Teva

Nebulizer solution 1 mg / ml 
(clear, colorless to light yellow)

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.

This leaflet contains information on: 
1. What Airomir Nebuliser Solution is and what it is used for 
2. What you need to know before using Airomir Nebulizer solution 
3. How to use Airomir Nebulizer solution 
4. Possible side effects 
5. How Airomir nebulizer solution should be stored 
6. Contents of the pack and other information

1. What Airomir Nebulizer Solution is and what it is used for

Your medicine is called Airomir solution for nebulizer. The active substance is salbutamol. Salbutamol belongs to a class of medicines called beta-agonists. Salbutamol is a bronchodilator and dilates the airways in the lungs so that you can breathe easier. Bronchodilators are used to treat severe asthma and prolonged bronchospasm that does not respond to other treatments.

Salbutamol contained in Airomir nebulizer solution 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 Airomir nebulizer solution

Do not use Airomir nebulizer solution

  • if you are allergic to salbutamol or any of the other ingredients of this medicine (listed in section 6)
  • as a treatment to prevent premature pain and imminent abortion.

Warnings and cautions

Talk to your doctor or pharmacist before using Airomir nebulizer solution:

  • if you have had heart problems, such as irregular or rapid heartbeat or angina
  • if you have thyroid problems
  • if you have high blood pressure
  • if you use anticholinergics in a nebulizer (such as ipratropium bromide) to treat your asthma, make sure you do not get the liquid in your eyes
  • if you have diabetes.

Other medicines and Airomir nebulizer solution

Some medicines may interact with Airomir nebulizer solution and may aggravate side effects or weaken the effect of Airomir. You must tell your doctor if you are taking any of the following medicines:

  • beta-blockers such as propranolol and cardiac glycosides including digoxin (ie medicines commonly used for heart problems such as chest pain caused by exertion (angina), irregular heartbeat or arrhythmias, and high blood pressure )
  • diuretics ( diuretics )
  • other asthma medicines (another beta-agonists, ipratropium bromide, theophylline, and steroids )
  • antidepressants (monoamine oxidase inhibitors and tricyclic antidepressants ).

If you are going to have surgery that requires general anesthetics (eg, enflurane), do not use Airomir solution for nebulizer for at least 6 hours before surgery. 
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

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. During pregnancy and lactation, Airomir nebulizer solution should only be used if prescribed by a doctor.

Driving and using machines

Airomir solution for nebulizer has no or negligible influence on the ability to drive or operate machinery.

3. How to use Airomir nebulizer solution

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

The recommended dose is 2.5 mg up to three or four times daily. Your doctor may increase the dose one to 5 mg up to three or four times daily.

Dose one to get out of Airomir solution nebulizer may vary depending on the nebulizer used. Dose adjustment may be necessary. Contact your doctor if you think the effect of the Airomir nebulizer solution is too weak or too strong.

Instructions for use

For inhalation.

Airomir solution for nebulizer solution should only be used in a nebulizer. The nebulizer converts the solution into finely divided liquid drops which you can then inhale. Read the manufacturer’s instructions so you know for sure how to use the nebulizer before taking your medicine.

  • Prepare the nebulizer according to the manufacturer’s instructions.
  • Twist and pull off a new single-dose container from the strip with a single dose (A).
  • Hold the single-dose container upright and turn off the top (picture B).
  • Squeeze the contents into the nebulizer chamber (Fig. C).
  • Use the nebulizer according to the manufacturer’s instructions.
  • After using the nebulizer, discard any solution remaining in the chamber.
  • Thoroughly clean the nebulizer.

A B C
Illustrated instructions for use.

The solution or the finely divided liquid droplets from the solution must not enter the eyes. Do not dilute the solution or mix it with other medicines, unless your doctor tells you to. Do not swallow the solution or use it for injection.

Use for children and adolescents

Children should always be supervised by an adult when using a nebulizer.

If you have taken a slightly larger dose than usual, you may experience palpitations or tremors. These effects usually go away in a couple of hours.

If you forget to use Airomir nebulizer solution

Do not take a double dose to make up for a forgotten dose.

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.

The most commonly reported side effects are altered taste (bad or unpleasant taste in the mouth), irritation of the throat and/or mouth, tremors ( tremor ), restlessness, headache, and dizziness. In addition, you may feel nauseous and sweat. These effects usually disappear after 1-2 weeks of continued treatment.

Common side effects (affects up to 1 in 10 people):

  • Tremors ( tremor )
  • Headache
  • Palpitations ( tachycardia ).

Uncommon side effects (affects up to 1 in 100 people):

  • Irritation of mouth and throat
  • Palpitations (heartbeats that suddenly become more noticeable often with a throbbing or fluttering sensation)
  • Muscle cramps.

Rare side effects (affects up to 1 in 1,000 people):

  • Decreased potassium content in the blood
  • Redness.

Very rare side effects (affects up to 1 in 10,000 people):

  • Allergic reactions that may include swelling of the face, itching, bronchospasm (shortness of breath and difficulty breathing) called angioedema, as well as low blood pressure and fainting
  • Low blood pressure with fainting and collapse
  • Lactic acidosis (which may cause abdominal pain, hyperventilation, shortness of breath, cold feet and hands, irregular heartbeat, or thirst)
  • Hyperreactivity (especially in children)
  • Paradoxical bronchospasm (pressure over the chest and difficulty breathing)
  • Abnormal heart rhythm.

No known frequency (cannot be calculated from the available data):

  • Insufficient blood flow to the heart muscle causing chest pain

Airomir nebulizer solution may cause low potassium levels in the blood. Your doctor may therefore want to check your blood potassium level regularly.

Additional side effects in children

Airomir nebulizer solution may in very rare cases cause hyperactivity and sleep problems in children up to 12 years of age.

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 nebulizer solution

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month. 
Do not store above 25 ° C. 
Store in the original package. Sensitive to light.

Each single-dose container is for single use only. Never use a single-dose container that has already been opened. Dispose of partially used, opened, or damaged single-dose containers. Do not use this medicine if the solution has become discolored or cloudy.

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
  • The other ingredients are sodium chloride, sulfuric acid (for pH adjustment), and water for injections.

Airomir 1 mg / ml nebuliser solution: Each 2.5 ml single-dose container contains 2.5 mg salbutamol .

Airomir 2 mg / ml nebuliser solution: Each 2.5 ml single-dose container contains 5 mg salbutamol .

What the medicine looks like and the contents of the pack

Each single-dose containers of plastic with Airomir solution nebulizer contains a clear solution.

Strips with 5 single-dose containers are packed in a foil laminate bag which in turn is packed in cartons containing 10, 15, 20, 25, 30, 50, or 60 single-dose containers.

Not all pack sizes may be marketed.

Muhammad Nadeem

Leave a Reply