Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
THEOPHYLLINE
Astellas Pharma Co. Ltd
R03DA04
THEOPHYLLINE
200 Milligram
Prolonged Release Capsules
Product subject to prescription which may be renewed (B)
Xanthines
Authorised
2005-09-30
PACKAGE LEAFLET: INFORMATION FOR THE USER ZEPHOLIN S.R. 100 MG / 200 MG / 350 MG PROLONGED RELEASE CAPSULES (Theophylline) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • 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 ZEPHOLIN S.R. IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEPHOLIN S.R. 3. HOW TO TAKE ZEPHOLIN S.R. 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ZEPHOLIN S.R. 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ZEPHOLIN S.R. IS AND WHAT IT IS USED FOR Zepholin S.R. contains theophylline as the active ingredient which acts on your lung cells causing relaxation of the muscles. This makes your breathing easier and relieves breathlessness. Zepholin S.R. is a prolonged release product which releases the theophylline slowly. Zepholin S.R. is used: • to treat asthma, chronic bronchitis and emphysema. Zepholin S.R. can be taken both as a preventative therapy, to stop you getting breathing problems and as a therapy to relieve your breathlessness. Zepholin S.R. should not be used as the first line treatment for asthma in children. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEPHOLIN S.R. DO NOT TAKE ZEPHOLIN S.R. IF YOU: • are allergic (hypersensitive) to theophylline or to any of the other ingredients of Zepholin S.R. prolonged release capsules. Please refer to section 6 of this leaflet for a Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zepholin S.R. 200 mg Prolonged Release Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200 mg of Theophylline. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release capsules, hard. Size 2, green opaque cap and green transparent body, printed ‘TH 200’ in white on both cap and body, containing white pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the symptomatic or prophylactic relief of bronchospasm associated with asthma, chronic bronchitis and emphysema. Zepholin should not be used as first drug of choice in the treatment of asthma in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use only. The capsules should be swallowed whole, after meals with plenty of fluid. The treatment should begin in the evening shortly before bed and should be increased slowly over 2-3 days. The daily dose should be divided between morning at breakfast and evening, shortly before bed. Duration of use is dependent on the severity of the condition. Adults: Recommended dose scheme: 1) : in the case of adipose patients the normal weight should be taken. An individual dosing scheme can be worked out on the basis of the theophylline serum profiles. Children: Children under 6 months: Zepholin should not be used in children under 6 months of age. Children under 6 years: Zepholin capsules should not be used in children under 6 years of age. Other dosage forms are available that are more suitable for children aged less than 6 years. AGE IN YEARS BODY WEIGHT IN KG 1) MG THEOPHYLLINE/KG/DAY MG THEOPHYLLINE/DAY Adults Non-smokers 60 - 70 11 - 13 660 – 910 Adults Smokers 60 - 70 18 1080 – 1260 HEALTH PRODUCTS REGULATORY AUTHORITY _______________________ Lees het volledige document