AstraZeneca Pharmaceuticals (Ireland) Ltd

Bricanyl^® Turbohaler^® 500 micrograms per metered dose, inhalation powder.

Each metered dose contains 500 micrograms Terbutaline Sulphate.

For a full list of excipients see section 6.1.

Inhalation powder.

Multi-dose breath-actuated metered dose powder inhaler. White to off-white spherical particles which break into a fine powder on inhalation.

Terbutaline is a selective beta₂-adrenergic agonist recommended for the relief and prevention of bronchospasm in bronchial asthma and in chronic bronchitis and other bronchopulmonary disorders in which bronchospasm is a complicating factor.

Adults and Children: One inhalation (500 micrograms) (metered dose) as required. Not more than 4 inhalations should be necessary in any 24 hour period.

Elderly: Dosage as for adults.

Instructions for use and cleaning are provided in the Patient Information Leaflet, which can be found in each pack.

Bricanyl preparations are contra-indicated in patients with a history of sensitivity to terbutaline sulphate.

Patients should be instructed in proper use and their inhalation technique checked regularly.

If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. 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.

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 rare occurrences of myocardial ischaemia associated with beta agonists. Patients with underlying severe heart disease (e.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 positive inotropic effect of beta₂-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy.

Due to the hyperglycaemic effects of beta₂-agonists, additional blood glucose measurements are initially recommended when Bricanyl therapy is commenced in diabetic patients.

Potentially serious hypokalaemia may result from beta₂-agonist therapy, mainly with parenteral or nebulised administration. Particular caution is advised in acute severe asthma as this effect may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and/or diuretics (see Section 4.5). It is recommended that serum potassium levels are monitored in such situations.

Beta-blocking agents (including eye drops), especially the non-selective ones such as propranolol, may partially or totally inhibit the effect of beta₂-stimulants. Therefore, Bricanyl preparations and non-selective β-blockers should not normally be administered concurrently. Bricanyl should be used with caution in patients receiving other sympathomimetics.

Hypokalaemia may result from beta₂-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and diuretics (see Section 4.4, Special Warnings and Precautions for use).

There are some data which indicate that there is a risk of interaction between monoamine oxidase inhibitors, tricyclic antidepressants and terbuatline.

Although no teratogenic effects have been observed in animals or in patients, Bricanyl should only be administered with caution during the first trimester of pregnancy.

Terbutaline is secreted via breast milk but any effect on the infant is unlikely at therapeutic doses.

Transient hypoglycaemia has been reported in newborn preterm infants after maternal beta₂-agonist treatment.

None.

The frequency of adverse reactions is low at the recommended dose. Terbutaline given by inhalation is unlikely to produce significant systemic effects when given in recommended doses. 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.

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

** Drugs for inhalation may through unspecified mechanisms cause bronchospasm.

i) Possible symptoms and signs: Headache, anxiety, tremor, nausea, tonic cramp, palpitations, tachycardia and arrhythmia. A fall in blood pressure sometimes occurs. Laboratory findings: Hypokalaemia, hyperglycaemia and metabolic acidosis sometimes occur.

ii) Treatment:

Mild and moderate cases: Reduce the dose.

Severe cases: Gastric lavage, administration of activated charcoal (where suspected that significant amounts have been swallowed). Determination of acid-base balance, blood sugar and electrolytes, particularly serum potassium levels. Monitoring of heart rate and rhythm and blood pressure. Metabolic changes should be corrected. A cardioselective beta-blocker (e.g. metoprolol) is recommended for the treatment of arrhythmias causing haemodynamic deterioration. The beta-blocker should be used with care because of the possibility of inducing bronchoconstriction: use with caution in patients with a history of bronchospasm. If the beta₂-mediated reduction in peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given.

Pharmaco-therapeutic group: Selective beta₂-agonist, terbutaline,

ATC code: R03A C03.

Terbutaline sulphate is an adrenergic agonist which predominantly stimulates beta₂-receptors, thus producing relaxation of bronchial smooth muscle, inhibition of the release of endogenous spasmogens, inhibitions of oedema caused by endogenous mediators and increased mucociliary clearance.

Inhaled terbutaline acts within a few minutes and has a duration for up to 6 hours. Treatment with Bricanyl Turbohaler is effective even during an acute asthma attack.

About 20-30% of the metered dose is deposited in the lungs at a normal inhalation flow rate. Terbutaline is metabolized mainly by conjugation with sulphuric acid and excreted as the sulphate conjugate. No active metabolites are formed.

The major toxic effect of terbutaline, observed in toxicological studies, is focal myocardial necrosis. This type of cardiotoxicity is a well-known class-effect, and the effect of terbutaline is similar to or less pronounced than that of other beta-receptor agonists.

None.

Not applicable.

2 years

Do not store above 30°C.

Replace the cover properly after use.

Bricanyl Turbohaler consists of a number of assembled plastic details, the main parts being the dosing mechanism, the drug substance store, the desiccant store and the mouthpiece. The inhaler is protected by an outer tubular cover screwed onto a bottom plate.

Each inhaler contains 100 metered doses.

None.

AstraZeneca UK Ltd.,

600 Capability Green,

Luton,

LU1 3LU, United Kingdom.

PA 970/36/8

7 February 1989 / 7 January 2009

13 August 2010