TEVA Airomir Autohaler

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Airomir™ Autohaler™ and Inhaler

Salbutamol sulfate (sal-bute-a-mol sull-fate)

Consumer Medicine Information

Airomir™ Autohaler™ and Inhaler Published by MIMS/myDr July 2014

What is in this leaflet

This leaflet answers some common

questions about Airomir Autohaler

and Airomir Inhaler. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using Airomir

Autohaler or Airomir Inhaler against

the benefits they expect it will have

for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What's in Airomir

Autohaler and Inhaler

The name of your medication is

Airomir Autohaler or Airomir

Inhaler. It contains a medicine called

salbutamol sulfate. Salbutamol

sulfate belongs to the beta-agonist

family of medicines. The amount of

medicine in each puff of Airomir

Autohaler or Inhaler is the same as

100 micrograms of salbutamol. Each

Airomir Autohaler or Inhaler

contains at least 200 puffs.

What Airomir Autohaler

and Inhaler are used for

Airomir Autohaler and Inhaler are

designed so the medicine can be

inhaled (breathed in) into the lungs to

treat asthma and other conditions

where breathing is difficult.

Salbutamol sulfate opens up the

airways to your lungs, thereby

relieving wheezing and the feeling of

tightness in your chest, and helps you

breathe more easily. Airomir

Autohaler and Airomir Inhaler are

therefore known as a RELIEVER

medicine.

Your medicine may also help prevent

wheezing and chest tightness in some

situations that cause narrowing of the

airways to your lungs, like exercise.

That's why your doctor or pharmacist

may advise you to take one or two

puffs of Airomir Autohaler or

Airomir Inhaler before exercise.

Your Airomir Autohaler or Inhaler is

designed to be just one part of a

general plan to help you manage your

asthma. Every asthma patient is

different. Ask your doctor or

pharmacist for an ASTHMA

MANAGEMENT PLAN that suits

you. Make sure you visit your doctor

or pharmacist regularly to check

whether your plan needs to be

changed.

Perhaps you have been prescribed

Airomir Autohaler or Inhaler for

something other than asthma.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

What's different about

Airomir Autohaler and

Airomir Inhaler?

If you have been using an older type

of inhaler you will find that Airomir

Autohaler or Inhaler has a different

taste and a warm, soft spray. But it is

still just as effective.

Each spray from Airomir Autohaler

or Inhaler contains exactly the same

dose of salbutamol sulfate active

ingredient as a spray from the older

type of inhaler.

Before you use Airomir

Autohaler or Airomir

Inhaler

When you must not use it

Do not use Airomir Autohaler or

Airomir Inhaler if you are allergic

to:

• salbutamol and similar drugs

• any of the ingredients listed under

"Product description" later in this

leaflet

Some of the symptoms of an allergic

reaction may include:

• shortness of breath

• wheezing or difficulty breathing

• swelling of the face, lips, tongue

or other parts of the body

• rash, itching or hives on the skin

Do not take this medicine after the

expiry date printed on the canister

or if the packaging is torn or shows

signs of tampering.

Need help?

Do you have a question about the TEVA Airomir Autohaler and is the answer not in the manual?

Summary

About Airomir Autohaler and Inhaler

What is in this leaflet

Overview of the leaflet's content and purpose, emphasizing consultation with healthcare professionals.

Product Contents

Details the medication's name, active ingredient (salbutamol sulfate), and dosage per puff.

Uses of Airomir Autohaler and Inhaler

Explains the primary use for treating asthma and other breathing difficulties by opening airways.

Airomir Autohaler vs. Airomir Inhaler

Compares the Autohaler and Inhaler, noting differences in feel but same effectiveness.

When Not to Use Airomir

Lists contraindications, including allergies to salbutamol or other ingredients, and expired products.

Before Using Airomir Autohaler or Inhaler

Medical Conditions and Allergies

Advises informing the doctor about allergies, heart problems, diabetes, high blood pressure, and thyroid issues.

Pregnancy and Breastfeeding

Guidance for pregnant, planning to be pregnant, or breastfeeding individuals.

Interactions with Other Medicines

Details potential interactions with medications for blood pressure, theophylline, steroids, and diuretics.

How to Use Airomir Autohaler and Inhaler

Autohaler Usage Instructions

Step-by-step guide for using the Airomir Autohaler, including priming and breathing technique.

