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MYLAN IBS RELIEF TABLETS

Active substance(s): MEBEVERINE HYDROCHLORIDE / MEBEVERINE HYDROCHLORIDE

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Package Leaflet: Information for the patient

Mebeverine 135 mg filmcoated tablets
Mebeverine hydrochloride

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
- 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
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Mebeverine is and what it is used for
2. What you need to know before you take
Mebeverine
3. How to take Mebeverine
4. Possible side effects
5. How to store Mebeverine
6. Contents of the pack and other information.
1. What Mebeverine is and what it is used
for
Mebeverine 135 mg film-coated tablets contain
the active ingredient mebeverine hydrochloride.
This belongs to a group of medicines called
antispasmodics.
Mebeverine helps to relax the muscles of
the gastro-intestinal tract (gut). It is used in
conditions such as irritable bowel syndrome
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
persistent diarrhoea, or alternating
constipation and diarrhoea
flatulence (wind) and feeling bloated
small, hard, pellet-like or ribbon-like stools
(faeces)

Black

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.
2. What you need to know before you take
Mebeverine
Do not take Mebeverine
If you are allergic to mebeverine or to any of
the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Mebeverine 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.
Other medicines and Mebeverine
hydrochloride
Mebeverine is not known to interact with other
medicines but you should tell your doctor or
pharmacist if you are taking, have recently
taken or might take any other medicines.
Mebeverine with alcohol
You can drink alcohol while you are taking
Mebeverine135 mg film-coated tablets.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
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
breastfeeding.
Driving and using machines
Mebeverine are not likely to affect your ability to
drive or use machines.

3. How to take Mebeverine
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Try to take the tablet 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: Mebeverine is not
recommended for use in children and adolescents
below 18 years of age.
If you take more Mebeverine than you should
If you or someone else take more Mebeverine
Tablets 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 Mebeverine
If you forget to take a dose of Mebeverine
film-coated tablets at the right time, take it as soon
as you remember, unless it is nearly time for your
next dose. Do not take a double dose to make up
for the forgotten tablet.
If you 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you notice the following stop taking the tablets
and go to your doctor immediately, or your
nearest hospital.
• Difficulty in breathing, swelling of the face,
neck, lips, tongue or throat (severe allergic
reactions)
Other side effects: allergic reactions may occur,
such as skin reactions, inflamed or reddened skin,
swelling, hives, 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.
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.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Mebeverine
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton or label 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 Mebeverine contains
The active substance is mebeverine
hydrochloride. Each film-coated tablet contains
135 mg 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 Mebeverine look like and contents of the
pack
Mebeverine tablets are white-coated tablets
marked “MV135” on one side.
The medicine is available in either plastic bottles
or blister packs of 12, 15, 18, 20, 21, 28, 30, 56,
60, 84, 90 and 100 tablets. Not all pack sizes may
be marketed.
Marketing Authorisation Holder:
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer:
Gerard Laboratories
35/36 Balydoyle Industrial Estate
Grange Road
Dublin 13
Ireland
This leaflet was last revised in 07/2016
S03087

Mebeverine 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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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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