LYRINEL XL 10 mg prolonged release tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

OXYBUTYNIN HYDROCHLORIDE

から入手可能:

IMED Healthcare Ltd.

ATCコード:

G04BD; G04BD04

INN（国際名）:

OXYBUTYNIN HYDROCHLORIDE

医薬品形態:

Prolonged-release tablet

治療領域:

Drugs for urinary frequency and incontinence; oxybutynin

承認日:

2022-07-15

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE
USER
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 your
symptoms worsen.
2. WHAT YOU NEED

製品の特徴

Health Products Regulatory Authority
18 July 2022
CRN00CSS7
Page 1 of 2
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
Excipient(s) with known effect:
Each LYRINEL XL prolonged release tablet contains 0.03 mg lactose.
Each LYRINEL XL prolonged release tablet contains less than 1 mmol
sodium (23 mg), and is essentially 'sodium-free'.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
_Product imported from Greece_
Round pink coloured tablet printed with "10 XL" on one side in black
ink
4 CLINICAL PARTICULARS
As per PA22612/008/002
5 PHARMACOLOGICAL PROPERTIES
As per PA22612/008/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
butylhydroxytoluene (E321)
cellulose acetate 398-10
hypromellose 5 cp
polyethylene glycol 3350
magnesium stearate
polyethylene oxide 200K
polyethylene oxide 2000K
sodium chloride
black iron oxide (E172)
ferric oxide red (E172)
lactose anhydrous.
Film coat:
ferric oxide red (E172)
hypromellose 3 cp and 6 cp
polyethylene glycol 400
polysorbate 80
titanium dioxide (E171)
Printing Ink:
black iron oxide (E172)
hypromellose 6 cp
propylene glycol.
Health Products Regulatory Authority
18 July 2022
CRN00CSS7
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Keep your medicine in the original package. Do not store above 25°C.
Keep the container tightly closed to protect from
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
High density polyethylene bottles with child resistant closure
(polypropylene) and desiccant. Pack sizes 30 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF TH