Bystolic (Page 6 of 7)

17 . PATIENT COUNSELING INFORMATION

See FDA- a pproved p atient l abeling ( Patient Information ).

  • Patient Advice

Advise patients to take BYSTOLIC regularly and continuously, as directed. BYSTOLIC can be taken with or without food. If a dose is missed, take the next scheduled dose only (without doubling it). Do not interrupt or discontinue BYSTOLIC without consulting the physician.

Patients should know how they react to this medicine before they operate automobiles, use machinery, or engage in other tasks requiring alertness.

Advise patients to consult a physician if any difficulty in breathing occurs, or if they develop signs or symptoms of worsening congestive heart failure such as weight gain or increasing shortness of breath, or excessive bradycardia.

Caution patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, that β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.

Inform patients or caregivers that there is a risk of hypoglycemia when BYSTOLIC is given to patients who are fasting or who are vomiting. Instruct patients or caregivers how to monitor for signs of hypoglycemia [see Warnings and Precautions ( 5.5)].

Distributed by:
Allergan USA, Inc.
Madison, NJ 07940

Licensed from Mylan Laboratories, Inc.

Under license from Janssen Pharmaceutica N.V., Beerse, Belgium

Actidose® -Aqua is a registered trademark of Paddock Laboratories, LLC

Bystolic® is a registered trademark of Allergan Sales, LLC.

© 2023 Allergan. All rights reserved.

V3.0USPI1402

PATIENT INFORMATION

BYSTOLIC ® (bi-STOL-ik)

(n ebivolol ) Tablets

Read the Patient Information that comes with BYSTOLIC before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about BYSTOLIC, ask your doctor or pharmacist.

WHAT IS BYSTOLIC?

BYSTOLIC is a kind of prescription medicine called a “beta-blocker”. BYSTOLIC treats:

  • High blood pressure (hypertension)

BYSTOLIC can lower blood pressure when used by itself and with other medicines.

BYSTOLIC is not approved for children less than 18 years of age.

WHO SHOULD NOT TAKE BYSTOLIC?

Do not take BYSTOLIC if you:

  • Have heart failure and are in the ICU or need medicines to keep up your blood circulation
  • 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. See the end of this leaflet for a list of ingredients.

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING BYSTOLIC?

Tell your doctor about all of your medical problems , 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
  • Had allergic reactions to medications or have allergies
  • Have a condition called pheochromocytoma
  • 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 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

Tell your doctor about all the medicines you take. Include prescription and non-prescription medicines, vitamins, and herbal products. BYSTOLIC and certain other medicines can affect each other and cause serious side effects.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.

HOW SHOULD I TAKE BYSTOLIC?

  • Do not suddenly stop taking BYSTOLIC. 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.
  • 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.
  • Take BYSTOLIC 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.

WHAT ARE POSSIBLE SIDE EFFECTS OF BYSTOLIC?

  • Low blood pressure and feeling dizzy. If you feel dizzy, sit or lie down and tell your doctor right away.
  • Tiredness
  • Slow heartbeat
  • Headache
  • Leg swelling due to fluid retention (edema). Tell your doctor if you gain weight or have trouble breathing while taking BYSTOLIC.
  • If you are diabetic or take medicine for high blood sugar or if you have a tendency to have low blood sugar, Bystolic can mask/cover some of the signs and symptoms that would tell you that your blood sugar may be low, like heart palpitations or rapid heart beating. Ask your doctor for other signs that may alert you when having low blood sugar.

Tell your doctor if you have any side effects that bother you or don’t go away.

HOW SHOULD I STORE BYSTOLIC?

  • Store BYSTOLIC between 68° to 77°F (20° — 25°C).
  • Safely throw away BYSTOLIC that is out of date or no longer needed.
  • Keep BYSTOLIC and all medicines out of the reach of children.

GENERAL INFORMATION ABOUT BYSTOLIC

Doctors sometimes prescribe medicines for conditions not included in the patient information leaflets.

  • Only use BYSTOLIC for the medical problem it was prescribed for.
  • Do not give BYSTOLIC to other people, even if they have the same symptoms. It may harm them.

This leaflet summarizes the most important information about BYSTOLIC. For more information:

  • Talk with your doctor.
  • Ask your doctor or pharmacist for information about BYSTOLIC that is written for healthcare professionals.
  • Visit www.BYSTOLIC.com on the web or call 1-800-678-1605.

WHAT IS IN BYSTOLIC?

Active Ingredient: Nebivolol

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, 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 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.

Rev. 06 2023

Distributed by:
Allergan USA, Inc.
Madison, NJ 07940 Licensed from Mylan Laboratories, Inc.

Under license from Janssen Pharmaceutica N.V., Beerse, Belgium

Actidose® -Aqua is a registered trademark of Paddock Laboratories, LLC

BYSTOLIC® is a registered trademark of Allergan Sales, LLC.

© 2023 Allergan. All rights reserved.

V3.0PPI1402

PRINCIPAL DISPLAY PANEL

Rx ONLY

NDC 0456-1402-30

Bystolic®

(nebivolol) tablets

2.5 mg/tablet

30 TABLETS

Allergan™

PRINCIPAL DISPLAY PANEL
Rx ONLY
NDC 0456-1402-30 
Bystolic®
(nebivolol) tablets 
2.5 mg/tablet
30 TABLETS
Allergan™
(click image for full-size original)

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