AUROBEVERINE MR 200 MG MODIFIED-RELEASE CAPSULES HARD - patient leaflet, side effects, dosage

Patient leaflet - AUROBEVERINE MR 200 MG MODIFIED-RELEASE CAPSULES HARD

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.

also help to treat IBS:

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.

28.12 mm

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

H Black A/s: 150 X 230 mm

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

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