Label: Information for the User

Salbuair 5 mg Solution for Inhalation by Nebulizer

Salbutamol Sulfate

Read this label carefully before you start taking this medicine, because it contains important information for you.

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

This medication is presented in ampoules containing a water solution for inhalation by nebulizer. Salbuair5 mgcontains 5 mg of salbutamol (equivalent to 6 mg of salbutamol sulfate) dissolved in 2.5 ml of sterile isotonic saline solution.

The active ingredient of this medication, salbutamol, belongs to a group of medications called bronchodilators, which relax the muscles of the walls of the airways of the lungs. This facilitates the opening of the airways for easier breathing.

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.

Do not useSalbuair5 mg:

• If you are allergic (hypersensitive) to salbutamol or to any of the other components of Salbuair 5 mg.
• Do not use during premature labor or in the threat of abortion.

Be especially careful with Salbuair5 mg

Inform your doctor before starting treatment with this medication:

• If you have any heart disease, irregular heart rhythm, or angina pectoris.
• If you have an overactive thyroid gland.
• If you have high levels of potassium in your blood.
• If you have diabetes.
• If you have elevated levels of lactate in your blood (lactic acidosis), as an increase in these levels may worsen respiratory problems.
• If you use salbutamol and ipratropium bromide together, as this combination may produce ocular alterations such as closed-angle glaucoma.

Use of other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those obtained without a prescription.

Some medications may interact with Salbuair 5 mg. It is essential to inform your doctor if you are taking any of the following medications:

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If it is necessary to administer Salbuair 5 mg during pregnancy or lactation, your doctor will carefully evaluate the potential benefits and risks based on the severity of the clinical condition.

Driving and operating machinery

No effects of Salbuair 5 mg on driving and operating machinery have been described.

Use in athletes

This medication contains salbutamol, which may produce a positive result in doping control tests (see references in the 4.4 section of the technical data sheet).

Follow exactly the administration instructions for Salbuair5 mgas indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Salbuair should be used on demand and not on a regular basis.

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

Inform your doctor as soon as possible if your medication seems not to be 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 medication.

If you use Salbuair 5 mgmore than two times 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 (worsening of asthma) that can have serious complications and may put your life at risk or even be fatal. You should contact your doctor as soon as possible to review your asthma treatment.

If you use a daily anti-inflammatory medication for 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.

Salbuair5 mgshould be used with suitable nebulizers. 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 through a nebulizer, so do not inject or swallow it.

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

2.Take a plastic strip with ampoules out of the box, open it and take one of the ampoules (Fig. 1). Leave the rest of the ampoules on the strip and return it to the box.

3.Take the ampoule and open it by turning the top (Fig. 2).

4.Unless your doctor gives you other instructions, add the entire liquid from the plastic ampoule to the solution container of the nebulizer.

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

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

If you estimate that the action of Salbuair5 mgis too strong or weak, inform your doctor or pharmacist.

If you use moreSalbuair5 mg than you should

If you use more than you should, you may experience arrhythmias, palpitations, tremors, increased or decreased blood pressure, pulse alterations, 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount administered. Contact your doctor or nearest Hospital Emergency Service. Bring this leaflet or a vial of this medication with you, so that the doctor treating you knows what you are taking.

If you forgot to use Salbuair 5 mg

If you forgot to use Salbuair 5 mg, use the next dose when it is due or before, if you start breathing with difficulty.

Do not take a double dose to compensate for the missed doses.

Like all medications, Salbuair5 mgmay cause adverse effects, although not everyone will experience them.

Although the exact frequency is not known, some people may occasionally experience chest pain (due to heart problems such as angina pectoris). Inform your doctor if you develop these symptoms while being treated with Salbuair 5 mg, but do not stop taking this medication unless your doctor tells you to.

The following adverse effects have been reported:

Frequent(affect 1 in 10 people)

• Headache (cephalalgia)
• Tremor
• Tachycardia

Infrequent(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 levels of potassium in the blood (hypokalemia).
• 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 supply to a part of the heart muscle).
• Lactic acidosis.

Reporting Adverse Effects

If you experience any type oftheadverseeffects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, Website:www.notificaram.es

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

Do not store at a temperature above25ºC. Store in the outer packaging to protect it from light.

Dispose of the ampoules within 3 months of opening the aluminum foil packet.

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

Do not use Salbuair2.5 mgafter the expiration date appearing on the bottle after Cad.. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofSalbuair5 mg

• The active ingredient is salbutamol sulfate. Each ampule contains 5 mg of salbutamol (equivalent to 6 mg of salbutamol sulfate) dissolved in 2.5 ml of sterile isotonic saline solution.
• The other components are: sodium chloride, water for injection, and sulfuric acid.

Appearance of the product and contents of the package:

Salbuair5 mgis presented in strips of10 ampulescontaining an colorless or pale yellow solution inside an aluminum foil pouch.

Each box contains 60 ampules.

Marketing Authorization Holder:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona (Spain)

Responsible for Manufacturing:

Laboratoire Unither

Espace Industriel Nord

151 rue André Durouchez-CS 28028

80084 AMIENS Cedex 2

France

Other presentations:

Salbuair 2.5 mg solution for inhalation via nebulizer.

This prospectus was approved in June 2013