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Salbutamol 1mg/Ml Nebuliser Solution

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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Salbutamol 1mg/ml Nebuliser Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each nebule contains 2.5mg / 2.5ml salbutamol (as sulphate).

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Nebuliser Solution (for use via a nebuliser).

Plastic ampoule containing 2.5 ml of a clear sterile solution containing 2.5mg salbutamol (as sulphate) in normal saline.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Salbutamol Nebules are indicated in adults, adolescents and children see section 4.2.

Salbutamol is a selective beta-2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction.

Salbutamol Nebuliser Solutions are indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma.

4.2 Posology and method of administration

For inhalation use, to be breathed in through the mouth The solution should not be injected or swallowed.

To be used with a suitable nebuliser device under the direction of a physician.

Adults (and the elderly): 2.5mg to 5mg salbutamol up to four times a day. Up to 40mg per day can be given under strict medical direction in hospital.

Infants under 18 months old: The clinical efficacy of nebulised salbutamol is uncertain. As transient hypoxia may occur supplemental oxygen therapy should be considered.

Paediatric Population

Children aged 12 years and over: Dose as per adult population.

Children aged 4 to 11 years: 2.5mg to 5mg up to four times a day.

Other pharmaceutical forms may be more appropriate for administration in children under 4 years old.

Salbutamol Nebulisers Solutions are intended to be used undiluted. However, if prolonged delivery time (more than 10 minutes) is required, the solution may be diluted with sterile normal saline.

4.3 Contraindications

Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante partum haemorrhage or toxaemia of pregnancy, inhaled salbutamol preparations are not appropriate for managing premature labour

Hypersensitivity to the salbutamol or to any excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Salbutamol Nebuliser Solution must only be used by inhalation, to be breathed in through the mouth and must not be injected or swallowed.

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires specialist medical assessment, including lung function testing, as patients are at risk of severe attacks or even death. Physicians should consider using the maximum recommended dose of inhaled corticosteroid and/or oral corticosteroid therapy in these patients.

Patients receiving treatment at home should seek medical advice if treatment with Salbutamol Nebules becomes less effective. The dosage or frequency of administration should only be increased on medical advice.

Patients being treated with Salbutamol Nebuliser Solution may also be receiving treatment with other short-acting inhaled bronchodilators to relieve symptoms. Increasing use of bronchodilators, in particular short-acting beta-2-agonists to relieve symptoms indicates deterioration of asthma control. Patients should be advised to seek medical advice if their treatment ceases to be effective, more inhalations than usual are required and/or their asthma seems to be getting worse. In this situation patients should be assessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroid or a course of oral corticosteroid). Patients should not increase their dose without medical advice.

Salbutamol should be administered cautiously to patients with thyrotoxicosis.

Severe exacerbations of asthma must be treated in the normal way.

Salbutamol Nebuliser Solutions should be used with care in patients known to have received large doses of other sympathomimetic drugs.

Cardiovascular effects may be seen with sympathomimetic drugs, including Salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with Salbutamol. Patients with underlying severe heart disease (e.g., ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea or chest pain, as they may be of either respiratory or cardiac origin.

Potentially serious hypokalaemia has been reported in patients taking beta-2-agonist therapy, mainly from parenteral and nebulised administration. Particular caution is advised in patients with acute severe asthma as hypokalaemia may be potentiated in hypoxic patients and those treated with xanthine derivatives, steroids, diuretics and long-term laxatives. In these groups of patients serum potassium levels should be monitored.

In common with other beta-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

Lactic acidosis has been reported in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Section 4.8). Increase in

lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.

A small number of cases of acute angle-closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide. A combination of nebulised salbutamol with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist, enter their eyes.

Patients receiving treatment at home should seek medical advice if treatment with nebulised salbutamol becomes less effective. The dosage or frequency of administration should only be increased on medical advice.

4.5 Interaction with other medicinal products and other forms of interaction

Salbutamol and beta-blockers (i.e propranolol) should not usually be prescribed together.

Hypokalaemia occurring with beta-2-agonist therapy may be exacerbated by treatment with xanthines, steroids, diuretics and long-term laxatives.

