PHL-Bisoprolol: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

phl-BISOPROLOL is for once-daily use. It belongs to the group of drugs called "beta-blockers". Your doctor may have prescribed phl-BISOPROLOL to help control hypertension (high blood pressure).

What it does and how to take it:

phl-BISOPROLOL decreases blood pressure and reduces how hard the heart has to work. Take phl-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.

phl-BISOPROLOL is taken once daily.

phl-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 phl-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).

phl-BISOPROLOL is not recommended for children under 18 years of age.

What the medicinal ingredient is:

Bisoprolol Fumarate, USP

What the important nonmedicinal 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 forms it comes in:

phl-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 phl-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 phl-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 phl-BISOPROLOL.

Keep phl-BISOPROLOL out of sight and reach of children.

Do not give phl-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 phl-BISOPROLOL include: other 13-blocking agents, catecholamine-depleting 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 phl-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.

phl-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

phl-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 phl-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 phl-BISOPROLOL with your doctor or pharmacist. Do not stop or restart phl-BISOPROLOL on your own.

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 phl-BISOPROLOL, contact your doctor or pharmacist immediately, so that these effects may be properly addressed.

HOW TO STORE IT

• phl-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.

monograph,

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting:

By mail: Pharmel Inc.

6111 Royalmount Ave., Suite 100

Montreal, Quebec H4P 2T4

By telephone: 1-888-550-6060

Last revised: March 27, 2008

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

By toll-free telephone: 866-234-2345 By toll-free fax: 866-678-6789

Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety and Effectiveness Information Bureau

Marketed Health Products Directorate Health Products and Food Branch

Health Canada

Tunney's Pasture, AL 0701C

Ottawa ON K1A OK9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.