had suicidal thoughts or actions, depression or mood problems
  • have any other medical conditions
  • drink grapefruit juice or eat grapefruit
  • use birth control. Carbamazepine extended-release capsules may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and carbamazepine extended-release capsules.
  • are pregnant or plan to become pregnant. Carbamazepine extended-release capsules may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking carbamazepine extended-release capsules. You and your healthcare provider should decide if you should take carbamazepine extended-release capsules while you are pregnant.
    • If you become pregnant while taking carbamazepine extended-release capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
    • are breastfeeding or plan to breastfeed. Carbamazepine extended-release capsules passes into breast milk. You and your healthcare provider should discuss whether you should take carbamazepine extended-release capsules or breastfeed. You should not do both.

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

Taking carbamazepine extended-release capsules with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

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

How Should I Take Carbamazepine Extended-release Capsules? 

  • Take carbamazepine extended-release capsules exactly as prescribed. Your doctor will tell you how much carbamazepine extended-release capsules to take.
  • Your healthcare provider may change your dose. Do not change your dose of carbamazepine extended-release capsules without talking to your healthcare provider.
  • Do not stop taking carbamazepine extended-release capsules without first talking to your healthcare provider. Stopping carbamazepine extended-release capsules suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
  • Take carbamazepine extended-release capsules with or without food.
  • Do not crush, chew, or breakcarbamazepine extended-release capsules. But, carbamazepine extended-release capsules can be opened and sprinkled over food such as a teaspoon of applesauce. Tell your healthcare provider if you can not swallow carbamazepine extended-release capsules whole.
  • If you take too much carbamazepine extended-release capsules, call your healthcare provider or local Poison Control Center right away.

What Should I Avoid While Taking Carbamazepine Extended-release Capsules? 

  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking carbamazepine extended-release capsules until you talk to your healthcare provider. Carbamazepine extended-release capsules taken with alcohol or drugs may make your sleepiness or dizziness worse.
  • Do not drive, or operate heavy machinery, or do other dangerous activities until you know how carbamazepine extended-release capsules affects you. Carbamazepine extended-release capsules can slow your thinking and motor skills.

What Are The Possible Side Effects Of Carbamazepine Extended-release Capsules? 

  • Store at 20 - 25 C (68 - 77 F)[

    Active ingredient: carbamazepine

    Inactive ingredients: ammonio methacrylate copolymer, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and triethyl citrate.

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

Do not stop taking carbamazepine without first talking to your healthcare provider.

Stopping carbamazepine suddenly can cause serious problems.

Carbamazepine Can Cause Serious Side Effects, Including: 

1.
Carbamazepine may cause rare but serious rashes that may lead to death. These serious skin reactions are more likely to happen within the first four months of carbamazepine treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent you may need a genetic blood test before you take carbamazepine to

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop carbamazepine without first talking to a healthcare provider.

Stopping carbamazepine suddenly can cause serious problems.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Carbamazepine Is A Medicine Used To Treat: 

  • certain types of seizures (partial, tonic-clonic, mixed)
  • certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).

Carbamazepine is not a regular pain medicine and should not be used for aches or pains.

Do Not Take Carbamazepine If You: 

  • have a history of bone marrow depression
  • are allergic to carbamazepine or any of the ingredients in carbamazepine.

Before You Take Carbamazepine, Tell Your Healthcare Provider If You: 

  • have or ever had heart problems
  • have or ever had blood problems
  • have or ever had liver or kidney problems
  • have or ever had allergic reactions to medicines
  • have or ever had increased pressure in your eye
  • have or have had suicidal thoughts or actions, depression or mood problems
  • have any other medical conditions
  • drink grapefruit juice or eat grapefruit
  • use birth control. Carbamazepine may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and carbamazepine.
  • are pregnant or plan to become pregnant. Carbamazepine may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking carbamazepine. You and your healthcare provider should decide if you should take carbamazepine while you are pregnant.
    • If you become pregnant while taking carbamazepine, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
  • are breastfeeding or plan to breastfeed. Carbamazepine passes into breast milk. You and your healthcare provider should discuss whether you should take carbamazepine or breastfeed. You should not do both.

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

Taking carbamazepine with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

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

How Should I Take Carbamazepine? 

