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CARVEDILOL tablet


  1. Patients Taking Carvedilol Should Be Advised Of The Following:
  2. What Is Carvedilol?
  3. Carvedilol Is Used, Often With Other Medicines, For The Following Conditions:
  4. Do Not Take Carvedilol If You:
  5. How Should I Take Carvedilol?
  6. What Should I Avoid While Taking Carvedilol?
  7. What Are Possible Side Effects Of Carvedilol?
  8. How Should I Store Carvedilol?
  9. What Are The Ingredients In Carvedilol Tablets?
  10. Manufactured By:
  11. Manufactured For:
  12. Revised: 12/2011document Id:
  13. Patient Information
  14. Distributed By:
  15. Carvedilol Tablets Is A Prescription Medicine That Belongs To A Group Of Medicines Called "beta-blockers". Carvedilol Tablets Is Used, Often With Other Medicines, For The Following Conditions:
  16. Do Not Take Carvedilol Tablets If You:
  17. Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  18. How Should I Take Carvedilol Tablets?
  19. What Should I Avoid While Taking Carvedilol Tablets?
  20. What Are Possible Side Effects Of Carvedilol Tablets?
  21. How Should I Store Carvedilol Tablets?
  22. What Are The Ingredients In Carvedilol Tablets?
  23. What Is High Blood Pressure (hypertension)?

Patients Taking Carvedilol Should Be Advised Of The Following: 

  • Patients should take carvedilol with food.
  • Patients should not interrupt or discontinue using carvedilol without a physician s advice.
  • Patients with heart failure should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
  • Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting. Patients should sit or lie down when these symptoms of lowered blood pressure occur.
  • If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks.
  • Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted.
  • Diabetic patients should report any changes in blood sugar levels to their physician.
  • Contact lens wearers may experience decreased lacrimation.

Glenmark Logo

Glenmark Generics Inc., USA

Mahwah, NJ 07430

17.2 FDA-Approved Patient Labeling

PATIENT INFORMATION

Carvedilol Tablets, USP

(kar' ve dil ol)

Read the Patient Information that comes with carvedilol before you start taking it 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. If you have any questions about carvedilol, ask your doctor or pharmacist.

What Is Carvedilol? 

Carvedilol is a prescription medicine that belongs to a group of medicines called beta-blockers .

Carvedilol Is Used, Often With Other Medicines, For The Following Conditions: 

  • To treat patients with high blood pressure (hypertension)
  • To treat patients who had a heart attack that worsened how well the heart pumps
  • Carvedilol is not approved for use in children under 18 years of age.

Do Not Take Carvedilol If You: 

  • Have severe heart failure and are hospitalized in the intensive care unit or require certain intravenous medications that help support circulation (inotropic medications)
  • Are prone to asthma or other breathing problems
  • Have a slow heartbeat or a heart that skips a beat (irregular heartbeat)
  • Have liver problems
  • Are allergic to any of the ingredients in carvedilol tablets. The active ingredient is carvedilol. See the end of this leaflet for a list of all the ingredients in carvedilol tablets.

How Should I Take Carvedilol? 

It is important for you to take your medicine every day as directed by your doctor. If you stop taking carvedilol suddenly, you could have chest pain and/or a heart attack. If your doctor decides that you should stop taking carvedilol, your doctor may slowly lower your dose over a period of time before stopping it completely.

  • Take carvedilol exactly as prescribed. Your doctor will tell you how many tablets to take and how often. In order to minimize possible side effects, your doctor might begin with a low dose and then slowly increase the dose.
  • Do not stop taking carvedilol and do not change the amount of carvedilol you take without talking to your doctor.
  • Tell your doctor if you gain weight or have trouble breathing while taking carvedilol.
  • Take carvedilol with food.
  • If you miss a dose of carvedilol, take your dose as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take 2 doses at the same time.
  • If you take too much carvedilol, call your doctor or poison control center right away.

What Should I Avoid While Taking Carvedilol? 

Carvedilol can cause you to feel dizzy, tired, or faint. Do not drive a car, use machinery, or do anything that needs you to be alert if you have these symptoms.

What Are Possible Side Effects Of Carvedilol? 

