0.1 mg / dose inhalation spray , suspension 
salbutamol (as sulphate)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Airsalb is and what it is used for 
2. What you need to know before using Airsalb 
3. How to use Airsalb 
4. Possible side effects 
5. How to store Airsalb 
6. Contents of the packaging and other information 

1. What Airsalb is and what it is used for

Airsalb is used to treat breathing problems caused by the following diseases:

  • asthma
  • chronic obstructive pulmonary disease (COPD) including- chronic bronchitis- emphysema

Airsalb is also used to prevent asthma symptoms caused by:

  • effort or
  • insoluble factors such as dust, pollen, cats, dogs, and cigarette smoke

Airsalb widens the airways, which allows the air to flow more freely. Airsalb should be used primarily to relieve symptoms rather than as a regular treatment.

Airsalb is intended for adults, adolescents, and children aged 4 to 11 years.

Salbutamol contained in Airsalb may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

2. What you need to know before using Airsalb

Do not use Airsalb

  • 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 or pharmacist before using Airsalb if any of the following conditions apply to you:

  • have or have had heart diseases, such as irregular or rapid heartbeat or chest pain
  • severely elevated and untreated blood pressure
  • overactive thyroid gland
  • too little potassium in the blood
  • the bulge on an artery ( aneurysm )
  • diabetes (extra checks of blood sugar levels are recommended at the beginning of treatment with Airsalb)
  • an adrenal tumor ( pheochromocytoma ). The adrenal glands are two glands located above the kidneys.

Other medicines and Airsalb

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following medicines may affect or be affected by Airsalb:

  • Cardiovascular drugs that can narrow the airways and contain active substances with names ending in “-ol” such as propranolol (beta-blocker). These can cause respiratory cramps.
  • some medicines to treat depression:
    • monoamine oxidase inhibitors (eg moclobemide)
    • tricyclic antidepressants, such as amitriptyline
  • anesthetics (drugs that lead to a partial or total loss of sensation) such as halothane
  • drugs for irregular heartbeats, such as digoxin
  • xanthine derivatives (helps patients breathe easier) such as theophylline
  • Steroids are (a group of hormones ) such as cortisone
  • diuretics ( diuretics ) such as furosemide

Pregnancy and breastfeeding

There is limited experience regarding use during pregnancy, but there is also a risk to the unborn baby if your asthma is not treated during pregnancy. Therefore, you should only use Airsalb if your doctor tells you that it is absolutely necessary. Do not change the dose yourself, but always follow the doctor’s recommendations.

It is unknown whether salbutamol passes into breast milk. Therefore, you should only use Airsalb if your doctor tells you that it is absolutely necessary.

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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Therefore, do not drive or use machines until you know how the medicine affects you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

3. How to use Airsalb

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults and adolescents aged 12 years and older

  • Relief of seizures: 1-2 inhalations are needed.
  • Prevention of symptoms caused by exertion or triggers: 2 inhalations 10-15 minutes in advance.
  • Maximum dose: 8 inhalations per day.

Bar n 4-11 years

  • Relief of seizures: 1 inhalation if necessary. Dose one can be increased to 2 inhalations if needed.
  • Prevention of symptoms caused by exertion or triggers:1 inhalation, or 2 if necessary, 10-15 minutes in advance.
  • Maximum dose: 8 inhalations per day.

Children under 4 years

No dose recommendations can be made as the effect has not yet been established.

Contact your doctor if the treatment is not effective enough or if you need more doses per day than usual. Never increase the dose or change the duration of use without your doctor’s approval.

Inhaler test before use

Test that the inhaler works if you use a new inhaler or if it has not been used for 7 days or more. Remove the protective cap, shake the inhaler and spray twice in the air.

Instructions for use: Inhale sitting or standing if possible.
1. Remove the protective cover. Check the inside and outside so that the nozzle is clean.

