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MEBEVERINE HYDROCHLORIDE 135MG COATED TABLETS

Active substance(s): MEBEVERINE HYDROCHLORIDE / MEBEVERINE HYDROCHLORIDE / MEBEVERINE HYDROCHLORIDE

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Package leaflet: Information for the patient

Mebeverine Hydrochloride 135 mg

coated tablets
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 or pharmacist have 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. 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.
What is in this leaflet
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what it is used for
This medicine contains an active substance called Mebeverine
hydrochloride, which belongs to a group of medicines called
antispasmodics.
This medicine is used to treat symptoms of irritable bowel syndrome
(IBS).
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 passes food 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.
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 this medicine
Do not take this medicine if:
• You are allergic to the active substance or any of the other
ingredients of this medicine (listed in section 6).
• You are younger than 18 years of age.
If any of the above applies to you, do not take this medicine and talk
to your doctor or pharmacist.

Warnings and precautions
See your doctor before using any IBS treatment if you:
• have not suffered from IBS before or
• have developed new symptoms or your symptoms have become
worse
• have liver or kidney problems.
Talk to your doctor or pharmacist if any of the following applies to
you:
• You are 40 years of age or over and your symptoms have changed
or it has been some time since you last had IBS
• You have passed blood in your stools (faeces)
• You are feeling sick (nauseous) or are sick (vomiting)
• You have lost appetite or lost weight
• You are looking pale and feeling tired
• You have constipation
• You have a fever
• You have recently travelled abroad
• You are pregnant, or planning to become pregnant
• You are a woman and you have unusual bleeding or discharge
from your vagina
• You have difficulty or pain when passing water (urinating)
Your doctor will tell you whether it is safe for you to start taking
mebeverine.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently
taken or might take any other medicines.
Taking with food and drink
You can drink alcohol while you are taking this medicine.
Pregnancy and breast-feeding
You should talk to your doctor or pharmacist before taking this
medicine if you are pregnant or might become pregnant. There is
only limited information about the safety of Mebeverine for pregnant
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3. How to take this medicine
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is
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.
Use in children and adolescents
Do not give this medicine to children or adolescents younger than
18 years.
Route and method of administration
• Swallow the tablet whole with water. Do not chew the tablet.
• Try to take the tablet twenty minutes before a meal - some people
find their symptoms to be strongest after they have eaten.
How to stop taking this medicine
You can lower the dose if your symptoms get better.
If you take more of this medicine than you should
If you or someone else takes too many tablets (an overdose), talk to

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a doctor or go to a hospital straight away. Take the medicine pack
with you.
If you forget to take this medicine
If you forget to take a dose at the usual time, take it as soon as you
remember, unless it is time to take your next dose. Do not take a
double dose to make up for a forgotten dose.
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 get any of these serious side effects, stop taking the
tablets. See a doctor at once if you have:
• 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 or pharmacist. 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 this medicine
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage
conditions.
• Do not use this medicine after the expiry date which is stated on
the label after EXP. The expiry date refers to the last day of that
month.

• 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 this medicine contains
• The active substance is 135mg of Mebeverine hydrochloride.
• The other ingredients are:
Tablet core: Lactose monohydrate, Maize starch, Povidone
K 30, Purified talc, Isopropyl alcohol, Magnesium stearate
(E470b).
Tablet coat: Sucrose, Gelatin, Purified talc, Ethanol, Shellac
(E904), Carnauba wax yellow (E903), Beeswax white (E901).
What this medicine looks like and contents of the pack
• The tablets are round, white to off-white, sugar coated tablets,
plain on both sides.
• This medicine is available in packs containing 10, 15, 84 or 100
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd.,
Unit-3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom.
Telephone: 0044 (0) 1442 200922
Fax:
0044 (0) 1442 873717
Email:
info@bristol-labs.co.uk
Mebeverine Hydrochloride 135 mg coated tablets;
PL 17907/0557
This leaflet was last revised in December 2016
To request a copy of this leaflet in braille, large print or audio format,
please contact the licence holder at the address (or telephone, fax,
email) above.
V1 15-12-16 D0

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women. Your doctor may advise you to stop taking this medicine
before you become pregnant or as soon as you know you are
pregnant. This medicine 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.
This medicine contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

Expand Transcript

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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