Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Salmeterol
GlaxoSmithKline (Ireland) Limited
R03AC; R03AC12
Salmeterol
25 Mcg/Acutuation
Pressurised inhalation, suspension
Product subject to prescription which may be renewed (B)
Selective beta-2-adrenoreceptor agonists; salmeterol
Marketed
2006-08-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SEREVENT EVOHALER 25 MICROGRAMS PER ACTUATION (PER PUFF) Pressurised inhalation, suspension salmeterol 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 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. IN THIS LEAFLET : 1. What Serevent Evohaler is and what it is used for 2. What you need to know before you use Serevent Evohaler 3. How to use Serevent Evohaler 4. Possible side effects 5. How to store Serevent Evohaler 6. Contents of the pack and other information 1. WHAT SEREVENT EVOHALER IS AND WHAT IT IS USED FOR Serevent Evohaler contains the medicine salmeterol. It is a ‘long-acting bronchodilator’. It helps the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects are usually felt within 10 to 20 minutes and last for 12 hours or more. The doctor has prescribed it to help prevent breathing problems. These could be caused by asthma. Taking Serevent Evohaler regularly will help prevent asthma attacks. This also includes asthma brought on by exercise or that happens only at night. Taking Serevent Evohaler regularly will also help prevent breathing problems caused by other chest illnesses such as chronic obstructive pulmonary disease (COPD). Serevent Evohaler helps to stop breathlessness and wheezing coming on. It does not work once you are breathless or wheezy. If that happens you need to use a fast-acting ‘reliever’ medicine, such as salbutamol. Serevent Evohaler is supplied to you in an inhaler. You breathe the medicine directly into your lungs. Serevent Evoh Přečtěte si celý dokument
Health Products Regulatory Authority 08 October 2019 CRN009D3T Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serevent Evohaler 25 micrograms per actuation pressurised inhalation suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose (ex-valve) contains 25 micrograms salmeterol (as xinafoate). This is equivalent to a delivered dose (ex-actuator) of 21 micrograms salmeterol (as xinafoate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation suspension. White to off white suspensionsealed in an aluminium canister in a green actuator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Serevent is indicated for the regular symptomatic add-on treatment of reversible airways obstruction in patients with asthma, including those with nocturnal asthma, who are inadequately controlled on inhaled corticosteroids in accordance with current treatment guidelines. Serevent is also indicated in the prevention of exercise-induced asthma. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Serevent is indicated in the treatment of patients with COPD. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Asthma _ _Adults and adolescents 12 years and older: _ Two actuations of 25 micrograms salmeterol twice daily. In asthma patients with more severe airways obstruction up to four inhalations of salmeterol twice daily may be of benefit. _Children aged 4 years and older: _ Two actuations of 25 micrograms salmeterol twice daily. _Children below 4 years of age: _ Serevent Evohaler is not recommended for use in children below four years of age due to insufficient data on safety and efficacy. _COPD _ _Adults aged 18 years and over: _ Two actuations of 25 micrograms salmeterol twice daily. Health Products Regulatory Authority 08 October 2019 CRN009D3T Page 2 of 9 _Paediatric population _ There is no relevant indication for use of Serevent Evohaler in the paediatric population in the indication for COPD. Special populations There is no need to adjust th Přečtěte si celý dokument