País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxybutynin hydrochloride
DE Pharmaceuticals
G04BD04
Oxybutynin hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200
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. Do not pass it on to others. It may harm them, even if their symptoms 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. Section 4. WHAT IS IN THIS LEAFLET: 1. What Ditropan Tablets is and what it is 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 WHAT DITROPAN TABLETS ARE Ditropan Tablets contains 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 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 breathing problems, swelling of your lips, face, throat or tongue You have a rare muscle illness called 'Myasthenia gravis' You have glaucoma (increased pressure in the eye, sometimes sudden and painful with blurred vision or loss of vision) Your gut (stomach or intestine) is blocked, perforated or not working properly You have a severe form of a condition known as 'ulcerative colitis’ You have a bloc Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ditropan tablets 5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg oxybutynin hydrochloride as the active ingredient. 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 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 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 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 5 mg four times a day to obtain a clinical response provided that the side effects are tolerated. _Elderly (including frail 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 day to obtain a clinical response provided the side effects are well tolerated. Nocturnal enuresis: the usual dose is 2.5mg twice a day. This d Leer el documento completo