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BERODUAL (COMBIVENT) INDICATIONS

Berodual Aerosol is used for treating chronic obstructive pulmonary disease (COPD) in patients who require more than one bronchodilator. Berodual 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.

BERODUAL (COMBIVENT) INSTRUCTIONS

Use Berodual Aerosol as directed by your doctor.

  • Insert the metal canister into the clear end of the mouthpiece. Make sure the canister is fully and firmly inserted into the mouthpiece. The canister is only to be used with the mouthpiece provided. Do not use the mouthpiece with other medicines.
  • Test spray Berodual 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 Berodual Aerosol in the eyes.
  • Remove the orange dust cap from the mouthpiece before using Berodual Aerosol and replace it after you are finished.
  • Shake well for at least 10 seconds before each use.
  • Keep your eyes closed while using Berodual 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 Berodual Aerosol.
  • Continue to use Berodual Aerosol even if you feel well. Do not miss any doses.
  • If you miss a dose of Berodual 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 Berodual Aerosol.

BERODUAL (COMBIVENT) STORAGE

Store Berodual 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 throw the container into a fire or incinerator. Keep Berodual Aerosol out of the reach of children and away from pets.
BERODUAL (COMBIVENT) MORE INFO:

Active Ingredients: Ipratropium bromide and Albuterol sulfate.

Do NOT use Berodual Aerosol if:

  • you are allergic to any ingredient in Berodual Aerosol, to atropine, or to similar medicines
  • you are allergic to soya lecithin or related foods, such as soybean.

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

Some medical conditions may interact with Berodual 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 (including peanuts)
  • if you have a history of heart problems, (eg, fast or irregular heartbeat, chest pain, low blood output), blood vessel problems, high blood pressure, or low blood potassium levels
  • 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
  • if you have had an unusual reaction to other sympathomimetic medicines (eg, pseudoephedrine)
  • if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or you have taken either of these medicines within the last 14 days.

Some medicines may interact with Berodual 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), MAOIs (eg, phenelzine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Berodual Aerosol's side effects
  • Beta-blockers (eg, propranolol) because they may decrease Berodual Aerosol's effectiveness.

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

Important safety information:

  • Berodual Aerosol is for use in the mouth only. Do not get Berodual 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 Berodual Aerosol in your eyes, rinse immediately with cool tap water. Check with your doctor if you develop any of these effects.
  • Berodual Aerosol may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you use it with alcohol or certain medicines. Use Berodual 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 Berodual Aerosol.
  • If Berodual Aerosol stops working well, if your symptoms become worse, or if you need to use Berodual Aerosol more often than usual, contact your doctor right away.
  • Berodual Aerosol may cause dry mouth or unpleasant taste in your mouth. To prevent dry mouth, rinse your mouth and gargle after using Berodual Aerosol. If you experience dry mouth, use sugarless gum or candy, or melt bits of ice in your mouth. If you have any of these problems, ask your health care provider if a spacing device may help.
  • Berodual Aerosol may sometimes 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.
  • Tell your doctor or dentist that you take Berodual Aerosol before you receive any medical or dental care, emergency care, or surgery.
  • Check with your doctor before using any other inhaled medicines while you are using Berodual Aerosol.
  • Carry an ID card at all times that says you use Berodual Aerosol.
  • Lab tests, including lung function tests, blood pressure, or potassium blood levels may be performed while you use Berodual Aerosol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • The contents of Berodual 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.
  • Berodual 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 Berodual Aerosol while you are pregnant. It is not known if Berodual Aerosol is found in breast milk. Do not breastfeed while using Berodual 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; nausea; nervousness; sinus inflammation; sore throat; trouble sleeping; unusual taste in mouth.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; clammy skin; difficulty urinating; fast or irregular heartbeat; new or worsening breathing problems; numbness of an arm or leg; pain, tightness, or pressure in the jaw, neck, or chest; pounding in the chest; severe headache, nausea, vomiting, or dizziness; severe stomach pain; shortness of breath; swelling of the arms or legs; tremors; vision changes; 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.



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