Consumer Information for: PMS-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
pms-BISOPROLOL is for once-daily use. It belongs to the group of drugs called "beta-blockers". Your doctor may have prescribed pms-BISOPROLOL to help control hypertension (high blood pressure).
What it does
pms-BISOPROLOL decreases blood pressure and reduces how hard the heart has to work. Take pms-BISOPROLOL 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 doctor or pharmacist.
pms-BISOPROLOL is taken once daily.
pms-BISOPROLOL may have been prescribed along with other medications to help control your particular health condition; it is important that you take these medications as prescribed. It is important to take pms-BISOPROLOL at about the same time every day. If you miss a dose, check with your doctor or pharmacist to see what you should do. Tablets are not to be chewed or crushed.
When it should not be used
If you are allergic to Bisoprolol Fumarate, or any of the nonmedicinal ingredients of the product (see What the nonmedicinal ingredients are section below).
pms-BISOPROLOL is not recommended for children under 18 years of age.
What the medicinal ingredient is
Bisoprolol Fumarate, USP
What the non-medicinal ingredients are
5 mg tablets: Colloidal silicon dioxide, Copovidone, Dibasic calcium phosphate anhydrous, Ferric oxide red, Hydroxypropyl methyl cellulose, Isopropyl alcohol, Magnesium stearate, Microcrystalline cellulose, Pregelatinised starch, Titanium dioxide and Triacetin.
10 mg tablets: Colloidal silicon dioxide, Copovidone, Dibasic calcium phosphate anhydrous, HPMC 2910/Hypromellose 5 cP, Isopropyl alcohol, Magnesium stearate, Microcrystalline cellulose, Pregelatinised starch, Titanium dioxide and Triacetin/Glycerol triacetate.
What dosage form it comes in
pms-BISOPROLOL (Bisoprolol Fumarate) 5 mg and 10 mg tablets are available in HDPE bottles of 100 tablets format for both strengths.
Warnings and precautions
Before you use pms-BISOPROLOL, talk to your doctor or pharmacist:
- if you are pregnant or plan to become pregnant;
- if you are breast-feeding;
- about all health problems you have or have had in the past, including: asthma, bronchitis, emphysema, or other lung disease, heart, kidney or liver disease, diabetes or an overactive thyroid gland;
- if you are allergic to non-medicinal substances like food products, preservatives or dyes, which may be present in pms-BISOPROLOL tablets;
- if you have ever had a bad or unusual allergic reaction to any drug containing bisoprolol in the past.
If you 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.
Before having surgery, tell your doctor or dentist that you are taking pms-BISOPROLOL. Keep pms-BISOPROLOL out of sight and reach of children.
Do not give pms-BISOPROLOL to other patients because it may not be suitable for them. Read your prescription label carefully. Consult your doctor or pharmacist if you have any questions.
Interactions with this medication
Drugs that may interact with pms-BISOPROLOL include: other 13-blocking agents, catecholaminedepleting drugs, centrally active antihypertensive agents, antiarrhythmic agents, calcium channel blockers and concurrent use of rifampin.
Proper use of this medication
Usual dose
The usual starting dose is 5 mg once daily either added to a diuretic or alone. If the response to 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. An appropriate interval for dose titration is 2 weeks. Increasing the dose beyond 20 mg once daily produces only a small incremental benefit.
Overdose
If you accidentally take too many tablets, therapy with pms-BISOPROLOL should be stopped and supportive, symptomatic treatment should be provided. You should get medical help immediately either by calling your doctor or by going to the nearest hospital. You should be monitored closely.
Missed Dose
If you miss a dose, check with your doctor or pharmacist to see what you should do.
pms-BISOPROLOL has been prescribed for you. Do not give these tablets to anyone else, even if you think they have the same condition as you.
Side effects and what to do about them
pms-BISOPROLOL, like any medication, may have some side effects. It is important that you keep your doctor informed of all side effects especially if you experience one of the following for several days. The most common side effects, whether or not caused by pms-BISOPROLOL, are: headache, fatigue, urinary tract infection, rhinitis or sinusitis (inflammation in the nose), diarrhea, dizziness, peripheral edema (swelling of the ankles), joint pain, cough, insomnia (trouble sleeping), nausea (feeling like vomiting), and sore throat. You must seek medical attention immediately if you experience an allergic reaction with symptoms of rash, itching, swelling, dizziness or trouble breathing.
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
pms-BISOPROLOL with your doctor or pharmacist.
Do not stop or restart pms-BISOPROLOL on your
own.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Urinary tract infection | ✔ | ||
| Inflammation in the nose | ✔ | ||
| Dizziness | ✔ | ||
| Swelling of the ankle | ✔ | ||
| Nausea | ✔ | ||
| less common | |||
| Rash | ✔ | ||
| Itching | ✔ | ||
| Trouble breathing | ✔ | ||
Do not be alarmed by this list of possible side effects. You may not experience any of them. This is not a complete list of side effects. For any unexpected effects while taking pms-BISOPROLOL, contact your doctor or pharmacist immediately, so that these effects may be properly addressed.
How to store
- pms-BISOPROLOL should be stored at room temperature (15 - 30ºC).
- The expiry date of this medicine is printed on the label. Do not use the medicine after this date.
- Keep this drug out of the reach of children.
Reporting side effects
To monitor drug safety, Health Canada
collects information on serious and unexpected
effects of drugs. If you suspect you have had a
serious or unexpected reactions to this drug
you may notify Health Canada by:
Toll-free telephone: 866-234-2345
Toll-free fax: 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and
Effectiveness
Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you
should contact your physician or pharmacist.
More information
This document plus the full product monograph,
prepared for health professionals can be obtained
by contacting:
By mail: Pharmascience Inc.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
By telephone: 1-888-550-6060
Last revised: November 23, 2007
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| APO-FUROSEMIDE | 00362166 | APOTEX INC | FUROSEMIDE 40 MG |
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