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CARVEDILOL PHOSPHATE capsule, extended release


  1. Patient Information
  2. Patients Taking Carvedilol Phosphate Extended-release Capsules Should Be Advised Of The Following:
  3. What Is The Most Important Information I Should Know About Carvedilol Phosphate Extended-release Capsules?
  4. Carvedilol Phosphate Extended-release Capsules Are A Prescription Medicine That Belongs To A Group Of Medicines Called Beta-blockers . Carvedilol Phosphate Extended-release Capsules Are Used, Often With Other Medicines, For The Following Conditions:
  5. Do Not Take Carvedilol Phosphate Extended-release Capsules If You:
  6. Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  7. How Should I Take Carvedilol Phosphate Extended-release Capsules?
  8. If You Have Trouble Swallowing Carvedilol Phosphate Extended-release Capsules Whole:
  9. What Should I Avoid While Taking Carvedilol Phosphate Extended-release Capsules?
  10. Serious Side Effects Of Carvedilol Phosphate Extended-release Capsules Include:
  11. How Should I Store Carvedilol Phosphate Extended-release Capsules?
  12. What Are The Ingredients In Carvedilol Phosphate Extended-release Capsules?
  13. What Is High Blood Pressure (hypertension)?
  14. Usual Dosage:
  15. Manufactured By:
  16. Manufactured For:
  17. Revised: 9/2017document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Patients Taking Carvedilol Phosphate Extended-release Capsules Should Be Advised Of The Following: 

Patients should not interrupt or discontinue using Carvedilol Phosphate extended-release capsules 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.
Patients should not crush or chew Carvedilol Phosphate extended-release capsules.
Patients should take Carvedilol Phosphate extended-release capsules with food.
Diabetic patients should report any changes in blood sugar levels to their physician.
Contact lens wearers may experience decreased lacrimation.

COREG CR is a trademark owned by or licensed to the GSK group of companies.

The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

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

It is important for you to take your medicine every day as directed by your doctor. If you stop taking Carvedilol Phosphate extended-release capsules suddenly, you could have chest pain and a heart attack. If your doctor decides that you should stop taking Carvedilol Phosphate extended-release capsules, your doctor may slowly lower your dose over time before stopping it completely.

Carvedilol Phosphate Extended-release Capsules Are A Prescription Medicine That Belongs To A Group Of Medicines Called Beta-blockers . Carvedilol Phosphate Extended-release Capsules Are 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 Phosphate extended-release capsules are not approved for use in children under 18 years of age.

Do Not Take Carvedilol Phosphate Extended-release Capsules If You: 

have severe heart failure and require certain intravenous medicines that help support circulation.
have asthma or other breathing problems.
have a slow heartbeat or certain conditions that cause your heart to skip a beat (irregular heartbeat).
have liver problems.
are allergic to any of the ingredients in Carvedilol Phosphate extended-release capsules.

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 Phosphate extended-release capsules can make some of your symptoms worse.
have diabetes.
have thyroid problems.
have a condition called pheochromocytoma.
have had severe allergic reactions.
are scheduled for surgery and will be given anesthetic agents.
are scheduled for cataract surgery and have taken or are currently taking Carvedilol Phosphate extended-release capsules.
are pregnant or trying to become pregnant. It is not known if Carvedilol Phosphate extended-release capsules are 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 Phosphate extended-release capsules passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking Carvedilol Phosphate extended-release capsules.

Tell your doctor about all of the medicines you takeincluding prescription and over-the-counter medicines, vitamins, and herbal supplements. Carvedilol Phosphate extended-release capsules and certain other medicines can affect each other and cause serious side effects. Carvedilol Phosphate extended-release capsules may affect the way other medicines work. Also, other medicines may affect how well Carvedilol Phosphate extended-release capsules work.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine.

How Should I Take Carvedilol Phosphate Extended-release Capsules? 

Take Carvedilol Phosphate extended-release capsules exactly as prescribed. Take Carvedilol Phosphate extended-release capsulesonetime each day with food.It is important that you take Carvedilol Phosphate extended-release capsules only one time each day.To lessen possible side effects, your doctor might begin with a low dose and then slowly increase the dose.
Swallow Carvedilol Phosphate extended-release capsules whole. Do not chew or crush Carvedilol Phosphate extended-release capsules.

If You Have Trouble Swallowing Carvedilol Phosphate Extended-release Capsules Whole: 

The capsule may be carefully opened and the beads sprinkled over a spoonful of applesauce which should be eaten right away. The applesauce should not be warm.
Do not sprinkle beads on foods other than applesauce.
Do not stop taking Carvedilol Phosphate extended-release capsules and do not change the amount of Carvedilol Phosphate extended-release capsules you take without talking to your doctor.
If you miss a dose of Carvedilol Phosphate extended-release capsules, 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 many Carvedilol Phosphate extended-release capsules, call your doctor or poison control center right away.

