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Byvalson

Generic Name: nebivolol and valsartan
Date of Approval: June 3, 2016
Company: Forest Laboratories, Inc.

Treatment for: Hypertension

FDA Approves Byvalson

The U.S. Food and Drug Administration (FDA) has approved Byvalson (nebivolol and valsartan) 5 mg/80 mg tablets, a fixed-dose combination (FDC) of a beta blocker (BB) and angiotensin II receptor blocker (ARB) for the treatment of hypertension.

Patient Information

Read this Patient Information before starting treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider. Talk to your healthcare provider if you have questions about your treatment.

Important information

  • 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 during treatment, tell your healthcare provider right away. Your healthcare provider may switch you to a different medicine to treat your high blood pressure.

What is Byvalson?

Byvalson is a prescription medicine that contains nebivolol, a beta-blocker and valsartan, an angiotensin receptor blocker (ARB). It is used to treat high blood pressure (hypertension) in adults.

It is not known if this medicine is safe and effective in children.

Who should not take Byvalson?

Do not take 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 nebivolol, valsartan, or any of the ingredients listed at the bottom of this page.
  • are taking a prescription medicine called aliskerin and you have diabetes

Before taking this medicine

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • have low blood pressure (hypotension)
  • have heart problems
  • have asthma, trouble breathing or other lung problems. Byvalson is 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 kidney problems
  • have liver problems
  • have or have had allergies
  • have a tumor on your adrenal gland called pheochromocytoma
  • are pregnant or plan to become pregnant. See Important information.
  • are breastfeeding or plan to breastfeed. It is not known if Byvalson passes into your breast milk. You should not breastfeed during treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking 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 medicines, potassium supplements, or salt substitutes containing potassium. Your healthcare provider may do certain tests to check your potassium blood level during treatment.
  • nonsteroidal anti-inflammatory drugs (NSAIDS)
  • an antibiotic called rifampin
  • an organ transplant rejection medicine called cyclosporine
  • fluoxetine
  • medicines used to treat Human Immunodeficiency Virus (HIV) that contain ritonavir
  • lithium

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Byvalson?

  • Take Byvalson exactly as your healthcare provider tells you. Your healthcare provider will tell you how much to take and when to take it.
  • Do not suddenly stop taking Byvalson. Stopping this medicine suddenly may cause you to have chest pain or a heart attack. Your healthcare provider may slowly lower your dose before you stop taking Byvalson.
  • Take the tablets with or without food.
  • If you take too much, or overdose, call your healthcare provider or go to the nearest emergency room right away.

Byvalson side effects

Byvalson may cause serious side effects, including:

  • See Important information.
  • Low blood pressure (hypotension) is most likely to happen if you 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). See How should I take Byvalson?
  • If you have diabetes, 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), Byvalson may hide signs of too much thyroid hormone in your blood, such as a fast heartbeat. If you stop taking 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. Call your healthcare provider if you get swelling in your feet, ankles, or hands, or unexplained weight gain.
  • Serious allergic reactions that can be life threatening. Stop treatment 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. Do not use salt substitutes containing potassium without first talking to your healthcare provider.

The most common side effect is:

  • slow 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. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store this medicine?

  • Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the tablets in a tightly closed container.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Byvalson.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

What is high blood pressure?

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. Byvalson 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.

What are the ingredients in Byvalson?

Active Ingredients: Nebivolol as hydrochloride salt and Valsartan

Inactive Ingredients: Lactose monohydrate, microcrystalline cellulose, copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, talc, ferric oxide, hypromellose, polysorbate 80, and Opadry® II Purple film-coat. The Opadry® II is made of polyvinyl alcohol-part hydrolyzed, titanium dioxide, talc, polyethylene glycol, iron oxide red, and ferrosoferric oxide/black iron oxide.

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