Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxybutynin hydrochloride
Neon Healthcare Ltd
G04BD04
Oxybutynin hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5026474000273
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DITROPAN ® TABLETS 2.5 MG AND DITROPAN ® TABLETS 5 MG 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 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. WHAT IS 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 use 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 in adults and children 5 years or older to treat: − loss of control in passing water (urinary incontinence), − increased need or urgency to pass water (urine), − night time bedwetting, when other treatments have not worked. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DITROPAN TABLETS DO NOT TAKE DITROPAN TABLETS − if you are allergic to oxybutynin hydrochloride or any of the other ingredients of this medicine (listed in section 6). 2 _Signs of an allergic reaction include_: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. − if you have a rare muscle illness called 'Myast Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ditropan tablets 5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg oxybutynin hydrochloride as the active ingredient. Excipients with known effect: lactose, sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ditropan tablets 5mg are pale blue circular tablets with a 8.0 mm nominal diameter, with a centre breakline on one side, and marked OXB5 on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ditropan is indicated for the symptomatic treatment of 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). Paediatric population Ditropan is indicated in children of 5 years of age or older 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 Posology The dosage should be determined individually. _Adults_ The usual dose is 5 mg two or three times a day. This may be increased to a maximum of 5 mg four times a day (maximum dose 20 mg oxybutynin hydrochloride per 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 2.5 mg twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be increased to 5 mg two times a day to obtain a clinical response provided the side effects are well tolerated. _Paediatric population _ _Children (under 5 years of age)_ Ditropan is not recommended in children under 5 years of age due to the absence of data. _ _ _Children Przeczytaj cały dokument