What Bystolic is used for and how to use it
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Bystolic - Consumer Medicine Information

Manufacture: Actavis
Country: Canada
Condition: High Blood Pressure (Hypertension)
Class: Cardioselective beta blockers
Form: Tablets
Ingredients: nebivolol (as nebivolol hydrochloride), colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake (10 and 20 mg only), FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate

About this medication

What the medication is used for:

BYSTOLIC is used to treat high blood pressure, also called hypertension, in adults. It can be used alone or together with a diuretic (water pill) or an angiotensin converting enzyme (ACE) inhibitor.

What it does:

BYSTOLIC contains nebivolol, a selective “beta-blocker.” Nebivolol acts on the heart and blood vessels to lower blood pressure.

This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking BYSTOLIC regularly even if you feel fine.

When it should not be used:

Do not take BYSTOLIC if you:

  • Are allergic to nebivolol (nebivolol hydrochloride) or any other ingredient in BYSTOLIC. See What the nonmedicinal ingredients are for a list of ingredients.
  • Have heart failure or need medicines to keep up your blood circulation
  • Have a slow heartbeat or your heart skips beats (irregular heartbeat)
  • Are on dialysis
  • Your doctor has told you you have a heart conduction disorder (symptoms include chest pain, palpitations, breathing difficulties, nausea, fatigue and fainting)
  • Are breastfeeding. It is not known if BYSTOLIC passes into human breast milk.
  • Have severe liver damage
  • Have serious blood flow problems in the feet and legs (severe peripheral vascular disease)

BYSTOLIC is not recommended for use in children 18 years and younger.

What the medicinal ingredient is:

Nebivolol (as nebivolol hydrochloride)

What the nonmedicinal ingredients are:

Colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake (10 and 20 mg only), FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.

What dosage forms it comes in:

Tablets: 2.5 mg, 5 mg, 10 mg and 20 mg

Warnings and precautions

BEFORE you use BYSTOLIC talk to your doctor or pharmacist if you:

  • Have asthma or other lung problems, such as chronic bronchitis or emphysema
  • Have problems with blood flow in your feet and legs (peripheral vascular disease) - BYSTOLIC can make symptoms of blood flow problems worse
  • Have diabetes and take medicine to control blood sugar or have low blood sugar (hypoglycemia)
  • Have thyroid problems
  • Have liver or kidney problems
  • Have had allergic reactions or have allergies
  • Have a condition called pheochromocytoma (tumor of the adrenal glands)
  • Are pregnant or trying to become pregnant
  • Are scheduled for surgery and will be given anesthetic agents
  • Have a history of fainting
  • Have a history of an irregular heartbeat or chest pain

Driving and using machines

Before you perform tasks which may require special attention, wait until you know how you respond to BYSTOLIC. Dizziness, lightheadedness, or fainting can occur especially after the first dose and when the dose is increased.

Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with BYSTOLIC:

  • Blood pressure lowering drugs (e.g. clonidine, guanethidine), calcium channel blockers (e.g. verapamil, diltiazem), ACE inhibitors (e.g. lisinopril)
  • Medicines for depression (e.g. fluoxetine, paroxetine, venlafaxine)
  • Medicines used during surgery (e.g. ether, cyclopropane, trichloroethylene)
  • Medicines used to treat diabetes (e.g. insulin, other medicines taken by mouth)
  • Medicines used for heartburn and ulcers (e.g. cimetidine)
  • Diuretics (hydrochlorothiazide, furosemide, spironolactone)
  • Medicines used to treat erectile dysfunction (e.g. sildenafil)
  • Medicines used to treat HIV/AIDS
  • Medicines used to treat heart rhythm disorders (e.g. amiodarone, disopyramide, flecainide, digoxin, quinidine, propafenone)
  • Dexamethasone, rifampin
  • Fingolimod

Proper use of this medication

Take BYSTOLIC exactly as prescribed. It is recommended to take your dose at about the same time every day.

BYSTOLIC can be taken with or without food.

Usual adult dose:

The usual starting dose is 5 mg once a day. In some cases, your doctor may prescribe a higher dose or add another medicine like a diuretic (water pill) or an ACE inhibitor to BYSTOLIC to treat your high blood pressure.

  • Do not suddenly stop taking BYSTOLIC. If you do, you could have chest pain or a heart attack. If your doctor decides to stop BYSTOLIC, your doctor may slowly lower your dose over time before stopping it completely.
  • Your doctor may start with a low dose and raise it over time.
  • Do not stop taking BYSTOLIC or change your dose without talking with your doctor.

Overdose:

If you think you have taken too much BYSTOLIC, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, skip the missed dose and carry on with the next one at the usual time. Do not double the dose.

Side effects and what to do about them

Side effects may include:

  • Dizziness
  • Tiredness
  • Headache
  • Diarrhea
  • Dry mouth
  • Stuffy nose and colds
  • Nausea
  • Joint pain, back pain
  • Insomnia
  • Cough
Tell your doctor if you have any side effects that bother you or don’t go away.

Serious side effects, how often they happen and what to do about them

Symptom / effect Talk with your doctor or pharmacist Stop taking drug and seek immediate medical help
Only if severe In all cases
Common Bradycardia:decreased heart rate leading to dizziness or fainting
Chest pain
Uncommon Allergic reactions:rash, swelling of the lips, face or neck, difficulty breathing or speaking
Heart attack: chest pain, squeezing or pressure, fast or irregular heartbeat, nausea, trouble breathing, sweating
Heart conduction disorders: lightheadedness, dizziness, fainting
Hypotension (low blood pressure): dizziness or lightheadedness leading to fainting can occur when changing position e.g. from lying to standing
Irregular heart beat or heart palpitations
Leg swelling due to fluid retention
Memory problems
Shortness of breath
Skin reaction: rash
Vision disturbances

This is not a complete list of side effects. For any unexpected effects while taking BYSTOLIC, contact your doctor or pharmacist.

How to store it

  • Store BYSTOLIC between 15–30°C. Protect from light.
  • Take BYSTOLIC that is out of date or no longer needed to your pharmacy or to your municipal waste disposal depot.
  • Keep BYSTOLIC and all medicines out of the reach and sight of children.
REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                        Health Canada
                        Postal Locator 0701E
                        Ottawa, Ontario
                        K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.


NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This Consumer Information Leaflet provides you with the most current information at the time of printing. For the most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at: www.frx.ca
or by contacting the sponsor, Forest Laboratories Canada Inc., at: 1-855-894-1747.