Two medications in one tablet to
help manage high blood pressure

BYVALSON is a prescription medication made up of nebivolol and valsartan. These medications are referred to as BYSTOLIC® (nebivolol) tablets and Diovan® (valsartan) tablets.

BYVALSON may be right for you if:

You were diagnosed with high blood pressure for the first time

Your blood pressure is not adequately controlled and your doctor thinks you'll need more than 1 medication

Most eligible insured patients* pay no more than $30 a month for BYVALSON prescriptions.

*Terms and conditions apply.

BYVALSON works in different ways to lower blood pressure

It is not known how nebivolol reduces blood pressure. Nebivolol may work in a number of ways to help reduce blood pressure. These ways may include allowing the heart to beat more slowly and less forcefully, and relaxing blood vessels so blood flows more easily.

ARBs allow blood vessels to widen by blocking a chemical known as angiotensin. Widening blood vessels increases blood flow. ARBs block aldosterone, a hormone that increases blood volume and stimulates the heart.

*ARB=angiotensin receptor blocker.

BYVALSON in clinical studies:

Proven blood pressure reductions

Incidence of side effects similar to patients taking placebo (sugar pills), only nebivolol, or only valsartan in the 4-week study period of the clinical study

- The number of patients that discontinued due to side effects was 2.0% with BYVALSON compared to 3.2% with sugar pills and 1% from only nebivolol or only valsartan.

Once-daily dosing

BYVALSON has been studied in more than 4000 patients. Studies of the individual medications that make up BYVALSON (BYSTOLIC and valsartan) showed that the blood pressure-lowering effects of each medication were not affected by the age of the patients or whether patients were male or female. In patients who are Black, there may be somewhat less of an effect compared with patients who are Caucasian.

INDICATIONS AND IMPORTANT RISK INFORMATION
What are BYSTOLIC and BYVALSON?

BYSTOLIC is a prescription medicine that belongs to a group of medicines called "beta blockers." BYVALSON is a prescription medicine that contains nebivolol, a beta blocker and the active ingredient in BYSTOLIC, and valsartan, an angiotensin receptor blocker (ARB). BYSTOLIC and BYVALSON are used to treat high blood pressure (hypertension) in adults. BYSTOLIC and BYVALSON should not be used together. It is not known if BYSTOLIC and BYVALSON are safe and effective in children under 18 years of age.

IMPORTANT RISK INFORMATION ABOUT BYSTOLIC AND BYVALSON

WARNING

  • BYVALSON can cause harm or death to your unborn baby.
  • Talk to your healthcare provider about other ways to lower your blood pressure if you plan to become pregnant.
  • If you become pregnant while taking BYVALSON, tell your healthcare provider right away. Your healthcare provider may switch you to a different medicine to treat your high blood pressure.
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). BYSTOLIC is not approved for use in children under 18 years of age.

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
What are BYSTOLIC and BYVALSON?

BYSTOLIC is a prescription medicine that belongs to a group of medicines called "beta blockers." BYVALSON is a prescription medicine that contains nebivolol, a beta blocker and the active ingredient in BYSTOLIC, and valsartan, an angiotensin receptor blocker (ARB). BYSTOLIC and BYVALSON are used to treat high blood pressure (hypertension) in adults. BYSTOLIC and BYVALSON should not be used together. It is not known if BYSTOLIC and BYVALSON are safe and effective in children under 18 years of age.

IMPORTANT RISK INFORMATION ABOUT BYSTOLIC AND BYVALSON

WARNING

  • BYVALSON can cause harm or death to your unborn baby.
  • Talk to your healthcare provider about other ways to lower your blood pressure if you plan to become pregnant.
  • If you become pregnant while taking BYVALSON, tell your healthcare provider right away. Your healthcare provider may switch you to a different medicine to treat your high blood pressure.
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). BYSTOLIC is not approved for use in children under 18 years of age.

Important Risk Information about BYSTOLIC
Who should not take BYSTOLIC or BYVALSON?

