Salbuair 2.5 mg solution for inhalation by nebulizer

Patient Information Leaflet

Introduction

Patient Information Leaflet

Salbuair 2.5 mg solution for inhalation by nebulizer

Salbutamol sulfate

Read the entire 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Salbuair 2.5 mg is and what it is used for
2. What you need to know before using Salbuair 2.5 mg
3. How to use Salbuair 2.5 mg
4. Possible adverse effects
5. How to store Salbuair 2.5 mg
6. Contents of the pack and other information

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

This medicine is presented in unit-dose vials 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 substance of this medicine, salbutamol, belongs to a group of medicines called bronchodilators, which relax the muscles in the walls of the air passages of the lungs. This helps open up the airways, making it easier to breathe.

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

2. BEFORE USING SALBUAIR 2.5 mg.

Do not use Salbuair 2.5 mg:

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

Take special care with Salbuair 2.5 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 elevated blood lactate levels (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 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 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 breast-feeding

Consult your doctor or pharmacist before using any medicine.

If Salbuair 2.5 mg needs to be administered during pregnancy or breastfeeding, your doctor will carefully assess the potential benefits and risks based on the severity of the clinical condition.

Driving and using machines

Effects of Salbuair 2.5 mg on driving and operating machinery have not been reported.

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 summary of product characteristics).

3. How to use SALBUAIR 2.5 mg

Follow exactly the administration instructions for Salbuair 2.5 mg 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 should 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 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 (worsening of asthma) which can lead to serious complications and 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 a daily medication to reduce lung inflammation, e.g., an “inhaled corticosteroid”, it is important that you continue using it regularly, even if you feel well.

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

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 and your doctor's instructions. Ensure that the nebulizing device is clean.

2. Remove a strip of plastic ampoules from the box, open it, and take out one ampoule (Fig. 1). Keep the remaining ampoules in the strip and return them 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 liquid content of the plastic ampoule into the nebulizer solution chamber.

5. Use the nebulizer according to your doctor's instructions. Dispose of 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 2.5 mg is too strong or too weak, inform your doctor or pharmacist.

If you use more Salbuair 2.5 mg than you should

If you use more than the prescribed amount, you may experience disturbances in heart rhythm, palpitations, tremor, increased or decreased blood pressure, pulse irregularities, angina pectoris, flushing, dry mouth, and visual accommodation disorders.

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

If you forget to use Salbuair 2.5 mg

If you forget to use Salbuair 2.5 mg, take the next dose as scheduled 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 2.5 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 2.5 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 (cephalalgia)
• 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 1000 people)

• Low levels of potassium in the blood (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 (inadequate 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 they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human 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. Keep in the outer packaging to protect from light.

Discard the ampoules 3 months after opening the aluminium foil pouch.

The ampoules should be opened immediately before use, and any remaining unused solution must 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 containers you no longer need. This helps protect the environment.

6. ADDITIONAL INFORMATION

Composition of Salbuair 2.5 mg

• The active substance 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 components are: sodium chloride, water for injections, and sulfuric acid.

Appearance of the medicinal product and contents of the container:

Salbuair 2.5 mg is supplied as strips of 10 ampoules containing a colourless or pale yellow solution, packed 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:

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 nebuliser.

This leaflet has been approved in June 2013