Important Safety Information

Indications and Usage:

Nitrolingual® Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

Important Safety Information:

Nitrolingual Pumpspray should not be used if you are allergic to nitroglycerin or if you are using medications for erectile dysfunction such as sildenafil, vardenafil, and tadalafil. Using Nitrolingual Pumpspray with these products may cause low blood pressure, known as hypotension, due to widening of blood vessels.

You should use Nitroglycerin with caution in the early days after a heart attack and it may aggravate the angina caused by a condition known as hypertrophic cardiomyopathy. Increased hypotension, mainly when standing upright, may occur even with small doses of nitroglycerin and may result in slow heart beat and increased angina. It should be used with caution if you are dehydrated due to drug therapy or if you have low blood pressure.

You might develop a tolerance to this drug or to other nitrates and nitrites.

Headache is the most reported side-effect and may be severe and persistent. Other side effects that may have been reported are headache, dizziness, or numbness and tingling of the skin.

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Talk to your healthcare provider to see if Nitrolingual is right for you.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088