Ditropan 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxybutynin hydrochloride

Available from:

Neon Healthcare Ltd

ATC code:

G04BD04

INN (International Name):

Oxybutynin hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040200; GTIN: 5026474000273

Patient Information leaflet

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

Summary of Product characteristics

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