DITROPAN oxybutynin hydrochloride 5mg tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxybutynin hydrochloride, Quantity: 5 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; brilliant blue FCF aluminium lake; lactose; calcium stearate

Administration route:

Oral

Units in package:

100 tablets, 30, 90 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of detrusor over-activity where conservative measures have failed.

Product summary:

Visual Identification: Light blue, round, single scored tablet, blank on both sides; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1994-05-30

Patient Information leaflet

DITROPAN
DIT-RO(H)-PAN)
_oxybutynin hydrochloride (oxy-BEAUT-in-in HIGH-dro(h)-CLOR-ride)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ditropan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
Ditropan against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DITROPAN IS USED
FOR
Ditropan is used to decrease the
urgency and the frequency of
urination. Ditropan works by
relaxing the bladder smooth muscle
and helps to decrease muscle spasm.
This delays the initial desire and the
urge to urinate.
Your doctor may have prescribed
Ditropan for another reason.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
DITROPAN HAS BEEN PRESCRIBED FOR
YOU.
There is no evidence that Ditropan is
addictive.
This medicine is available only with
a doctor's prescription.
Ditropan is not recommended for use
in children under the age of 5 years,
as there have been no studies of its
effects in children.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DITROPAN IF YOU HAVE
AN ALLERGY TO DITROPAN OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
DO NOT TAKE DITROPAN IF YOU HAVE:
•
angle closure glaucoma or
shallow anterior chamber -
disorders of the eye
•
partial or complete intestinal
blockage; stomach, intestinal or
large bowel problems including
colitis (inflammation of the
colon)
•
myasthenia gravis - a disease of
the muscles
•
urinary tract blockage
•
severe bleeding
DO NOT TAKE DITROPAN IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
The safety of the use of Ditropan in
women who are pregnant or may
become pregnant has not been
established.
Like most medicines, Ditropan is not
recommended for use during

Summary of Product characteristics

ditropan-ccdsv5-piv12-22jul22
1
AUSTRALIAN PRODUCT INFORMATION – DITROPAN
(OXYBUTYNIN HYDROCHLORIDE)
1
NAME OF THE MEDICINE
oxybutynin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains oxybutynin hydrochloride 5 mg.
EXCIPIENTS WITH KNOWN EFFECT:
Sugars as lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Light blue, round, single scored uncoated tablet, blank on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of detrusor over-activity where conservative measures have
failed.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults: The usual dose is one 5 mg tablet two to three times a day.
The maximum
recommended dose is one 5 mg tablet four times a day.
In the frail and elderly patient it is advisable to initiate treatment
at a low dose and, if
necessary to increase the dose carefully according to tolerance and
response. Initial doses for
geriatric patients of 2.5 mg twice daily have been reported in the
literature.
Children over 5 years of age: The usual dose is one 5 mg tablet twice
a day. The maximum
recommended dose is one 5 mg tablet three times a day.
4.3
CONTRAINDICATIONS
Ditropan is contraindicated in patients with increased intraocular
pressure associated with
angle closure (glaucoma) or shallow anterior chamber since
anticholinergic drugs may
ditropan-ccdsv5-piv12-22jul22
2
aggravate this condition. It is also contraindicated in partial or
complete obstruction of the
gastrointestinal tract, paralytic ileus, intestinal atony of the
elderly or debilitated patient,
megacolon, toxic megacolon complicating ulcerative colitis, severe
colitis, and myasthenia
gravis. It is contraindicated in patients with obstructive uropathy
and in patients with
unstable cardiovascular status in acute haemorrhage.
Ditropan is contraindicated in patients who have demonstrated
hypersensitivity to the
product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid dosage in high environmental temperatures and excessive exercise
in high
tempe