OXYBUTYNIN HYDROCHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYBUTYNIN HYDROCHLORIDE

Available from:

Accord Healthcare Limited

ATC code:

G04BD04

INN (International Name):

OXYBUTYNIN HYDROCHLORIDE

Dosage:

5 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

oxybutynin

Authorization status:

Marketed

Authorization date:

2012-05-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYBUTYNIN HYDROCHLORIDE
2.5 MG TABLETS
OXYBUTYNIN HYDROCHLORIDE
5 MG TABLETS
OXYBUTYNIN HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your
doctor, pharmacist or nurse.
-
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs are the same as yours.
-
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in the leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Oxybutynin Tablets are and what they
are used for
2. What you need to know before you take
Oxybutynin Tablets
3. How to take Oxybutynin Tablets
4. Possible side effects
5. How to store Oxybutynin Tablets
6. Contents of the pack and other information 1. WHAT OXYBUTYNIN TABLETS ARE
AND WHAT THEY ARE USED FOR
Oxybutynin Tablets contains a medicine called
Oxybutynin hydrochloride. This belongs to two
groups of medicines called “anticholinergics and
“antispasmodics”. It works by relaxing the
muscles of the bladder and stops sudden muscle
contractions (spasms). This helps control the
release of water (urine).
Oxybutynin Tablets can be used to treat:
Adults:
Frequent and severe urinary urgency or Loss of
control in passing urine (urge incontinence).
Children over 5 years:
-
Loss of control in passing water (urinary
incontinence).
-
Increased need or urgency to pass urine
(frequent and excessive urination).
-
Night time bedwetting in children when other
treatments have not worked. 2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE OXYBUTYNIN TABLETS
DO NOT TAKE OXYBUTYNIN TABLETS AND TELL YOUR
DOCTOR IF:
-
You are allergic to Oxybutynin hydrochloride or
any of the other ingredients of this medicine
(listed in Section 6).
-
You have a rare condition called “Myasthenia
gravis” that makes the muscles in the body
be

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxybutynin Hydrochloride 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5mg tablet contains 5mg Oxybutynin hydrochloride
Excipient(s) with known effect: Contains 106.50mg Lactose monohydrate
per tablet.
For
full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
White to off white, odourless, 7.9mm round biconvex, uncoated tablets
with inscription "B" and "R" on either side of
the score line on one side and plain on the other side.
The 5mg tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
Treatment of frequency, urgency or urge incontinence as may occur in
bladder overactivity whether due to neurogenic
bladder disorders (detrusor hyperreflexia) or idiopathic detrusor
overactivity.
PAEDIATRIC POPULATION
Oxybutynin hydrochloride is indicated for children over 5 years for:
-
Urinary incontinence, urgency and frequency in overactive bladder
conditions caused by idiopathic overactive
bladder or neurogenic bladder dysfunction (detrusor over activity).
-
Nocturnal enuresis associated with detrusor over activity, in
conjuction with non-drug therapy , when other
treatment not been successful.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE AND ADMINISTRATION:
Adults: The dosage should be determined individually, with an initial
dose of 2.5 mg three times daily. Thereafter, the
lowest effective dose should be selected. The daily dose may vary
between 10 and 15 mg per day (maximum dose is 20
mg per day) divided into 2-3 (max. 4) doses.
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): The safety and efficacy of oxybutynin
hydrochloride in children below 5 years of age
has not been established. No data