Mebeverine Hydrochloride 135mg Tablets
1. What Colofac is and what it is used
for
1. What Colofac is and what it is used
for
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Colofac 135mg
tablets but it will be referred to as Colofac
throughout this leaflet.
In this leaflet:
1. What Colofac is and what it is used for
2. Before you take Colofac
3. How to take Colofac
4. Possible side effects
5. How to store Colofac
6. Further information
Package leaflet: information for the user
Colofac®
135mg tablets
(mebeverine hydrochloride)
Colofac contains Mebeverine hydrochloride. This belongs to a group of medicines called antispasmodics.
This medicine is used to treat symptoms of irritable bowel syndrome (IBS) and similar problems such as chronic irritable colon, spastic constipation, mucous colitis and spastic colitis.
Irritable bowel syndrome (IBS) is a very common condition which causes spasm and pain in the gut or intestine.
The intestine is a long muscular tube which food passes down so it can be digested. If the intestine goes into spasm and squeezes too tightly, you get pain. The way this medicine works is by relieving the spasm, pain and other symptoms of IBS.
The main symptoms of irritable bowel syndrome (IBS) include:
• stomach pain and spasm
• feeling bloated and having wind
• having diarrhoea (with or without constipation)
• small, hard, pellet-like or ribbon-like stools (faeces)
These symptoms may vary from person to person.
Talk to your doctor if these symptoms do not improve after a while, if you develop new symptoms or you are concerned about your symptoms.
3. How to take Colofac
How you restrict your diet depends on the way IBS affects you. If you find that certain foods bring on the symptoms, then it makes sense not to eat them. A high fibre diet may help, but ask your pharmacist for more information.
Some people find that learning to relax can help to lessen their symptoms of IBS. You may find it helpful to set aside a few moments each day to relax and gently unwind.
2. Before you take Colofac
Do not take Colofac if:
• You are allergic to any of the tablet ingredients (see section 6 for a list of ingredients).
If any of the above applies to you, do not take this medicine and talk to your doctor or pharmacist.
Take special care with Colofac
Check with your doctor or pharmacist before taking your medicine if:
• You have developed new symptoms or your symptoms have become worse.
• You have liver or kidney problems.
If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Taking Colofac with food and drink
You can drink alcohol while you are taking Colofac.
No interactions with other medicines are known.
Pregnancy and breast-feeding
You should talk to your doctor or pharmacist before taking Colofac if you are pregnant or might become pregnant. There is only limited information about the safety of Mebeverine for pregnant women. Your doctor may advise you to stop taking Colofac before you become pregnant or as soon as you know you are pregnant. Colofac should not be used during breast-feeding.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Colofac
This medicine contains lactose and sucrose (types of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
How to take Colofac
• Try to take the tablet twenty minutes before a meal - some people find their symptoms to be strongest after they have eaten.
• Swallow the tablet whole with water. Do not chew the tablet.
5. How to store Colofac
How many Colofac to take Adults and the elderly:
• Take 1 tablet 3 times a day
• The number of tablets you take can be lowered if your symptoms improve
• Do not take more than 3 tablets per day.
Do not give Colofac to children or adolescents younger than 18 years.
If you take more Colofac than you should
If you or someone else takes too many Colofac (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Colofac
If you miss a tablet, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
How to stop taking Colofac
Do not stop taking the tablets without talking to your doctor, even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Most people will not have problems, but some may get some side effects (unwanted effects or reactions).
If you get any of these serious side effects, stop taking the tablets. See a doctor at once:
• Difficulty in breathing, swelling of face, neck, tongue or throat (severe allergic reactions)
These other effects are less serious. If they bother you talk to a pharmacist:
• Skin rash, red itchy skin
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.qov.uk/vellowcard By reporting side effects, you can help provide more information on the safety of this medicine.
• Keep out of the sight and reach of children
• Do not store above 30°C. Store in the original package in order to protect from light.
• Do not use after the expiry date which is stated on the carton and blister strips after ‘Exp’. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Colofac contains
• The active ingredient is mebeverine hydrochloride. Each tablet contains 135mg mebeverine hydrochloride.
• The other ingredients are:
- Tablet core: lactose monohydrate, starch (potato or maize), povidone, talc and magnesium stearate.
- Coating: talc, sucrose, gelatin, acacia and carnauba wax.
What Colofac looks like and contents of the
pack
The tablets are round, white and sugar-coated.
Colofac comes in PVC/Aluminium blister strips of
100 tablets.
Manufactured by: Abbott Healthcare SAS, Route de Belleville, 01400 Chatillon-sur-Chalaronne, France. OR
Mylan Laboratories SAS, Route de Belleville, 01400 Chatillon-sur-Chalaronne, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
POM
HA4 0NU, UK.
