Oxybutynin hydrochloride 5 mg/5 ml oral solution

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Oxybutynin hydrochloride

Beszerezhető a:

Syri Pharma Limited t/a Thame Laboratories

ATC-kód:

G04BD; G04BD04

INN (nemzetközi neve):

Oxybutynin hydrochloride

Adagolás:

5 mg/5ml

Gyógyszerészeti forma:

Oral solution

Terápiás terület:

Drugs for urinary frequency and incontinence; oxybutynin

Engedélyezési státusz:

Not marketed

Engedély dátuma:

2015-03-27

Betegtájékoztató

VAR/IA-014
1.3.1. Package Leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYBUTYNIN HYDROCHLORIDE 5MG/5ML ORAL SOLUTION
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 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.
The name of your medicine is Oxybutynin hydrochloride 5mg/5ml Oral
Solution but it will be
referred to as Oxybutynin throughout this leaflet.
WHAT IS IN THIS LEAFLET
1. What Oxybutynin is and what it is used for
2. What you need to know before you take Oxybutynin
3. How to take Oxybutynin
4. Possible side effects
5. How to store Oxybutynin
6. Contents of the pack and other information
1. WHAT OXYBUTYNIN IS AND WHAT IT IS USED FOR
Oxybutynin 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 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 must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYBUTYNIN
DO NOT TAKE OXYBUTYNIN IF:

you are allergic to oxybutynin hydrochloride or any of the other
ingredients of this
medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of
your lips, face, t

Termékjellemzők

Health Products Regulatory Authority
26 July 2023
CRN00DQ0P
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxybutynin hydrochloride 5 mg/5 ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml solution contains 5mg oxybutynin hydrochloride.
_Excipients with known effect:_Each 5ml of solution contains 1.3gm
liquid sorbitol (non-crystallising) (E420) and 6.0mg methyl
parahydroxybenzoate (E218).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, colourless solution with raspberry odour.
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
ADULTS:
The usual dose is 5mg (5ml) two or three times a day. This may be
increased to a maximum of 5mg (5ml) 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 (2.5ml) twice a day, particularly if the patient is
frail, is likely to be adequate. This dose may be titrated upwards to
5mg (5ml) twice a day to obtain a clinical response provided
that the side effects are tolerated. Children (under 5 years of age):
Not recommended.
CHILDREN (OVER 5 YEARS OF AGE):
Neurogenic bladder instability:
The usual dose is 2.5mg (2.5ml) twice a day. This dose ma