Skip to Content

AUROBEVERINE MR 200 MG MODIFIED-RELEASE CAPSULES HARD

Active substance(s): MEBEVERINE HYDROCHLORIDE / MEBEVERINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

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 Aurobeverine MR is and what it is
used for
2. What you need to know before you take
Aurobeverine MR
3. How to take Aurobeverine MR
4. Possible side effects
5. How to store Aurobeverine MR
6. Contents of the pack and other information
1. What Aurobeverine MR is and what it is
used for
Aurobeverine MR contains the active ingredient
mebeverine, 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 goes 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.

Black

A/s: 150 X 230 mm

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
Aurobeverine MR
Do not take Aurobeverine MR:
- 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.
Other medicines and Aurobeverine MR
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
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.
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 and prescribe a different
medicine instead.
Mebeverine should not be used during breastfeeding.
Driving and using machines
This medicine is not likely to affect you being
able to drive or use any tools or machines.
Aurobeverine MR contains sucrose
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. How to take Aurobeverine MR
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.



Aurobeverine MR may be used by adults
and children over 10 years
The capsules should be swallowed whole
with a glass of water. Do not chew or crush

28.12 mm

Aurobeverine MR 200 mg
modified-release capsules, hard

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.
PHARMA CODE

Package leaflet: Information for the patient

the capsules. If you do, the medicine will be
absorbed into your body too quickly and may
not work properly.
The recommended dose is one 200 mg capsule
twice a day. Take one capsule in the morning
and one capsule in the evening.
If you take more Aurobeverine MR than you
should
If you or someone else takes too much medicine
(an overdose), talk to a doctor or go to the
hospital straight away. Take the medicine pack
with you.
If you forget to take Aurobeverine MR
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 Aurobeverine MR
Do not stop taking your medicine 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 or go to your nearest hospital if
needed:
Frequency not known (cannot be estimated from
the available data):
• Signs of a serious allergic reaction such as a
raised itchy skin rash (hives), swelling of the
face, neck, tongue or throat causing difficulty
breathing or swallowing
Other possible side effects
Frequency not known (cannot be estimated from
the available data):
• Skin rash, red and/or 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 national
reporting system listed in 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 Aurobeverine MR
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 after EXP. The
expiry date refers to the last day of that month.
Do not store above 30 °C. Do not refrigerate or
freeze. Store in the original package in order to
protect from moisture.
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 Aurobeverine MR contains
The active substance is mebeverine
hydrochloride. Each capsule contains 200 mg
mebeverine hydrochloride.
The other ingredients are:
Capsule core: Sugar spheres (sucrose, maize
starch), povidone, hypromellose
Capsule shell: Gelatin, titanium dioxide (E 171)
Capsule coating: Ethylcellulose, macrogol,
magnesium stearate
What Aurobeverine MR looks like and
contents of the pack
Your medicine comes as hard gelatin capsules
with creamy white bodies and caps, filled with
white to off-white spherical pellets.
The modified-release capsules are available in
blister packs containing 30 and 60 capsules.
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
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 04/2017.

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