SALBUAIR 2.5 mg SOLUTION FOR NEBULIZER INHALATION

Introduction

Leaflet: Information for the user

Salbuair 2.5 mg solution for inhalation by nebulizer

Salbutamol sulfate

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Salbuair 2.5 mg and what is it used for
2. What you need to know before taking Salbuair 2.5 mg
3. How to take Salbuair 2.5 mg
4. Possible side effects
5. Storage of Salbuair 2.5 mg
6. Package contents and additional information

1. What is SALBUAIR 2.5 mg and what is it used for

This medicine comes in ampoules containing an aqueous solution for inhalation by nebulizer. Salbuair 2.5 mg contains 2.5 mg of salbutamol (equivalent to 3 mg of salbutamol sulfate) dissolved in 2.5 ml of sterile isotonic saline solution.

The active ingredient of this medicine, salbutamol, belongs to a group of medicines called bronchodilators, which relax the muscles of the airway walls in the lungs. This makes it easier to breathe.

It is indicated for the treatment of chronic bronchospasm (closure of the airways in the lungs) that does not respond to conventional therapy and for the treatment of severe acute asthma.

2. BEFORE USING SALBUAIR 2.5 mg.

Do not useSalbuair2.5 mg:

• If you are allergic (hypersensitive) to salbutamol or any of the other components of Salbuair 2.5 mg.
• It should not be used during premature labor or threatened abortion.

Be careful with Salbuair2.5 mg

Tell your doctor before starting treatment with this medicine:

• If you have any heart disease, irregular heartbeat, or angina pectoris.
• If you have an overactive thyroid gland.
• If you have high potassium levels in your blood.
• If you have diabetes.
• If you have high lactate levels in your blood (lactic acidosis), as an increase in these levels can worsen respiratory problems.
• If you use salbutamol and ipratropium bromide together, as this combination can cause eye disorders such as angle-closure glaucoma.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those purchased without a prescription.

Some medicines may interact with Salbuair 2.5 mg. It is important that you inform your doctor if you are taking any of the following medicines:

• Medicines containing non-selective beta-blockers, such as propranolol.
• Certain medicines for treating depression (known as monoamine oxidase inhibitors and tricyclic antidepressants).
• Medicines containing anticholinergics (used to treat asthma, irritable bowel syndrome, Parkinson's disease, and incontinence).
• Other medicines that help you breathe more easily, such as terbutaline.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If it is necessary to administer Salbuair 2.5 mg during pregnancy or breastfeeding, your doctor will carefully weigh the potential benefits and risks based on the severity of the clinical condition.

Driving and using machines

The effects of Salbuair 2.5 mg on driving and using machines have not been described.

Use in athletes

This medicine contains salbutamol, which can produce a positive result in doping tests (see references in section 4.4 of the technical sheet).

3. How to use SALBUAIR 2.5 mg

Follow the administration instructions for Salbuair 2.5 mg exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

Salbuair should be used as needed and not on a regular basis.

If your asthma is active (for example, you have symptoms or frequent crises, such as difficulty breathing that makes it hard to speak, eat, or sleep, coughing, wheezing, chest tightness, or limited physical capacity), you should inform your doctor immediately, who may start administering a medicine or increase the treatment dose, such as an inhaled corticosteroid, to control your asthma.

Tell your doctor as soon as possible if your medicine seems to be not working as well as usual (for example, if you need higher doses to relieve your respiratory problems or if your inhaler does not provide relief for at least 3 hours), as your asthma may be worsening and you may need a different medicine.

If you use Salbuair 2.5 mg more than twice a week to treat your asthma symptoms, excluding preventive use before exercise, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (asthma worsening) that can have serious complications and can be life-threatening. You should contact your doctor as soon as possible to review your asthma treatment.

If you use a daily medicine to reduce inflammation in your lungs, e.g., an "inhaled corticosteroid", it is essential that you continue to use it regularly, even if you feel better.

Use in adults and children:

The recommended dose is 2.5 mg up to four times a day. Your doctor may increase this dose to 5 mg up to four times a day. Your doctor may tell you to use your nebulizer every day regularly or only when you have wheezing or shortness of breath.

