Combivent Aerosol

Combivent Aerosol is used for:

Treating chronic obstructive pulmonary disease (COPD) in patients who require more than one bronchodilator.

Combivent Aerosol is a combination of a beta-adrenergic (sympathomimetic) bronchodilator and an anticholinergic bronchodilator. It works by relaxing and widening the air passages, which helps you breathe more easily.

Do NOT use Combivent Aerosol if:

• you are allergic to any ingredient in Combivent Aerosol, to atropine, or to similar medicines
• you are allergic to soya lecithin, soybean, peanut, or related food products

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

Before using Combivent Aerosol:

Some medical conditions may interact with Combivent Aerosol. 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 have a history of heart problems (eg, irregular heartbeat), blood vessel problems, or high blood pressure
• if you have a history of other lung or breathing problems (eg, asthma, hyperactive airway)
• if you have a history of an overactive thyroid, diabetes, seizures, liver or kidney problems, or an adrenal gland tumor (pheochromocytoma)
• if you have a history of an enlarged prostate, blockage or narrowing of the bladder, or glaucoma, or if you are at risk for glaucoma
• if you have low blood potassium levels
• if you have had an unusual reaction to other sympathomimetic medicines

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

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium levels may be increased
• Anticholinergics (eg, bromocriptine, methscopolamine), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Combivent Aerosol's side effects
• Beta-blockers (eg, propranolol) because they may decrease Combivent Aerosol's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Combivent Aerosol 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 Combivent Aerosol:

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

• An extra patient leaflet is available with Combivent Aerosol. Talk to your pharmacist if you have questions about this information.
• A health care provider will teach you how to use Combivent Aerosol at home. Be sure you understand how to use Combivent Aerosol. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Insert the metal canister into the clear end of the mouthpiece. Make sure the canister is fully and firmly inserted into the actuator. The canister is only to be used with the mouthpiece provided. Do not use the mouthpiece with other medicines.
• Test spray Combivent Aerosol 3 times before the first use of a new canister and when the canister has not been used for more than 24 hours. Do NOT spray Combivent Aerosol in the eyes.
• Remove the orange dust cap from the mouthpiece before using Combivent Aerosol and replace it after you are finished.
• Shake well for at least 10 seconds before each use.
• Keep your eyes closed while using Combivent Aerosol to avoid getting it in your eyes.
• Keep the mouthpiece clean. Wash it with hot water. If soap is used, rinse well with plain water. Dry completely before using.
• Keep track of the number of sprays used. Throw the canister away after 200 sprays. After 200 sprays, the canister may not deliver the correct amount of medicine with each spray.
• Contact your health care provider at once if you feel you have taken too much of Combivent Aerosol.
• Continue to use Combivent Aerosol even if you feel well. Do not miss any doses.
• If you miss a dose of Combivent Aerosol, take it as soon as possible. If it is almost time for the next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Combivent Aerosol.

Important safety information:

• Combivent Aerosol is for use in the mouth only. Do not get Combivent Aerosol in your eyes. Getting it in your eyes may cause eye pain, redness, irritation, or discomfort; blurred vision or other vision changes; or worsening of narrow-angle glaucoma. If you get Combivent Aerosol in your eyes, rinse immediately with cool tap water. Check with your doctor if you develop any of these effects.
• Combivent Aerosol may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you use it with alcohol or certain medicines. Use Combivent Aerosol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose without checking with your doctor. The risk of severe heart problems and sometimes death may be increased with overuse of Combivent Aerosol.
• If Combivent Aerosol stops working well, if your symptoms become worse, or if you need to use Combivent Aerosol more often than usual, contact your doctor right away.
• Combivent Aerosol may cause dry mouth or unpleasant taste in your mouth. To prevent dry mouth, rinse your mouth and gargle after using Combivent Aerosol. If you experience dry mouth, use sugarless gum or candy, or melt bits of ice in your mouth.
• Combivent Aerosol may sometime cause severe breathing problems right after you use a dose. When this problem occurs, it is often after the first use of a new canister. If this happens, seek medical care at once.
• Carry an ID card at all times that says you use Combivent Aerosol.
• The contents of Combivent Aerosol are under pressure. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty.
• Combivent Aerosol 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 Combivent Aerosol while you are pregnant. It is not known if Combivent Aerosol is found in breast milk. Do not breast-feed while using Combivent Aerosol.

Possible side effects of Combivent Aerosol:

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:

Coughing; dizziness; dry mouth; headache; nervousness; sinus inflammation; sore throat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; fast or irregular heartbeat; new or worsening breathing problems; pounding in the chest; shortness of breath; swelling of the arms or legs; tremors; unexplained hoarseness; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Symptoms may include chest pain; fast or irregular heartbeat; seizures; severe headache, dizziness, or nervousness; tremors; weakness.

Store Combivent Aerosol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid excessive humidity or direct sunlight. Contents are under pressure. Exposure to heat above 120 degrees F (50 degrees C) may cause bursting. Do not use or store near heat or open flame. Never thrown the container into a fire or incinerator. Keep Combivent Aerosol out of the reach of children and away from pets.

General information:

• If you have any questions about Combivent Aerosol, please talk with your doctor, pharmacist, or other health care provider.
• Combivent Aerosol 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.
• If using Combivent Aerosol for an extended period of time, obtain refills before your supply runs out.

This information is a summary only. It does not contain all information about Combivent Aerosol. 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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