Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking COLOFAC?
COLOFAC contains the active ingredient mebeverine hydrochloride. COLOFAC is taken
to relieve the symptoms of irritable bowel syndrome, which can include, abdominal
pain and cramps, bowel spasm, diarrhoea and flatulence.
2. What should I know before I take COLOFAC?
Do not take if you have ever had an allergic reaction to COLOFAC or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with COLOFAC and affect how it works.
4. How do I take COLOFAC?
Take COLOFAC at about the same time each day. The usual dose is one tablet three times
a day.
Take COLOFAC immediately before or during a meal. Swallow the tablets with a glass
of water.
5. What should I know while taking COLOFAC?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking COLOFAC.
If you become pregnant while you are taking COLOFAC, tell your doctor immediately.
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Things you should not do
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Do not take COLOFAC to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not give COLOFAC to anyone else, even if they have the same condition as you.
Do not stop taking COLOFAC, or lower the dosage, without checking with your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how COLOFAC
affects you.
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Looking after your medicine
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Keep your tablets in the pack until it is time to take them.
Keep COLOFAC in a cool, dry place where the temperature stays below 25°C.
Keep it where young children cannot reach it.
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6. Are there any side effects?
Speak to your doctor if you have any of these less serious side effects and they worry
you: indigestion or heartburn, constipation, dizziness, headache, tiredness, difficulty
sleeping, loss of appetite. Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects: swelling of the face, lips or tongue, difficulty swallowing or breathing.
Active ingredient:
mebeverine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking COLOFAC. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking COLOFAC.
Where to find information in this leaflet:
1. Why am I taking COLOFAC?
COLOFAC contains the active ingredient
mebeverine hydrochloride. COLOFAC belongs to a group of medicines called known as antispasmodic agents.
COLOFAC works by relaxing the muscles in the gut, thereby relieving the symptoms of
irritable bowel syndrome.
COLOFAC is taken to relieve the symptoms of irritable bowel syndrome, which can include,
abdominal pain and cramps, bowel spasm, diarrhoea and flatulence.
2. What should I know before I take COLOFAC?
Warnings
Do not take COLOFAC if:
you are allergic to mebeverine hydrochloride, or any of the ingredients listed at
the end of this leaflet. Always check the ingredients to make sure you can take this
medicine.
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.
Check with your doctor if you:
have any of the following medical conditions:
angina or other heart conditions
liver problems
kidney problems
lactose intolerance
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect COLOFAC.
4. How do I take COLOFAC?
How much to take
The usual dose is one tablet three times a day.
Follow the instructions provided and continue taking COLOFAC until your doctor tells
you to stop.
It is important to keep taking your medicine even if you feel well.
When to take COLOFAC
Take COLOFAC immediately before or during a meal.
Take COLOFAC at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How to take COLOFAC
Swallow the tablets with a glass of water.
If you forget to take COLOFAC
COLOFAC should be taken at the same time each day. If you miss your dose at the usual
time, take it as soon as you remember, and then go back to taking your medicine as
you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
advice.
If you take too much COLOFAC
If you think that you have taken too much COLOFAC, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking COLOFAC?
Things you should do
Call your doctor straight away if you:
become pregnant while you are taking COLOFAC
If you are going to have surgery, tell the surgeon that you are taking COLOFAC.
Remind any doctor, dentist or pharmacist you visit that you are taking COLOFAC.
Things you should not do
Do not take COLOFAC to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not give COLOFAC to anyone else, even if they have the same condition as you.
Do not stop taking COLOFAC, or lower the dosage, without checking with your doctor
Driving or using machines
Be careful before you drive or use any machines or tools until you know how COLOFAC
affects you.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the box or the blister pack they may not keep well.
Keep the medicine in a cool, dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What COLOFAC contains
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Active ingredient
(main ingredient)
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mebeverine hydrochloride 135 mg per tablet
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Other ingredients
(inactive ingredients)
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lactose monohydrate
potato starch
povidone
purified talc
magnesium stearate
sucrose
gelatin
acacia
carnauba wax
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Potential allergens
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lactose, sugars and traces of sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What COLOFAC looks like
COLOFAC tablets are white, round sugar-coated tablets. (AUST R 79335).
COLOFAC tablets are available in boxes of 30 and 90 tablets.
Who distributes COLOFAC
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
COLOFAC is made in France.
This leaflet was prepared in February 2022.
COLOFAC® is a Viatris company trade mark
COLOFAC_cmi\Feb22/00