Consumer Information for: APO-BISOPROLOL

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

APO-BISOPROLOL (bisoprolol fumarate) is used to treat mild to medium high blood pressure. It can be used alone or with other drugs to control blood pressure.

What it does

APO-BISOPROLOL is a type of medicine called a beta-blocker. It works by decreasing the blood pressure and reducing how hard the heart has to work.

What the medicinal ingredient is

bisoprolol fumarate

What the non-medicinal ingredients are

crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose polyethylene glycol and titanium dioxide.
The 5 mg tablets also contain ferric oxide red.

What dosage form it comes in

Tablets: 5 mg (pink) and 10 mg (white).

When it should not be used
  • you are allergic to bisoprolol fumarate or any of the non-medicinal ingredients found in APOBISOPROLOL.
  • you are pregnant or plan to become pregnant, or if you are breast-feeding. You must stop breastfeeding before taking APO-BISOPROLOL.
  • you have one of the following heart problems: heart failure or any other heart condition.
Warnings and precautions

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

  • have a history of heart failure.
  • have asthma, bronchitis, emphysema, or other lung diseases.
  • heart, kidney or liver disease.
  • diabetes. APO-BISOPROLOL may hide some of the symptoms of diabetes.
  • an overactive thyroid gland (hyperthyroidism). APO-BISOPROLOL may hide the symptoms of an overactive thyroid.
  • will have an anaesthetic for surgery.
  • have a history of allergic type reactions or are allergic to a many allergens.
  • have a condition called peripheral artery disease. This means that your arteries are more narrow and don’t carry blood to your legs as easily. Taking APO-BISOPROLOL may cause symptoms or make your symptoms worse.

Other warnings you should know about:

Heart Failure
Patients taking beta-blockers can develop heart failure. Your doctor will check you for signs and symptoms of heart failure while you are taking APO-BISOPROLOL.

Stopping treatment with APO-BISOPROLOL
You should keep taking APO-BISOPROLOL until your doctor tells you to stop. Your doctor will tell you to slowly stop taking it over a two week period if and when it is time for you to stop.

Rash
You may develop a skin rash while taking APO-BISOPROLOL. Tell your doctor if your rash becomes severe.

Lowered heart rate
Your heart rate may lower while you are taking APO-BISOPROLOL. If it gets too low, your dose may be reduced or your doctor may tell you to stop taking APO-BISOPROLOL.

Allergic reactions
While you are taking APO-BISOPROLOL:

  • a severe allergy reaction may be harder to treat.
  • you may be more likely to have a severe allergic reaction.

Blood Tests
Your doctor will order regular blood tests for you while you are taking APO-BISOPROLOL. The blood tests will help monitor your blood cells, kidneys and liver.

Interactions with this medication

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. The following may interact with APO-BISOPROLOL:

  • Other beta-blocking Agents
  • Reserpine or guanethidine (heart medications)
  • Clonidine (high blood pressure medications)
  • Verapamil, diltiazem, disopyramide (high blood pressure and heart medications)
  • Fingolimod (immunosuppressant drugs)
  • Rifampin (antibiotic): may cause APO-BISOPROLOL to work less effectively because it causes bisoprolol to leave the body quicker
  • Common cold remedies and nasal drops: may cause an increase in blood pressure
Proper use of this medication
  • Take APO-BISOPROLOL exactly as your healthcare professional tells you.
  • Do not miss doses or take extra doses, unless your healthcare professional tells you. If you are not clear about the directions, ask your healthcare professional or pharmacist. You may take APO-BISOPROLOL along with other medications to help control your blood pressure. Take these medications as prescribed.
  • Take APO-BISOPROLOL once daily and at about the same time every day.
  • Take APO-BISOPROLOL tablets whole. Do not chew or crush them.

Usual Dose

Your doctor will determine your dose. You will likely take 5 mg to 20 mg once a day.

Your healthcare professional will regularly monitor your condition. Your dose may change depending on how well APO-BISOPROLOL is working.

Overdose

If you think you have taken too much APO-BISOPROLOL, 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 of APO-BISOPROLOL, take it as soon as you remember on the same day.
  • Take your next dose at your usual time the next day.
  • Do not take more than one dose of APO-BISOPROLOL at the same time to make up for a missed dose.
Side effects and what to do about them

These are not all the possible side effects you may feel when taking APO-BISOPROLOL. If you experience any side effects not listed here, contact your healthcare professional. The most common side effects are:

  • headache
  • fatigue
  • inflammation in the nose (rhinitis or sinusitis)
  • diarrhea
  • dizziness
  • joint pain
  • trouble sleeping
  • nausea (feeling like vomiting)
  • sore throat
  • abdominal pain, indigestion
  • back pain
  • coughing

Tell your healthcare professional if:

  • any of the side effects are serious or severe.
  • you have any of the side effects for several days.

Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on APO-BISOPROLOL with your healthcare professional or pharmacist. Do not stop or restart APO-BISOPROLOL on your own.

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
COMMON
Aching muscles ✔    
Allergic Reactions: dizziness or trouble breathing, hot or itching skin, rashes, swelling.     ✔
Bronchitis: cough, production of mucus, fatigue, shortness of breath, chest discomfort, slight fever ✔    
Chest pain   ✔  
Depression   ✔  
Diarrhea ✔    
Difficulty breathing: shortness of breath, stuffy nose, wheezing ✔    
Dizziness ✔    
Fatigue ✔    
Fever ✔    
Generalized body swelling   ✔  
Hot flushes ✔    
Impotence (in men): trouble getting or keeping an erection   ✔  
Joint pain   ✔  
Muscle cramps ✔    
Nerve pain: stabbing or burning pain   ✔  
Persistent noise in the ears ✔    
Swelling of hands, ankles or feet   ✔  
Vision abnormali   ✔  

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 1908C
      Ottawa, ON
      K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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.

How to store
  • Store at room temperature 15°C-30°C.
  • Keep out of sight and reach of children.
More information
  • Talk to your healthcare professional.
  • For questions or concerns contact DISpedia, Apotex's Drug Information Service at 1-800-667-4708.
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: http://hc-sc.gc.ca/index-eng.php; Apotex Inc.’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: January 6, 2017

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