When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to mannitol or gelatin. You should not receive this medicine if you have other conditions that may cause bronchospasm (lung spasms with breathing problems) such as a heart or blood vessel problem, high blood pressure that is not controlled, or a recent heart attack or stroke.

How to Use This Medicine:
Capsule

• This medicine is used with a special inhaler which will measure the effect of Aridol™ on your lungs. It is given by a doctor or other trained health professional who will be with you during the test. After you have completed the test, your doctor will know the result right away (positive or negative for asthma).
• Aridol™ is a test kit containing one single patient use inhaler and 3 blister packs containing 19 capsules of mannitol for inhalation in marked doses to perform one bronchial challenge test.
• Do not put the capsules in your mouth or swallow them.
• To perform the test:
  
  • Before doing the bronchial challenge test, your doctor may ask you to perform a breathing or lung test (such as spirometry test).
  • A nose clip will then be put on your nose so you will only able to breathe in and out of your mouth.
  • Place 0 mg capsule into the inhaler. Press the side buttons of the inhaler once to puncture the capsule.
  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the inhaler just in front of your mouth.
  • Open your mouth and breathe in slowly and deeply (like yawning).
  • Hold your breath for about 5 seconds, then breathe out slowly before removal of the nose clip.
  • You will be asked to repeat the above steps up to 8 times (total of 9 increasing doses of Aridol™). This is to measure the effect of Aridol™ in your lungs.
  • Once you have finished the test, you will be given a short-acting inhaler to help you breathe (for patients who have a positive result).
  • Throw away the inhaler after using.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, angina (chest pain), severe cough or coughing up blood (hemoptysis), lung disease or other breathing problems (such as upper or lower respiratory tract infection), or a recent surgery of your stomach, chest, or eyes.
• This medicine may cause severe bronchospasm. Tell your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing after receiving this medicine. Your doctor will give you a short-acting inhaler right away to treat your symptoms.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Cough, fever, chills, runny or stuffy nose, sore throat, and body aches.
• Coughing or spitting up blood.
• Severe pain in the chest.
• Shortness of breath or troubled breathing.

If you notice these less serious side effects, talk with your doctor:

• Headache or dizziness.
• Nausea.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088