LYRINEL XL 10 mg prolonged release tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Oxybutynin hydrochloride

Предлага се от:

PCO Manufacturing Ltd.

АТС код:

G04BD; G04BD04

INN (Международно Name):

Oxybutynin hydrochloride

дозиране:

10 milligram(s)

Лекарствена форма:

Prolonged-release tablet

Терапевтична област:

Drugs for urinary frequency and incontinence; oxybutynin

Дата Оторизация:

2021-12-17

Листовка

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 TO

Данни за продукта

Health Products Regulatory Authority
17 December 2021
CRN00CPC9
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 oxybutynin hydrochloride
Excipient(s) with known effect:
Each LYRINEL XL 10 mg prolonged release tablet contains 0.03 mg
lactose.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
_Product imported from Greece_
Round pink coloured tablet, approximately 7.5 mm in diameter, 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.
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
17 December 2021
CRN00CPC9
Page 2 of 2
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 the container tightly closed in order to protect from moisture.
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
High density polyethylene bottles with child resistant closure
(polypropylene) and desiccant. Pack size 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 THE PRODUCT
Do not remove or swallow the sachet of granules in the bottle. This
contains desiccant, which keeps the tablets dry.
7 PARALLEL PRODUCT AUTHORISATI