Details for: OXEZE TURBUHALER

The dosage of OXEZE TURBUHALER is individual. Follow your doctor’s instructions carefully. They may differ from the information contained in this leaflet.

Asthma:

For the maintenance treatment of asthma, OXEZE TURBUHALER should be taken at the same time with an anti-inflammatory medication, such as a corticosteroid to reduce the inflammation in your lungs due to your asthma. Your anti-inflammatory medication and OXEZE TURBUHALER are designed to work together to best treat your condition. You must continue to regularly take the anti-inflammatory medications your doctor has given you. Even if you feel better, DO NOT STOP or reduce your doses of either the anti-inflammatory medication or OXEZE TURBUHALER without first checking with your doctor.

Usual Adult Dose

6 mcg or 12 mcg twice a day, taken 12 hours apart. Some adults may need to take 24 mcg, twice a day.
Maximum daily dose: 48 mcg a day.
Usual Child (6-16 years old) Dose: 6 or 12 mcg twice a day, taken 12 hours apart.
Maximum daily dose: 24 mcg a day.

Note to Parents: It is important that you watch your child(ren) to make sure that they take both OXEZE TURBUHALER and an inhaled corticosteroid at the same time. If you cannot ensure that your child(ren) is taking both medications at the same time, then talk to your doctor. A combination product may be required.

For the prevention of exercise-induced asthma:

Usual Adult and Child (6 years of age and older) Dose

6 or 12 mcg before you exercise.
Maximum Adult Dose: 48 mcg in a 24 hour period.
Maximum Child and Adolescent Dose: 24 mcg in a 24 hour period.

Do NOT take more than the dose prescribed by your doctor.

You should see your doctor if:

• your usual dose does not provide relief;
• the effects of one dose last less than 12 hours;
• you use more than 48 mcg of OXEZE TURBUHALER for 3 days in a row.

These may be signs that your asthma is getting worse.

Missed Dose

If you miss a dose and you remember within 6 hours, you should take it as soon as possible. You should then go back to your regular schedule. However, if it has been more than 6 hours when you remember, do not take the missed dose. Just take the next dose on time.

Never take a double dose of OXEZE 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

There is no clinical experience on the management of overdose. The most common signs and symptoms of an overdose are:

• trembling;
• headache;
• rapid heartbeat.

HOW TO USE YOUR OXEZE TURBUHALER INHALER

Before you start using OXEZE TURBUHALER for the first time it is important that you read the instructions below and follow them carefully. TURBUHALER is a multidose inhaler from which very small amounts of powder are administered. When you breathe in through 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). You will hear a rattling sound when you unscrew the cover. This is normal.
STEP 2	Hold the inhaler upright. Do not hold the inhaler by the mouthpiece. Turn the greenish-blue 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 greenish-blue 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). You will hear a rattling sound when you unscrew the cover. This is normal.
STEP 2	Hold the inhaler upright. Do not hold the inhaler by the mouthpiece. Turn the greenish-blue 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 greenish-blue 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 is part of the loading process. NOTE: If you accidentally drop, shake or breathe out into OXEZE 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 number of doses, replace the cover and screw it back on.

Note: Do not try to take off the mouthpiece or to twist it unnecessarily. The mouthpiece can be rotated but it is fixed to the inhaler and must not be taken off. Do not use the TURBUHALER if it has been damaged.

I cannot remember how many times I turned the greenish-blue 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 greenish-blue 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:”.

For regular use of 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 greenish-blue 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.
How do I clean my inhaler?
Clean the outside of the mouthpiece once a week with a dry 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?
OXEZE TURBUHALER has a dose indicator. The dose indicator tells you around how many doses are left in the inhaler. The dose indicator moves slowly each time you load a dose. Every 20th dose is marked with a number and every 10th dose is marked with a dash (Figure 5). For the last 10 doses, the background of the indicator is red. When the “0” on the red background has reached the middle 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 medication. OXEZE TURBUHALER cannot be refilled with the drug and should be thrown away.