Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Theophylline
Mawdsley-Brooks & Company Ltd
R03DA04
Theophylline
250mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010300
NUELIN ® SA 250 MG TABLETS (theophylline) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. - You must talk to a doctor if you do not feel better or if you feel worse. Your medicine is available as Nuelin SA 250mg Tablets but will be referred to as Nuelin SA throughout this leaflet. Also available in 175 mg strength. WHAT IS IN THIS LEAFLET: 1. What Nuelin SA is and what it is used for 2. What you need to know before you take Nuelin SA 3. How to take Nuelin SA 4. Possible side effects 5. How to store Nuelin SA 6. Contents of the pack and other information 1. WHAT NUELIN SA IS AND WHAT IT IS USED FOR Nuelin SA belongs to a family of medicines called bronchodilators. Bronchodilators are used to treat, and relieve the symptoms of diseases where the passages in your lungs are blocked. Nuelin SA works by widening the air passages in your lungs which allows you to breathe more easily and feel less tight chested. You may take Nuelin SA if you have asthma or a chest disease such as chronic obstructive pulmonary disease (COPD) that makes you wheeze, cough or become short of breath. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NUELIN SA DO NOT TAKE NUELIN SA: - if you are allergic to theophylline or other bronchodilators (such as xanthines), or any of the other ingredients of this medicine (listed in Section 6). - if you are under 6 years of age - if you are a child and are taking medicines containing ephedrine (e.g. children's cold and cough medicines) - if you have recentl Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nuelin SA 250 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Theophylline 250mg Excipients with known effect: Each tablet contains Lactose Ph Eur. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet The tablets are white, round, biconvex, uncoated tablets with “T” on one face and “250” on the other with a score line The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nuelin SA are indicated for the prophylaxis and treatment of reversible bronchospasm associated with asthma and chronic obstructive pulmonary disease. Because effective plasma levels are maintained for up to twelve hours from a single dose, less frequent dosing is required than with conventional theophylline preparations. Theophylline should not be used as first drug of choice in the treatment of asthma in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One tablet twice daily, preferably after food, increasing to two tablets twice daily, if necessary. _Paediatric population _ Below 6 months: Nuelin should not be used in children below 6 months of age. Below 6 years: Nuelin should not be used in children below 6 years of age. Other dosage forms are available that are more suitable for children aged less than 6 years. 6 to 12 years: One tablet twice daily, preferably after food. _Elderly _ Elderly patients may require lower doses due to reduced theophylline clearance. Method of administration Nuelin SA-250 tablets are scored and may be halved but should not be crushed or chewed. The dosage should be titrated for each individual and adjusted with caution. Serum theophylline levels should be monitored to ensure that they remain within the therapeutic range. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, xanthines or any of the excipients listed in section 6.1 Recent myocardial infarction Acute tachy Les hele dokumentet