4.6 Fertility, pregnancy and lactation

Pregnancy

Salbutamol should not be used in pregnancy and lactation unless the expected benefit to the mother is thought to outweigh the risk to the foetus.

The safe use of inhaled Salbutamol during pregnancy has not been established but it is reported that in animal studies at high doses there is evidence of harmful effects to the foetus.

Breast-feeding

As salbutamol is probably secreted in breast milk, Careful consideration should be given to the use of Salbutamol in nursing mothers, It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

Fertility

There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals (see section 5.3).

4.7 Effects on ability to drive and use machines

None reported.

4.8 Undesirable effects

Adverse reactions are listed by frequency: common (>1/100 and <1/10); uncommon (>1/1000 and <1/100), rare (>1/10,000 and <1/1,000); very rare (<1/10,000).

The following undesirable effects have been observed:

Immune system disorders

Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.

Metabolism and nutrition disorders

Rare: Hypokalaemia, potentially serious hypokalaemia may result from beta2 agonist therapy (see section 4.4)

Unknown: Lactic acidosis may occur during prolonged or repeated high-dose therapy.

Nervous system disorders Common: Headache, tremor.

Salbutamol Nebuliser Solutions may cause a fine tremor of skeletal muscle; usually the hands are most obviously affected. This effect is dose related and is common to all beta-adrenergic stimulants.

Very rare: Hyperactivity in children has been reported

Cardiac disorders Common: Tachycardia Uncommon: Palpitations

Very rare: Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)

Unknown: Myocardial ischaemia* (see section 4.4).

Vascular disorders

Rare: Peripheral vasodilatation

Respiratory, thoracic and mediastinal disorders Very rare: Paradoxical bronchospasm.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. The preparation should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.

Solutions which are not of neutral pH may rarely cause bronchospasm.

Gastrointestinal disorders Uncommon: Mouth and throat irritation

Musculoskeletal and connective tissue disorders Uncommon: Muscle cramps

* reported spontaneously in post-marketing data therefore frequency regarded as unknown

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia and lactic acidosis (see sections 4.4 and 4.8).

Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). Betablocking drugs should be used with caution in patients with a history of bronchospasm.

The preferred antidote to overdosage with salbutamol is a cardioselective beta-blocking agent, but beta-blocking drugs should be used with caution in patients with a history of bronchospasm.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

R03A C02

Salbutamol is a selective beta-2-adrenoceptor agonist with effects on bronchial muscle.

5.2 Pharmacokinetic properties

When salbutamol is taken by the inhalation route only about 10% - 20% of the dose is deposited in the airways, with the remainder either being retained in the delivery system or swallowed.

Inhaled Salbutamol has a fast onset of action (within 5 - 10 minutes of inhalation) and lasts 4-6 hours in most patients.

Salbutamol does not appear to be metabolised in the lung. The swallowed part of the salbutamol dose is absorbed from the gastrointestinal tract and is subject to first-pass metabolism in the liver; about half is excreted in the urine as an inactive sulphate conjugate.

5.3 Preclinical safety data

In an oral fertility and general reproductive performance study in rats at doses of 2 and 50 mg/kg/day, with the exception of a reduction in number of weanlings surviving to day 21 post partum at 50 mg/kg/day, there were no adverse effects on fertility, embryofetal development, litter size, birth weight or growth rate.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sodium chloride

Sulphuric acid to adjust pH

Water for injection

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2    years unopened.

3    months after opening the foil over-wrap.

6.4 Special precautions for storage

Store in the original package.

The ampoules should be protected from light after removal from the foil over-wrap.

6.5 Nature and contents of container

Plastic polyethylene ampoules in strips of 5 ampoules, with a protective foil over-wrap. Available in boxes containing 20 ampoules.

6.6 Special precautions for disposal

Nebulisers should be used in a well ventilated room as it is usual for some nebulised drug to be released into the local environment.

Dilution: May be diluted with sterile sodium chloride solution, (normal saline) if required.

For instructions on the use of this product refer to the Patient Information Leaflet.

7 MARKETING AUTHORISATION HOLDER

Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 20417/0076

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/04/2011

10 DATE OF REVISION OF THE TEXT

28/04/2014