Airsalb 0.1 mg/dose inhalation Spray, Suspension Salbutamol (as sulfate)
1. What Is Airsalb, And What Is Airsalb 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
- Cigarette smoke
Airsalb widens the airways, which allows the air to flow more freely. Airsalb inhalers 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.
Salbutamol contained in Airsalb may also be approved for treating conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have 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 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 other medicines. The following medicines may affect or be affected by Airsalb:
- Cardiovascular drugs 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 (e.g., 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 more accessible), 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 says it is necessary.
Do not change the dose yourself, but follow the doctor’s recommendations. It is unknown whether salbutamol passes into breast milk. Therefore, you should only use Airsalb inhalers if your doctor says it is necessary.
If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 can drive a motor vehicle or perform work requiring increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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.
- Preventing 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 ineffective or if you need more daily doses than usual. Never increase the dose or change the duration of use without your doctor’s approval.
- Adults and adolescents aged 12 years and older
- 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.
Some people find it difficult to give a medicine dose right after inhaling. If this applies to you and your 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:
- Remove the metal container from the plastic cover and remove the nozzle cover.
- 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. 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.
- The plastic cover and protective cover should dry in a warm place. Avoid excessive heat.
- 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 the 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 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
Ask your doctor or pharmacist if you have any further questions about using this product.
4. Possible Airsalb Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. Stop taking Airsalb and contact your doctor immediately if you develop any of the following infrequent side effects:
- Allergic symptoms such as
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives
- Breathing difficulties
- Breathing worsens immediately after inhalation with Airsalb, although Airsalb reduces the symptoms. This may mean that your illness has worsened and another urgent treatment is needed.
Contact your doctor as soon as possible if you:
Get chest pain (symptoms of angina) when taking Airsalb. Do not stop taking 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
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 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 briefly. 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 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 that are 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 of salbutamol (as sulfate).
- The other ingredients are norflurane (HFA 134a), anhydrous ethanol, and oleic acid.
What Does The Medicine Look Like And The Contents Of The Pack?
- This medicine is a white inhalation spray suspension 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