  • Take carbamazepine exactly as prescribed. Your doctor will tell you how much carbamazepine to take.
  • Your healthcare provider may change your dose. Do not change your dose of carbamazepine without talking to your healthcare provider.
  • Do not stop taking carbamazepine without first talking to your healthcare provider. Stopping carbamazepine suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
  • Take carbamazepine with or without food.
  • Do not crush, chew, or break carbamazepinecapsules or the beads inside of the capsules. But, carbamazepine capsules can be opened and sprinkled over food such as a teaspoon of applesauce. Tell your healthcare provider if you can not swallow carbamazepine whole.
  • If you take too much carbamazepine, call your healthcare provider or local Poison Control Center right away.

What Should I Avoid While Taking Carbamazepine? 

  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking carbamazepine until you talk to your healthcare provider. Carbamazepine taken with alcohol or drugs may make your sleepiness or dizziness worse.
  • Do not drive, or operate heavy machinery, or do other dangerous activities until you know how carbamazepine affects you. Carbamazepine can slow your thinking and motor skills.

What Are The Possible Side Effects Of Carbamazepine? 

  • Store carbamazepine between 59 F to 86 F (15 C to 30 C).
  • Keep carbamazepine out of the light.
  • Keep carbamazepine capsules dry.

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

General information about carbamazepine

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

For more information call 1-800-828-2088.

What Are The Ingredients In Carbamazepine? 

Active ingredient: carbamazepine

Inactive ingredients: citric acid, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, talc, triethyl citrate and Eudragit.

In Addition: 

  • the 100 mg capsules contain gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and titanium dioxide and are imprinted with white ink
  • the 200 mg capsules contain gelatin-NF, FD&C Red #3, FD&C Yellow #6, Yellow Iron Oxide, FD&C Blue #2, and titanium dioxide, and are imprinted with white ink
  • the 300 mg capsules contain gelatin-NF, FD&C Blue #2, FD&C Yellow #6, Red Iron Oxide, Yellow Iron Oxide, and titanium dioxide, and are imprinted with white ink

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

Distributed by:
Prasco Laboratories
Mason, OH 45040 USA

Manufactured for:
Shire US Inc.
300 Shire Way, Lexington, MA 02421

2015 Prasco Laboratories

Issued [11/2015]

DRUG: Carbamazepine

GENERIC: carbamazepine

DOSAGE: CAPSULE, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0124-0

COLOR: black

SHAPE: CAPSULE

SCORE: No score

SIZE: 23 mm

IMPRINT: S433;300mg

PACKAGING: 90 in 1 BOTTLE, PLASTIC

Active Ingredient(s): 

  • CARBAMAZEPINE 300mg in 1

Inactive Ingredient(s): 

  • AMMONIO METHACRYLATE COPOLYMER TYPE A
  • FD&C YELLOW NO. 6
  • FD&C BLUE NO. 2
  • FERRIC OXIDE RED
  • FERRIC OXIDE YELLOW
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
  • GELATIN, UNSPECIFIED
  • TITANIUM DIOXIDE
  • CITRIC ACID MONOHYDRATE
  • LACTOSE MONOHYDRATE
  • MICROCRYSTALLINE CELLULOSE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • SILICON DIOXIDE
  • POVIDONE, UNSPECIFIED
  • SODIUM LAURYL SULFATE
  • TALC
  • TRIETHYL CITRATE

Remedy_Label

CARBAMAZEPINE
carbamazepine capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70518-0124(NDC:66993-409)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMAZEPINE(UNII: 33CM23913M) (CARBAMAZEPINE - UNII:33CM23913M)CARBAMAZEPINE300 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
Product Characteristics
Colorblack (black) , green (green)Scoreno score
ShapeCAPSULE (CAPSULE)Size23mm
FlavorImprint CodeS433;300mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0124-090 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02071201/16/2017
Labeler -REMEDYREPACK INC. (829572556)

Revised: 2/2019document Id: 

81279f69-ff12-fd02-e053-2a91aa0a03e6Set id: 0a6c9407-35b2-4ad5-b6c3-43af24906839Version: 4Effective Time: 20190205REMEDYREPACK INC.



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com