Patient leaflet - Aurobeverine MR 200 mg modified-release capsules hard

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) in adults. 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.

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 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.

Take special care with Aurobeverine MR

Check with your doctor or pharmacist before taking your medicine if:

You have developed new symptoms or your symptoms have become worse
You have liver or kidney problems. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.

Taking Aurobeverine MR with food and drink

You can drink alcohol while you are taking Aurobeverine MR.

Other medicines and Aurobeverine MR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

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 breast-feeding.

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 use 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.

The capsules should be swallowed whole with a glass of water. Do not chew or crush
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Team Leader

Initiator

Design Agency

APL_LN 1402

Date - Designer - Run:

Additional Information:

Customer / Country Reason of Issue

No. of Colours : 1

Aurobeverine 200 mg Leaflet S06354 02.06.2025 & 04:12 PM

Nezela Colaco

Ramesh

Sign / Date

the capsules. If you do, the medicine will be

absorbed into your body too quickly and

may not work properly.

Adults (including the elderly)

The normal starting dose is one capsule twice

a day. Take one capsule in the morning and

one capsule in the evening.

Children

This medicine is not recommended for use in

children.

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 (Severe
allergic reactions) 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 Yellow Card Scheme, Website:

www.mhra.gov.uk/yellowcard or search for MHRA

Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide

more information on the safety of this medicine.

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.

Blister Pack:

Do not store above 30°C. Do not refrigerate or freeze. Store in the original package in order to protect from moisture.

HDPE container pack:

Store below 25°C. Store in the original container in order to protect from light and moisture. Use within 3 months after first opening the HDPE container.

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 and HDPE packs.

Pack sizes of blister: 20, 30, 50, 60, 90 and 100 capsules.

Pack sizes of HDPE container: 250 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