Patient Medication Information: uses, side effects, how to take - M-Bisoprolol
What is M-BISOPROLOL used for?
M-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.
How does M-BISOPROLOL work?
M-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 are the ingredients in M-BISOPROLOL?
Medicinal ingredient: bisoprolol fumarate
Non-medicinal ingredients: colloidal anhydrous silica, crospovidone, ferric oxide yellow, magnesium stearate, maize starch, microcrystalline cellulose, Opadry white (HPMC 2910/hypromellose, macrogol/PEG, titanium dioxide) and purified water. The 10 mg tablets also contain ferric oxide red.
M-BISOPROLOL comes in the following dosage forms:
Tablets: 5 mg (Yellowish-white, heart shaped film coated tablets, with score-lines on both sides) and 10 mg (Pale orange-light orange coloured, heart shaped, film coated tablets, with non-functional score-lines on both sides).
Do not use M-BISOPROLOL if:
you are allergic to bisoprolol fumarate or any of the non-medicinal ingredients found in M-BISOPROLOL. • you are pregnant or plan to become pregnant, or if you are breast-feeding. You must stop breast-feeding before taking M-BISOPROLOL.
- you have one of the following heart problems: heart failure or any other heart condition.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M-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.
- have heart, kidney or liver disease.
- have diabetes. M-BISOPROLOL may hide some of the symptoms of diabetes.
- have an overactive thyroid gland (hyperthyroidism). M-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 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 M-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 M-BISOPROLOL.
Stopping treatment with M-BISOPROLOL
You should keep taking M-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 M-BISOPROLOL. Tell your doctor if your rash becomes severe.
Lowered heart rate
Your heart rate may lower while you are taking M-BISOPROLOL. If it gets too low, your dose may be reduced, or your doctor may tell you to stop taking M-BISOPROLOL.
Allergic reactions
While you are taking M-BISOPROLOL:
- a severe allergic 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 M-BISOPROLOL. The blood tests will help monitor your blood cells, kidneys and liver.
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 M-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 drug).
- rifampin (antibiotic): may cause M-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.
How to take M-BISOPROLOL:
- take M-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 M-BISOPROLOL along with other medications to help control your blood pressure. Take these medications as prescribed.
- take M-BISOPROLOL once daily and at about the same time every day.
- take M-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 M-BISOPROLOL is working.
Overdose:
| If you think you, or a person you are caring for, have taken too much M-BISOPROLOL, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
- if you miss a dose of M-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 M-BISOPROLOL at the same time to make up for a missed dose.
What are possible side effects from using M-BISOPROLOL?
These are not all the possible side effects you may feel when taking M-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 M-BISOPROLOL with your healthcare professional or pharmacist. Do not stop or restart M-BISOPROLOL on your own.
Serious side effects and what to do about them
| Frequency/Side Effect/ Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||||
|---|---|---|---|---|---|---|---|
| Only if severe | In all cases | ||||||
| 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 | √ | ||||||
| Serious side effects and what to do about them | |||||||
| Frequency/Side Effect/ Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||||
| Only if severe | In all cases | ||||||
| Muscle cramps | √ | ||||||
| Nerve pain: stabbing or burning pain | √ | ||||||
| Persistent noise in the ears | √ | ||||||
| Swelling of hands, ankles or feet | √ | ||||||
| Vision abnormality | √ | ||||||
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:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice |
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Storage:
- store at room temperature 15°C - 30°C.
- keep out of sight and reach of children.
If you want more information about M-BISOPROLOL:
- 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 Drug Product Database website (Drug Product Database: Access the database); or by contacting Mantra Pharma Inc. at medinfo@mantrapharma.ca or at 1-833-248-7326.
1000 rue Du Lux, Suite 201
Brossard, Quebec
J4Y 0E3