Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OXYBUTYNIN HYDROCHLORIDE
Sanofi-Aventis Ireland Limited T/A SANOFI
G04BD; G04BD04
OXYBUTYNIN HYDROCHLORIDE
3 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Drugs for urinary frequency and incontinence; oxybutynin
Marketed
1993-03-26
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 Cystrin Tablets are and what they are used for 2. What you need to know before you take Cystrin Tablets 3. How to take Cystrin Tablets 4. Possible side effects 5. How to store Cystrin Tablets 6. Contents of the pack and other information 1. WHAT CYSTRIN TABLETS ARE AND WHAT THEY ARE USED FOR WHAT CYSTRIN TABLETS ARE Cystrin Tablets contain a medicine called oxybutynin hydrochloride. This belongs to two groups of medicines called 'anticholinergics' and 'antispasmodics'. HOW CYSTRIN 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 CYSTRIN TABLETS ARE USED FOR Cystrin 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 Cystrin 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 CYSTRIN TABLETS You are allergic (hypersensitive) to oxybutynin hydrochloride or any of the other ingredients of Cystrin Tablets (listed in Section 6 Contents of the pack and other information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cystrin 3mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Oxybutynin hydrochloride 3.00 mg. Excipients: contains 91.92 mg lactose anhydrous per tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Light blue, biconvex, round tablet, engraved ‘OXB 3’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxybutynin is indicated for the management of urinary frequency, incontinence, nocturnal enuresis, bladder dysfunction particularly in the elderly. It is also useful for control of vesical hyperactivity seen after surgery of 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 _Children under 5 years of age_: Not recommended _Children over 5 years of age_: The usual total daily dose is 5mg to 15mg in divided doses. _Adults_: The usual total daily dose is 10mg to 20mg in divided doses. Following initial control a reduced maintenance dose may be introduced. The product should be swallowed with a copious draught of fluid to ensure transit through the oesophagus. _Elderly_: There is little experience of use of oxybutynin in the elderly. The dosage should be individually titrated. The final dosage will depend on response and tolerance to side-effects. As with other anticholinergic drugs, caution should be observed in frail and elderly patients. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Read the complete document