Lyrinel XL 5mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Oxybutynin hydrochloride

Dostępny od:

Janssen-Cilag Ltd

Kod ATC:

G04BD04

INN (International Nazwa):

Oxybutynin hydrochloride

Dawkowanie:

5mg

Forma farmaceutyczna:

Modified-release tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 07040200; GTIN: 5012674901021

Ulotka dla pacjenta

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

Charakterystyka produktu

OBJECT 1
LYRINEL XL PROLONGED RELEASE TABLET
Summary of Product Characteristics Updated 08-Dec-2016 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Lyrinel XL 5 mg prolonged release tablet
Lyrinel XL 10 mg prolonged release tablet
2. Qualitative and quantitative composition
Each prolonged release tablet contains 5 mg of oxybutynin
hydrochloride
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.
Lyrinel XL 5 mg prolonged release tablets: Round yellow coloured
tablet, approximately 7.5 mm in
diameter, printed with “5 XL" on one side in black ink.
Lyrinel XL 10 mg prolonged release tablets: 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 dec