Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
PCO Manufacturing Ltd.
R03BA; R03BA01
BECLOMETASONE DIPROPIONATE
250 microgram(s)
Pressurised inhalation, solution
Product subject to prescription which may be renewed (B)
Glucocorticoids; beclometasone
Authorised
2007-10-19
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER BECOTIDE ® EVOHALER ® 50 AND 250 MICROGRAMS PRESSURISED INHALATION SOLUTION (Beclometasone dipropionate) 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. WHAT IS IN THIS LEAFLET: 1. What Becotide Evohaler is and what it is used for 2. What you need to know before you use Becotide Evohaler 3. How to use Becotide Evohaler 4. Possible side effects 5. How to store Becotide Evohaler 6. Contents of the pack and other information 1. WHAT BECOTIDE EVOHALER IS AND WHAT IT IS USED FOR Becotide contains the active substance beclometasone dipropionate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids (often just called steroids). A very small dose of steroid is needed when it is inhaled. This is because it is inhaled straight to your lungs. Becotide works by reducing swelling and irritation in the lungs. It has what is called an 'anti-inflammatory action'. Becotide helps to prevent asthma attacks in people who need regular treatment. This is why it is sometimes called a 'preventer'. It needs to be used regularly, every day. Becotide will not help treat sudden asthma attacks where you feel breathless. A different medicine is used for treating sudden attacks (called a 'reliever') If you have more than one medicine, be careful not to confuse them. Becotide is supplied to you in an inhaler. You breathe the medicine directly into your lungs. Becotide contains norflurane. This is less harmful to the environment than older inhalers. Older inhalers Pročitajte cijeli dokument
Health Products Regulatory Authority 15 March 2019 CRN008WK7 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose contains 250 micrograms of Beclometasone Dipropionate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised Inhalation, Solution _Product imported from Italy and Spain:_ Pressurised aluminium container closed with a metering valve containing a pressurised inhalation solution. 4 CLINICAL PARTICULARS As per PA1077/042/009 5 PHARMACOLOGICAL PROPERTIES As per PA1077/042/009. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Norflurane (Hydrofluoroalkane (HFA) 134a) Ethanol Anhydrous Glycerol 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister. Protect from frost and direct sunlight. Do not refrigerate or freeze. As with most inhaled medications in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold. 6.5 NATURE AND CONTENTS OF CONTAINER Health Products Regulatory Authority 15 March 2019 CRN008WK7 Page 2 of 2 The inhaler comprises an aluminium can fitted with a metering valve, plastic actuator and dust cap. Each canister contains 200 metered doses. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Patients should be carefully monitored in the proper use of their inhaler. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PP Pročitajte cijeli dokument