Salbuair 2.5 mg should be used with suitable nebulizer devices. The mist produced is inhaled through the mask or mouthpiece. Your doctor will indicate which nebulizer is suitable and how to use it.

Instructions for correct administration of the preparation:

Your medication is for inhalation via a nebulizer, so it should not be injected or swallowed.

1. Prepare your nebulizer following the manufacturer's instructions and your doctor's instructions. Make sure the nebulizer device is clean.

1. Take a plastic strip with ampoules from the box, open it, and remove one of the ampoules (Fig. 1). Leave the rest of the ampoules in the strip and return it to the box.

1. Take the ampoule and open it by twisting the top (Fig. 2).

1. Unless your doctor gives you other instructions, add all the liquid from the plastic ampoule to the nebulizer solution container.

1. Use the nebulizer according to your doctor's instructions. Discard the empty plastic ampoule.

1. After using the nebulizer, clean it according to the manufacturer's instructions.

If you think the effect of Salbuair 2.5 mg is too strong or too weak, tell your doctor or pharmacist.

If you use moreSalbuair2.5 mg than you should

If you use more than you should, you may experience changes in heart rhythm, palpitations, tremors, increased or decreased blood pressure, changes in pulse, angina pectoris, hot flashes, dry mouth, and visual accommodation disorders.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount administered. Contact your doctor or the nearest Hospital Emergency Service. Bring this leaflet or an ampoule of this medicine with you, so the doctor treating you knows what you are taking.

If you forget to use Salbuair 2.5 mg

If you forget to use Salbuair 2.5 mg, use the next dose when it is due or before, in case you start to have difficulty breathing.

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

4. Possible side effects

Like all medicines, Salbuair 2.5 mg can cause side effects, although not everyone gets them.

Although it is not known exactly how often it occurs, some people may occasionally experience chest pain (due to heart problems such as angina pectoris). Tell your doctor if you develop these symptoms while being treated with Salbuair 2.5 mg, but do not stop taking this medicine unless your doctor tells you to.

The following side effects have been reported:

Frequent(affect 1 in 10 people)

• Headache (cephalalgia)
• Tremors
• Tachycardia

Uncommon(affect less than 1 in 100 people)

• Palpitations
• Irritation of the mouth and throat
• Muscle cramps

Rare(affect less than 1 in 1000 people)

• Low potassium levels in the blood (hypokalemia).
• Dilation of peripheral blood vessels (peripheral vasodilation).

Very rare(affect less than 1 in 10,000 people)

• Allergic reactions (hypersensitivity) including angioedema and urticaria, bronchospasm, hypotension, and collapse.
• Hyperactivity.
• Cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles (heart rhythm disorders).
• Paradoxical bronchospasm.

Unknown

• Myocardial ischemia (lack of blood flow to a part of the heart muscle).
• Lactic acidosis.

Reporting side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaram.es

5. Storage of SALBUAIR 2.5 mg.

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

Do not store above 25°C. Store in the outer packaging to protect from light.

Discard the ampoules 3 months after opening the aluminum pouch.

The ampoules should be opened immediately before use, and any remaining solution should be discarded.

Do not use Salbuair 2.5 mg after the expiration date shown on the vial after Cad.. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition ofsalbuair2.5 mg

• The active ingredient is salbutamol sulfate. Each ampoule contains 2.5 mg of salbutamol (equivalent to 3 mg of salbutamol sulfate) dissolved in 2.5 ml of sterile isotonic saline solution.
• The other ingredients are: sodium chloride, water for injection, and sulfuric acid.

Appearance of the product and package contents:

Salbuair 2.5 mg is presented in strips of 10 ampoules containing a colorless or pale yellow solution inside an aluminum pouch.

Each box contains 60 ampoules.

Marketing authorization holder:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona (Spain)

Manufacturer:

Laboratoire Unither

Espace Industriel Nord

151 rue André Durouchez–CS 28028

80084 AMIENS Cedex 2

France

Other presentations:

Salbuair 5 mg solution for inhalation by nebulizer.

This leaflet was approved in June 2013