Details for: BISOPROLOL TABLETS
Company: SIVEM PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02495562 | BISOPROLOL TABLETS | BISOPROLOL FUMARATE | 5 MG | TABLET | ORAL |
| 02495570 | BISOPROLOL TABLETS | BISOPROLOL FUMARATE | 10 MG | TABLET | ORAL |
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
BISOPROLOL TABLETS is used to treat hypertension (high blood pressure).
What it does
Bisoprolol belongs to the group of drugs called "beta-blockers". BISOPROLOL TABLETS decreases blood pressure and reduces how hard the heart has to work.
When it should not be used
Do not use BISOPROLOL TABLETS 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).
What the medicinal ingredient is
Medicinal ingredients: Bisoprolol fumarate
What the non-medicinal ingredients are
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).
What dosage form it comes in
5 mg, 10 mg tablets
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BISOPROLOL TABLETS. 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 TABLETS.
Other warnings you should know about:
Stopping treatment with BISOPROLOL TABLETS
You should keep taking BISOPROLOL TABLETS 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
TABLETS. The blood tests will help monitor your blood cells, kidneys and liver.
Driving and using machines
Know how you feel while taking BISOPROLOL TABLETS 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.
Interactions with this medication
The following may interact with BISOPROLOL TABLETS:
- 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.
Proper use of this medication
How to take BISOPROLOL TABLETS:
Take BISOPROLOL TABLETS 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 TABLETS is taken once daily.
- BISOPROLOL TABLETS 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 TABLETS 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
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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking BISOPROLOL TABLETS.
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
| 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 |
|---|---|---|---|
| RARE | |||
| Allergic Reactions: skin reactions such as rash, itching, worsening of psoriasis | ✔ | ||
| Depression | ✔ | ||
| Difficulty breathing: shortness of breath, stuffy nose, wheezing | ✔ | ||
| Difficulty hearing | ✔ | ||
| Dizziness or lightheadedness (sometimes with fainting), especially on standing up, which may be due to low blood pressure | ✔ | ||
| Hallucinations | ✔ | ||
| Muscular weakness or cramps | ✔ | ||
| Peripheral edema (swelling of the ankles) | ✔ | ||
| Very slow heart beat | ✔ | ||
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.
How to store
- Keep BISOPROLOL TABLETS out of sight and reach of children.
- BISOPROLOL TABLETS should be stored between 15 and 25ºC.
- Do not give BISOPROLOL TABLETS to other patients because it may not be suitable for them
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.
More information
If you want more information about BISOPROLOL TABLETS
- 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 www.sivem.ca, or by calling 1-855-788-3153.
This leaflet was prepared by Sivem Pharmaceuticals ULC.
Last Revised: January 13, 2020