BRICANYL

g. inhaled corticosteroids, leukotriene receptor antagonists. Bricanyl Tablets have a duration of action of 7 to 8 hours. The minimum recommended dosage interval is therefore 7 hours. 5mg (half a tablet) 3 times in a 24-hour period is recommended.

The dose may then be increased to 5mg (1 tablet) 3 times in a 24-hour period to achieve adequate bronchodilation.

Elderly:

Dosage as for Adults. 5mg (half a tablet) 2 times in 24 hours. 5mg 3 times in 24 hours. Method of administration For oral use.

Summary of safety profile The intensity of the adverse reactions depends on dosage and route of administration. Most of the adverse reactions are characteristic of sympathomimetic amines. The majority of these effects have reversed spontaneously within the first 1-2 weeks of treatment.

The frequency of side-effects is low at the recommended doses. Tabulated list of adverse reactions Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

g. 4) Vascular Disorders Not Known ^ Peripheral vasodilation Respiratory, Thoracic and Mediastinal Disorders Not Known ^ Paradoxical bronchospasm* Gastrointestinal Disorders Not Known ^ Nausea Mouth and throat irritation Skin and Subcutaneous Tissue Disorders Not Known ^ Urticaria Rash Musculoskeletal and Connective Tissue Disorders # Common Muscle spasm ^ Reported spontaneously in post-marketing data and therefore frequency regarded as unknown * In rare cases, through unspecified mechanisms, paradoxical bronchospasm may occur, with wheezing immediately after inhalation.

This should be immediately treated with a rapid-onset bronchodilator. Bricanyl therapy should be discontinued and after assessment, an alternative therapy initiated. # A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

As for all beta2-agonists caution should be observed in patients with thyrotoxicosis. Cardiovascular effects may be seen with sympathomimetic drugs, including Bricanyl. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with beta agonists.

Due to the positive inotropic effect of beta2-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy. g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Bricanyl 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 and chest pain, as they may be of either respiratory or cardiac origin. Due to the hyperglycaemic effects of beta2-agonists, additional blood glucose controls are recommended initially in diabetic patients.

Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. 5, Interactions). It is recommended that serum potassium levels are monitored in such situations.

g. inhaled corticosteroids, leukotriene receptor antagonists. These patients must be advised to continue taking their anti-inflammatory therapy after the introduction of Bricanyl even when symptoms decrease. Should symptoms persist, or if treatment with beta2-agonists needs to be increased, this indicates a worsening of the underlying condition and warrants a reassessment of the therapy.

Consideration should be given to the requirements for additional therapy (including increased dosages of anti- inflammatory medication). Severe exacerbations of asthma should be treated as an emergency in the usual manner. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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