0.1 mg / dose inhalation spray , suspension
Salbutamol
1. What Airomir Autohaler is and what it is used for
Airomir Autohaler is an inhalation-controlled inhalation spray that contains the active substance salbutamol, which acts on the trachea so that they dilate and make it easier to breathe.
Airomir Autohaler is used for symptom relief in asthma and chronic obstructive pulmonary disease (COPD).
Note that the drug should primarily be used to relieve acute discomfort in adults and children from 4 years.
Salbutamol contained in Airomir Autohaler may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Airomir Autohaler
Do not use Airomir Autohaler
- if you are allergic to salbutamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Airomir Autohaler.
Before starting treatment with Airomir Autohaler, talk to your doctor if you have any of the following conditions:
- cardiovascular disease
- angina
- increased thyroid function ( hyperthyroidism )
- the condition with decreased potassium in the blood
- diabetes.
If asthma symptoms increase or if the effect of Airomir Autohaler worsens, consult a doctor immediately. Repeated inhalation that does not have an effect on severe asthma attacks may mean that another treatment is needed.
Other medicines and Airomir Autohaler
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of the treatment can be affected if Airomir Autohaler and certain other medicines are taken at the same time. Therefore, consult a physician before taking other concomitant medications. Some antihypertensive drugs ( beta-blockers ) may reduce the effect of Airomir Autohaler.
If you have too low potassium levels in your blood ( hypokalaemia ), this condition may worsen if Airomir Autohaler is used with diuretics, cortisone, or some other asthma medicines (xanthine derivatives). In such cases, contact your doctor for advice.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Limited experience with use during pregnancy. Therefore consult a doctor in case of more than temporary use.
It is unknown whether salbutamol passes into breast milk. Therefore consult a doctor before use during breast-feeding.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Airomir Autohaler contains ethanol
This medicine contains 4.33 mg of alcohol ( ethanol ) per inhalation. The amount of inhalation of this medicine corresponds to less than 0.1 ml of beer or 0.04 ml of wine.
The low amount of alcohol in this medicine does not produce any noticeable effects.
3. How to use Airomir Autohaler
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults and children from 12 years
The usual dose is 1-2 inhalations if needed, which should provide relief in an acute asthma attack or acute breathing problems in COPD. Do not take more than 16 inhalations per day.
Children between 4-11 years
The usual dose for relieving acute cramping in the trachea is 1 inhalation. Dose one can be increased to 2 inhalations as needed. The total use if necessary should not exceed 2 inhalations 4 times daily.
If the treatment has no effect or you need several doses per day, contact your doctor. Never increase your dose without consulting your doctor.
See the instructions for use at the end of this leaflet for more information.
Shake inhalation spray one before use.
Airomir Autohaler can normally be used by children from 4 years. For younger children, Airomir inhalation spray together with a respirator is recommended instead. Airomir Autohaler should not be used with a respirator.
For children under 4 years of age, no dosage recommendation can be made as the effect has not yet been established.
The most common signs of overdose are headache, palpitations, muscle cramps, and anxiety.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Airomir Autohaler and contact your doctor immediately if you develop any of the following:
- allergic symptoms (very rare – may affect up to 1 in 10,000 users) such as
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives
- breathing difficulties
- chest pain (very rare – may affect up to 1 in 10,000 people)
- breathing becomes worse immediately (very rare – may affect up to 1 in 10,000 people) after inhalation with Airomir Autohaler, even if Airomir Autohaler reduces symptoms. This may mean that your illness has worsened and that another treatment is urgently needed.
Side effects can occur to the following extent:
Common ( may affect up to 1 in 10 people) :
- tremor
- increased heart rate
- headache
- muscle cramps
Uncommon ( may affect up to 1 in 100 people) :
- fast heartbeat
- irritation of mouth and throat
Rare ( may affect up to 1 in 1,000 people) :
- decreased potassium in the blood
- flushing
Very rare ( may affect up to 1 in 10,000 people) :
- lowering blood pressure
- collapse
- increased degree of activity
- increased arousal
- hallucinations
- sleep disorders
- irregular heartbeat
- itchy rash
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Airomir Autohaler
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Avoid exposing the Autohaler to high heat, for example. direct sunlight. The contents of the bottle are stored under pressure. Airomir Autohaler gives the correct dose even if it is cold, e.g. wintertime, down to -10 ° C.
Do not use this medicine after the expiry date which is stated on the outer carton and inhaler after “EXP”. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is salbutamol. Each spray dose contains 0.1 mg salbutamol.
- The other ingredients (excipients) are oleic acid, ethanol, and norflurane (a freon-free propellant that is not harmful to the earth’s ozone layer).
What the medicine looks like and the contents of the pack
The package contains an inhalation- controlled inhaler with 200 doses.
Marketing Authorization Holder and Manufacturer
Manufacturer:
3M Health Care, Loughborough, UK
Norton (Waterford) Limited,
T / A Teva Pharmaceuticals Ireland
Waterford, Ireland
This leaflet was last modified on 26 June 2020
Instructions for use
Children under 4 years of age should not use Airomir Autohaler. Instead, use Airomir inhalation spray together with a respirator. Airomir Autohaler should not be used with a respirator.
Before use
The first time you use Airomir Autohaler or if it has been unused for 14 days or longer, you must first push two spray doses into the air before using Airomir Autohaler. Do as follows:
- Remove the protective cover by pulling on the rear edge.
- Hold the nozzle so that the dose that comes out is directed away from you, into the air. Pull the charger so that it is upright.
- To trigger a dose, slide the dose trigger at the bottom of the nozzle in the direction shown in Figure 3.
- To be able to trigger the second spray dose, the charger must be depressed again, and then steps 2 and 3 are repeated. After the second spray dose, the charger is pressed down again and the Airomir Autohaler is ready for use.
Do not use the automatic dose trigger when taking your medicine. Airomir Autohaler automatically triggers a dose when you inhale through the mouthpiece.
In use:
To use Airomir Autohaler:
- Remove the protective cover by pulling on the rear edge (Fig. 1) and shaking the container slightly.
- Hold the inhaler upright. Pull the charger so that it is upright (picture 2). Continue to hold the inhaler upright. Be careful that your fingers do not block the air valve (marked X in picture 2) at the bottom of the inhaler.
- Exhale as much as you can, place the mouthpiece in your mouth and close your lips tightly around the mouthpiece (Figures 3 and 4).
- Inhale slowly and deeply through the mouthpiece. The drug now follows the inhaled air into the lungs. Continue inhaling even when you hear a “click” and feel the taste of medicine in your mouth. It is important that you continue inhaling after dose one is released (Figure 4).
- Hold your breath for 5-10 seconds and then exhale slowly (Fig. 5).
- The charger must be pushed back after each dose (Fig. 6).
- If your doctor has prescribed more than one dose, repeat steps 2-6. After use, replace the protective cover.
Caring for your Airomir Autohaler
The nozzle is dried on the outside with a clean and dry cloth or napkin.
Warning: Do not put the cloth or napkin in the inhaler. It can destroy the mechanism. Do not disassemble the inhaler. The inhaler must not come into contact with water.
How do I know when the Airomir Autohaler is empty?
The Airomir Autohaler is empty if you cannot feel the liquid in the inhaler when you shake it lightly or if there is no puff when you press the automatic dose release at the bottom of the mouthpiece.