Colofac

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Mebeverine hydrochloride

Available from:

Abbott Australasia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

COLOFAC
®

_mebeverine hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Colofac.
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 has weighed
the risks of you taking this medicine
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 COLOFAC IS USED
FOR
Colofac is used relieve the symptoms
of irritable bowel syndrome, which
can include, abdominal pain and
cramps, bowel spasm, diarrhoea and
flatulence.
Colofac belongs to a group of
medicines called known as
antispasmodic agents. Colofac is also
known as mebeverine hydrochloride.
Colofac works by relaxing the
muscles in the gut, thereby relieving
the symptoms of irritable bowel
syndrome.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
COLOFAC
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE COLOFAC IF YOU HAVE AN
ALLERGY TO:
•
ANY MEDICINE CONTAINING
MEBEVERINE HYDROCHLORIDE
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT TAKE IT AFTER THE EXPIRY DATE
PRINTED ON THE PACK OR IF THE
PACKAGING IS DAMAGED OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged return
it to your pharmacist for disposal.
_BEFORE YOU START TO TAKE IT_
TELL YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY ALLERGIES TO ANY OTHER
MEDICINES, FOODS, PRESERVATIVES OR
DYES.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
angina or other he

Summary of Product characteristics

 
_Colofac PI _
_version 2 _
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PRODUCT INFORMATION 
COLOFAC


NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Mebeverine hydrochloride 
CHEMICAL STRUCTURE 

CAS NUMBER 
3625-06-7 
DESCRIPTION 
Mebeverine  hydrochloride  is  4-[ethyl-[2-(4-methoxyphenyl)-1-methylethyl]  aminobutyl 
veratrate  hydrochloride,  a  derivative  of  -phenylethylamine.    It  is  a  white  to  almost  white, 
crystalline powder having a very bitter taste, very soluble in water, freely soluble in ethanol 
and practically insoluble in ether. The empirical formula is C
25
H
35
NO
5
.HCl. MW: 466.0 
Each  Colofac  tablet  contains  mebeverine  hydrochloride  135  mg.    The  tablets  also  contain 
acacia,  carnauba  wax,  gelatine,  lactose,  magnesium  stearate,  povidone,  potato  starch, 
sucrose and purified talc. 
PHARMACOLOGY 
PHARMACODYNAMICS 
Category : Antispasmodic; smooth muscle relaxant. 
Mebeverine has a direct non-specific relaxant effect on vascular, cardiac, and other smooth 
muscle.  Studies indicate that the spasmolytic activity of mebeverine is not restricted to one 
particular system, but the compound possesses a polyvalent spasmolytic action in which at 
least three types of mechanisms are involved: 
- 
a  direct  musculotropic  action  involving  calcium  ion  exchange  and    stabilization  of 
excitable membranes; 
- 
a competitive antimuscarinic activity of about 0.05 - 0.1 times that of atropine; 
- 
a  local  anaesthetic  activity  together  with  potentiation  of  sympathetic  inhibitory 
influences due to blockade of noradrenaline uptake into sympathetic nerve endings. 
In  _in  vitro_  studies  mebeverine  hydrochloride  has  been  shown  to  have  a  papaverine-like 
spasmolytic  effect  on  the  smooth