  • Low blood pressure (which may cause dizziness or fainting when you stand up). If these happen, sit or lie down right away and tell your doctor.
  • Tiredness.If you feel tired or dizzy you should not drive, use machinery, or do anything that needs you to be alert.
  • Slow heartbeat.
  • Changes in your blood sugar. If you have diabetes, tell your doctor if you have any changes in your blood sugar levels.
  • Carvedilol may hide some of the symptoms of low blood sugar, especially a fast heartbeat.
  • Carvedilol may mask the symptoms of hyperthyroidism (overactive thyroid).
  • Worsening of severe allergic reactions.
  • Rare but serious allergic reactions (including hives or swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing) have happened in patients who were on carvedilol. These reactions can be life-threatening.

Other side effects of carvedilol include shortness of breath, weight gain, diarrhea, and fewer tears or dry eyes that become bothersome if you wear contact lenses.

Call your doctor if you have any side effects that bother you or don t go away.

How Should I Store Carvedilol? 

  • Store carvedilol at less than 86 F (30 C). Keep the tablets dry.
  • Safely, throw away carvedilol that is out of date or no longer needed.
  • Keep carvedilol and all medicines out of the reach of children.

General Information about Carvedilol

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use carvedilol for a condition for which it was not prescribed. Do not give carvedilol to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about carvedilol. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about carvedilol that is written for healthcare professionals. You can also find out more about carvedilol by visiting the websitewww.glenmarkgenerics.comor calling 1 (888)721-7115. This call is free.

What Are The Ingredients In Carvedilol Tablets? 

Active Ingredient: Carvedilol, USP.

Inactive Ingredients: Colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.

Carvedilol tablets, USP come in the following strengths: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg.

Manufactured By: 

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured For: 

Glenmark Logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkgenerics.com

March 2011

Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444

12.5 mg Label
CARVEDILOL
carvedilol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52959-204(NDC:68462-164)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARVEDILOL(UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)CARVEDILOL12.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeG;164
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-204-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07825109/05/2007
Labeler -H.J. Harkins Company, Inc. (147681894)
Registrant -Glenmark Generics Inc., USA (835917282)
Establishment
NameAddressID/FEIBusiness Operations
Glenmark Generics Limited677318665ANALYSIS, MANUFACTURE

Revised: 12/2011document Id: 

68fe3dfd-c27f-4558-b1b1-6aff37213809Set id: 354d1689-53f9-42d3-8308-08b6d9a04404Version: 2Effective Time: 20111208H.J. Harkins Company, Inc.

Patient Information 

See FDA-Approved Patient Labeling (Patient Information).

17.1Patient Advice

  • Patients taking Carvedilol Tablet should be advised of the following: Patients should take Carvedilol Tablet with food.
  • Patients should not interrupt or discontinue using Carvedilol Tablet without a physician's advice.
  • Patients should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
  • Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting. Patients should sit or lie down when these symptoms of lowered blood pressure occur.
  • If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks.
  • Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted.
  • Diabetic patients should report any changes in blood sugar levels to their physician.
  • Contact lens wearers may experience decreased lacrimation.

17.2FDA-Approved Patient Labeling is provided as a tear off leaflet with this fullprescribing information.

Manufactured By:
Beximco Pharmaceuticals Limited,
126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh

Mfg. Lic. No. 379 & 119

Manufactured By:
Beximco Pharmaceuticals Limited

Distributed By: 

Marlex Pharmaceuticals, Inc. New Castle, DE 19720

Revised 12/2017 BS

Carvedilol Tablets Is A Prescription Medicine That Belongs To A Group Of Medicines Called "beta-blockers". Carvedilol Tablets Is Used, Often With Other Medicines, For The Following Conditions: 

  • to treat patients with certain types of heart failure
  • to treat patients who had a heart attack that worsened how well the heart pumps
  • to treat patients with high blood pressure (hypertension)

Carvedilol tablets is not approved for use in children under 18 years of age.

Do Not Take Carvedilol Tablets If You: 

  • have severe heart failure and are hospitalized in the intensive care unit or require certain intravenous medications that help support circulation (inotropic medications).
  • are prone to asthma or other breathing problems.
  • have a slow heartbeat or a heart that skips a beat (irregular heartbeat).
  • have liver problems.
  • are allergic to any of the ingredients in carvedilol tablets. The active ingredient is carvedilol.

Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

  • have asthma or other lung problems (such as bronchitis or emphysema)
  • have problems with blood flow in your feet and legs (peripheral vascular disease) carvedilol tablets can make some of your symptoms worse.
  • have diabetes.
  • have thyroid problems.
  • have a condition called pheochromocytoma.
  • have had severe allergic reactions.
  • are pregnant or trying to become pregnant. It is not known if carvedilol is safe for your unborn baby. You and your doctor should talk about the best way to control your high blood pressure during pregnancy.
  • are breastfeeding. It is not known if carvedilol passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking carvedilol tablets.
  • are scheduled for surgery and will be given anesthetic agents.
  • are scheduled for cataract surgery and have taken or are currently taking carvedilol tablets.
  • are taking prescription or over-the-counter medicines, vitamins, and herbal supplements. Carvedilol tablets and certain other medicines can affect each other and cause serious side effects. Carvedilol tablets may affect the way other medicines work. Also, other medicines may affect how well carvedilol tablets works.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.

How Should I Take Carvedilol Tablets? 

It is important for you to take your medicine every day as directed by your doctor. If you stop taking carvedilol tablets suddenly, you could have chest pain and/or a heart attack. If your doctor decides that you should stop taking carvedilol tablets, your doctor may slowly lower your dose over a period of time before stopping it completely.

  • Take carvedilol tablets exactly as prescribed. Your doctor will tell you how many tablets to take and how often. In order to minimize possible side effects, your doctor might begin with a low dose and then slowly increase the dose.
  • Do not stop taking carvedilol tablets and do not change the amount of carvedilol tablets you take without talking to your doctor.
  • Tell your doctor if you gain weight or have trouble breathing while taking carvedilol tablets.
  • Take carvedilol tablets with food.
  • If you miss a dose of carvedilol tablets, take your dose as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take 2 doses at the same time.
  • If you take too much carvedilol tablets, call your doctor or poison control center right away.

What Should I Avoid While Taking Carvedilol Tablets? 

  • Carvedilol tablets can cause you to feel dizzy, tired, or faint. Do not drive a car, use machinery, or do anything that needs you to be alert if you have these symptoms.

What Are Possible Side Effects Of Carvedilol Tablets? 

  • Low blood pressure (which may cause dizziness or fainting when you stand up).If these happen, sit or lie down right away and tell your doctor.
  • Tiredness. If you feel tired or dizzy you should not drive, use machinery, or do anything that needs you to be alert.
  • Slow heartbeat.
  • Changes in your blood sugar. If you have diabetes, tell your doctor if you have any changes in your blood sugar levels.
  • Carvedilol tablets may hide some of the symptoms of low blood sugar, especially a fast heartbeat.
  • Carvedilol tablets may mask the symptoms of hyperthyroidism (overactive thyroid).
  • Worsening of severe allergic reactions.
  • Rare but serious allergic reactions (including hives or swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing) have happened in patients who were on carvedilol tablets. These reactions can be life-threatening.

Other side effects of carvedilol tablets include shortness of breath, weight gain, diarrhea, and fewer tears or dry eyes that become bothersome if you wear contact lenses.

Call your doctor if you have any side effects that bother you or don't go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Carvedilol Tablets? 

  • Store carvedilol tablets at 20 to 25 C (68 to 77 F). Keep the tablets dry.
  • Safely, throw away carvedilol tablets that is out of date or no longer needed.
  • Keep carvedilol tablets and all medicines out of the reach of children.

General Information about carvedilol tablets

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use carvedilol tablets for a condition for which it was not prescribed. Do not give carvedilol tablets to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about carvedilol tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about carvedilol tablets that is written for healthcare professionals.

You can also find out more about carvedilol tablets by calling 1-866-604-3268. This call is free.

What Are The Ingredients In Carvedilol Tablets? 

Active Ingredient: Carvedilol

Inactive Ingredients: Hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, starch (corn) and titanium dioxide.

Carvedilol tablets, USP come in the following strengths: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg.

What Is High Blood Pressure (hypertension)? 

Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. High blood pressure makes the heart work harder to pump blood through the body and causes damage to blood vessels. Carvedilol tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure may lower your chance of having a stroke or heart attack.

Manufactured by:

Cipla Ltd.,

Kurkumbh, India

Manufactured for:

Cipla USA, Inc.

1560 Sawgrass Corporate Parkway,

Suite 130, Sunrise, FL 33323

Issued: 10/2017



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