Skip to Content

MEBEVERINE 200MG MODIFIED RELEASE CAPSULES

Active substance(s): MEBEVERINE HYDROCHLORIDE / MEBEVERINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the patient

Mebeverine 200mg modified-release capsules
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
This medicine is a capsule containing Mebeverine
hydrochloride, which belongs to a group of medicines
called antispasmodics.
This medicine is used to treat the symptoms of irritable
bowel syndrome (IBS).
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, 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 or pharmacist 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 to 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 doctor or 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 hydrochloride or
any of the other ingredients of this medicine (listed in
section 6).
If the above applies to you, do not take this medicine and
talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Mebeverine:
• if you have developed new symptoms or your
symptoms have become worse.
• if you have liver or kidney problems.
Children and adolescents
This medicine is not recommended for use in children and
adolescents below 18 years old.
Other medicines and Mebeverine
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 Mebeverine.
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.
Pregnancy
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.
Breast-feeding
Mebeverine 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.
Mebeverine contains Sucrose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking the medicinal product.

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 capsule 20 minutes before a meal - some
people find their symptoms to be strongest after they
have eaten.
• Swallow the capsule whole with a drink of water. Do not
chew the capsule.
Adults (including the elderly)
• The recommended starting dose is one capsule
twice a day.
If you take more Mebeverine than you should
If you or someone else takes too much Mebeverine
(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
If you miss a capsule, take it when you remember.
However, if it is nearly time for the next dose, skip the
missed dose and carry on as normal with the next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Mebeverine
Do not stop taking Mebeverine 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 get any of these serious side effects, stop taking
the capsules. See a doctor at once:
• 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, 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 (website:
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 out of the sight and reach of children.
• Do not use this medicine after the expiry date which is

stated on the carton and blister pack. The expiry date
refers to the last day of that month.
• Store Mebeverine in the original package.
• Store below 30°C.
• Return any unused capsules to a pharmacist. 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 capsule contains 200mg of mebeverine
hydrochloride in a modified release formulation.
The other ingredients are:
Capsule core
Sugar spheres (sucrose, maize)
Povidone
Hypromellose
Capsule Coating
Ethyl cellulose N-45
Macrogol 6000
Magnesium stearate
Capsule Shell
Gelatin
Titanium dioxide (E171)
What Mebeverine looks like and the contents
of the pack
Mebeverine comes as creamy white hard capsules,
filled with white to off white coloured spherical pellets.
Packs may contain 10, 30 or 60 capsules. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Aspire Pharma Limited
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire, GU32 3QG
United Kingdom
This leaflet was last revised in 09/2016.

1010390-P1.8

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.

Hide