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CARVEDILOL tablet, film coated


  1. Patient Information
  2. What Are Possible Side Effects Of Carvedilol?
  3. Manufactured By:
  4. Patients Taking Carvedilol Should Be Advised Of The Following:
  5. What Is Carvedilol?
  6. Carvedilol Is Used, Often With Other Medicines, For The Following Conditions:
  7. Do Not Take Carvedilol If You:
  8. Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  9. How Should I Take Carvedilol?
  10. What Should I Avoid While Taking Carvedilol?
  11. How Should I Store Carvedilol?
  12. What Are The Ingredients In Carvedilol Tablets?
  13. What Is High Blood Pressure (hypertension)?
  14. Patients Taking Carvedilol Tablets Should Be Advised Of The Following:

Patient Information 

Carvedilol (kar ve dil ol) Tablets USP

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 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.

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

Manufactured By: 

Glenmark Pharmaceuticals Ltd.
India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888)721-7115
www.glenmarkpharma.com/usa

December 2015

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.

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 who had a heart attack that worsened how well the heart pumps
  • To treat patients with high blood pressure (hypertension)

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.

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 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. You should not breastfeed while using carvedilol.
  • Are scheduled for surgery and will be given anesthetic agents
  • Are scheduled for cataract surgery and have taken or are currently taking carvedilol.
  • Are taking prescription or non-prescription medicines, vitamins, and herbal supplements. Carvedilol and certain other medicines can affect each other and cause serious side effects. Carvedilol may affect the way other medicines work. Also, other medicines may affect how well carvedilol 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? 

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.

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 website www.glenmarkgenerics.com or 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.

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 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.

Patients Taking Carvedilol Tablets Should Be Advised Of The Following: 

  • Patients should take carvedilol tablets with food.
  • Patients should not interrupt or discontinue using carvedilol tablets 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.

The brands listed are registered trademark of their respective owner.

PACKAGING INFORMATION
American Health Packaging unit dose blisters (seeHow Suppliedsection) contain drug product from BluePoint Laboratories as follows:
(3.125 mg / 100 UD) NDC 68084-843-01 packaged from NDC 68001-153
(6.25 mg / 100 UD) NDC 68084-854-01 packaged from NDC 68001-154
(12.5 mg / 100 UD) NDC 68084-865-01 packaged from NDC 68001-151
(25 mg / 100 UD) NDC 68084-876-01 packaged from NDC 68001-152

Distributed by:
American Health Packaging
Columbus, OH 43217

8284301/0218



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