MYLAN IBS RELIEF TABLETS

Active substance: MEBEVERINE HYDROCHLORIDE

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There is only limited information about the safety
of mebeverine hydrochloride for pregnant
women. Your doctor may advise you to stop taking
Mylan IBS Relief before you become pregnant or
as soon as you know you are pregnant. Mylan IBS
Relief should not be used during breast-feeding.

These symptoms may vary from person to person.

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MYLAN IBS RELIEF
TABLETS
(mebeverine hydrochloride 135 mg)

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in
this leaflet or as your doctor, pharmacist or nurse
has told you
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• If you get any side effects, talk to your doctor, or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
• You must talk to a doctor if you do not feel
better or if you feel worse after 2 weeks of
treatment.

What is in this leaflet
1. What Mylan IBS Relief is and what it is used for
2. What you need to know before you take Mylan
IBS Relief
3. How to take Mylan IBS Relief
4. Possible side effects
5. How to store Mylan IBS Relief
6. Contents of the pack and other information.
1. WHAT MYLAN IBS RELIEF IS AND WHAT IT IS
USED FOR

This 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 and pain.
The main symptoms of irritable bowel syndrome
(IBS) include:
• stomach pain and spasm
• persistent diarrhoea, or alternating constipation
and diarrhoea
• flatulence (wind) and feeling bloated
• small, hard, pellet-like or ribbon-like stools
(faeces)

Mylan IBS Relief contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

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.

3. HOW TO TAKE MYLAN IBS RELIEF
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MYLAN IBS RELIEF
Do not take Mylan IBS Relief:
• if you are allergic to mebeverine hydrochloride or
to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor before using any IBS treatment:
• If this is the first time you have had the symptoms
described above or have developed new or
worsened symptoms.
• If you have liver or kidney problems.
Please contact your doctor so that he can decide if
Mylan IBS Relief is the right treatment for you if you:
• are aged 40 years or over and your symptoms
have changed or it has been some time since you
last had IBS
• have passed blood from the bowel
• are feeling or being sick
• have lost your appetite or lost weight
• are looking pale and feeling tired
• are suffering from severe constipation
• have a fever
• have recently travelled abroad
• are, may be or are planning to become pregnant
• have unusual bleeding or discharge from the
vagina
• have difficulty or pain passing urine.

The tablet should be taken 20 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.
Adults (including the Elderly):
The recommended dose is one tablet three times a
day. Do not take more than three tablets per day.
The number of tablets you take may be lowered if
your symptoms improve.
Children and adolescents:
Mylan IBS Relief is not recommended for use in
children and adolescents below 18 years of age.

Consult your doctor if you have developed new
symptoms, or if the symptoms worsen, or if they
do not improve after 2 weeks of treatment.

If you take more Mylan IBS Relief than you
should
If you take more Mylan IBS Relief than you should
(overdose), contact your doctor or hospital
emergency department immediately. Take this
leaflet and any remaining tablets with you.
If you forget to take Mylan IBS Relief
If you forget to take a dose of Mylan IBS Relief at
the right time, do not take a double dose to make
up for the forgotten tablet.

5. HOW TO STORE MYLAN IBS RELIEF
Keep this medicine out of the sight and reach of
children.
Do not take this medicine after the expiry date,
which is stated on the carton after 'EXP'. The expiry
date refers to the last day of that month.
Store this medicine in a dry place below 30°C and
protect from light.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Mylan IBS Relief tablet contains
The active substance is 135 mg of mebeverine
hydrochloride.
The other ingredients are microcrystalline
cellulose, lactose monohydrate, povidone, talc,
magnesium stearate and sodium starch glycollate.
The tablet coating includes hydroxypropyl
methylcellulose (E464), titanium dioxide (E171)
and polyethylene glycol.
What Mylan IBS Relief tablet looks like and
contents of the pack
Mylan IBS Relief is a white film coated tablet
marked 'MV135' on one side. It is available in
blister packs of 15.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Manufacturer
Gerard Laboratories 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.

If you have any further questions on the use of this
medicine, ask your pharmacist.
4. POSSIBLE SIDE EFFECTS

Other medicines and Mylan IBS Relief
Mylan IBS Relief is not known to interact with
other medicines but you should tell your doctor or
pharmacist if you are taking or have recently taken
any other medicines and notice any strange side
effects when you start taking Mylan IBS Relief.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
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Other side effects (frequency unknown)
allergic reactions may occur, such as skin reactions
(inflamed or reddened skin, itching or skin rashes).

If you suffer from swelling of the face, lips and/or
tongue, stop taking the tablets and go to your
doctor immediately, or your nearest hospital.

This leaflet was last revised in: 08/2012.

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Mylan IBS Relief is used to treat the symptoms of
irritable bowel syndrome (IBS).

Driving and using machines
Mylan IBS Relief should not affect your ability to
drive or use machines.

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Mylan IBS Relief is a tablet containing mebeverine
hydrochloride. This belongs to a group of
medicines called antispasmodics.

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 things 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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Talk to your doctor if you develop new symptoms
or if these symptoms continue for more than
2 weeks.

If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not
listed in this leaflet.

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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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