Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
AstraZeneca AB SE-151 85, Södertälje, Sweden
R03AC03
TERBUTALINE SULFATE 500 µg/spray
INHALATION POWDER
TERBUTALINE SULFATE 500 µg/spray
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Authorised
2024-01-24
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER BRICANYL TURBOHALER ® 500 MICROGRAMS PER METERED DOSE, INHALATION POWDER terbutaline sulfate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bricanyl Turbohaler is and what it is used for 2. What you need to know before you use Bricanyl Turbohaler 3. How to use Bricanyl Turbohaler 4. Possible side effects 5. How to store Bricanyl Turbohaler 6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU USE BRICANYL TURBOHALER DO NOT USE BRICANYL TURBOHALER: • If you are allergic to terbutaline. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Bricanyl Turbohaler if: • You have diabetes. If so, you may need some extra blood sugar tests when you start using Bricanyl Turbohaler. • You have a heart problem. • You have an overactive thyroid gland. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Bricanyl Turbohaler. Page 2 of 7 OTHER MEDICINES AND BRICANYL TURBOHALER Tell your doctor or pharmacist if you are taking, have recently taken or mig Soma hati kamili
1 1. NAME OF THE MEDICINAL PRODUCT Bricanyl ® Turbohaler ® 500 micrograms per metered dose, inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose contains: Terbutaline sulfate 400 micrograms (which corresponds to 500 micrograms metered dose). Excipients with known effect Bricanyl Turbohaler 500 micrograms/dose: each delivered dose contains approximately 400 micrograms of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. A white inhaler comprising a blue turning grip, an integral dose indicator and a white cover. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Terbutaline is a selective beta 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 Posology 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. Method of administration Instructions for use and cleaning are provided in the Patient Information Leaflet, which can be found in each pack. 2 4.3 CONTRAINDICATIONS Hypersensitivity TO THE ACTIVE SUBSTANCE (TERBUTALINE) OR TO ANY OF THE EXCIPIENTS LISTED IN SECTION 6.1. 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. For further information see section 4.9. Patients who are prescribed regular anti-inflammatory therapy should be advised to continue taking their anti-inflammatory medication even when symptoms decrease and they do not require Bricanyl Turbohaler. If a previously Soma hati kamili