Consumer Information for: PULMICORT TURBUHALER

The dosage of PULMICORT TURBUHALER is individual.

Follow your doctor’s instructions carefully. They may differ from the information in this leaflet. It is important that you use PULMICORT TURBUHALER daily at the intervals recommended by your doctor.

IMPORTANT: DO NOT EXCEED THE DOSE PRESCRIBED BY YOUR DOCTOR. IF DIFFICULTY IN BREATHING PERSISTS, CONTACT YOUR DOCTOR OR PHARMACIST.

DO NOT STOP TAKING PULMICORT TURBUHALER ON YOUR OWN. Treatment with PULMICORT TURBUHALER should not be stopped abruptly, but tapered off gradually. Follow your doctor's directions.

Suggested starting doses are:

Adults and Children 12 Years of Age and Older: 400-2400 mcg daily, divided into 2-4 administrations.

Children 6 to 12 Years Old: 200-400 mcg daily, divided into 2 administrations.

Maintenance Dose:

Adults and Children 12 Years of Age and Older: 200-400 mcg daily, divided into 2 administrations. Your doctor will prescribe the lowest dose necessary to control symptoms.

In adults who require 400 mcg daily, PULMICORT TURBUHALER may be taken once daily, either in the morning or evening.

Children 6 to 12 Years Old: Your doctor will prescribe the lowest dose necessary to control symptoms.

In adults who require 400 μg daily, PULMICORT TURBUHALER may be taken once daily, either in the morning or evening.

You may notice that your symptoms improve after the first dose of PULMICORT TURBUHALER. However, 1 - 2 weeks may pass before the full effect is achieved. Don't forget to take it even when you feel well.

If you have been prescribed PULMICORT TURBUHALER and are still using "cortisone" tablets, your doctor may gradually (over a period of weeks or months) reduce your dose of tablets. You may even be able to eventually stop using the tablets.

If your medication is changed from "cortisone" tablets to PULMICORT TURBUHALER, you may temporarily regain symptoms which may have bothered you earlier, e.g. runny nose, rash, pain in muscle and joints. If any of these symptoms bothers you, or if you get symptoms such as headache, tiredness, nausea or vomiting, contact your doctor.

Missed dose

If you miss a dose of PULMICORT TURBUHALER and remember within 6 hours, you should take your usual dose as soon as possible. Then go back to your regular schedule. If it has been more than 6 hours, do not take the missed dose. Just take the next dose on time.

Never take a double dose of PULMICORT TURBUHALER to make up for missed doses. If you are still unsure, check with your doctor or pharmacist to see what you should do.

Overdose

HOW TO USE YOUR PULMICORT TURBUHALER INHALER

Before you start using PULMICORT TURBUHALER for the first time it is important that you read the instructions below and follow them carefully

TURBUHALER is an inhaler from which very small amounts of powder are administered. When you breathe in through PULMICORT TURBUHALER the powder is delivered to the lungs. It is therefore important that you inhale as deeply and strongly as you can through the mouthpiece

Before you use a NEW inhaler for the first time you must prepare the inhaler for use. Follow the steps under “A. How to prepare a NEW inhaler for use:”.

For regular use of your inhaler follow the steps under “B. How to take a dose:”.

A. How to prepare a NEW inhaler for use:
You only need to prepare your NEW inhaler for use once. You do not need to repeat these steps even if your inhaler is not used regularly.

STEP 1     Unscrew and lift off the cover (Figure 1).
STEP 2     Hold the inhaler upright. Do not hold the inhaler by the mouthpiece. Turn the brown grip as far as it will go in one direction (clockwise or counterclockwise, it does notmatter which way you turn it first). Then turn the brown grip as far as it will go in the opposite direction (Figure 2). At some point when you are turning the grip you will hear a “click”. This is part of the preparation process.
STEP 3     Repeat STEP 2 one more time. Then follow the steps under “B. How to take a dose:”, starting at STEP 2.

B. How to take a dose:

To properly take a dose, follow these 4 steps:

STEP 1     Unscrew and lift off the cover (Figure 1).
STEP 2     Hold the inhaler upright. Do not hold the inhaler by the mouthpiece. Turn the brown grip as far as it will go in one direction (clockwise or counter-clockwise, it does not matter which way you turn it first). Then turn the brown grip as far as it will go in the opposite direction (Figure 2). A dose has now been loaded. At some point when you are turning the grip you will hear a “click”. This ispart of the loading process. NOTE: If you accidentally drop, shake or breathe out into PULMICORT TURBUHALER after the dose has been loaded, you will lose your dose. If this happens, repeat STEP 2 to load a new dose.
STEP 3     Breathe out, with your mouth away from the mouthpiece (Figure 3). Then, place the mouthpiece gently between your teeth.
STEP 4     Now close your lips over the mouthpiece. Do not bite or chew the mouthpiece. Inhale as deeply and strongly as you can (Figure 4). You may not feel or taste the medication when inhaling. This is common. Before you exhale, remember to remove the inhaler from your mouth. Repeat STEPS 2-4 if more than one dose has been prescribed. When you have taken the prescribed amount of doses, replace the cover of the inhaler by screwing it back on. With each inhalation some medication may stick to the inside of your mouth and throat. To reduce the risk of side effects rinse your mouth with water, and do not swallow.

Note: Do not try to remove the mouthpiece or to twist it unnecessarily. It is fixed to the inhaler and must not be taken off. Do not use PULMICORT TURBUHALER if it has been damaged or if the mouthpiece has become detached.

I cannot remember how many times I turned the brown grip. What should I do?

The TURBUHALER is designed to load only one dose at a time. If you can’t remember how many times you have turned the brown grip, you can start the process again. Follow the steps below. You will not end up loading two doses.

If you are using a NEW inhaler for the first time, start at the beginning of STEP 2 under the section “A. How to prepare a NEW inhaler for use:”.

If you are already regularly using your inhaler, start at the beginning of STEP 2 under the section “B. How to take a dose:”.

How do I know my dose has been loaded?

By turning the brown grip all the way in BOTH directions, you will properly load a dose of your medication. At some point when you are turning the grip you will hear a “click”. This is part of the loading process. If you are not sure you heard the “click”, repeat from the beginning of STEP 2 under the section “B. How to take a dose:”. This will not result in two doses being loaded. The TURBUHALER is designed to load only one dose at a time. If you do not hear the “click” sound when the turning grip is rotated, you will not receive any medication. If this problem persists, you need to replace the PULMICORT TURBUHALER.

How do I clean my inhaler?

Clean the outside of the mouthpiece once a week with a clean tissue. Never use water or any other fluid. If fluid enters the inhaler it may not work properly.

How do I know when to start a new inhaler?

PULMICORT TURBUHALER has a dose indicator. When a red mark first appears in the little window underneath the mouthpiece, there are approximately 20 doses left (Figure 5). Now is the time to obtain your next inhaler. When the red mark reaches the bottom of the window, you should throw out your inhaler and start a new inhaler. The sound you hear if you shake the inhaler is made by a drying agent, not the medication. PULMICORT TURBUHALER cannot be refilled with drug and should be thrown away when it is empty.