Toilax Micro Enema 10 mg/5 ml Rectal Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bisacodyl

Available from:

Orion Corporation

ATC code:

A06AG; A06AG02

INN (International Name):

Bisacodyl

Dosage:

10mg/5 millilitre(s)

Pharmaceutical form:

Rectal suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Enemas; bisacodyl

Authorization status:

Marketed

Authorization date:

1981-01-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOILAX MICRO ENEMA 10MG/5ML RECTAL SUSPENSION
(BISACODYL)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
This medicine is for short term use only.
-
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.
WHAT IS IN THIS LEAFLET:
1.
What Toilax is and what it is used for
2.
What you need to know before you use Toilax
3.
How to use Toilax
4.
Possible side effects
5.
How to store Toilax
6.
Contents of the pack and other information
1.
WHAT TOILAX IS AND WHAT IT IS USED FOR
Toilax Micro Enema contains bisacodyl. It belongs to a group of
medicines
called laxatives, which are used to treat constipation. Enemas are an
injection of
a liquid through the back passage (rectum) to induce bowel movement.
Toilax can be used when required to clear the back passage (rectum)
and
relieve constipation for short term use only. It may also be used to
clear the back
passage before operations or childbirth.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TOILAX
DO NOT USE TOILAX IF YOU:

have ever used Toilax or any other enemas before and have had a bad
reaction to them

are hypersensitive (allergic) to any of the ingredients in Toilax

suffer from severe abdominal or stomach pain

have been told by a doctor that you have a condition called Ileus
(swelling of
the intestines when the bowel muscles have stopped working)

are dehydrated

are breast-feeding (please refer to section ‘pregnancy and
breast-feeding’)

suffer from ulcers, haemorrhoids, or inflammation in or around the
back
passage (rectum).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Toilax if any of the
fo

Summary of Product characteristics

Health Products Regulatory Authority
23 December 2020
CRN00C1M1
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Toilax Micro Enema 10 mg/5 ml Rectal Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bisacody.
Each micro-enema contains 2mg/ml of bisacodyl.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Rectal suspension (enema).
Disposable yellow enema applicator tube with elongated tube nozzle
containing a white/grey ointment like preparation.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Toilax is indicated in adults and children over 10 years for
evacuation of the colon in constipation for short term use only. Prior
to surgical and diagnostic procedures and in obstetrics prior to
delivery. Use for other purposes must be under medical
supervision.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Children aged 10 years or younger with chronic constipation should
only be treated under the guidance of a physician.
Bisacodyl should not be used in children below 2 years of age.
_Short-term treatment for constipation:_
Adults and children over 10 years: One micro enema (10 mg) applied to
the rectum for immediate effect.
Children 2 - 10 years: Half a micro enema (5 mg) applied to the rectum
for immediate effect.
_For preparation of diagnostic procedures and preoperatively: _
Should only be used under medical supervision
Adults and children over 10 years: The recommended dose is one micro
enema (10 mg) rectally on the morning of the
examination, (preceded the previous day by two 5 mg bisacodyl oral
tablets in the morning and two 5 mg bisacodyl oral
tablets again in the evening).
Children 4-10 years of age: The recommended dose is half a micro enema
(5 mg) rectally on the morning of the examination,
(preceded the previous evening by one 5 mg bisacodyl oral tablet).
Older people: Dose as in adults for both indications. In some cases no
more than 5 mg should be administered.
The dosage refers to one administration per day. Long term use cannot
be recommended.
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