Ditropan

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OXYBUTYNIN HYDROCHLORIDE

Available from:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC code:

G04BD04

INN (International Name):

OXYBUTYNIN HYDROCHLORIDE 5 mg

Pharmaceutical form:

TABLET

Composition:

OXYBUTYNIN HYDROCHLORIDE 5 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2006-02-28

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.
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

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ditropan tablets 5mg
Oxybutynin hydrochloride 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 8.0mm
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
Oxybutinin 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 othet 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
Page 2 of 6
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