Colofac 135mg tablets ; PL 18799/2488
Leaflet date: 08.06.2016
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Mebeverine hydrochloride 135mg tablets but it will be referred to as Mebeverine throughout this leaflet.
In this leaflet:
1. What Mebeverine is and what it is used for
2. Before you take Mebeverine
3. How to take Mebeverine
4. Possible side effects
5. How to store Mebeverine
6. Further information
Package leaflet: information for the user
Mebeverine hydrochloride 135mg tablets
Mebeverine contain Mebeverine hydrochloride. This belongs to a group of medicines called antispasmodics.
This medicine is used to treat symptoms of irritable bowel syndrome (IBS) and similar problems such as chronic irritable colon, spastic constipation, mucous colitis and spastic colitis.
Irritable bowel syndrome (IBS) is a very common condition which causes spasm and pain in the gut or intestine.
The intestine is a long muscular tube which food passes down so it can be digested. If the intestine goes into spasm and squeezes too tightly, you get pain. The way this medicine works is by relieving the spasm, pain and other symptoms of IBS.
The main symptoms of irritable bowel syndrome (IBS) include:
• stomach pain and spasm
• feeling bloated and having wind
• having diarrhoea (with or without constipation)
• small, hard, pellet-like or ribbon-like stools (faeces)
These symptoms may vary from person to person.
Talk to your doctor if these symptoms do not improve after a while, if you develop new symptoms or you are concerned about your symptoms.
3. How to take Mebeverine
How you restrict your diet depends on the way IBS affects you. If you find that certain foods bring on the symptoms, then it makes sense not to eat them. A high fibre diet may help, but ask your pharmacist for more information.
Some people find that learning to relax can help to lessen their symptoms of IBS. You may find it helpful to set aside a few moments each day to relax and gently unwind.
2. Before you take Mebeverine
Do not take Mebeverine if:
• You are allergic to any of the tablet ingredients (see section 6 for a list of ingredients).
If any of the above applies to you, do not take this medicine and talk to your doctor or pharmacist.
Take special care with Mebeverine
Check with your doctor or pharmacist before taking your medicine if:
• You have developed new symptoms or your symptoms have become worse.
• You have liver or kidney problems.
If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Taking Mebeverine with food and drink
You can drink alcohol while you are taking Mebeverine.
No interactions with other medicines are known.
Pregnancy and breast-feeding
You should talk to your doctor or pharmacist before taking Mebeverine if you are pregnant or might become pregnant. There is only limited information about the safety of Mebeverine for pregnant women. Your doctor may advise you to stop taking Mebeverine before you become pregnant or as soon as you know you are pregnant. Mebeverine should not be used during breast-feeding.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Mebeverine
This medicine contains lactose and sucrose (types of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
How to take Mebeverine
• Try to take the tablet twenty minutes before a meal - some people find their symptoms to be strongest after they have eaten.
• Swallow the tablet whole with water. Do not chew the tablet.
5. How to store Mebeverine
How many Mebeverine to take Adults and the elderly:
• Take 1 tablet 3 times a day
• The number of tablets you take can be lowered if your symptoms improve
• Do not take more than 3 tablets per day.
Do not give Mebeverine to children or adolescents younger than 18 years.
If you take more Mebeverine than you should
If you or someone else takes too many Mebeverine (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Mebeverine
If you miss a tablet, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
How to stop taking Mebeverine
Do not stop taking the tablets without talking to your doctor, even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Most people will not have problems, but some may get some side effects (unwanted effects or reactions).
If you get any of these serious side effects, stop taking the tablets. See a doctor at once:
• Difficulty in breathing, swelling of face, neck, tongue or throat (severe allergic reactions)
These other effects are less serious. If they bother you talk to a pharmacist:
• Skin rash, red itchy skin
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.qov.uk/vellowcard By reporting side effects, you can help provide more information on the safety of this medicine.
• Keep out of the sight and reach of children
• Do not store above 30°C. Store in the original package in order to protect from light.
• Do not use after the expiry date which is stated on the carton and blister strips after ‘Exp’. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Mebeverine contains
• The active ingredient is mebeverine hydrochloride. Each tablet contains 135mg mebeverine hydrochloride.
• The other ingredients are:
- Tablet core: lactose monohydrate, starch (potato or maize), povidone, talc and magnesium stearate.
- Coating: talc, sucrose, gelatin, acacia and carnauba wax.
What Mebeverine looks like and contents of
the pack
The tablets are round, white and sugar-coated.
Mebeverine comes in PVC/Aluminium blister strips
of 100 tablets.
Manufactured by: Abbott Healthcare SAS, Route de Belleville, 01400 Chatillon-sur-Chalaronne, France. OR
Mylan Laboratories SAS, Route de Belleville, 01400 Chatillon-sur-Chalaronne, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK. [pqm
Mebeverine hydrochloride 135mg tablets;
PL 18799/2488
Leaflet date: 08.06.2016