Ditropan 5 mg tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

OXYBUTYNIN HYDROCHLORIDE

Prieinama:

PCO Manufacturing Ltd.

ATC kodas:

G04BD; G04BD04

INN (Tarptautinis Pavadinimas):

OXYBUTYNIN HYDROCHLORIDE

Dozė:

5 milligram(s)

Vaisto forma:

Tablet

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Drugs for urinary frequency and incontinence; oxybutynin

Autorizacija statusas:

Authorised

Leidimo data:

2010-08-27

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DITROPAN
® 5MG TABLETS
Oxybutynin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
IN THIS LEAFLET:
1.
What Ditropan tablets are and what are they used for
2.
What you need to know before you take Ditropan Tablets
3.
How to take Ditropan Tablets
4.
Possible side effects
5.
How to store Ditropan Tablets
6.
Contents of the pack and other information
1.
WHAT DITROPAN TABLETS ARE AND WHAT THEY ARE USED FOR?
WHAT DITROPAN TABLETS ARE
Ditropan tablets contain a medicine called oxybutynin
hydrochloride. This belongs to two groups of medicines called
‘anticholinergics’ and ‘antispasmodics’
HOW DITROPAN TABLETS WORK
It works by relaxing the muscles of the bladder and stops sudden
muscle contractions (spasms). This helps control the release of
water (urine).
WHAT DITROPAN TABLETS ARE USED FOR
Ditropan Tablets can be used to treat:
•
Loss of control in passing water (urinary incontinence)
•
Increased need or urgency to pass water (urine)
•
Night time bedwetting in children 5 years or older, when other
treatments have not worked
Ditropan Tablets can be used 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
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DITROPAN TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic (hypersensitive) to oxybutynin hydrochloride or
any of the other

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ditropan 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg oxybutynin hydrochloride as the active
ingredient.
Also contains lactose, anhydrous.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from_ the UK:
Pale blue circular tablet with a centre break-line on one side and
marked ‘OXB5’ on the reverse.
4 CLINICAL PARTICULARS
As per PA0540/146/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/146/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose, anhydrous
Microcrystalline cellulose
Calcium stearate
Indigo carmine aluminium lake (E132)
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 on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30
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6.5 NATURE AND CONTENTS OF CONTAINER
Packs containing 84 tablets in four foil blister strips of 21 tablets
each in an over-labelled outer carton.
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
No special requirements.
7 PARALLEL PRODUCT AUTHORISA