Consumer Information for: TEVA-CARVEDILOL

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

TEVA-CARVEDILOL is used to treat heart failure in adults.

What it does

TEVA-CARVEDILOL works by relaxing and widening your blood vessels. This makes it easier for your heart to pump blood around your body. This helps reduce your blood pressure and the strain on your heart.

When it should not be used

  • Your doctor did not prescribe it for you
  • You are allergic to carvedilol or any of the other ingredients in TEVA-CARVEDILOL
  • You have severe heart failure that requires you to be in the hospital for treatment
  • You have asthma, wheezing, bronchitis or other breathing problems
  • You have an abnormal heart beat and do not have a permanent pacemaker in place
  • You have severe heart damage and your heart is not able to pump enough blood to meet your body’s needs
  • You have very low blood pressure
  • You have a very slow heart beat
  • You have heart valve problems (primary obstructive valvular disease)
  • You have severe liver disease
  • You have problems making decisions (for example, if you have dementia, alcohol or drug problems). Do not use TEVA-CARVEDILOL unless you are being cared for by an appropriate caregiver.
  • Have one of the following rare hereditary diseases:
    • Galactose intolerance
    • Lapp lactase deficiency
    • Glucose-galactose malabsorption
  • If you are 18 years or younger
What the medicinal ingredient is

carvedilol

What the non-medicinal ingredients are

What dosage form it comes in

Warnings and precautions

Serious Warnings and Precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-CARVEDILOL. Talk about any health conditions or problems you may have, including if you:

  • Have a history of heart problems or disease
  • Have or had kidney or liver problems
  • Have low blood pressure
  • Are pregnant or thinking of becoming pregnant
  • Are breastfeeding
  • Have diabetes. You could become less aware of the symptoms of hyperglycemia (high blood sugar) and you should monitor your blood sugar levels more carefully.
  • Have thyroid problems
  • Have Raynaud’s syndrome. TEVA-CARVEDILOL may increase the symptoms of coldness and/or spasms in your hands and feet or cramping pains in the legs when exercising.
  • Have psoriasis (scaly red patches on your skin)
  • Have problems with blood flow to your feet and legs (peripheral artery disease). TEVACARVEDILOL can make your symptoms worse.
  • Have a condition called pheochromocytoma (a tumour of the adrenal gland)
  • Have allergic reactions or allergies
  • Are having a planned surgery and will be given an anesthetic
  • Wear contact lenses. You may suffer from eye dryness while using TEVACARVEDILOL.

Other warnings you should know about:

Pregnancy: TEVA-CARVEDILOL is not usually recommended for use during pregnancy. Your doctor will consider the benefit to you versus the risk to your unborn baby. Breastfeeding: TEVA-CARVEDILOL can pass into breast milk. Do not use TEVACARVEDILOL if you are breastfeeding. Driving and using machines: Before doing tasks that require special attention, wait until you know how you respond to TEVA-CARVEDILOL.

Do not drink alcohol while taking TEVA-CARVEDILOL. You should have regular eye exams while taking TEVA-CARVEDILOL. Tell your health professional if you notice that your heart failure symptoms are getting worse, like an increase in shortness of breath, tiredness, dizziness, or swelling of the ankles. This may occur when your dose is increased and may indicate that your dose needs to be changed.

Do not stop taking TEVA-CARVEDILOL all of a sudden. Under the care of your healthcare professional, it should be stopped slowly over 2 weeks.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

  • Alcohol
  • Antidepressants used in the treatment of depression and mood disorders
  • Antidiabetic drugs including insulin and oral medications
  • Blood pressure drugs such as clonidine
  • Cyclosporine used after organ transplants
  • Digoxin, a heart medication
  • Drugs used to treat stomach acid or heartburn (such as cimetidine)
  • Drugs used to treat hypertension and irregular heartbeat (such as diltiazem and verapamil)
  • Fingolimod, a medicine used to treat multiple sclerosis
  • Grapefruit juice
  • MAO inhibitors such as selegiline (Parkinson’s Disease), tranylcypromine (depression)
  • Nitroglycerin used to treat chest pain
  • Rifampin used to treat tuberculosis
  • Warfarin used to prevent blood clots

Proper use of this medication

Swallow the tablet whole with water. DO NOT chew, crush or break the tablet. Take TEVA-CARVEDILOL:

  • exactly as prescribed
  • every day
  • twice a day, at about the same time every day
  • with food

Usual Dose

Usual adult dose: Starting dose: 3.125 mg twice a day for 2 weeks Maximum daily dose: 25 mg twice a day Your doctor may start you on a different dose or change your dose over time depending on how TEVA-CARVEDILOL works for you. Do not stop taking TEVA-CARVEDILOL without consulting your doctor. This can be dangerous

Overdose

If you think you have taken too much TEVA-CARVEDILOL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose, take it as soon as you remember. You can take your next dose at the normal time, but do NOT take 2 doses within 6 hours of each other. If you miss more than 2 doses of TEVA-CARVEDILOL, contact your healthcare professional. Do NOT restart taking TEVA-CARVEDILOL until you have spoken to your healthcare professional

Side effects and what to do about them

These are not all possible side effects you may feel when taking TEVA-CARVEDILOL. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions. Side effects may include:

  • headache
  • trouble sleeping
  • drowsiness
  • weakness
  • cough, stuffy and runny nose
  • rash, itching
  • abdominal pain, diarrhea, indigestion, nausea, vomiting
  • back pain

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Breathing problems: trouble breathing, wheezing, shortness of breath and stuffy nose    
Common
Allergic Reactions: rashes, hot or itching skin    
Blurred vision    
Chest pain    
Constipation    
Diarrhea    
Dizziness when standing up    
Fainting (passing out)    
Headache    
Impotence (in men): trouble getting or keeping an erection    
Pain in the side including passing urine more or less frequently    
Sleep disturbance: problems falling or staying asleepe    
Slowing of the heart rate    
Nausea and vomiting    
Swelling    
Weight gain    

How to store

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at MedEffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information
  • Talk to your doctor or pharmacist.
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***