Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TERBUTALINE SULFATE
PCO Manufacturing
500 Microgram
Inhalation Powder, Capsule
2003-02-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bricanyl Turbohaler 500 micrograms per metered dose, Inhalation powder. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 500 micrograms terbutaline sulfate. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Inhalation powder Breath acutated metered dose powder inhaler. White to off-white spherical particles which break into a fine powder on inhalation. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Terbutaline is a selective 2 -adrenergic agonist recommended for the relief and prevention of bronchospasm in bronchial asthma and in chronic bronchitis, emphysema and other bronchopulmonary disorders in which bronchospasm is a complicating factor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. 4.3 CONTRAINDICATIONS Bricanyl preparations are contra-indicated in patients with a history of sensitivity to terbutaline sulfate. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients should be instructed in proper use and their inhalation technique checked regularly. Care should be taken in patients suffering from myocardial insufficiency or thyrotoxicosis. Due to the hyperglycaemic effects of ß 2 -stimulants, additional blood glucose measurements are initially recommended when Bricanyl therapy is commenced in diabetic patients. If 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 re Read the complete document