Ditropan 2.5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYBUTYNIN HYDROCHLORIDE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

G04BD; G04BD04

INN (International Name):

OXYBUTYNIN HYDROCHLORIDE

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Drugs for urinary frequency and incontinence; oxybutynin

Authorization status:

Marketed

Authorization date:

1995-08-24

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ditropan 2.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg oxybutynin hydrochloride as the active
ingredient.
Also contains 76.53mg lactose, anhydrous
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Pale blue oval bi-convex tablet, 8mm x 5.5mm, marked ‘OXB2.5’ on
one side.
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 5 mg 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 day to obtain
a cl