Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Salbutamol
GlaxoSmithKline (Ireland) Limited
R03AC; R03AC02
Salbutamol
100 microgram(s)/dose
Pressurised inhalation, suspension
Product subject to prescription which may be renewed (B)
Selective beta-2-adrenoreceptor agonists; salbutamol
Marketed
1999-10-01
Reason for update: Type IAIN – PRAC Recommendation HPRA Approval date: 19/01/2024 Text Date: 02/11/2023 Text Issue 4 Draft 1 - 1 - GSK LOGO PACKAGE LEAFLET: INFORMATION FOR THE USER VENTOLIN EVOHALER 100 MICROGRAMS PRESSURISED INHALATION SUSPENSION salbutamol (as sulfate) 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 Evohaler is and what it is used for 2 What you need to know before you use Ventolin Evohaler 3 How to use Ventolin Evohaler 4 Possible side effects 5 How to store Ventolin Evohaler 6 Contents of the pack and other information 1 WHAT VENTOLIN EVOHALER IS AND WHAT IT IS USED FOR Ventolin Evohaler 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 Evohaler is for use in adults, adolescents and children. For babies and children under 4 years of age, see section 3. Ventolin Evohaler is used to help prevent and treat breathing problems in people with asthma and chronic obstructive airways disease. Ventolin Evohaler contains a propellant called Norflurane. This is less harmful to the environment than older inhalers. Older inhalers may taste differently to Ventolin Evohaler. This will make no difference to how your medicine works. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN EVOHALER DO NOT USE VENTOLIN EVOHALER: Leggi il documento completo
Health Products Regulatory Authority 27 February 2024 CRN00F2MV Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ventolin Evohaler 100 micrograms pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 100 micrograms of Salbutamol (as sulfate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation suspension Pressurised inhalation suspension supplied in an aluminium can with metering valve and a blue actuator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ventolin is indicated in adults, adolescents and children. For babies and children under 4 years of age, see sections 4.2 and 5.1. Ventolin Evohaler is indicated for the treatment or prevention of bronchospasm. It provides short acting (four hours) bronchodilation in reversible airways obstruction due to asthma and chronic obstructive pulmonary disease (COPD) such as chronic bronchitis and emphysema. For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them prior to a known trigger. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ventolin Evohaler is administered by the inhaled route only, to be breathed in through the mouth. Salbutamol has a duration of action of 4 to 6 hours in most patients. Increasing use of beta-2agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant corticosteroid therapy should be considered. In patients who find co-ordination of a pressurised metered-dose inhaler difficult, a spacer may be used with Ventolin Evohaler. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice. Patients' inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of breath for optimum delivery of the drug to the lungs. ADULTS AND ADOLESCENTS (CHILDREN 12 YEARS AND OVER) _R Leggi il documento completo