Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Theophylline
Ennogen Healthcare Ltd
R03DA04
Theophylline
400mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010300; GTIN: 5012854061347
6152-15 460X148MM (LSN-NAPP-02) (L) V1 V10-2018 _ITEM DESCRIPTION:_ _TEMPLATE NO.:_ _MANUFACTURER / PACKER:_ _ITEM CODE 2:_ _DIMENSIONS:_ _SECURITY CODE TYPE:_ _UNWIND NO.:_ _PMS NO.:_ _CREATED BY:_ _DATE CREATED:_ _VERSION:_ _POR NO.:_ COLOUR(S): NON-PRINTING COLOURS PINK BLUE PURPLE BUFF _PACKAGI NG _ _ARTWORK _ _TEAM_ _Bard Pharmaceuticals Ltd._ _Cambridge Science Park, Milton Road, _ _Cambridge CB4 0GW, UK_ _Tel: +44 (0) 1223 424 444_ cgr01 31-01-19 V1 N/A 460X148mm Datamatrix N/A PRD-PMS-005 460x148mm (LSN-NAPP-02)(L) V1 LSN-NAPP-02 N/A 148x36,34mm 6152-15 N/A UNIPHYLLIN TABS PIL UK 6152-15 BARD 7542 PMS 280 PMS 280 @ 20% UNIPHYLLIN TABS PIL UK 6152-15 V1.indd 1 31/01/2019 17:00 6152-15 _ UNIPHYLLIN_ _®_ _CONTINUS_ _®_ 200 MG, 300 MG AND 400 MG PROLONGED-RELEASE TABLETS Theophylline PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 after 3 days. 1. WHAT _UNIPHYLLIN_ _CONTINUS_ TABLETS ARE AND WHAT THEY ARE USED FOR These tablets are used to treat asthma, long-term breathing difficulties such as chronic obstructive pulmonary disease and chronic bronchitis, and are sometimes used to treat heart failure. They contain the active ingredient theophylline which belongs to a group of medicines called bronchodilators. Bronchodilators help stop you wheezing and being breathless. Theophylline also reduces swelling in the lungs of asthma patients and relieves the feeling of ‘tightness’ in their chest. These tablets may be taken by adults Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT UNIPHYLLIN CONTINUS 400mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 400 mg theophylline as 440 mg theophylline monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablets Capsule shaped, white, tablet with ‘UNIPHYLLIN’ on one side and the ‘U400’ and the Napp logo on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment and prophylaxis of bronchospasm associated with asthma, chronic obstructive pulmonary disease and chronic bronchitis. Also indicated for the treatment of left ventricular and congestive cardiac failure. 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 _ _ _Adults and the elderly _ The usual maintenance dose is 200 mg 12 hourly. This may be titrated to either 300 mg or 400 mg dependent on the therapeutic response. _ _ _Paediatric population aged 6 years and above _ The usual paediatric maintenance dose is 9 mg/kg twice daily. Some children with chronic asthma require and tolerate much higher doses (10-16 mg/kg twice daily). Clearance is increased in children compared to values observed in adult subjects. The rapid clearance observed in children decreases towards adult values in late teens. Therefore, lower dosages (based on usual adult dose) may be required for adolescents. UNIPHYLLIN CONTINUS tablets 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. Theophylline distributes poorly into body fat, therefore mg/kg doses should be calculated on the basis of lean (ideal) bodyweight. Plasma theophylline concentrations should ideally be maintained between 5 and 12 micrograms/ml. A plasma level of 5 micrograms/ml probably represents the lower level of clinical effectiveness. Significant adverse Baca dokumen lengkap