Inhaler Usage Instructions

Step-by-step guide for using the Airomir Inhaler, emphasizing breathing and pressing the canister.

Troubleshooting Inhaler Issues

Addresses common problems like blocked mouthpieces, incorrect assembly, or empty canisters.

Dosage Guidance

Provides recommended dosage for adults, children, and the elderly, and maximum daily limits.

Important Usage and Safety Information

Overdose Precautions

Advises on immediate actions to take if too much medicine is used, including contacting medical services.

Ongoing Usage Recommendations

Emphasizes informing healthcare providers about Airomir use and seeking advice if effectiveness changes.

Common Side Effects

Lists potential side effects such as shaking, headache, dizziness, and palpitations.

Inhaler Care and Cleaning

Instructions for weekly cleaning of the mouthpiece and cover to maintain functionality.

Storage, Disposal, and Product Details

Storage Guidelines

Recommends storing the inhaler in a cool, dry place away from heat and moisture.

Disposal Advice

Instructs on responsible disposal, warning against puncturing or burning the pressurized canister.

Product Appearance

Describes the physical components of the Airomir Autohaler and Airomir Inhaler units.

Active and Inactive Ingredients

Lists the active ingredient (salbutamol) and other components like ethanol, oleic acid, and norflurane.

Sponsor and Manufacturer Information

Provides contact details for the supplier and developer of the Airomir products.

The Airomir™ Autohaler™ and Inhaler are medical devices designed to deliver salbutamol sulfate, a beta-agonist medicine, directly into the lungs to treat asthma and other conditions that cause breathing difficulties. These devices are known as "RELIEVER" medicines, as they help open up the airways, relieving wheezing and chest tightness, and facilitating easier breathing. Each puff from either device delivers 100 micrograms of salbutamol. Both the Autohaler and Inhaler contain at least 200 puffs.

Function Description:

The primary function of both the Airomir Autohaler and Inhaler is to administer salbutamol sulfate to the lungs. Salbutamol sulfate works by relaxing the muscles in the airways, which helps to widen them and improve airflow. This action provides rapid relief from symptoms such as wheezing, shortness of breath, and chest tightness. The medicine can also be used preventatively before exercise to avoid exercise-induced narrowing of the airways.

The Airomir Autohaler is designed for ease of use, automatically releasing a dose when the user begins to breathe in from the mouthpiece. This eliminates the need for precise coordination between pressing and inhaling, which can be challenging with traditional inhalers. A distinct "click and whoosh" sound confirms that the correct dose has been released.

The Airomir Inhaler, while also delivering salbutamol, requires the user to manually press down on a metal canister with their forefinger as they begin to breathe in slowly and deeply through the mouthpiece. This method requires more coordination from the user compared to the Autohaler.

Important Technical Specifications:

Active Ingredient: Salbutamol sulfate.
Dose per Puff: 100 micrograms of salbutamol.
Puffs per Device: At least 200 puffs.
Propellant: Norflurane (a non-CFC propellant that does not deplete ozone).
Other Ingredients: Ethanol (0.0036 mL per puff), oleic acid.
Storage Temperature: Below 30°C.
Device Type:
- Airomir Autohaler (AUST R 67257): Consists of a metal canister sealed inside a plastic autohaler unit with a mouthpiece, plastic cover, and a lever at the top. Available in pack sizes of 100* & 200 doses.
- Airomir Inhaler (AUST R 64799): Consists of a metal canister inside a plastic inhaler unit with a mouthpiece and plastic cover. Available in pack sizes of 100* & 200 doses.
- (*100 dose packs are not currently marketed.)

Usage Features:

Airomir Autohaler Instructions for Use:

