MYLAN IBS RELIEF TABLETS

Active substance: MEBEVERINE HYDROCHLORIDE

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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).
These symptoms may vary from person to person.
Talk to your doctor if you develop new symptoms or
if these symptoms continue for more than 2 weeks.

3. HOW TO TAKE MYLAN IBS RELIEF

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. This is to make sure
that the treatment is suitable for you.
• If you have developed new or worsened symptoms.
• If you have liver or kidney problems.
Do not use this medicine without talking to your
doctor 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 in your stools or motions
• are feeling sick or being sick
• have lost your appetite or lost weight
• look pale and feel tired
• are suffering from severe constipation
• have a fever
• have recently travelled abroad
• are, may be or are planning to become pregnant
• have abnormal bleeding or discharge from the
vagina
• have difficulty or pain when passing water.
Talk to your doctor if you get new symptoms, your
symptoms get worse, or if they do not improve
after 2 weeks of treatment.
Mylan IBS Relief with alcohol
You can drink alcohol while you are taking 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.
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.
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.

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.
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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If you forget to take Mylan IBS Relief
If you forget to take a dose of Mylan IBS Relief at
the right time, wait until the next tablet is due.
Do not take a double dose to make up for the
forgotten tablet.
If you have any further questions on the use of this
medicine, ask your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you suffer from difficulty in breathing, swelling of
the face, neck, lips, tongue or throat (severe allergic
reactions), stop taking the tablets and go to your
doctor immediately, or your nearest hospital.

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 30ºC 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
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.

Other side effects (frequency unknown): allergic
reactions may occur, such as skin reactions
(inflamed or reddened skin, itching or skin rashes).
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.

This leaflet was last revised in 07/2013

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

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).

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MYLAN IBS RELIEF

5. HOW TO STORE MYLAN IBS RELIEF

240mm

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.

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.

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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.
See section 4.
• You must talk to a doctor if you do not feel
better or if you feel worse after 2 weeks of
treatment.

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

Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you
can call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.

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(mebeverine hydrochloride 135 mg)

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.

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MYLAN IBS RELIEF
TABLETS

There is only limited information about the safety
of Mebeverine for pregnant woman. 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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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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