Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Salbutamol
Orion Pharma (UK) Ltd
R03AC02
Salbutamol
100microgram/1dose
Inhalation powder
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010101; GTIN: 6432100007957
PACKAGE LEAFLET: INFORMATION FOR THE USER EASYHALER SALBUTAMOL SULFATE 100 AND 200 MICROGRAMS/DOSE INHALATION POWDER Salbutamol sulfate (salbutamol) 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, pharmacist or asthma nurse. • 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 Easyhaler Salbutamol is and what it is used for 2. What you need to know before you use Easyhaler Salbutamol 3. How to use Easyhaler Salbutamol 4. Possible side effects 5. How to store Easyhaler Salbutamol 6. Contents of the pack and other information 1. WHAT EASYHALER SALBUTAMOL IS AND WHAT IT IS USED FOR WHAT IS EASYHALER SALBUTAMOL? Easyhaler Salbutamol is a “reliever” inhaler. The active ingredient is salbutamol, an asthma medicine, which opens up the airways. Salbutamol has a quick effect and a short duration of action (4 to 6 hours). WHAT IS EASYHALER SALBUTAMOL USED FOR? Salbutamol is used to relieve symptoms of asthma and other asthma-like conditions such as chest tightness, wheezing and coughing in adults and children aged 4 years and over. It is also used for prevention of asthma symptoms brought on by exercise or a known allergen exposure that cannot be avoided. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EASYHALER SALBUTAMOL DO NOT USE EASYHALER SALBUTAMOL: • if you are allergic to salbutamol or the other ingredient of this medicine (listed in section 6), which is lactose (which contains small amounts of milk protein) WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or pharmacist before using Easyhaler Salbutamol if you have any of the following: • any diseases a Прочитать полный документ
OBJECT 1 EASYHALER SALBUTAMOL 100MCG Summary of Product Characteristics Updated 04-Oct-2016 | Orion Pharma (UK) Limited 1. Name of the medicinal product Easyhaler Salbutamol Sulfate 100 micrograms per actuation inhalation powder 2. Qualitative and quantitative composition Metered dose delivery 100 mcg of Salbutamol per actuation as Salbutamol Sulfate Ph.Eur. Excipient with known effect: Lactose monohydrate For the full list of excipients, see Section 6.1. 3. Pharmaceutical form White or almost white odourless powder intended for respiratory use by oral inhalation 4. Clinical particulars 4.1 Therapeutic indications Symptomatic treatment of asthma attacks and exacerbations of asthma in adults and children aged 4 years and over. Prevention of exercise-induced bronchospasm or before exposure to a known unavoidable allergen challenge. Symptomatic treatment of broncho-asthma and other conditions associated with reversible airways obstruction. Salbutamol provides a short-acting bronchodilation with fast onset of action in reversible airways obstruction due to asthma. Easyhaler Salbutamol Sulfate should be used to relieve symptoms when they occur and to prevent them in those circumstances recognised by the patient to precipitate an attack (e.g. before exercise or unavoidable allergen exposure). Salbutamol is valuable as a rescue medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy. Easyhaler Salbutamol Sulfate is indicated in adults, adolescents and children aged 4 to 11 years. 4.2 Posology and method of administration Posology _Adults and Older people_: For the relief of acute bronchospasm and for managing intermittent episodes of asthma, one inhalation (100 micrograms) may be administered as a single starting dose; this may be increased to two inhalations (200 micrograms) if necessary. To prevent exercise-induced bronchospasm _or allergen bronchospasm_ two inhalations (200 micrograms) should be taken before _challen Прочитать полный документ