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Details for: APO-CARVEDILOL

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02247933APO-CARVEDILOLCARVEDILOL3.125 MGTABLETORAL
02247934APO-CARVEDILOLCARVEDILOL6.25 MGTABLETORAL
02247935APO-CARVEDILOLCARVEDILOL12.5 MGTABLETORAL
02247936APO-CARVEDILOLCARVEDILOL25 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for
  • APO-CARVEDILOL is used in the treatment of heart failure.
  • APO-CARVEDILOL has been prescribed to you by your doctor to help manage your symptoms of heart failure.

What it does

APO-CARVEDILOL helps the heart to work more effectively in heart failure by blocking the action of certain hormones on the heart and blood vessels and reducing the resistance that the heart has to pump against.

When it should not be used
  • Do not use APO-CARVEDILOL if you are allergic to it or any of the components of its formulation (see What the important nonmedicinal ingredients are).
  • You should not take APO-CARVEDILOL if you have any of the following health problems:
    • Severe heart failure that requires treatment with certain medications (usually given in the hospital)
    • Asthma, wheezing, bronchitis or other breathing problems
    • Certain types of abnormal heart beat (i.e., second- or third- degree AV block, or sick sinus syndrome) unless treated with a heart pacemaker
    • Shock, caused by weakened heart
    • Very low blood pressure
    • Very slow heart beat
    • Certain heart valve problems (i.e., primary obstructive valvular heart disease)
    • Liver disease
    • Inability to make decisions (for example, if you have dementia, alcohol or drug problems), unless closely supervised by an appropriate caregiver
What the medicinal ingredient is

Carvedilol

What the non-medicinal ingredients are

croscarmellose sodium, hydroxyethyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide

What dosage form it comes in

Tablets 3.125 mg, 6.25 mg, 12.5 mg and 25 mg.

Warnings and precautions

If you become unwell while taking APO-CARVEDILOL tell your doctor at once. You should be especially careful when starting or changing the dose of APOCARVEDILOL.

BEFORE and while you use APO-CARVEDILOL tell your doctor or pharmacist:

  • all your medical conditions, including a history of heart, kidney or liver problems, asthma or breathing difficulties;
  • if you are pregnant or thinking of becoming pregnant, or if you are breast feeding. You should not take APO-CARVEDILOL if you are pregnant or if you plan to become pregnant unless your doctor tells you so;
  • if you change the amount of any other medicine you are taking;
  • if you suffer from diabetes, thyroid problems, Raynaud’s phenomenon (coldness/spasm in the hands or feet with changes in colour) or cramping pains in the leg when exercising:
    • If you have diabetes, you could become less aware of symptoms of hypoglycemia (low blood sugar). You should monitor your blood sugar more carefully while on APO-CARVEDILOL. Tell your doctor if you see any significant changes;
    • If you have certain types of thyroid problem, abrupt stopping of APOCARVEDILOL may lead to worsening symptoms;
    • If you suffer from Raynaud’s phenomenon, an increase in symptoms of coldness/spasms in the hands or feet may be seen;
  • If you have psoriasis (scaly red patches on the skin). Psoriasis may occur or, if you already have psoriasis, it may become worse.
Interactions with this medication
  • APO-CARVEDILOL should not be taken with alcohol.
  • Taking APO-CARVEDILOL with certain medications (prescription or non prescription), especially anti-hypertensives, digoxin, insulin, hypoglycemics, stomach medication, tricyclic antidepressants, clonidine, and rifampin, may cause unintended effects and you should discuss the possibilities with your doctor.
Proper use of this medication
  • It is very important that you take APOCARVEDILOL exactly as your doctor has instructed. The doctor will decide how many tablets you need to take each day, when and for how long. It may be necessary for the doctor to increase or decrease the dose.
  • You should swallow the tablets whole with water. Do not chew or break your tablet.
  • Take your tablets at the same time each day. You should take APO-CARVEDILOL with food.

Do not stop taking APO-CARVEDILOL without first consulting with your doctor.

Remember: This medicine is for the person named by the doctor. Do not give it to anybody else.

Overdose

If you have taken more tablets than the recommended dose, contact your doctor or the nearest hospital emergency department immediately. Show the doctor your bottle of tablets and any other medications you are taking.

Missed Dose

If you forget to take a tablet, take it as soon as you remember. If possible, take your next dose at the normal time, but do not take two doses within 6 hours of each other.

If you miss more than two doses of APO-CARVEDILOL, contact your doctor for instructions. Do not re-start APOCARVEDILOL until you have spoken to the doctor.

Side effects and what to do about them
  • Some people may have unwanted effects when taking APO-CARVEDILOL. Dizziness, headache and tiredness are the most common and often occur when APO-CARVEDILOL is started or when the dose of APOCARVEDILOL is changed. These symptoms generally go away with continued use. If they do not, or appear to become more severe then tell your doctor.
  • If you experience dizziness or fatigue while taking your tablets, do not drive or operate machinery.
  • Other possible effects are: stomach complaints such as diarrhea, constipation, nausea and vomiting, allergic reactions such as rashes and hot or itching skin, pain in the side, urinating more or less frequently, breathing problems such as wheezing, breathlessness and stuffy nose, depressed mood, sleep disturbance, dry mouth, slowing of heart rate, dizziness when standing up, fainting, cold or painful hands and feet, general swelling of parts of the body, weight gain, impotence, blurred vision, cramping pain on exercise.
  • If you develop any unusual discomfort, tell the doctor as soon as possible, especially if you have unusual dizziness, ankle swelling, tiredness or breathlessness when you start using APO-CARVEDILOL or when your dose is being increased.
  • If you wear contact lenses you may suffer from dryness of the eyes while taking your tablets.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN 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
Very Common
Dizziness and/or headache    
Common
Low blood pressure (symptoms of low blood pressure include dizziness, lightheadedness and/or feeling faint)    
Fluid retention or swelling    
Unusually slow heartbeat    
Breathing problems (such as wheezing, shortness of breath)    
Uncommon
Vision abnormalities    
Fainting    
Feeling of irregular heart beat    
Rare
Kidney problems including urinating more or less frequently than normal    
Very rare
Allergic reactions (sudden wheezing, chest tightness, swelling of the eyelids face or lips, lumpy skin rash or hives)    

How to store
  • Store your tablets at room temperature (15°C to 30°C) in a dry place. Protect from high humidity and light.
  • Keep container tightly closed.
  • Do not use the medicine if it has expired.
  • Keep out of reach and sight of children.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about APO-CARVEDILOL:

  • Talk to your healthcare professional
  • 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 http://www.apotex.ca/products, or by calling 1-800-667-4708.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: December 19, 2017

Date modified: