Lyrinel XL 10mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Oxybutynin hydrochloride

متاح من:

Janssen-Cilag Ltd

ATC رمز:

G04BD04

INN (الاسم الدولي):

Oxybutynin hydrochloride

جرعة:

10mg

الشكل الصيدلاني:

Modified-release tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 07040200; GTIN: 5012674901038

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
LYRINEL
® XL 10MG 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, nurse 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, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Lyrinel XL 10mg prolonged release tablets
but will be referred to as Lyrinel XL throughout the remainder of the
leaflet.
Lyrinel XL is also available in strengths of 5mg and 15mg prolonged
release tablets.
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
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:
−
Loss of control in passing urine (urinary incontinence)
−
Increased need or urgency to pass urine
−
Night time bedwetting, when other treatments have not worked.
If your symptoms

خصائص المنتج

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