Salbuair 5 mg solution for inhalation by nebulizer

Patient Information Leaflet

Introduction

Patient Information Leaflet

Salbuair 5 mg solution for inhalation by nebulizer

Salbutamol sulfate

Read all of this leaflet carefully before you start using 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, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Salbuair 5 mg is and what it is used for.
2. Before you use Salbuair 5 mg.
3. How to use Salbuair 5 mg.
4. Possible adverse effects.
5. How to store Salbuair 5 mg.
6. Further information.

1. What SALBUAIR 5 mg is and what it is used for

This medicine comes in blisters containing an aqueous solution for inhalation by nebulizer. Salbuair 5 mg contains 5 mg of salbutamol (equivalent to 6 mg of salbutamol sulfate) dissolved in 2.5 ml of sterile isotonic saline solution.

The active substance of this medicine, salbutamol, belongs to a group of medicines called bronchodilators, which relax the muscles in the walls of the airways of the lungs. This helps open the air passages, making it easier to breathe.

It is indicated for the treatment of chronic bronchospasm (narrowing of the airways in the lungs) unresponsive to conventional therapy, and for the treatment of acute severe asthma.

2. BEFORE USING SALBUAIR 5 mg.

Do not use Salbuair 5 mg:

• If you are allergic (hypersensitive) to salbutamol or to any of the other components of Salbuair 5 mg.
• It should not be used during premature labor or in cases of threatened abortion.

Take special care with Salbuair 5 mg

Inform 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 levels of potassium in the blood.
• If you have diabetes.
• If you have high levels of lactate in the blood (lactic acidosis), as an increase in these levels may worsen respiratory problems.
• If you are using salbutamol together with ipratropium bromide, as this combination may cause eye disorders such as closed-angle glaucoma.

Use of other medicines

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

Some medicines may interact with Salbuair 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 used to treat 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 Salbuair 5 mg needs to be administered during pregnancy or breastfeeding, your doctor will carefully assess the potential benefits and risks based on the severity of your clinical condition.

Driving and using machines

The effects of Salbuair 5 mg on driving and using machines have not been described.

Use in athletes

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

3. How to use SALBUAIR 5 mg

Follow exactly the instructions for administration of Salbuair 5 mg as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

If your asthma is active (for example, you have symptoms or frequent attacks, such as difficulty breathing that interferes with speaking, eating, or sleeping, coughing, wheezing, chest tightness, or limited physical capacity), you must inform your doctor immediately. Your doctor may start or increase treatment with another medication, such as an inhaled corticosteroid, to control your asthma.

Inform your doctor as soon as possible if your medication does not seem to be working as well as usual (for example, if you need higher doses to relieve breathing problems or if your inhaler does not provide relief for at least 3 hours), since your asthma may be worsening and you may require a different treatment.

If you use Salbuair 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 (worsening of asthma) that can lead to serious complications, may be life-threatening, or even fatal. You should contact your doctor as soon as possible to review your asthma treatment.

If you are taking daily medication for lung inflammation, e.g., an "inhaled corticosteroid," it is important that you continue using it regularly, even if you feel better.

Use in adults and children:

The recommended dose is 2.5 mg up to four times daily. Your doctor may increase this dose to 5 mg up to four times daily. Your doctor may instruct you to use your nebulizer daily on a regular basis or only when you experience wheezing or shortness of breath.

Salbuair 5 mg must be used with appropriate nebulizing devices. The mist produced is inhaled through a face mask or mouthpiece. Your doctor will advise you on the suitable nebulizer and how to use it correctly.

Instructions for correct administration of the preparation:

Your medication is intended for inhalation via a nebulizer and must not be injected or swallowed.

1. Prepare your nebulizer according to the manufacturer's instructions and those provided by your doctor. Ensure that the nebulizing device is clean.

2. Remove a plastic strip containing ampoules from the box, open it, and take out one ampoule (Fig. 1). Leave the remaining ampoules in the strip and return the strip to the box.

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

4. Unless otherwise directed by your doctor, add the entire contents of the plastic ampoule to the nebulizer solution chamber.

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 feel that the effect of Salbuair 5 mg is too strong or too weak, inform your doctor or pharmacist.

If you use more Salbuair 5 mg than you should

If you use more than you should, symptoms such as heart rhythm disturbances, palpitations, tremor, increased or decreased blood pressure, pulse abnormalities, angina pectoris, flushing, dry mouth, and visual accommodation disorders may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medication and the amount taken. Contact your doctor or the nearest hospital emergency service. Bring this patient information leaflet or an ampoule of the medication with you so that the treating doctor knows what you have taken.

If you forget to use Salbuair 5 mg

If you forget to use Salbuair 5 mg, take the next dose at the scheduled time or earlier if you begin to experience difficulty breathing.

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

4. Possible adverse effects

Like all medicines, Salbuair 5 mg can cause adverse effects, although not everyone experiences them.

Although the frequency is not exactly 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 medicine unless instructed by your doctor.

The following adverse effects have been reported:

Frequent (affects 1 in 10 people)

• Headache
• Tremor
• Tachycardia

Uncommon (affects less than 1 in 100 people)

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

Rare (affects less than 1 in 1,000 people)

• Low blood potassium levels (hypokalaemia)
• Dilation of peripheral blood vessels (peripheral vasodilation)

Very rare (affects 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

Not known

• Myocardial ischaemia (lack of blood supply to part of the heart muscle)
• Lactic acidosis

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicinal Products, Website: www.notificaram.es

5. Storage of SALBUAIR 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 aluminium pouch.

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

Do not use Salbuair 2.5 mg after the expiry date stated on the vial after Exp.. The expiry date refers to 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 medicines and packaging that you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Salbuair 5 mg

• The active substance is salbutamol sulfate. Each ampoule 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 injections, and sulfuric acid.

Appearance of the medicinal product and contents of the pack:

Salbuair 5 mg is supplied in strips of 10 ampoules containing a colourless or pale yellow solution, inside an aluminium sachet.

Each carton contains 60 ampoules.

Marketing Authorisation Holder:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona (Spain)

Manufacturer 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 by nebulizer.

This leaflet was last approved in June 2013