Colofac(R)
mebeverine hydrochloride tablets
Consumer Medicine Information
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 COLOFAC 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 to relieve the symptoms of irritable bowel syndrome, which include, abdominal pain and cramps, bowel spasm, diarrhoea and flatulence.
COLOFAC belongs to a group of medicines 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.
Your doctor may have prescribed COLOFAC for another reason. Ask your doctor if you have any questions about why COLOFAC has been prescribed for you.
There is no evidence that COLOFAC is addictive.
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 are allergic to mebeverine hydrochloride or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include:
Do not take COLOFAC if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking COLOFAC, talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
Tell your doctor if you have or have had any medical conditions, especially the following:
Tell your doctor if you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits of using COLOFAC during pregnancy.
Tell your doctor if you are breast-feeding or plan to breast-feed.
Your doctor will discuss the possible risks and benefits of using COLOFAC during breastfeeding.
If you have not told your doctor about any of the above, tell them before you start taking COLOFAC.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
How to take COLOFAC
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
Your doctor or pharmacist will tell you how many tablets you will need to take each day.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
The usual dose is one tablet three times a day.
How to take it
Swallow COLOFAC with a glass of water.
When to take it
Take COLOFAC immediately before or during a meal, at about the same time each day.
How long to take it
Do not stop taking it unless your doctor or pharmacist tells you to – even if you feel better.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much COLOFAC. Do this even if there are no signs of discomfort or poisoning.
While you are taking COLOFAC
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking COLOFAC.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking COLOFAC.
If you become pregnant while taking COLOFAC, tell your doctor.
Things you must not do
Do not give COLOFAC to anyone else, even if they have the same condition as you.
Do not take COLOFAC to treat any other complaints unless your doctor or pharmacist tells you to.
Do not stop taking COLOFAC, or lower the dosage, without checking with your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how COLOFAC affects you.
As with other medicines, COLOFAC may cause dizziness, in some people. Make sure you know how you react to COLOFAC before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking COLOFAC.
COLOFAC helps most people with irritable bowel syndrome, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
These are the more common side effects of Colofac. Mostly these are mild.
Tell your doctor as soon as possible if you notice any of the following:
These may be serious side effects, which need immediate medical attention. All of these side effects are very rare.
Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.
After using COLOFAC
Storage
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they will not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30 degrees C.
Do not store COLOFAC or any other medicine in the bathroom or near a sink.
Do not leave it on a window sill or in the car on hot days.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor or pharmacist tells you to stop taking COLOFAC or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
COLOFAC tablets are white, round, biconvex, sugar-coated tablets. Available in packs of 30 and 90 tablets.
AUST R: 79335.
Ingredients
Active ingredients:
Mebeverine hydrochloride 135 mg.
Other ingredients
Lactose, potato starch, povidone, purified talc, magnesium stearate, sucrose, gelatin, acacia and carnauba wax.
Sponsor
Solvay Pharmaceuticals
Level 1, Building 2, 20 Bridge St.
Pymble NSW 2073
A division of Solvay Biosciences Pty. Ltd.
Telephone: (02) 944 00 977
This leaflet was prepared in May 2001