Cystrin 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:

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:

1991-10-11

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 Cystrin Tablets are and what they
are used for
2. What you need to know before you take
Cystrin Tablets
3. How to take Cystrin Tablets
4. Possible side effects
5. How to store Cystrin Tablets
6. Contents of the pack and other information
1. WHAT CYSTRIN TABLETS ARE AND WHAT
THEY ARE USED FOR
WHAT CYSTRIN TABLETS ARE
Cystrin Tablets contain a medicine called
oxybutynin hydrochloride. This belongs to two
groups of medicines called 'anticholinergics'
and 'antispasmodics'.
HOW CYSTRIN 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 CYSTRIN TABLETS ARE USED FOR
Cystrin 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
Cystrin 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
CYSTRIN TABLETS
You are allergic (hypersensitive) to
oxybutynin hydrochloride or any of the
other ingredients of Cystrin 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cystrin 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Oxybutynin hydrochloride 5.0 mg.
Excipients: Lactose 153.20mg per tablet.
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Tablet.
Light blue, biconvex, round tablet, engraved OXB5 on one side and with
a scored line on the reverse side.
The scored line allows the tablet to be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cystrin is indicated for the management of urinary frequency,
incontinence, nocturnal enuresis, bladder dysfunction
particularly in the elderly. It is also useful for control of vesical
hyperactivity seen after surgery of 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
Children under 5 years of age:
Not recommended.
Children over 5 years of age:
The usual total daily dose is 5mg to 15mg in divided doses.
Adults: The usual total daily dose is 10mg to 20mg in divided doses.
Following initial control a reduced maintenance dose may be
introduced. The product should be swallowed with a
copious draught of fluid to ensure transit through the oesophagus.
Elderly: There is little experience of use of oxybutynin in the
elderly. The dosage should be individually titrated. The
final dosage will depend on response and tolerance to side-effects. As
with other anticholinergic drugs, caution should
be observed in frail and elderly patients.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__