Nitrolingual Spray

Nitrolingual Spray is used for:

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Preventing or relieving a sudden attack of angina (chest pain) caused by heart disease. It may also be used for other conditions as determined by your doctor.

Nitrolingual Spray is a nitrate. It works by dilating (widening) blood vessels. Chest pain occurs when the heart needs more oxygen than it can get. Dilating blood vessels allows blood to flow more easily. This reduces the heart's workload and the amount of oxygen needed by the heart.

Do NOT use Nitrolingual Spray if:

• you are allergic to any ingredient in Nitrolingual Spray
• you are also taking a phosphodiesterase type 5 inhibitor (eg, sildenafil)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nitrolingual Spray:

Some medical conditions may interact with Nitrolingual Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you drink alcoholic beverages
• if you have a history of other heart problems (eg, heart failure, enlarged heart, heart attack), overactive thyroid, stroke or other bleeding in the brain, increased pressure in the head, or recent head injury
• if you have anemia, low blood pressure, dehydration, or low blood volume

Some MEDICINES MAY INTERACT with Nitrolingual Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), diuretics (eg, furosemide, hydrochlorothiazide), medicines for high blood pressure, phenothiazines (eg, thioridazine), or phosphodiesterase type 5 inhibitors (eg, sildenafil) because the risk of low blood pressure and dizziness on standing may be increased
• Salicylates (eg, aspirin) because they may increase the risk of Nitrolingual Spray's side effects
• Long-acting nitrates (eg, nitroglycerin patch) because they may decrease Nitrolingual Spray's effectiveness
• Alteplase because its effectiveness may be decreased by Nitrolingual Spray

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitrolingual Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitrolingual Spray:

Use Nitrolingual Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Nitrolingual Spray. Talk to your pharmacist if you have questions about this information.
• Do NOT shake Nitrolingual Spray.
• Do NOT inhale the spray. Nitrolingual Spray is to be used on or under the tongue.
• Before using the medicine for the first time, prime the pump by spraying once into the air away from yourself and others. If you do not use Nitrolingual Spray within 6 weeks, reprime by spraying once into the air.
• To use Nitrolingual Spray, remove the plastic cover. Hold the container upright with your forefinger on top of the grooved button. Open your mouth and bring the container as close to your mouth as possible. Press the button firmly to release the spray onto or under your tongue. Do NOT inhale the spray. Release the button and close your mouth.
• Replace the plastic cover after you are finished using Nitrolingual Spray.
• Do not swallow right away you use a dose. Do not spit or rinse your mouth for 5 to 10 minutes after you use Nitrolingual Spray.
• To treat an angina attack, use 1 to 2 sprays on or under the tongue as directed by your doctor. Sit quietly after using a dose. A spray may be repeated every 3 to 5 minutes as directed by your doctor. Do not use more than 3 sprays in 15 minutes unless your doctor tells you otherwise. If chest pain continues after a total of 3 sprays, seek medical attention at once, unless your doctor gives you different instructions.
• If you use Nitrolingual Spray to prevent angina caused by physical activity, use it 5 to 10 minutes before activity unless your doctor tells you otherwise.
• If you miss a dose of Nitrolingual Spray and you are still having chest pain, contact your doctor right away. Ask your health care provider any questions you may have about the proper use of Nitrolingual Spray.

Ask your health care provider any questions you may have about how to use Nitrolingual Spray.

Important safety information:

• Nitrolingual Spray may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nitrolingual Spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol while you are using Nitrolingual Spray. Drinking alcohol may increase the risk of low blood pressure with Nitrolingual Spray.
• Nitrolingual Spray may cause dizziness, lightheadedness, or fainting. Sit down while taking Nitrolingual Spray to avoid falling caused by lightheadedness or dizziness.
• Nitrolingual Spray can cause tingling or burning when you put it under your tongue. However, lack of tingling or burning does not mean the medicine is not working.
• Contact your doctor right away if you develop slow heartbeat or new or worsening chest pain after you take Nitrolingual Spray.
• The risk of tolerance to Nitrolingual Spray may be greater if you take Nitrolingual Spray in high doses or more often than prescribed. Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
• Nitrolingual Spray is flammable. Do not store near an open flame. Do not force open or burn the container.
• Keep medicine in the original glass bottle with cap tightly closed. Throw away the cotton inside once the bottle is opened.
• Tell your doctor or dentist that you take Nitrolingual Spray before you receive any medical or dental care, emergency care, or surgery.
• Nitrolingual Spray may interfere with certain lab tests, including certain cholesterol tests. Be sure your doctor and lab personnel know you are using Nitrolingual Spray.
• Lab tests, including heart function, blood pressure, and blood electrolyte levels, may be performed while you use Nitrolingual Spray. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Nitrolingual Spray should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nitrolingual Spray while you are pregnant. It is not known if Nitrolingual Spray is found in breast milk. If you are or will be breast-feeding while you are using Nitrolingual Spray, check with your doctor. Discuss any possible risks to your baby.

When used at higher doses or more often than prescribed, Nitrolingual Spray may not work as well. This is known as TOLERANCE. Tolerance to other nitrates and nitrites may also occur. Increasing the dose is not effective in managing tolerance to Nitrolingual Spray. Talk with your doctor if this medicine stops working well. Do not take more than prescribed.

Possible side effects of Nitrolingual Spray:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning or tingling sensation; dizziness; headache; lightheadedness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dry mouth; fainting; flushing; heavy sweating; irregular heartbeat; nausea; new or worsening chest pain; pale skin; pounding in the chest; severe dizziness or headache; shortness of breath; slow heartbeat; swelling of the hands, ankles, or feet; unusual weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include changes in heart rate; changes in vision; confusion; dizziness; flushing; nausea; persistent, throbbing headache; sweating; vomiting; weakness.

Store Nitrolingual Spray at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Protect from heat, moisture, and light. Do not store in bathroom. Keep Nitrolingual Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Nitrolingual Spray, please talk with your doctor, pharmacist, or other health care provider.
• Nitrolingual Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Nitrolingual Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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