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Flohale General Information

Flohale is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Flohale works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Flohale belongs to a class of drugs known as corticosteroids.

Flohale must be used regularly to be effective. Flohale does not work immediately and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

OTHER USES: This section contains uses of Flohale that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use Flohale for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Flohale may also be used with other medications to control symptoms of ongoing lung disease (such as chronic bronchitis, emphysema, COPD).

How to Use Flohale

Read the Patient Information Leaflet that comes with Flohale before you start using Flohale and each time you get a refill. Read the patient instructions on how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist.

Follow the instructions for priming the inhaler if you are using it for the first time, if you have not used it for more than 1 week, or if you dropped the inhaler. When priming the inhaler, make sure to spray away from your face so that you do not get the medication into your eyes.

Shake the inhaler well for 5 seconds before each use. Inhale Flohale by mouth as directed by your doctor, usually twice a day (in the morning and evening). The dosage is based on your medical condition and response to treatment.

Talk to your doctor or pharmacist if you have trouble using this inhaler. Young children may get better results using a spacer device and face mask with Flohale.

If two inhalations/puffs are prescribed, wait about 30 seconds between them. Shake the inhaler well between each puff. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use Flohale (the corticosteroid) last.

Gargle and rinse your mouth with water after each use to help prevent irritation and fungal/yeast infections (thrush) in the mouth and throat. Do not swallow the rinse water.

Use Flohale regularly to get the most benefit from it. Flohale works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use Flohale more often, or stop using it without first consulting your doctor.

If you are regularly using a different corticosteroid taken by mouth (such as prednisone), you should not stop using it unless directed by your doctor. You may have withdrawal symptoms if the drug is suddenly stopped. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication after you begin using Flohale. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. See also Precautions section.

Clean the inhaler regularly as directed. Keep track of the number of inhalations used. Discard the canister after using the labeled number of inhalations on the package, even if it feels as though there is medication left in the canister.

It may take up to 2 weeks or longer before the full benefit of Flohale takes effect. Tell your doctor if your condition does not improve or if it worsens.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

Flohale Possible Side Effects

Hoarseness or throat irritation may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed Flohale because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using Flohale do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: white patches in your mouth/on your tongue, signs of infection (such as fever, chills, cough, persistent sore throat), vision problems, increased thirst/urination, easy bruising/bleeding, mental/mood changes (such as depression, mood swings, agitation), bone pain.

Infrequently, Flohale may cause sudden severe wheezing/trouble breathing immediately after you use it. If this occurs, use your quick-relief inhaler and get medical help right away.

A very serious allergic reaction to Flohale is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Flohale Precautions

Before using Flohale, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Flohale may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using Flohale, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), certain eye problems (cataracts, glaucoma, herpes infection of the eye), bone loss (osteoporosis), liver disease.

Flohale may mask signs of infection. Flohale can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using Flohale in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using Flohale or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Flohale may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, Flohale should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Flohale Possible Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of Flohale from your body, which may affect how Flohale works. Examples include boceprevir, HIV protease inhibitors (such as lopinavir, ritonavir), some azole antifungals (such as ketoconazole), among others.

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