국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
BUDESONIDE
AstraZeneca UK Limited
R01AD05
BUDESONIDE
100 Mcg/Acutuation
Nasal Powder
Product subject to prescription which may be renewed (B)
budesonide
Not Marketed
1995-09-19
BODY TEXT SIZE 9.5 pt SMALLEST TEXT SIZE 6.0 pt 567913-A02 30-06-17 PS10481 AZL010A 7851 SB Rhinocort 100mcg Leaflet: Patient IE Black Technical Info Profile 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 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 Rhinocort Turbohaler is and what it is used for 2. What you need to know before you use Rhinocort Turbohaler 3. How to use Rhinocort Turbohaler 4. Possible side effects 5. How to store Rhinocort Turbohaler 6. Contents of the pack and other information 1. What Rhinocort Turbohaler is and what it is used for The name of your medicine is Rhinocort Turbohaler, 100 micrograms per metered dose, Nasal Powder (called Rhinocort Turbohaler in the rest of this leaflet). Rhinocort Turbohaler contains a medicine called budesonide. This belongs to a group of medicines called corticosteroids. • Corticosteroids help to reduce and prevent inflammation. • Rhinocort Turbohaler is used to treat the effects of allergies, such as hay fever, and inflammation inside the nose (rhinitis). • It can also stop these effects from coming on. • It is also used to treat small growths inside the nose (nasal polyps). • When you sniff through the Turbohaler, the medicine is delivered to the inside of your nose. 2. What you need to know before you use Rhinocort Turbohaler Do not use Rhinocort Turbohaler: • If you are allergic to budesonide. If you are not sure if this applies to you, talk to your doctor of pharmacist before using Rhinocort Turbohaler. Warnings and precautions Talk to your doctor or pharmacist 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rhinocort Turbohaler, 100 micrograms per metered dose, Nasal Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 100 micrograms Budesonide. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Nasal powder Rhinocort Turbohaler is a metered dose, powder, nasal inhaler. White to off-white rounded granules which break into a fine nasal powder on inhalation. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Seasonal and perennial allergic rhinitis and vasomotor rhinitis. Treatment of nasal polyps. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS AND VASOMOTOR RHINITIS ADULTS: The recommended dose is 400 mcg. Rhinocort Turbohaler may be given once daily (two applications into each nostril in the morning). When good effect has been achieved the dosage may be reduced to one application into each nostril. Rhinocort Turbohaler may also be given twice daily (one application into each nostril morning and evening). If symptoms are not controlled, or persist for longer than 2 weeks of treatment, medical advice should be sought. Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. The patient should be informed that the full effect of Rhinocort Turbohaler is not achieved until after a few days treatment. Treatment of seasonal rhinitis should, if possible, start before exposure to allergens. ELDERLY: Dosage as for adults. PAEDIATRIC POPULATION: There are insufficient data to recommend the use of Rhinocort Turbohaler in children. TREATMENT OF NASAL POLYPS ADULTS: The recommended dose is 200 mcg twice daily (one application into each nostril morning and evening). If symptoms are not controlled, or persist for longer than 2 weeks of treatment, medical advice should be sought. Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. ELDERLY: Dosage as 전체 문서 읽기