Oxybutynin 3mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxybutynin hydrochloride

Available from:

Zentiva

ATC code:

G04BD04

INN (International Name):

Oxybutynin hydrochloride

Dosage:

3mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040200; GTIN: 5000283661603

Patient Information leaflet

1
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 any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What oxybutynin is and what it is
used for
2. Before you take oxybutynin
3. How to take oxybutynin
4. Possible side effects
5. How to store oxybutynin
6. Further information
1. WHAT OXYBUTYNIN IS AND
WHAT IT IS USED FOR
WHAT OXYBUTYNIN IS
The name of your medicine is Oxybutynin
Hydrochloride 3mg Tablets (referred to as
oxybutynin throughout this leaflet).
It contains a medicine called oxybutynin
hydrochloride. This belongs to two groups
of medicines called ‘anticholinergics’ and
‘antispasmodics’.
HOW OXYBUTYNIN WORKS
It works by relaxing the muscles of the
bladder and stops sudden muscle
contractions (spasms). This helps control
the release of water (urine).
WHAT OXYBUTYNIN IS USED FOR
Oxybutynin 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. BEFORE YOU TAKE OXYBUTYNIN
DO NOT TAKE THIS MEDICINE AND TELL
YOUR DOCTOR IF:
✕ You are allergic (hypersensitive) to
oxybutynin hydrochloride or any of the
other ingredients in this medicine
(listed in Section 6 Further
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

Summary of Product characteristics

OBJECT 1
OXYBUTYNIN HYDROCHLORIDE 3MG TABLETS
Summary of Product Characteristics Updated 16-Aug-2016 | Zentiva
1. Name of the medicinal product
Oxybutynin Hydrochloride 3mg Tablets
2. Qualitative and quantitative composition
Oxybutynin hydrochloride 3.00mg
For excipients, see 6.1.
3. Pharmaceutical form
Tablet
4. Clinical particulars
4.1 Therapeutic indications
Oxybutynin is indicated for urinary incontinence, urgency and
frequency in unstable bladder conditions
due either to idiopathic detrusor instability or neurogenic bladder
disorders (detrusor hyperreflexia) in
conditions such as spina bifida and multiple sclerosis.
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
CHILDREN UNDER 5 YEARS OF AGE: Not recommended
Children over 5 years of age:
_Neurogenic bladder disorders_: The usual dose is 5mg twice a day.
This may be increased to a maximum
of 5mg three times a day to obtain a clinical response provided that
the side effects are tolerated.
_Nocturnal enuresis_: The usual dose is 5mg two or three times a day.
The last dose should be given before
bedtime.
In children the maintenance dose may be achieved by upward titration
from an initial dose of 3mg twice
daily.
ADULTS: The usual dose is 5mg two or three times a day. This may be
increased to a maximum dosage of
5mg four times a day (20mg) to obtain a satisfactory clinical response
provided that the side effects are
tolerated.
ELDERLY: The elimination half-life may be increased in some elderly
patients, therefore, dosage should be
individually titrated commencing at 3mg twice a day. The final dosage
will depend on response and
tolerance to side-effects. As with other anticholi