DITROPAN TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmaco Distribution (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 5 mg

Authorization status:

Registered

Authorization date:

1980-06-10

Patient Information leaflet

DITROPAN
®
PHARMACO DISTRIBUTION (PTY) LTD
1.3.2
L/5.4/104
Each tablet contains 5 mg oxybutynin chloride
Amended: 15 Jan 2020
_ _
_ _
Page 1 of 8
1.3.2
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S3
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
DITROPAN, 5 mg, tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DITROPAN

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or pharmacist.

DITROPAN has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT DITROPAN CONTAINS

The active substance is oxybutynin hydrochloride, 5 mg per tablet.

The other ingredients are calcium stearate, cellulose
(microcrystalline), Indigo carmine aluminium
lake (E132) and lactose (anhydrous).

Contains sugar (anhydrous lactose).
WHAT DITROPAN IS USED FOR
DITROPAN is used to decrease the urgency and the frequency of
urination.
DITROPAN is also used to decrease bed-wetting in children older than 5
years.
BEFORE YOU TAKE DITROPAN
DO NOT TAKE DITROPAN:

if you are hypersensitive (allergic) to oxybutynin hydrochloride or
any of the other ingredients
of
DITROPAN.
Signs
of
an
allergic
reaction
include:
a
rash,
swallowing
or
breathing
problems, swelling of your lips, face, throat or tongue
DITROPAN
®
PHARMACO DISTRIBUTION (PTY) LTD
1.3.2
L/5.4/104
Each tablet contains 5 mg oxybutynin chloride
Amended: 15 Jan 2020
_ _
_ _
Page 2 of 8

if you have increased pressure in the eye (glaucoma)

if your stomach or intestine are blocked, perforated or not working
properly

if you have a severe form of a condition known as ‘ulcerative
colitis’

if you have a rare muscle illness called ‘myasthenia gravis’

if you have a blockage of your bladder that makes it difficult for
your to pass water(urine)

if you have severe bleeding

if you have a hypotonic neurogenic bladder (an enlarged bladder in
which the emptying reflex
beco

Summary of Product characteristics

DITROPAN
®
PHARMACO DISTRIBUTION (PTY) LTD
1.3.1.1
L/5.4/104
Each tablet contains 5 mg oxybutynin chloride
Amended: 15 Jan 2020
_ _
_ _
Page 1 of
8
1.3.1.1
PACKAGE INSERT
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
DITROPAN
®
Tablets
COMPOSITION
Each tablet contains oxybutynin hydrochloride 5 mg.
_Excipients _
Indigo carmine aluminium lake (E132), microcrystalline cellulose,
anhydrous lactose, calcium stearate.
Contains sugar (anhydrous lactose).
PHARMACOLOGICAL CLASSIFICATION
A 5.4 Medicines affecting autonomic functions: cholinolytics
(anticholinergics).
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES:
Oxybutynin hydrochloride exerts a direct antispasmodic effect on
smooth muscle and inhibits the
muscarinic action of acetylcholine on smooth muscle.
In
patients
with
uninhibited
neurogenic
and
reflex
neurogenic
bladder,
cystometric
studies
have
demonstrated that oxybutynin hydrochloride increases bladder capacity,
diminishes the frequency of
uninhibited contractions of the detrusor muscle and delays the initial
desire to void.
PHARMACOKINETIC PROPERTIES:
Oxybutynin is poorly absorbed from the gastrointestinal tract. It is
highly bound to plasma proteins, the
peak
plasma
level
in
healthy
young
volunteers
is
reached
between
0,5
and
1
hour
after
administration. The elimination phase is biexponential, with an
elimination half-life of about 2-3 hours.
DITROPAN
®
PHARMACO DISTRIBUTION (PTY) LTD
1.3.1.1
L/5.4/104
Each tablet contains 5 mg oxybutynin chloride
Amended: 15 Jan 2020
_ _
_ _
Page 2 of
8
The elimination half-life is increased in the elderly, particularly if
they are frail.
Oxybutynin and its metabolites are excreted in the feces and urine.
INDICATIONS

DITROPAN tablets are indicated for the relief of symptoms associated
with voiding in patients
with uninhibited neurogenic and reflex neurogenic bladder, (i.e.
urgency, frequency, urinary
leakage, urge incontinence, dysuria).

DITROPAN is indicated for spastic neurogenic bladder (and not
hypotonic neurogenic bladder –
see “CONTRAINDICATI