Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
OXYBUTYNIN HYDROCHLORIDE
Sanofi-Aventis Ireland Limited T/A SANOFI
G04BD; G04BD04
OXYBUTYNIN HYDROCHLORIDE
5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Drugs for urinary frequency and incontinence; oxybutynin
Marketed
1995-08-24
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. IN THIS LEAFLET: 1. What Ditropan Tablets are and what they are used for 2. What you need to know before you take Ditropan Tablets 3. How to take Ditropan Tablets 4. Possible side effects 5. How to store Ditropan Tablets 6. Contents of the pack and other information 1. WHAT DITROPAN TABLETS ARE AND WHAT THEY ARE USED FOR WHAT DITROPAN TABLETS ARE Ditropan Tablets contain a medicine called oxybutynin hydrochloride. This belongs to two groups of medicines called 'anticholinergics' and 'antispasmodics'. HOW DITROPAN TABLETS WORK It works by relaxing the muscles of the bladder and stops sudden muscle contractions (spasms). This helps control the release of water (urine). WHAT DITROPAN TABLETS ARE USED FOR Ditropan Tablets can be used to treat: • Loss of control in passing water (urinary incontinence) • Increased need or urgency to pass water (urine) • Night time bedwetting in children 5 years or older, when other treatments have not worked Ditropan Tablets can be used 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 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DITROPAN TABLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: You are allergic (hypersensitive) to oxybutynin hydrochloride or any of the other ingredients of Ditropan Tablets (listed in Section 6 Contents of the pack and other information) Signs of an allergic reaction include: a rash, swallowing or breathi read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ditropan 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg oxybutynin hydrochloride as the active ingredient. Also contains 153.20mg lactose, anhydrous For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Pale blue circular tablet with a centre break-line on one side and marked ‘OXB5’ on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Urinary incontinence, urgency and frequency in the unstable bladder, whether due to neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as multiple sclerosis and spina bifida, or to idiopathic detrusor instability (motor urge incontinence). It is also useful in the control of vesical hyperactivity seen after surgery of the bladder or prostate or accompanying cystitis. PEADIATRIC POPULATION Oxybutnin 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 non-drug therapy, when other treatment has failed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE AND ADMINISTRATION: _Adults_: The usual dose is 5mg two or three times a day. This may be increased to a maximum of 5mg four times a day to obtain a clinical response provided that the side effects are tolerated. _Elderly_: The elimination half-life is increased in the elderly; therefore, a dose of 2.5mg twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be titrated upwards to 5mg two times a day to obtain a clinical response provided the side effects are well tolerated. _Children (under 5 years of age)_: Not recommended. _Children (over 5 years of age)_: Neurogenic bladder instability: the usual dose is 2.5mg twice a day. This dose may be titrated upwards to 5mg two or three times a read_full_document