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

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Sources: Original (products.mhra.gov.uk)

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

or

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

United Kingdom

This leaflet was last revised in 08/2018.

5. how to store aurobeverine mr

Keep this medicine out of the sight and reach of children.

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

A ALIMENTARY TRACT AND METABOLISM DRUGS

A03 DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

A03A DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

A03AA Synthetic anticholinergics, esters with tertiary amino group for functional gastrointestinal disorders

A03AA04 mebeverine

Frequently Asked Questions

What is AUROBEVERINE MR 200 mg used for?

AUROBEVERINE MR 200 mg is primarily used to relieve symptoms of irritable bowel syndrome (IBS), including abdominal pain and discomfort.

How does AUROBEVERINE MR work in the body?

AUROBEVERINE MR works by relaxing the muscles in the gut, which can help reduce spasms and ease abdominal pain associated with IBS.

Is AUROBEVERINE MR suitable for children?

AUROBEVERINE MR is generally not recommended for children under 18 years of age. Always consult a doctor for appropriate treatment options for children.

Can I take AUROBEVERINE MR if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult your healthcare provider before taking AUROBEVERINE MR to assess any potential risks.

What should I do if I miss a dose of AUROBEVERINE MR?

If you miss a dose of AUROBEVERINE MR, take it as soon as you remember. If it's close to your next dose, skip the missed dose and continue your regular schedule. Never double up on doses.

Are there any food interactions with AUROBEVERINE MR?

There are no specific food interactions with AUROBEVERINE MR, but it's advisable to take it as directed by your healthcare provider regarding meals.

Can I drink alcohol while taking AUROBEVERINE MR?

It's best to avoid alcohol while taking AUROBEVERINE MR, as it may exacerbate side effects like dizziness or drowsiness.

What are common side effects of AUROBEVERINE MR?

Common side effects may include dizziness, nausea, headache, or dry mouth. Most side effects are mild and temporary.

How long does it take for AUROBEVERINE MR to work?

Many patients may start to feel relief within a few days of starting treatment, but individual responses can vary.

Can I drive after taking AUROBEVERINE MR?

If you experience dizziness or drowsiness after taking AUROBEVERINE MR, avoid driving or operating machinery until you know how it affects you.

Is it safe to take AUROBEVERINE MR with other medications?

Always inform your doctor about all medications you are currently taking, as some interactions may occur with other drugs.

How should I store AUROBEVERINE MR capsules?

Store AUROBEVERINE MR capsules in a cool, dry place away from direct sunlight and out of reach of children.

How often should I take AUROBEVERINE MR capsules?

Typically, the recommended dosage is one capsule taken three times a day. Follow your doctor's instructions for the exact dosage.

What should I do if I experience severe side effects?

If you experience severe side effects such as swelling, difficulty breathing, or an allergic reaction, seek immediate medical attention.

Can older adults use AUROBEVERINE MR safely?

Older adults can use AUROBEVERINE MR but should consult their healthcare provider for proper dosage and monitoring due to possible increased sensitivity to medications.

What lifestyle changes can help manage IBS symptoms alongside taking AUROBEVERINE MR?

Incorporating dietary adjustments, regular exercise, stress management techniques, and hydration can complement the treatment of IBS symptoms.

Is there anyone who should avoid taking AUROBEVERINE MR?

People with certain conditions such as severe liver problems or those allergic to mebeverine should avoid this medication. Always consult your doctor before starting any new medication.

Does AUROBEVERINE MR cause constipation or diarrhea?

AUROBEVERINE MR is designed to relieve symptoms of IBS. However, individual experiences may vary; consult your doctor if you notice significant changes in bowel habits.

Can lifestyle changes enhance the effect of AUROBEVERINE MR?

Yes! Managing stress through relaxation techniques and maintaining a balanced diet can enhance the effectiveness of AUROBEVERINE MR in managing IBS symptoms.