Package leaflet: Information for the patient

Auroverin MR, 200 mg, modified-release capsules, hard
Mebeverini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

What Auroverin MR is and what it is used for
What you need to know before taking Auroverin MR
How to take Auroverin MR
Possible side effects
How to store Auroverin MR
Contents of the pack and other information

1. What Auroverin MR is and what it is used for

Auroverin MR contains an active substance called mebeverine hydrochloride, which belongs to a group of medicines known as spasmolytics.
This medicine is used in the treatment of irritable bowel syndrome (IBS) symptoms in adults. This is a very common condition causing intestinal cramps and pain. The intestine is a long muscular tube through which digested food passes. When the intestinal muscles contract strongly, it causes pain. This medicine works by relieving the muscle spasms, pain, and other symptoms of irritable bowel syndrome.
Symptoms of irritable bowel syndrome include:

abdominal pain and cramps
bloating and passing wind
diarrhoea, constipation, or both
small, hard, pellet-shaped or ribbon-like stools.

Symptoms may vary from person to person. Please contact your doctor or pharmacist if symptoms do not improve after some time, if new symptoms appear, or if symptoms cause concern.
Diet and lifestyle may help in managing irritable bowel syndrome
Changing your diet may positively influence the reduction of irritable bowel syndrome symptoms. If you notice that certain foods trigger your symptoms, it may be helpful to eliminate them from your diet. A high-fibre diet may help, but please consult your doctor or pharmacist for further advice.
Some people find that relaxation helps relieve symptoms of irritable bowel syndrome. You may wish to try spending a few minutes each day relaxing and unwinding to see if this helps reduce your symptoms.

2. Important information before taking Auroverin MR

When not to take Auroverin MR

if the patient is allergic to mebeverine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
if the patient has intestinal obstruction (paralytic ileus).

Do not take this medicine if any of the above apply to the patient. Consult a doctor or pharmacist.
Auroverin MR and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
There is limited information available on the safety of mebeverine in pregnant women. The doctor may advise discontinuing mebeverine before becoming pregnant or as soon as pregnancy occurs and may prescribe an alternative medicine.
Mebeverine should not be used during breastfeeding.
Driving and operating machinery
It is unlikely that this medicine affects the ability to drive or operate tools or machinery.
Auroverin MR contains sucrose
If a sugar intolerance has previously been diagnosed in the patient, the patient should consult a doctor before using this medicine.

3. How to take Auroverin MR

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.

Auroverin MR can be taken by adults.
The capsules should be swallowed whole with a glass of water. Do not chew or crush the capsules. If this happens, the medicine will be absorbed too quickly into the body and will not work properly.

The usual dose is 1 capsule of 200 mg twice daily. One capsule should be taken in the morning and one in the evening.
Taking more Auroverin MR than recommended
If a patient or someone else has taken too much medicine (overdose), contact a doctor immediately or go to a hospital.
Take the medicine packaging with you.
Missing a dose of Auroverin MR
If a patient forgets to take a capsule, they should take it as soon as they remember. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule should be continued. Do not take a double dose to make up for a missed dose.
Stopping Auroverin MR treatment
Do not stop taking this medicine without discussing it with your doctor, even if you feel better.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If a patient experiences severe adverse reactions, the medicine must be discontinued immediately.
Seek immediate medical advice or go to the nearest hospital if necessary.
Frequency unknown (cannot be estimated from available data)

Symptoms of a severe allergic reaction, such as skin rash (swelling), swelling of the face, neck, tongue or throat, causing difficulty in breathing or swallowing.

Other adverse reactions
Frequency unknown (cannot be estimated from available data)

Skin rash, red and (or) itchy skin.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Auroverin MR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after: EXP. The expiry date refers to the last day of the stated month.
Blister:
Do not store above 30°C. Do not store in the refrigerator or freeze.
Keep in the original packaging to protect from moisture.
HDPE bottle:
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
After first opening the HDPE bottle, use within 3 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
Other components are:
Capsule core: sucrose granules (sucrose, corn starch), povidone, hypromellose.
Capsule shell: gelatin, titanium dioxide (E 171).
Pellet coating: ethylcellulose, polyethylene glycol, magnesium stearate.

What Auroverin MR looks like and contents of the pack
Auroverin MR capsules are hard gelatin capsules with a cream-colored body and a cream-white cap, filled with white or whitish spherical pellets.
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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Mebeverine AB 200 mg hard capsules with prolonged release / 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