Auroverin Mr

Package Leaflet: Information for the Patient

Auroverin MR, 200 mg, Modified-Release Hard Capsules

Mebeverine Hydrochloride

Read All of This Leaflet Carefully Before Taking This Medicine.

• You should 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. Do not pass it on to others. It may harm them, even if their symptoms 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.

Contents of the Pack

• 1. What Auroverin MR is and What it is Used For
• 2. Before You Take Auroverin MR
• 3. How to Take Auroverin MR
• 4. Possible Side Effects
• 5. How to Store Auroverin MR
• 6. Contents of the Pack and Other Information

1. What Auroverin MR is and What it is Used For

Auroverin MR contains the active substance mebeverine hydrochloride, which belongs to a group of medicines called antispasmodics.

This medicine is used to treat the symptoms of irritable bowel syndrome (IBS) in adults. IBS is a very common condition that causes pain and spasm in the intestines. The intestines are a long, muscular tube through which food passes. If the muscles in the intestines contract too much, it can cause pain. This medicine works by relaxing the muscles in the intestines, which helps to relieve the symptoms of IBS.

The symptoms of IBS can include:

• stomach cramps and spasms
• bloating and gas
• diarrhea, constipation, or both
• small, hard stools that look like pellets or ribbons.

The symptoms can vary from person to person. If your symptoms do not improve after a while, or if you get new symptoms or if your symptoms worry you, you should talk to your doctor or pharmacist.

Diet and Lifestyle May Help with IBS

Changing your diet may help to reduce the symptoms of IBS. If you find that certain foods trigger your symptoms, it may be helpful to avoid them. A high-fiber diet may help, but you should talk to your doctor or pharmacist for more information.

Some people find that relaxation helps to reduce their symptoms of IBS. You may want to try setting aside a few minutes each day to relax and unwind.

2. Before You Take Auroverin MR

Do Not Take Auroverin MR

• if you are allergic to mebeverine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have a condition where the muscles in your intestines are paralyzed (paralytic ileus)

Do not take this medicine if any of the above applies to you. Talk to your doctor or pharmacist.

Auroverin MR with Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, or might take.

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 limited information on the use of mebeverine in pregnant women. Your doctor may advise you to stop taking mebeverine before you become pregnant or as soon as you find out you are pregnant, and prescribe an alternative medicine.

Mebeverine should not be used during breast-feeding.

Driving and Using Machines

Auroverin MR is unlikely to affect your ability to drive or use machines.

Auroverin MR Contains Sugar

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to Take Auroverin 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.

• Auroverin MR can be taken by adults.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. If you do, the medicine will be released too quickly and will not work properly.

The usual dose is one 200 mg capsule twice a day. Take one capsule in the morning and one in the evening.

If You Take More Auroverin MR than You Should

If you or someone else has taken too much Auroverin MR (overdose), contact your doctor or go to the nearest hospital casualty department immediately. Take the medicine pack with you.

If You Forget to Take Auroverin MR

If you forget to take a capsule, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten dose.

If You Stop Taking Auroverin MR

Do not stop taking this medicine without talking to your doctor first, even if you feel better.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Auroverin MR can cause side effects, although not everybody gets them.

Stop Taking the Medicine and Seek Immediate Medical Attention if You Experience Any of the Following

Severe Allergic Reactions

• symptoms of a severe allergic reaction, such as skin rash (hives), swelling of the face, neck, tongue, or throat, which may cause difficulty in breathing or swallowing.

Other Side Effects

• 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 the website: https://smz.ezdrowie.gov.pl.

5. How to Store Auroverin 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.

Store in the original package in order to protect from moisture.

Do not store above 30°C. Do not store in the refrigerator or freeze.

After first opening the bottle, use within 3 months.

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 Auroverin MR Contains

The active substance is mebeverine hydrochloride. Each capsule contains 200 mg of mebeverine hydrochloride.

The other ingredients are:

capsule core: sugar spheres (sugar, maize starch), povidone, hypromellose.

capsule shell: gelatin, titanium dioxide (E 171).

pellet coating: ethylcellulose, macrogol, magnesium stearate.

What Auroverin MR Looks Like and Contents of the Pack

Auroverin MR are hard gelatin capsules with a cream-colored body and a cream-white cap, filled with white or off-white spherical pellets.

The modified-release capsules are available in packs containing blisters and HDPE bottles.

Pack Sizes

Blisters: 20, 30, 50, 60, 90, and 100 capsules.

HDPE bottle: 250 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warszawa

e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This Medicinal Product is Authorized in the Member States of the European Economic Area

Under the Following Names:

Belgium:

Mebeverine AB 200 mg harde capsules met gereguleerde afgifte / gélules à libération modifiée / Hartkapseln mit veränderter Wirkstofffreisetzung

Germany:

Mebeverin PUREN 200 mg Retardkapseln

Netherlands:

Mebeverine HCl Aurobindo Retard 200 mg, harde capsules met gereguleerde afgifte

Poland:

Auroverin MR

Date of Last Revision: 03/2023