"The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure."...
BiDil Consumer (continued)
Headache is often a sign that this medication is working. Your doctor may recommend treating headaches with an over-the-counter pain reliever (such as acetaminophen). If the headaches continue or become severe, tell your doctor promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may infrequently cause nerve problems. Tell your doctor promptly if you experience numbness or tingling. Your doctor may recommend a vitamin B6 supplement (pyridoxine).
Tell your doctor immediately if any of these unlikely but serious side effects occur: severe tiredness, aching/swollen joints, rash on nose and cheeks, swollen glands, change in the amount of urine, bloody/pink urine, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding, fainting, fast/irregular/pounding heartbeat.
Seek immediate medical attention if this rare but serious side effect occurs: chest/jaw/left arm pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the BiDil (isosorbide dinitrate and hydralazine hcl) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to either isosorbide dinitrate or hydralazine; or to similar drugs (such as isosorbide mononitrate, nitroglycerin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other heart problems (such as recent heart attack, rheumatic heart disease of the mitral valve), previous stroke, low blood pressure, blood vessel problems, loss of too much body water (dehydration), recent head injury, anemia, kidney problems.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist that you are using this medication.
Older adults may be more sensitive to the side effects of this drug, especially dizziness and lightheadedness, which could increase the risk of falls.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk or if it may harm a nursing infant. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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