Package leaflet: information for the patient

Mebelin
200 mg, modified-release hard capsules
Mebeverini hydrochloridum
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

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

Table of contents

What Mebelin is and what it is used for
Important information before taking Mebelin
How to take Mebelin
Possible side effects
How to store Mebelin
Contents of the pack and other information

1. What Mebelin is and what it is used for

Mebelin 200 mg is available as modified-release hard capsules containing
mebeverine hydrochloride. Mebelin belongs to a group of medicines called spasmolytics.
It is used for the symptomatic treatment of irritable bowel syndrome (IBS) 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 intestinal muscles contract strongly, this causes pain. This medicine works by relieving spasms, pain, and other IBS symptoms.

The main symptoms of irritable bowel syndrome (IBS) are:

abdominal pain and cramps,
bloating and flatulence,
diarrhoea (with or without constipation),
small, hard stools in the form of pellets or ribbons.

These symptoms may vary among individual patients.

Diet and lifestyle may help in managing irritable bowel syndrome (IBS)
Dietary changes may positively influence the reduction of IBS 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 be beneficial, but you should consult your doctor or pharmacist for further advice.
Some people find that rest may help relieve IBS symptoms. You may wish to try setting aside some time each day for relaxation and rest to see if this helps reduce your symptoms.

2. Important information before taking Mebelin

When not to take Mebelin

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).

Warnings and precautions
Before starting to take Mebelin, discuss this with a doctor or pharmacist.
Mebeverine and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
No interactions between mebeverine and other medicines are known.
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.
Pregnancy
Mebeverin is not recommended during pregnancy.
Breastfeeding
Mebeverine is not recommended during breastfeeding.
Driving and operating machinery
Previous experience indicates that this medicine generally has no effect on the ability to drive or operate machinery.
Mebeverine contains sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Mebelin

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Adult patients (including elderly patients)
The recommended initial dose is one capsule twice daily, one capsule in the morning and one in the evening.
Use in children and adolescents
Use of Mebelin is not recommended in children and adolescents.
Method of administration
The capsules should be swallowed regularly, at 12-hour intervals (e.g. in the morning and in the evening), without chewing, with sufficient amount of water (at least 100 ml).
If you take more Mebelin than you should
If you or someone else accidentally swallows too many capsules, or if a child takes the medicine, contact your doctor or pharmacist immediately.
If you forget to take Mebelin
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
Stopping Mebelin
Do not stop taking Mebelin without discussing it with your doctor, even if you feel better.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You must stop taking Mebelin and contact your doctor immediately if any of the following serious adverse reactions occur,
as such a condition may require treatment:

Difficulty breathing, swelling of the face, neck, lips, tongue or throat (severe allergic reaction).
Other possible adverse reactions include:
Hives,
Swelling of the face, tongue, throat,
Skin rash.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 the medicine Mebelin

Keep the medicine out of the 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.
Store below 30°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater 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 Mebelin contains

The active substance is mebeverine hydrochloride. Each capsule contains 200 mg of mebeverine hydrochloride in a modified-release capsule.
Other ingredients are:
Pellet core: sugar spheres (sucrose, corn starch), povidone K29/32, hypromellose.
Pellet coating: ethylcellulose N-45, macrogol 6000, magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E 171).

What Mebelin looks like and contents of the pack
Cream-white body and cream-white cap, size 1, filled with spherical pellets ranging from white to off-white in colour.
Mebelin 200 mg is available in packs of 30 and 60 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
+48 22 855 40 93

Manufacturer/Importer
Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Mebeverine Aristo 200 mg Retardkapseln
Denmark Mebeverinhydrochlorid “Aristo”
Netherlands Mebeverine HCl Aristo 200 mg hard capsules with controlled release
Germany Mebeverin Aristo 200 mg Retardkapseln
Poland Mebelin
Portugal Mebeverina Aristo 200 mg capsula de libertação prolongada