Each 5 ml contains orciprenaline sulphate 10 mg.

Syrup.

ALUPENT is indicated for the relief of reversible airways obstruction. ALUPENT Syrup is suggested for maintenance therapy.

Children 3-12 years: The usual starting dose is 1 x 5 ml four times daily. This may be increased to 2 x 5 ml three times daily as necessary. The maximum recommended daily dosage is 6 x 5 ml spoonfuls.

Children 1-3 years: The usual starting dose is ½ x 5 ml four times daily. This may be increased to 1 x 5 ml four times daily as necessary. The maximum recommended daily dosage is 4 x 5 ml spoonfuls.

Children 0-1 year: The usual starting dose is ½ x 5 ml three times daily. This may be increased to 1 x 5 ml three times daily as necessary. The maximum recommended daily dosage is 3 x 5 ml spoonfuls.

Diluents: ALUPENT Syrup may be diluted with either Syrup BP or Sorbitol Solution BP.

No specific information on the use of this product in the elderly is available.

Alupent Tablets and Syrup: Up to 1 year, 2.5 - 5 mL three times daily; 1 - 3 years, 2.5 - 5 mL four times daily; 3 - 12 years, 5 mL four times daily to 10 mL three times daily.

Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

Hypertrophic obstructive cardiomyopathy, tachyarrhythmia. Hypersensitivity to any of the ingredients in ALUPENT Syrup.

A chronic requirement for treatment would suggest the need for clinical review of the management of the patient's asthma. The patient's need for anti-inflammatory therapy (e.g. corticosteroids), or the adequacy of such therapy in patients already receiving it should be assessed.

Patients must be warned not to exceed the prescribed dose. In the case of acute rapidly worsening dyspnoea a doctor should be consulted immediately.

Sympathomimetic agents can cause unwanted effects. The concomitant use of other sympathomimetic drugs should be avoided or only used under strict medical supervision. ALUPENT and anticholinergic bronchodilators have been administered concurrently in reversible airways obstruction. In some situations, co-administered sympathomimetic agents and anticholinergics have been shown to produce greater bronchodilatation than the use of either agent alone (but see Interactions).

In the following conditions ALUPENT should only be used after careful risk/benefit assessment, especially when doses higher than those recommended are used:

Insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, pheochromocytoma, hyperthyroidism.

Potentially serious hypokalaemia may result from excessive beta-agonist therapy. This effect may be potentiated by concomitant treatment with xanthine derivatives, glucocorticosteroids and diuretics.

Additionally, hypoxia may aggravate the effects of hypokalaemia on cardiac rhythm. It is recommended that serum potassium levels are monitored in such situations.

In view of the possible interaction between beta-adrenergics and monoamine oxidase inhibitors or tricyclic anti-depressants, care should be exercised if it is proposed to administer these compounds concurrently with ALUPENT.

Beta-adrenergics, anticholinergics and xanthine derivatives (such as theophylline) may enhance the bronchodilator effect of orciprenaline.

The concurrent administration of the other beta-adrenergics, systemically absorbed anticholinergics and xanthine derivatives (e.g. theophylline) may increase the frequency and severity of unwanted effects.

Beta₂-receptor blockers counteract the action of ALUPENT.

Potentially serious bronchospasm may occur during concurrent administration of beta-blockers to patients with reversible airways obstruction.

Inhalation of halogenated hydrocarbon anaesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility to the cardiovascular effects of beta-agonists.

The most frequently reported undesirable effects observed with ALUPENT are tremor and nervousness, headache, dizziness, tachycardia, palpitations, gastro-intestinal discomfort, nausea and vomiting. Some patients have experienced a feeling of tightness of the chest.

Potentially serious hypokalaemia may result from beta₂-agonist therapy.

As with other beta-mimetics, sweating, weakness and myalgia/muscle cramps may occur. In rare cases decrease in diastolic blood pressure, increase in systolic blood pressure, arrhythmias, particularly after higher doses may occur.

In rare cases, local irritation, skin reactions or allergic reactions have been reported. There have been isolated cases of anaphylactic or anaphylactoid reactions.

In individual cases psychological alterations have been reported under inhalational therapy with beta-mimetics.

Boehringer Ingelheim Limited

(POM)

12 March 2009