国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxybutynin hydrochloride
Janssen-Cilag Ltd
G04BD04
Oxybutynin hydrochloride
10mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5012674901038
PACKAGE LEAFLET: INFORMATION FOR THE USER LYRINEL ® XL 10MG PROLONGED RELEASE TABLETS (oxybutynin hydrochloride) 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, nurse 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Lyrinel XL 10mg prolonged release tablets but will be referred to as Lyrinel XL throughout the remainder of the leaflet. Lyrinel XL is also available in strengths of 5mg and 15mg prolonged release tablets. WHAT IS IN THIS LEAFLET: 1. WHAT LYRINEL XL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LYRINEL XL 3. HOW TO TAKE LYRINEL XL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LYRINEL XL 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT LYRINEL XL IS AND WHAT IT IS USED FOR Lyrinel XL contains a medicine called oxybutynin hydrochloride. This belongs to a group of medicines called ‘anticholinergics’ or ‘antispasmodics’. Lyrinel XL works by relaxing your bladder muscles. It also stops bladder contractions and delays the desire to pass urine (water). Your tablets are made in a 'prolonged release' form. The tablets are coated with a ‘special membrane’ which slowly release the medicine. This membrane may pass through your body unchanged. This does not affect the way the medicine works. Lyrinel XL can be used: • To help adults control when and how often they pass urine • In children 5 years or older to treat: − Loss of control in passing urine (urinary incontinence) − Increased need or urgency to pass urine − Night time bedwetting, when other treatments have not worked. If your symptoms 阅读完整的文件
OBJECT 1 LYRINEL XL PROLONGED RELEASE TABLET Summary of Product Characteristics Updated 08-Dec-2016 | Janssen-Cilag Ltd 1. Name of the medicinal product Lyrinel XL 5 mg prolonged release tablet Lyrinel XL 10 mg prolonged release tablet 2. Qualitative and quantitative composition Each prolonged release tablet contains 5 mg of oxybutynin hydrochloride Each prolonged release tablet contains 10 mg of oxybutynin hydrochloride For the full list of excipients, see Section 6.1. Excipient(s) with known effect: Each LYRINEL XL prolonged release tablet contains 0.03 mg lactose. 3. Pharmaceutical form Prolonged release tablet. Lyrinel XL 5 mg prolonged release tablets: Round yellow coloured tablet, approximately 7.5 mm in diameter, printed with “5 XL" on one side in black ink. Lyrinel XL 10 mg prolonged release tablets: Round pink coloured tablet, approximately 7.5 mm in diameter, printed with “10 XL" on one side in black ink. 4. Clinical particulars 4.1 Therapeutic indications Adults Lyrinel XL is indicated in adults for the symptomatic treatment of urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with unstable bladder. Paediatric population Oxybutynin hydrochloride is indicated in children over 5 years of age for: - Urinary incontinence, urgency and frequency in unstable bladder conditions due to idiopathic overactive bladder or neurogenic bladder disorders (detrusor overactivity). - Nocturnal enuresis associated with detrusor overactivity, in conjunction with nondrug therapy, when other treatment has failed. 4.2 Posology and method of administration Posology Lyrinel XL may be administered with or without food (see section 5.2). _Adults_ Starting dose: the recommended starting dose is one 5 mg tablet once daily. Maintenance dose/dose adjustment: In order to achieve a maintenance dose giving an optimal balance of efficacy and tolerability, after at least one week on 5 mg daily, the dose may be increased to 10 mg once daily, with subsequent incremental increases or dec 阅读完整的文件