LYRINEL XL

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

OXYBUTYNIN HYDROCHLORIDE

Disponible depuis:

Janssen-Cilag Ltd

Code ATC:

G04BD04

DCI (Dénomination commune internationale):

OXYBUTYNIN HYDROCHLORIDE

Dosage:

10 Milligram

forme pharmaceutique:

Tablet Prolonged Release

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

oxybutynin

Statut de autorisation:

Marketed

Date de l'autorisation:

2004-08-27

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
LYRINEL XL 5 MG PROLONGED RELEASE TABLETS
LYRINEL XL 10 MG PROLONGED RELEASE 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 of illness 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 this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Lyrinel XL is and what it is used for
2.
What you need to know before you take Lyrinel XL
3.
How to take Lyrinel XL
4.
Possible side effects
5.
How to store Lyrinel XL
6.
Contents of the pack and other information
1.
WHAT LYRINEL XL IS AND WHAT IT IS USED FOR
The name of your medicine is Lyrinel XL prolonged release tablets. It
is called Lyrinel XL in this
leaflet. Lyrinel XL contains a medicine called oxybutynin
hydrochloride. This belongs to a group of
medicines called ‘anticholinergics’ or ‘antispasmodics’.
Lyrinel XL works by relaxing your bladder muscles. It also stops
bladder contractions and delays the
desire to pass urine (water).
Your tablets are made in a 'prolonged release' form. The tablets are
coated with a ‘special membrane’,
which slowly release the medicine. This membrane may pass through your
body unchanged. This
does not affect the way the medicine works.
Lyrinel XL can be used:

To help adults control when and how often they pass urine

In children 5 years or older to treat:
o
Loss of control in passing urine (urinary incontinence)
o
Increased need or urgency to pass urine
o
Night time bedwetting, when other treatments have not worked.
If your symptoms do not improve after 7 days talk to your doctor.
You must talk to a doctor if at any time you

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
LYRINEL XL 10 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains 10 mg of oxybutynin
hydrochloride
For the full list of excipients, see Section 6.1.
Excipient(s) with known effect: Each LYRINEL XL prolonged release
tablet contains 0.03 mg lactose.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
Round pink coloured tablet, approximately 7.5 mm in diameter, printed
with “10 XL" on one side in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
Lyrinel XL is indicated in adults for the symptomatic treatment of
urge incontinence and/or increased urinary
frequency associated with urgency as may occur in patients with
unstable bladder.
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 nondrug therapy, when other
treatment has failed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lyrinel XL may be administered with or without food (see section 5.2).
_Adults_
Starting dose: the recommended starting dose is one 5 mg tablet once
daily.
Maintenance dose/dose adjustment: In order to achieve a maintenance
dose giving an optimal balance of efficacy and
tolerability, after at least one week on 5 mg daily, the dose may be
increased to 10 mg once daily, with subsequent
incremental increases or decreases of 5 mg/day. There should be an
interval of at least one week between dose changes.
Maximum dose: in patients requiring a higher dose, the total daily
dose should not exceed 20 mg.
For patients currently taking oxybutynin immediate release, clinical
judgement should be exercised in selecting the
appropriate dose of Lyrinel XL.
The dosage should be adjusted to the minimum dose that achieves