Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
SALBUTAMOL SULFATE
Glaxo Wellcome UK Limited
R03AC02
SALBUTAMOL SULFATE
INHALATION POWDER
SALBUTAMOL SULFATE 200 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Authorised
Reason for update: GDS025 Revised contraindication to specify non-IV formulations contraindicated in obstetrics + QRD version 9 + Excipients guidelines MHRA Approval Date: 09/07/2015 Text Date: 12/03/2015 Text Issue and Draft No: Issue 3 draft 2 annotated SPC Issue and Draft No.: Issue 3 draft 1 Agile Ref: TBC - 1 - GSK LOGO PACKAGE LEAFLET: INFORMATION FOR THE USER VENTOLIN ® ACCUHALER ® 200 micrograms SALBUTAMOL SULFATE [PRODUCT PICTURE WITH PART DESCRIPTIONS] READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 What Ventolin Accuhaler is and what it is used for 2 What you need to know before you use Ventolin Accuhaler 3 How to use Ventolin Accuhaler 4 Possible side effects 5 How to store Ventolin Accuhaler 6 Contents of the pack and other information 1 WHAT VENTOLIN ACCUHALER IS AND WHAT IT IS USED FOR Ventolin Accuhaler contains a medicine called salbutamol. This belongs to a group of medicines called fast-acting bronchodilators. Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out. They help to relieve chest tightness, wheezing and cough. Ventolin Accuhaler is used to treat breathing problems in people with asthma and similar conditions. This includes relieving and preventing asthma brought on by exercise or other “triggers”. These are things, which bring on asthma symptoms in some people. Common triggers include house dust, pollen, cats, dogs and cigarette smoke. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ventolin Accuhaler 200 micrograms 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ventolin Accuhaler is a plastic inhaler device containing a foil strip with 60 regularly spaced blisters each containing a mixture of 200 micrograms of microfine salbutamol (as sulfate) and larger particle lactose. Excipients with known effect: Contains Lactose monohydrate 12.5 mg/blister (see section 4.4). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Multi-dose dry powder inhalation device. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ventolin Accuhaler is indicated in adults, adolescents and children aged 4 to 11 years. Ventolin Accuhaler can be used in the management of asthma, bronchospasm and/or reversible airways obstruction. Ventolin Accuhaler is particularly suitable for the relief of asthma symptoms. It should be used to relieve symptoms when they occur, and to prevent them in those circumstances recognised by the patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure). Ventolin Accuhaler is particularly valuable as relief medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ventolin Accuhaler is for inhalation use only. Ventolin Accuhaler is suitable for many patients including those who cannot use a metered-dose inhaler successfully. Adults (including the elderly)_ _ For the relief of acute bronchospasm, 200 micrograms as a single dose. The maximum daily dose is 200 micrograms four times a day. To prevent allergen- or exercise-induced symptoms, 200 micrograms should be taken 10-15 minutes before challenge. _ _ Paediatric Population _ _ _Relief of acute bronchospasm _ Children aged 4 to 11 years 200 micrograms as required. Children aged 12 years and over: Dose as per adult population. _Prevention of allergen or exercise-induced bronchospasm _ Perskaitykite visą dokumentą