Byvalson

Byvalson is a prescription medication used to treat high blood pressure. It is a single product containing 2 medications: nebivolol and valsartan. 

Nebivolol belongs to a group of drugs called beta blockers which work by relaxing blood vessels and slowing heart rate. This improves blood flow and decreases overall blood pressure. Valsartan belongs to a group of drugs called angiotensin II receptor antagonists, which help blood vessels to relax.

This medication is available in tablet form and is usually taken once daily. 

Byvalson may cause an increase in potassium levels in the blood. This medication may make you feel tired or make you feel like you are going to faint. Do not drive or operate heavy machinery until you know how this medication affects you. 

Byvalson is a prescription medication used to treat hypertension (high blood pressure).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Byvalson is 5 mg nebivolol / 80 mg valsartan, administered once a day, with or without food.

WARNING: FETAL TOXICITY

• When pregnancy is detected, discontinue BYVALSON as soon as possible.
• Drugs, including BYVALSON, that act directly on the renin angiotensin system can cause injury and death to the developing fetus. 

Serious side effects have been reported with Byvalson including the following:

Byvalson may cause serious side effects, including:

• 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).
• 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.
• 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.

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 in Byvalson. See the end of this Patient Information leaflet for a complete list of ingredients in Byvalson.
• are taking a prescription medicine called aliskerin and you have diabetes

Serious side effects have been reported with Byvalson. See the “Byvalson Precautions” section.

The most common side effect of Byvalson 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 with Byvalson.

For more information, ask your healthcare provider or pharmacist.

You may report side effects to FDA at 1-800-FDA-1088.

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
• potassium-sparing diuretics such as spironolactone (Aldactone), triamterene (Dyrenium), amiloride (Midamor)
• potassium-containing medicines, potassium supplements, or salt substitutes containing potassium. Your healthcare provider may do certain tests to check your potassium blood level while you take Byvalson.
• aspirin and other NSAIDs (nonsteroidal anti-inflammatory drugs) such as
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• an antibiotic called rifampin (Rifadin)
• an organ transplant rejection medicine called cyclosporine (Gengraf, Neoral, Sandimmune)
• fluoxetine (Prozac)
• medicines used to treat Human Immunodeficiency Virus (HIV) that contain ritonavir (Kaletra)
• lithium (Lithobid)

Tell your doctor if you are pregnant or plan to become pregnant.

Do not use Byvalson while you are pregnant. Byvalson can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away. See "FDA Warning".

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Byvalson crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, Byvalson should be taken while breastfeeding. Talk with your doctor about the best way to feed your baby if you take Byvalson.