What Should I Avoid While Taking Carvedilol Phosphate Extended-release Capsules? 

Carvedilol Phosphate extended-release capsules 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.

Serious Side Effects Of Carvedilol Phosphate Extended-release Capsules Include: 

chest pain and heart attack if you suddenly stop taking Carvedilol Phosphate extended-release capsules.
slow heart beat.
low blood pressure (which may cause dizziness or fainting when you stand up).If these happen, sit or lie down, and tell your doctor right away.
worsening heart failure.Tell your doctor right away if you have signs and symptoms that your heart failure may be worse, such as weight gain or increased shortness of breath.
changes in your blood sugar. If you have diabetes, tell your doctor if you have any changes in your blood sugar levels.
masking (hiding) the symptoms of low blood sugar, especially a fast heartbeat.
new or worsening symptoms of peripheral vascular disease.
leg pain that happens when you walk, but goes away when you rest
no feeling (numbness) in your legs or feet while you are resting
cold legs or feet
masking the symptoms of hyperthyroidism (overactive thyroid), such as a fast heartbeat.
worsening of severe allergic reactions.Medicines to treat a severe allergic reaction may not work as well while you are taking Carvedilol Phosphate extended-release capsules.
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 immediate-release carvedilol tablets or Carvedilol Phosphate extended-release capsules. These reactions can be life-threatening. In some cases, these reactions happened in patients who had been on immediate-release carvedilol tablets before taking Carvedilol Phosphate extended-release capsules.

Common side effects of Carvedilol Phosphate extended-release capsules include shortness of breath, weight gain, diarrhea, and tiredness. If you wear contact lenses, you may have fewer tears or dry eyes that can become bothersome.

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 Phosphate Extended-release Capsules? 

Store Carvedilol Phosphate extended-release capsules at less than 86 F (30 C).

Safely throw away Carvedilol Phosphate extended-release capsules that are out of date or no longer needed.

Keep Carvedilol Phosphate extended-release capsules and all medicines out of the reach of children.

General information about Carvedilol Phosphate extended-release capsules

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use Carvedilol Phosphate extended-release capsules for a condition for which it was not prescribed. Do not give Carvedilol Phosphate extended-release capsules 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 Phosphate extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Carvedilol Phosphate extended-release capsules that is written for healthcare professionals.

What Are The Ingredients In Carvedilol Phosphate Extended-release Capsules? 

Active ingredient: carvedilol phosphate

Inactive ingredients: crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone

Carvedilol Phosphate extended-release capsules come in the following strengths: 10 mg, 20 mg, 40 mg, 80 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 Phosphate extended-release capsules 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.

Usual Dosage: 

See prescribing information for complete dosing information. This extended-release capsule formulation differs in strength from carvedilol tablets.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional help or contact a poison control center immediately.

Manufactured By: 

GlaxoSmithKline

RTP, NC 27709

Manufactured For: 

Apotex Corp.

Weston, FL 33326

Made in Canada

Rev. 1/17

10000000143782

Carvedilol Phosphate ER 80mg capsule 30 count label
CARVEDILOL PHOSPHATE
carvedilol phosphate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60505-3678
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARVEDILOL PHOSPHATE(UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2)CARVEDILOL PHOSPHATE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
ColorWHITE, GREENScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeGSK;COREG;CR;10;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-3678-330 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02201211/09/2017
CARVEDILOL PHOSPHATE
carvedilol phosphate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60505-3679
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARVEDILOL PHOSPHATE(UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2)CARVEDILOL PHOSPHATE20 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
ColorWHITE, YELLOWScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeGSK;COREG;CR;20;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-3679-330 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02201211/09/2017
CARVEDILOL PHOSPHATE
carvedilol phosphate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60505-3680
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARVEDILOL PHOSPHATE(UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2)CARVEDILOL PHOSPHATE40 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
ColorGREEN, YELLOWScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeGSK;COREG;CR;40;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-3680-330 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02201211/09/2017
CARVEDILOL PHOSPHATE
carvedilol phosphate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60505-3681
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARVEDILOL PHOSPHATE(UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2)CARVEDILOL PHOSPHATE80 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeGSK;COREG;CR;80;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-3681-330 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02201211/09/2017
Labeler -Apotex Corp. (845263701)
Registrant -GlaxoSmithKline LLC (167380711)

Revised: 9/2017document Id: 

0105386a-7d8b-4c0b-bcc9-d23594c77b57Set id: bcfe4b84-500e-4b93-ba20-aa7c4297b0aeVersion: 7Effective Time: 20170929Apotex Corp.



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