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Important Risk Information
What is BYSTOLIC?

BYSTOLIC is a prescription medicine that belongs to a group of medicines called beta blockers. BYSTOLIC is used, often with other medicines, to treat adults with high blood pressure (hypertension).

What is High Blood Pressure (Hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great.

High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. BYSTOLIC tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

Important Risk Information about BYSTOLIC
Who should NOT take BYSTOLIC?

Do not take BYSTOLIC if you:

  • Have heart failure. BYSTOLIC is not approved for the treatment of heart failure. If you have heart failure and the symptoms are controlled, BYSTOLIC may be used for the treatment of hypertension. Talk to your healthcare provider if your symptoms of heart failure worsen.
  • Have a slow heartbeat or your heart skips beats (irregular heartbeat)
  • Have severe liver damage
  • Are allergic to any ingredient in BYSTOLIC. The active ingredient is nebivolol.
  • Are under 18 years of age. BYSTOLIC is not approved for use in children under 18 years of age.
What should I tell my healthcare provider before taking BYSTOLIC?

Before starting BYSTOLIC, tell your healthcare provider about all of your medical conditions, including if you:

  • Have asthma or other lung problems (such as 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
  • Have thyroid problems
  • Have liver or kidney problems
  • Have had allergic reactions to medications or have allergies
  • Have a condition called pheochromocytoma (rare adrenal gland tumor)
  • Are pregnant or trying to become pregnant. It is not known if BYSTOLIC is safe for your unborn baby. Talk with your doctor about the best way to treat your high blood pressure while you are pregnant.
  • Are breastfeeding. It is not known if BYSTOLIC passes into your breast milk. You should not breastfeed while using BYSTOLIC.
  • Are scheduled for surgery and will be given anesthetic agents
  • Have had acute angina (symptoms include chest pain or discomfort) or an MI (heart attack) as BYSTOLIC has not been studied in patients with these conditions.

Also, to avoid a potentially serious or life-threatening condition, tell your healthcare provider if you are taking or plan to take any prescription or over-the-counter medications, vitamins, or herbal products, including:

  • Certain CYP2D6 inhibitors (such as some antiarrhythmics like quinidine or propafenone or certain antidepressants such as fluoxetine or paroxetine, etc)
  • Other beta blockers
  • Digitalis
  • Certain calcium channel blockers (such as verapamil and diltiazem)
  • Antiarrhythmic agents (such as disopyramide)
What are the possible side effects of BYSTOLIC?

The most common side effects people taking BYSTOLIC report are headache, fatigue (tiredness), dizziness (if you feel dizzy, sit or lie down and tell your doctor right away), diarrhea, nausea, insomnia (difficulty falling or staying asleep), chest pain, bradycardia (slow heartbeat), dyspnea (shortness of breath), rash, and peripheral edema (leg swelling due to fluid retention). Other possible side effects include masking (hiding) the symptoms of low blood sugar and hyperthyroidism (overactive thyroid), especially a fast heartbeat. Tell your doctor if you gain weight or have trouble breathing while taking BYSTOLIC.

This is not a complete list of side effects. Tell your doctor if you have any side effects that bother you or don't go away.

What other information do I need to know about taking BYSTOLIC?

  • Do not stop taking BYSTOLIC suddenly. You could have chest pain or a heart attack. If your doctor decides that you should stop taking BYSTOLIC, he or she will lower your dose slowly and over time.
  • Take BYSTOLIC every day exactly as your doctor tells you. Your doctor will tell you how much BYSTOLIC to take and how often. 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.
  • BYSTOLIC can be taken with or without food.
  • If you miss a dose, take your dose as soon as you remember, unless it is close to the time to take your next dose. Do not take 2 doses at the same time. Take your next dose at the usual time.
  • If you take too much BYSTOLIC, call your doctor or poison control center right away.

Please also see full Prescribing Information.

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