Mebelin

Leaflet attached to the packaging: patient information

Mebelin

200 mg, modified-release capsules, hard
Mebeverine hydrochloride

Please read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Mebelin and what is it used for
• 2. Important information before taking Mebelin
• 3. How to take Mebelin
• 4. Possible side effects
• 5. How to store Mebelin
• 6. Contents of the packaging and other information

1. What is Mebelin and what is it used for

Mebelin, 200 mg, is in the form of modified-release capsules containing mebeverine hydrochloride. The medicine belongs to a group of medicines called antispasmodics. The medicine is used for the symptomatic treatment of irritable bowel syndrome (IBS) in adult patients.
This is a very common condition that causes cramps and pain in the intestines.
The intestine is a long, muscular tube through which digested food passes. If the muscles of the intestine contract too strongly, it causes pain. This medicine works by relieving cramps, pain, and other symptoms of IBS.
The main symptoms of irritable bowel syndrome (IBS) are:

• abdominal pain and cramps,
• bloating and gas,
• diarrhea (with or without constipation),
• small, hard stools in the shape of balls or ribbons.

These symptoms may vary from patient to patient.

Diet and lifestyle may help in the treatment of irritable bowel syndrome (IBS)

A change in diet may have a positive effect on reducing IBS symptoms. If the patient finds that certain foods trigger symptoms, it is worth eliminating them from the diet. A high-fiber diet may help, but the patient should consult a doctor or pharmacist for additional information.
Some people believe that rest can help alleviate IBS symptoms. The patient may find that setting aside time for relaxation and rest each day helps to alleviate symptoms.

2. Important information before taking Mebelin

When not to take Mebelin

Warnings and precautions

Before starting to take Mebelin, the patient should discuss it with their doctor or pharmacist.

Mebelin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
No interactions between mebeverine and other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Mebelin should not be used during pregnancy.
Breastfeeding
Mebelin should not be used during breastfeeding.

Driving and using machines

Past experience indicates that this medicine generally has no effect on driving or operating machines.

Mebelin contains sucrose.

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Mebelin

This medicine should always be taken exactly as the doctor or pharmacist has advised. If the patient is unsure, they should consult their doctor or pharmacist.

Adult patients (including elderly patients)

The recommended initial dose is one capsule, twice a day, taken one capsule in the morning and one in the evening.

Use in children and adolescents

Mebelin should not be used in children and adolescents.
Method of administration
The capsules should be swallowed regularly, at 12-hour intervals (e.g., morning and evening), without chewing, with a sufficient amount of water (at least 100 ml).

Taking a higher dose of Mebelin than recommended

In case of accidental ingestion of too many capsules or if someone else or a child takes the medicine, the patient should immediately contact their doctor or pharmacist.

Missing a dose of Mebelin

If the 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 patient should skip the missed dose and continue with the next dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Mebelin

The patient should not stop taking Mebelin without discussing it with their doctor, even if they feel better.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking Mebelin and contact their doctor immediately if they experience any of the following serious side effects, as they may require treatment:

• Difficulty breathing, swelling of the face, neck, lips, tongue, or throat (severe allergic reaction) Other side effects may include:
• Hives,
• Swelling of the face, tongue, or throat,
• Skin rash.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Mebelin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging 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.
• The other ingredients are: Core pellet: sucrose 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

Capsules with a cream-white body and cream-white cap, size 1, filled with white to off-white spherical pellets.
Mebelin, 200 mg is available in packs of 30, 60 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder

Aristo Pharma Sp. z o.o.
ul. Baletowa 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 authorized 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 regulated release

Germany

Mebeverin Aristo 200 mg Retardkapseln

Poland

Mebelin

Portugal

Mebeverina Aristo 200 mg prolonged-release capsules
Date of last revision of the leaflet:August 2024