BISALAX bisacodyl 10mg/5mL enema tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bisacodyl, Quantity: 10 mg

Available from:

Orion Pharma (AUS) Pty Limited

Pharmaceutical form:

Enema

Composition:

Excipient Ingredients: citric acid monohydrate; macrogol 400; macrogol 4000; macrogol 3000; sodium citrate dihydrate

Administration route:

Rectal

Units in package:

25

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Constipation due to confinement to bed, unaccustomed diet or change of environment. Constipation in cases of serious diseases, circulatory disturbances and metabolic disorders; occasional use in chronic constipation; bowel re-training; postoperatively in cases of haemorrhoids and anal fissures; colostomies; preparation for radiography; preparation for sigmoidoscopy or proctoscopy; preoperative preparation; postoperative care; antepartum and postpartum constipation; and preparation for delivery.

Product summary:

Visual Identification: Yellow tube with yellow flip off cap which contains a white to grey viscous material; Container Type: Tube; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-21

Patient Information leaflet

BISALAX enemas - Consumer Medicine Information
1
BISALAX
® ENEMA
_bisacodyl _
CONSUMER MEDICINE INFORMATION (CMI)
IMPORTANT
This leaflet answers some common questions about
BISALAX enemas. It does not replace the advice from
your doctor or pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BISALAX ENEMAS ARE USED FOR
BISALAX contains bisacodyl as the active ingredient.
Bisacodyl is a stimulant laxative and is used to
provide relief from constipation or to empty the large
bowel before some medical procedures, operations or
X-rays.
It acts on the wall of the large bowel, encouraging
bowel movements by increasing muscle contractions
which push the stool mass along.
BEFORE USING IT
_WHEN YOU MUST NOT USE BISALAX _
BISALAX is not suitable for some patients. You should
not use this medicine if you have:
•
had an allergic reaction to bisacodyl
•
stomach cramps, colic or stomach pain
•
nausea or vomiting
•
blood in the stool
•
inflammatory bowel disease
•
a condition of the intestine called ‘ileus’
•
acute abdominal conditions such as appendicitis
•
an intestinal obstruction
•
severe dehydration
•
low potassium levels in the blood
•
haemorrhoids, or inflammation in or around the
back passage (rectum) or rectal ulcers.
_BEFORE YOU START TO USE IT _
TELL YOUR DOCTOR IF YOU ARE ALLERGIC TO ANY OTHER
MEDICINES OR ANY FOODS, DYES OR PRESERVATIVES.
TELL YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
had any unusual or allergic reaction to laxatives
•
noticed a sudden change in bowel habits or bowel
motions, that lasts longer than two weeks
•
missed a bowel motion for only a few days.
_USE IN CHILDREN _
ALWAYS ASK YOUR DOCTOR OR PHARMACIST BEFORE
GIVING ANY MEDICINES TO CHILDREN.
BISALAX enemas may be used in children.
_USE IN PREGNANCY OR BREAST FEEDING _
BISALAX is not known to be harmful in pregnancy or
while breast feeding.
However, if you are pregnant or breast feeding you
should discuss with your doctor or pharmacist the
ris

Summary of Product characteristics

PI – Bisalax (bisacodyl)
1 of 6
AUSTRALIAN PRODUCT INFORMATION
– BISALAX (BISACODYL) ENEMA
1
NAME OF THE MEDICINE
bisacodyl
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bisalax enema contains 10 mg bisacodyl/5 mL tube.
For the full list of excipients, see _section 6.1 List of excipients_.
3
PHARMACEUTICAL FORM
Enema
White to grey viscous material.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Constipation due to confinement to bed, unaccustomed diet or change of
environment.
Constipation in cases of serious diseases, circulatory disturbances
and metabolic disorders;
occasional
use
in
chronic constipation; bowel re-training; postoperatively in cases
of
haemorrhoids and anal fissures; colostomies; preparation for
radiography; preparation for
sigmoidoscopy or proctoscopy; preoperative preparation; postoperative
care; antepartum and
postpartum constipation; and preparation for delivery.
4.2 DOSE AND METHOD OF ADMINISTRATION
The enemas can be used in conjunction with tablets. Taken at bedtime,
Bisalax tablets are
almost invariably effective by the following morning. When taken
before breakfast, they usually
produce an effect within 6-8 hours. The effects of the enema occur
normally within 5 to
15 minutes.
ADULTS
_PREPARATION FOR X-RAY EXAMINATION OF ABDOMINAL ORGANS: _The day prior
to the examination,
2 tablets are taken orally at lunchtime and 2 tablets in the evening.
One enema is inserted into
the rectum in the morning one to two hours prior to examination. No
food should be given
following the administration of the tablets to prevent re-accumulation
of material in the caecum.
_AFTER X-RAY EXAMINATION: _To treat constipation due to barium
contrast medium, use one
enema.
_ACUTE CONSTIPATION: _Initially one enema, then 1 or 2 tablets late in
the evening and 1 enema
in the morning (after breakfast) for about three days.
_CONSTIPATION IN ELDERLY PATIENTS:_ One enema in the morning (after
breakfast) on days in
which defecation is desired.
_CHRONIC CONSTIPATION AND BOWEL RETRAINING: _By gradually increasing
the in