País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
TERBUTALINE SULFATE
B & S Healthcare
TERBUTALINE SULFATE
500 Microgram
Powder for Inhalation
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER BRICANYL ® TURBOHALER ® 500MICROGRAMS PER METERED DOSE, INHALATION POWDER (terbutaline sulphate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is “Bricanyl ® Turbohaler ® 500micrograms per metered dose, inhalation powder” but will be referred to as “Bricanyl Turbohaler“ throughout this leaflet. IN THIS LEAFLET: 1. What Bricanyl Turbohaler is and what it is used for 2. Before you use Bricanyl Turbohaler 3. How to use Bricanyl Turbohaler 4. Possible side effects 5. How to store Bricanyl Turbohaler 6. Further information 1. WHAT BRICANYL TURBOHALER IS AND WHAT IT IS USED FOR Bricanyl Turbohaler is an inhaler. It contains a medicine called terbutaline. This belongs to a group of medicines called ‘beta- agonists’. These work by relaxing certain muscles and opening up the airways in the lungs. Bricanyl Turbohaler is used for asthma and other breathing problems where you have a tight chest and difficulty breathing. 2. BEFORE YOU USE BRICANYL TURBOHALER DO NOT USE BRICANYL TURBOHALER IF: • You are allergic (hypersensitive) to terbutaline or any of the other ingredients of Bricanyl Turbohaler (listed in Section 6: Further information). TAKE SPECIAL CARE WITH BRICANYL TURBOHALER Check with your doctor or pharmacist before using Bricanyl Turbohaler if: • Leia o documento completo
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 Sulphate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder. _Product imported from UK:_ Multi-dose breath-actuated 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 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 sulphate. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients should be instructed in proper use and their inhalation technique checked regularly. With each inhalation a fraction of the delivered dose will be deposited in the oral cavity. To minimize unnecessary systemic exposure to terbutaline, the patients should be advised to, when possible, rinse their mouth after each use. 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 th Leia o documento completo