2. Shake the inhaler firmly for a few seconds before use.

3. Hold the inhaler upright with the bottom of the container facing up, put your thumb on the bottom, under the mouthpiece. Exhale as much as you can without it becoming uncomfortable, but not through the mouthpiece.
4. Place the mouthpiece in your mouth between your teeth and close your lips around the mouthpiece but do not bite into it.
5. Just as you begin to inhale through your mouth, push the upper part of the inhaler down so that a dose is delivered while continuing to inhale steadily and deeply.

6. Hold your breath for 5-10 seconds. Remove the inhaler from your mouth and remove your finger from the top of the inhaler.
7. If you need another dose, hold the inhaler upright and wait about half a minute before repeating steps 2-6.
8. After use, always put the protective cap on the nozzle so that it is protected from dust and dirt. Attach the protective cover securely and make sure that it is pressed into place.

Some people find it difficult to give a dose of medicine right after they start inhaling. If this applies to you, as well as to children, the inhalation aids Vortex® or AeroChamber® Plus can be used. See the inhalation aid product information for handling information.

Cleaning

To prevent the inhaler from clogging, or if it becomes clogged, clean it at least once a week, according to the instructions below:

  1. Remove the metal container from the plastic cover and remove the nozzle cover.
  2. Rinse the plastic cover and the nozzle cover in lukewarm water. Do not attempt to remove any deposits around the mouthpiece with a sharp object, such as a needle. You can add a mild detergent to the water, then rinse the nozzle thoroughly with clean water before drying. The metal container must not be placed in water.
  3. The plastic cover and protective cover should dry in a warm place. Avoid excessive heat.
  4. Replace the container and nozzle cover.

Contents of the inhaler:

Shake the spray to check how much medicine is left in the inhaler. Do not use Airsalb if you can not detect any liquid in the inhaler when you shake it.

Use in cold:

If the inhaler has been stored below 0 ºC, warm it in your hands for 2 minutes, shake it and then spray it twice in the air before use.

Typical symptoms if you have ingested too much are:

  • Tremors
  • Headache
  • Fast heartbeat
  • Nausea or vomiting
  • Inability to sit still
  • Irritation, arousal
  • Cramps
  • Somnolence

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Airsalb and contact your doctor immediately if you develop any of the following very rare side effects:

  • allergic symptoms such as
    • swelling of the face, tongue, or throat
    • difficulty swallowing
    • hives
    • breathing difficulties
  • breathing becomes worse immediately after inhalation with Airsalb, ​​although Airsalb reduces the symptoms. This may mean that your illness has worsened and that another treatment is urgently needed.

Contact your doctor as soon as possible if you:

get chest pain (symptoms of angina) when taking Airsalb. Do not stop taking the medicine without consulting your doctor. It is not known how often this occurs.

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
  • sleep disorders
  • irregular heartbeat
  • itchy rash

Has been reported (occurs in an unknown number of users):

  • lactic acidosis (a condition with increased production of lactic acid in the body)

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 Airsalb

Keep this medicine out of the sight and reach of children.

Store below 30 ° C.

Airsalb should be stored horizontally or upside down, with the nozzle facing downwards.

The container contains a compressed liquid. Do not expose it to temperatures above 50 o C, not even for a short time. Protect from heat, direct sunlight, and frost! Do not puncture or burn the container, even empty containers.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. 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 dose contains 100 micrograms of salbutamol (as sulfate). Each dose delivered after passage through the mouthpiece is 90 micrograms salbutamol (as sulfate).
  • The other ingredients are norflurane (HFA 134a), anhydrous ethanol, oleic acid.

What the medicine looks like and the contents of the pack

This medicine is a white inhalation spray, suspension, which is packaged in an aluminum container with a dosing valve and a plastic cover.

The package contains

200 doses (equivalent to 8.5 g inhalation spray, suspension )

2 x 200 doses (equivalent to 2 x 8.5 g inhalation spray , suspension )

3 x 200 doses (equivalent to 3 x 8.5 g inhalation spray , suspension )

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Aeropharm GmbH, François-Mitterrand-Allee 1, 07407 Rudolstadt, Germany

Muhammad Nadeem

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