Ditropan 5mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Oxybutynin hydrochloride

זמין מ:

Mawdsley-Brooks & Company Ltd

קוד ATC:

G04BD04

INN (שם בינלאומי):

Oxybutynin hydrochloride

כמות:

5mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 07040200

עלון מידע

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

מאפייני מוצר

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