Do not take BYSTOLIC or BYVALSON if you:

  • have a very low heart rate (severe bradycardia)
  • have heart block that is greater than the 1st degree
  • have symptoms of heart failure that recently worsened and you were hospitalized or require certain medicines to help with your blood circulation (decompensated cardiac failure)
  • have a certain heart condition called sick sinus syndrome, unless you have a permanent pacemaker
  • have severe liver damage
  • are allergic to any of the ingredients in BYSTOLIC or BYVALSON
  • Do not take BYVALSON if you are taking a prescription medicine called aliskiren and you have diabetes
What should I tell my healthcare provider before taking BYSTOLIC or BYVALSON?

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

  • have low blood pressure (hypotension) and are planning on taking BYVALSON
  • have heart problems
  • have asthma, trouble breathing or other lung problems. BYSTOLIC and BYVALSON are not recommended for use in patients with lung problems
  • plan to have surgery with general anesthesia
  • have diabetes and take medicine to help control your blood sugar
  • have thyroid problems
  • have problems with decreased blood flow to your feet and legs (peripheral vascular disease)
  • have liver or kidney problems
  • have or have had allergies
  • have a tumor on your adrenal gland called pheochromocytoma
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if BYSTOLIC and BYVALSON pass into your breast milk. You should not breast feed while taking either medicine
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BYSTOLIC or BYVALSON with certain other medicines can affect each other and cause serious side effects.
Especially tell your healthcare provider if you take:
  • other medicines for high blood pressure or heart problems
  • water pills (diuretics)
  • potassium-containing products
  • nonsteroidal anti-inflammatory drugs (NSAIDs)
  • rifampin
  • cyclosporine
  • fluoxetine
  • medicines containing ritonavir
  • lithium
What are the possible side effects of BYSTOLIC and BYVALSON?
BYSTOLIC and BYVALSON may cause serious side effects, including:
  • See "Boxed Warning" for BYVALSON above
  • Low blood pressure (hypotension) is most likely to happen if you take BYVALSON and also:
    • take water pills (diuretics)
    • are on a low salt diet
    • are on kidney dialysis
    • have heart problems
    • have vomiting or diarrhea

    Stop taking BYVALSON, lie down and call your healthcare provider right away if you feel faint or dizzy.

  • Worsening of chest pain (angina) or a heart attack (myocardial infarction). Do not suddenly stop taking BYSTOLIC or BYVALSON. Stopping suddenly may cause you to have chest pain or a heart attack.
  • If you have diabetes, BYSTOLIC and BYVALSON may hide signs of low blood sugar, such as fast heartbeat.
  • Worsening of heart failure. If you suddenly develop shortness of breath, increased swelling of feet or legs, or gain more than 5 pounds quickly, contact your doctor right away.
  • If you have an overactive thyroid gland (hyperthyroidism), BYSTOLIC and BYVALSON may hide signs of too much thyroid hormone in your blood, such as a fast heartbeat. If you stop taking BYSTOLIC or BYVALSON suddenly, your symptoms of having too much thyroid hormone in your blood may become much worse, and could be life-threatening.
  • Worsening of blood flow to the feet and legs. If you have problems with decreased blood flow to your feet and legs (peripheral vascular disease), your symptoms could get worse.
  • Kidney problems. Some people with certain conditions may develop kidney problems and may need to stop treatment with BYVALSON. Call your healthcare provider it you get swelling in your feet, ankles, or hands, or unexplained weight gain.
  • Serious allergic reactions that can be life threatening. Stop taking BYSTOLIC or BYVALSON and get emergency medical help right away if you get any of these symptoms of a serious allergic reaction:
    • swelling of your face, lips, tongue, throat, arms, hands, legs, or feet
    • trouble swallowing
    • trouble breathing
    • stomach (abdomen) pain with or without nausea or vomiting
  • Increased amount of potassium in the blood. Your healthcare provider may do certain tests to check your potassium blood level during your treatment with BYVALSON. Do not use salt substitutes containing potassium without first talking to your healthcare provider while taking BYVALSON.

The most common side effect of BYVALSON is slowed heartbeat.

The most common side effects of BYSTOLIC 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 healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects with BYSTOLIC and BYVALSON.

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.
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.
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.

Please also see full Prescribing Information for BYSTOLIC.

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