Oxybutynin Hydrochloride 5mg Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Oxybutynin hydrochloride

Disponible desde:

Accord Healthcare Ireland Ltd.

Código ATC:

G04BD; G04BD04

Designación común internacional (DCI):

Oxybutynin hydrochloride

Dosis:

5 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Drugs for urinary frequency and incontinence; oxybutynin

Estado de Autorización:

Marketed

Fecha de autorización:

2012-05-25

Información para el usuario

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)
caused by damage to the nervous system.
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�

Ficha técnica

Health Products Regulatory Authority
25 September 2023
CRN00DM11
Page 1 of 7
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
conjunction with non-drug therapy, when other
treatment not been successful.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage should be adapted individually. Unless otherwise specified,
the following recommendations apply:
Adults: Theinitial starting dose is 2.5 mg three times daily.
Thereafter, the lowest effective dose should be selected. The daily
dose may vary between 5mg two or three times daily (10 and 15 mg per
day) and maximum dose is 5mg four times daily
(maximum dose is 20 mg per day).
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 we