Test Firing (if new or unused for two weeks): Release four puffs into the air away from the face.
- Remove the mouthpiece cover by unclipping it from the back.
- Hold the autohaler upright between thumb and index finger and shake well.
- Push the lever up until it stays up.
- Point the mouthpiece away from you.
- Push the dose release slide on the bottom of the Autohaler unit in the direction of the arrow to release a puff.
- Return the lever to the down position, then repeat for a total of four puffs.
- Always push the lever back down after test firing.
Regular Use:
- REMOVE COVER AND SHAKE: Unclip the mouthpiece cover, check for cleanliness, hold upright, and shake well.
- HOLD UPRIGHT AND PUSH LEVER UP: Keep the autohaler upright and push the lever up until it stays in position. Ensure the hand is not blocking the air vent at the bottom.
- BREATHE OUT AND POSITION MOUTHPIECE: Breathe out as much as comfortably possible, then immediately close lips around the mouthpiece.
- BREATHE IN: Inhale slowly and deeply through the mouthpiece. Continue breathing in after hearing the "click and whoosh" and feeling the puff.
- HOLD YOUR BREATH: Hold breath for 10 seconds, then breathe out slowly.
- PUSH LEVER DOWN: After each puff, return the lever to the down position while holding the autohaler upright.
- Repeat: If more than one puff is prescribed, repeat steps 2 to 6. Replace the mouthpiece cover after use. The lever should be left down between treatments.
- Empty Device Check: If the Autohaler is empty during test firing, no puff will be felt or heard.

Airomir Inhaler Instructions for Use:

Test Firing (if new or unused for two weeks): Release four puffs into the air away from the face.
- Remove the mouthpiece cover, check for cleanliness, hold upright, and shake well.
- Breathe out as far as comfortably possible.
- Place the mouthpiece in the mouth and close lips firmly around it.
- As you start to breathe in slowly, firmly press the metal canister downwards with your forefinger until a puff is released.
- Finish breathing in and hold breath for 10 seconds before breathing out slowly.
- Repeat for additional puffs if needed.
Regular Use:
- REMOVE COVER AND SHAKE: Remove the mouthpiece cover, check for cleanliness, hold upright, and shake well.
- BREATHE OUT: Breathe out as much as comfortably possible.
- POSITION MOUTHPIECE, START TO BREATHE IN AND PRESS: Place the mouthpiece in the mouth, close lips firmly around it. As you start to breathe in slowly, press the metal canister downwards until a puff is released.
- FINISH BREATHING IN AND HOLD: Hold breath for 10 seconds, then breathe out slowly.
- Repeat: If more than one puff is prescribed, repeat steps 2 to 4. Replace the mouthpiece cover after use and store in a safe place.

General Usage Guidelines:

Dosage: The usual dose is one or two puffs to relieve wheezing or before exercise. Do not exceed 16 puffs per day without consulting a doctor.
Supervision: Children using Airomir Autohaler or Inhaler should be supervised by a responsible adult.
Effectiveness: If the usual dose does not seem to be working or lasting as long, contact a doctor urgently.
Troubleshooting (if device does not work properly):
- Check for a dirty or clogged mouthpiece (wash and air dry).
- Check if the device is empty (shake it).
- Ensure the metal canister is correctly positioned in the small socket.
- Do not disassemble, drop, or hit the device.

Maintenance Features:

Care and Cleaning:

Frequency: The inhaler mouthpiece should be cleaned at least once a week to prevent blockage from medication build-up.
Cleaning Steps:
1. WASH MOUTHPIECE UNDER WARM RUNNING WATER: Remove the canister and set it aside in a safe place (never immerse the canister in water). Wash the mouthpiece through the top and bottom with warm running water for 30 seconds. Wash the mouthpiece cover as well.
2. SHAKE OFF EXCESS WATER AND AIR DRY: Shake off excess water and leave the mouthpiece and cover in a safe place to air dry thoroughly, ideally overnight.
3. Reassembly: Once the mouthpiece is dry, replace the canister and the mouthpiece cover.
4. Urgent Use (if not completely dry): If the inhaler is needed before it's completely dry, shake off excess water, replace the canister, and remove most remaining water by test spraying twice into the air away from the face. Then take the dose as prescribed. After such use, wash and air dry thoroughly again.

Storage:

Keep the Airomir Autohaler or Inhaler in a cool, dry place where the temperature stays below 30°C.
Do not store in the bathroom, near a sink, on a windowsill, or in a car, as heat and dampness can damage medicines.
Keep the device (with its mouthpiece cover) in a place where children cannot reach, ideally in a locked cupboard at least one-and-one-half meters above the ground.

Disposal:

Dispose of the Airomir Autohaler or Inhaler thoughtfully.
The metal canister is pressurized; do not burn or puncture it, even when empty, as it may explode.
If the doctor advises to stop taking the medicine or if the expiry date has passed, ask a pharmacist for disposal instructions.