MEBEVERINE HYDROCHLORIDE 135MG TABLETS

Active substance: MEBEVERINE HYDROCHLORIDE

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S544 LEAFLET Colofac 20120712

PACKAGE LEAFLET: INFORMATION FOR THE USER

2. BEFORE YOU TAKE COLOFAC TABLETS
Do not take Colofac Tablets if:


COLOFAC 135mg TABLETS
(mebeverine hydrochloride)
Your medicine is known by Colofac 135mg Tablets but will be
referred to as Colofac Tablets throughout the following leaflet.

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 Tablets
Check with your doctor or pharmacist before taking your medicine
if:

Read all of this leaflet carefully before you start taking this
medicine.



You have developed new symptoms or your symptoms have
become worse



Keep this leaflet. You may need to read it again.



You have liver or kidney problems.



If you have any further questions, ask your doctor or
pharmacist.

If the above applies to you (or you are not sure), talk to your doctor
or pharmacist before taking this medicine.



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.

Taking Colofac Tablets with food and drink



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.
In this leaflet

You can drink alcohol while you are taking Colofac Tablets.
Taking other medicines
No interactions with other medicines are known.

1 What Colofac Tablets are and what they are used for
2 Before you take Colofac Tablets

Pregnancy and breast-feeding

3 How to take Colofac Tablets

You should talk to your doctor or pharmacist before taking Colofac
Tablets if you are pregnant or might become pregnant. There is
only limited information about the safety of Mebeverine for pregnant
woman. Your doctor may advice you to stop taking Colofac Tablets
before you become pregnant or as soon as you know you are
pregnant. Colofac Tablets should not be used during breastfeeding.

4 Possible side effects
5 How to store Colofac Tablets
6 Further information
1. WHAT COLOFAC TABLETS ARE AND WHAT THEY ARE USED
FOR
Colofac Tablets 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:

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
Tablets
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.
3. HOW TO TAKE COLOFAC TABLETS



stomach pain and spasm



How to take Colofac Tablets

feeling bloated and having wind





having diarrhoea (with or without constipation)



small, hard, pellet-like or ribbon-like stools (faeces)

Try to take the tablet twenty minutes before a meal - some
people find their symptoms to be strongest after they have
eaten.

These symptoms may vary from person to person.



Swallow the tablet whole with water. Do not chew the tablet.

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.

How many Colofac Tablets to take
Adults and the elderly:


Your diet and lifestyle can also help treat IBS:
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.

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 Tablets to children or adolescents younger than
18 years.
If you take more Colofac Tablets than you should
If you or someone else takes too many Colofac Tablets (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 Tablets
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 Tablets
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines Colofac Tablets can cause side effects
(unwanted effects or reaction) but not everyone gets them.
Allergic reactions such as:


swelling of your face, lips or tongue



a red skin rash, itching, inflamed skin.

If you notice any of the above, stop taking this medicine and see
your doctor straight away.
If you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE COLOFAC TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Colofac Tablets should not be stored above 25°C. Store in the
original package.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

6. FURTHER INFORMATION
What Colofac Tablets contains


Each tablet contains 135mg of the active ingredient mebeverine
hydrochloride



Colofac Tablets also contain the following inactive ingredients:
lactose, starch, povidone, talc, magnesium stearate, sucrose,
gelatin, acacia gum carnauba wax and beeswax.

What Colofac Tablets looks like and contents of the pack


Colofac Tablets are round white sugar coated tablets.



Colofac Tablets are available as blister packs of 60 or 100
tablets.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by either of the below manufacturers

Abbott Healthcare, S.A, Av Diagonal 507, 08029 Barcelona,
Spain



Solvay Pharma S.A, Av Diagonal 507, 08029 Barcelona, Spain



Recipharm Parets, S.L. Ramon y Cajal, 2 08150 Parets del
Valles, Barcelona, Spain

POM PL No. 19488/0544
Leaflet revision date: 12 July 2012
Colofac is a registered trade mark of Solvay Pharmaceuticals BV,
The Netherlands.
S544 LEAFLET Colofac 20120712

S544 LEAFLET Mebeverine 20120712

2. BEFORE YOU TAKE MEBEVERINE TABLETS
Do not take Mebeverine Tablets if:

PACKAGE LEAFLET: INFORMATION FOR THE USER

MEBEVERINE HYDROCHLORIDE 135mg TABLETS
Your medicine is known by Mebeverine hydrochloride 135mg
Tablets but will be referred to as Mebeverine Tablets throughout the
following leaflet.

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.



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 Tablets
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 Tablets with food and drink
You can drink alcohol while you are taking Mebeverine Tablets.



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.
In this leaflet

Taking other medicines
No interactions with other medicines are known.

1 What Mebeverine Tablets are and what they are used for

Pregnancy and breast-feeding

2 Before you take Mebeverine Tablets

You should talk to your doctor or pharmacist before taking
Mebeverine Tablets if you are pregnant or might become pregnant.
There is only limited information about the safety of Mebeverine for
pregnant woman. Your doctor may advice you to stop taking
Mebeverine Tablets before you become pregnant or as soon as you
know you are pregnant. Mebeverine Tablets should not be used
during breast-feeding.

3 How to take Mebeverine Tablets
4 Possible side effects
5 How to store Mebeverine Tablets
6 Further information
1. WHAT MEBEVERINE TABLETS ARE AND WHAT THEY ARE
USED FOR

Driving and using machines

Mebeverine Tablets contain Mebeverine hydrochloride. This belongs
to a group of medicines called antispasmodics.

This medicine is not likely to affect you being able to drive or use
any tools or machines.

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



small, hard, pellet-like or ribbon-like stools (faeces)

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.
3. HOW TO TAKE MEBEVERINE TABLETS
How to take Mebeverine Tablets

having diarrhoea (with or without constipation)



Important information about some of the ingredients of
Mebeverine Tablets



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.

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.
Your diet and lifestyle can also help treat IBS:
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.

How many Mebeverine Tablets 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 Tablets to children or adolescents younger
than 18 years.
If you take more Mebeverine Tablets than you should
If you or someone else takes too many Mebeverine Tablets (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 Tablets
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 Tablets
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines Mebeverine Tablets can cause side effects
(unwanted effects or reaction) but not everyone gets them.
Allergic reactions such as:


swelling of your face, lips or tongue



a red skin rash, itching, inflamed skin.

If you notice any of the above, stop taking this medicine and see
your doctor straight away.
If you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE MEBEVERINE TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Mebeverine Tablets should not be stored above 25°C. Store in
the original package.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

6. FURTHER INFORMATION
What Mebeverine Tablets contains


Each tablet contains 135mg of the active ingredient mebeverine
hydrochloride



Mebeverine Tablets also contain the following inactive
ingredients: lactose, starch, povidone, talc, magnesium
stearate, sucrose, gelatin, acacia gum carnauba wax and
beeswax.

What Mebeverine Tablets looks like and contents of the pack


Mebeverine Tablets are round white sugar coated tablets.



Mebeverine Tablets are available as blister packs of 60 or 100
tablets.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by either of the below manufacturers

Abbott Healthcare, S.A, Av Diagonal 507, 08029 Barcelona,
Spain



Solvay Pharma S.A, Av Diagonal 507, 08029 Barcelona, Spain



Recipharm Parets, S.L. Ramon y Cajal, 2 08150 Parets del
Valles, Barcelona, Spain

POM PL No. 19488/0544
Leaflet revision date: 12 July 2012
S544 LEAFLET Mebeverine 20120712

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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