Bisoprolol Fumarate: Uses, Side Effects and Dosage

What is BISOPROLOL FUMARATE used for?

BISOPROLOL FUMARATE is used to treat hypertension (high blood pressure).

How does BISOPROLOL FUMARATE work?

Bisoprolol belongs to the group of drugs called "beta-blockers". BISOPROLOL FUMARATE decreases blood pressure and reduces how hard the heart has to work.

What are the ingredients in BISOPROLOL FUMARATE?

Medicinal ingredients: Bisoprolol fumarate

Non-medicinal ingredients: calcium hydrogen phosphate, colloidal anhydrous silica, croscarmellose sodium, hypromellose, lactose monohydrate, macrogol (polyethylene glycol), maize starch (pregelatinised), magnesium stearate, microcrystalline cellulose, red ferric oxide (10 mg only), titanium dioxide and yellow ferric oxide (5 mg and 10 mg only).

BISOPROLOL FUMARATE comes in the following dosage forms:

5 mg, 10 mg tablets

Do not use BISOPROLOL FUMARATE if you:

• are allergic to bisoprolol, any of the non-medicinal ingredients or to another beta- blocker;
• have severe drops in blood pressure, dizziness, fast heartbeat, rapid and shallow breathing, cold clammy skin (signs of a heart disorder called cardiogenic shock);
• have a slow or irregular heartbeat or have been told you have heart block;
• have heart failure and your symptoms are getting worse. For example you feel more tired, more out of breath or have swollen ankles;
• have low blood pressure;
• have severe asthma or a history of difficulty breathing with wheezing or coughing (chronic obstructive lung disease);
• have leg numbness or weakness or painful cramping your feet and legs after walking or climbing stairs (peripheral arterial occlusive disease);

• have numbness, tingling and color change in fingers and toes when exposed to the cold

  (Raynaud's syndrome);

• have non-treated tumour of the adrenal gland (phaeochromocytoma);
• have abnormally high levels of acid in the blood (metabolic acidosis).

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

• are pregnant or plan to become pregnant;

• are breastfeeding;
• have asthma, difficulty breathing, bronchitis, emphysema, or other lung problems;
• have shortness of breath, fatigue, weakness, swelling in legs, ankles and feet, persistent cough;
• have Prinzmetal angina or variant angina;
• have diabetes;
• have any allergic conditions;
• have psoriasis, a skin disease with thickened patches of red skin, often with silvery scales;
• have hyperthyroidism, an over active thyroid gland;
• have any blood vessel disorder causing poor circulation in the arms and legs;
• have kidney problems;
• have liver problems;
• have phaeochromocytoma, a rare tumour of the adrenal gland;
• visit more than one doctor. Make sure each knows about all the medicines you are taking, including ones you can buy without a prescription, especially diuretics (water pills), cold remedies, nasal decongestants and other heart or blood pressure medication;

• are having surgery. Tell your doctor or dentist that you are taking BISOPROLOL

  FUMARATE.

Other warnings you should know about:

Stopping treatment with BISOPROLOL FUMARATE

You should keep taking BISOPROLOL FUMARATE 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.

Blood Tests

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

Driving and using machines

Know how you feel while taking BISOPROLOL FUMARATE before you drive or use heavy machines.

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 BISOPROLOL FUMARATE:

• calcium channel blockers, medicines used to treat high blood pressure and angina such as

  diltiazem, verapamil and amlodipine;

• clonidine, a medicine used to treat high blood pressure;
• monoamine oxidase inhibitors, medicines used to treat depression such as phenelzine, tranylcypromine;
• anti-arrhythmic drugs used to treat irregular or abnormal heartbeat such as flecainide, amiodarone, disopyramide;
• certain medicines, knows as NSAIDs used to treat arthritis, pain or inflammation such as indomethacin or ibuprofen;
• other beta-blockers, including eye drops;
• insulin and oral drugs for diabetes;
• anaesthetic agents used in surgery;
• digoxin, a medicine used to treat heart failure;
• ergot derivatives, medicines commonly used to treat migraines;
• tricyclic antidepressants;
• barbiturates, medicines used to treat epilepsy;
• phenothiazines, a type of medicine used to treat some mental conditions;
• rifampicin, a medicine use to treat tuberculosis;
• mefloquine, a medicine used to treat malaria;
• adrenaline, a medicine used to treat allergic reactions;
• fingolimod, a medicine to treat multiple sclerosis.

How to take BISOPROLOL FUMARATE:

Take BISOPROLOL FUMARATE exactly as your doctor tells you. Do not miss doses or take extra doses, unless your doctor tells you. If you are not clear about the directions, ask your healthcare professional.

• BISOPROLOL FUMARATE is taken once daily.
• BISOPROLOL FUMARATE may have been prescribed along with other medications to help control your particular health condition. Make sure you take these medications as prescribed.
• It is important you take BISOPROLOL FUMARATE at about the same time every day.
• Do not chew or crush the tablets.

Usual dose:

The usual starting dose is 5 mg once daily added to a diuretic or alone. If well tolerated, your doctor will gradually increase your dose over the next 2 weeks. The usual effective dosage range is 5 mg to 20 mg once daily.

Overdose:

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

Missed Dose:

Take your dose as soon as you remember, and continue to take it as you would normally. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Do not take a double dose to make up for the dose that you missed.

What are possible side effects from using BISOPROLOL FUMARATE?

These are not all the possible side effects you may feel when taking BISOPROLOL FUMARATE. If you experience any side effects not listed here, contact your healthcare professional.

Common side effects:

• headache;
• fatigue, tiredness or exhaustion;
• urinary tract infection;
• rhinitis or sinusitis (inflammation in the nose);
• diarrhea or constipation;
• dizziness;
• joint pain;
• cough;
• insomnia (trouble sleeping), sleep disturbances, nightmares;
• nausea (feeling like vomiting);
• sore throat;
• coldness or numbness in the hands or feet.

These are mild side effects of the medicine, and are short-lived.

Serious side effects and what to do about them

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

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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.

L6Y 5S5

Brampton, Ontario

1 President's Choice Circle

Sanis Health Inc.

or quality@sanis.com

1-866-236-4076

www.sanis.com, or by contacting Sanis Health Inc. at:

(https://health-products.canada.ca/dpd-bdpp/index-eng.jsp)

the manufacturer’s website this

Patient

Medication

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by visiting the

by visiting the Health Canada website

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Find the full product monograph that is prepared for healthcare professionals and includes

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BISOPROLOL FUMARATE:

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Do not give

BISOPROLOL FUMARATE

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BISOPROLOL FUMARATE

should be stored between 15 and 25ºC.

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Keep

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Storage:

Last Revised: March 9, 2020