Ditropan 5 mg Tablets

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

OXYBUTYNIN HYDROCHLORIDE

Fáanlegur frá:

LTT Pharma Limited

ATC númer:

G04BD; G04BD04

INN (Alþjóðlegt nafn):

OXYBUTYNIN HYDROCHLORIDE

Skammtar:

5 milligram(s)

Lyfjaform:

Tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Drugs for urinary frequency and incontinence; oxybutynin

Leyfisstaða:

Authorised

Leyfisdagur:

2016-10-07

Upplýsingar fylgiseðill

*
You have an enlarged prostate gland
*
You suffer from gastrointestinal disorders
*
You have indigestion or heart burn caused by a 'hiatus hernia'
(where part of your stomach pushes through the diaphragm)
*
You suffer from ulcerative colitis
*
You have porphyria, a rare blood disorder
*
You will be taking this medicine in a hot climate. Ditropan can make
you
more prone to decreased sweating which can cause heat stroke. If you
develop a fever while taking this medicine contact your doctor or
hospital
immediately to seek medical advice.
*
You suffer from liver enzyme disorders
*
Ditropan may reduce the amount of saliva resulting in tooth decay or
fungal
infection of the mouth.
If you are not sure if any of the above apply to you, talk to your
doctor or
pharmacist before taking Ditropan Tablets.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or have
recently taken
any other medicines. This includes medicines you buy without a
prescription,
including herbal medicines. This is because Ditropan Tablets can
affect the
way some other medicines work. Also some medicines can affect the way
Ditropan Tablets work.
IN PARTICULAR, TELL YOUR DOCTOR IF YOU ARE TAKING ANY OF THE
FOLLOWING:
*
Other anticholinergic medicines - such as some medicines for irritable
bowel syndrome, asthma or incontinence
*
Medicines that help the stomach empty more quickly
*
Medicines used to make you feel sleepy (sedatives) or if you are
feeling
sick (nausea) or have vertigo - such as prochlorperazine or
chlorpromazine
*
Medicines used to treat certain mental illnesses - such as haloperidol
or
beneridol (butyrophenones)
*
Medicines for depression - such as amitriptyline, imipramine or
dosulepin
('tricyclic antidepressants')
*
Bisphosphonates, as the risk of oesophagitis (inflammation of the
lining
of the oesophagus) may be increased
*
Amantadine - used in Parkinson's disease or to treat and prevent some
virus infections
*
L-dopa, biperiden - used to treat Parkinson's disease
*
Quinidine, digoxin - used to treat heart

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ditropan 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg oxybutynin hydrochloride as the active
ingredient.
Also contains Lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from UK_
Pale blue circular tablet with a centre break-line on one side and
marked with ‘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
Cellulose
Calcium Stearate
Indigo Carmine (E132)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30
o
C.
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6.5 NATURE AND CONTENTS OF CONTAINER
Packs contain 84 tablets in three foil blister strips of 28 tablets
each.
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 AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18
Oxleasow Road
East Moons Moat
Redditch
Wo