Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Duspatalin retard (Duspatalin)
200 mg, prolonged-release hard capsules
Mebeverini hydrochloridum
Duspatalin retard and Duspatalin are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Duspatalin retard is and what it is used for

What Duspatalin retard is
Duspatalin retard is available in the form of prolonged-release hard capsules. Duspatalin retard contains a medicine called mebeverine hydrochloride. It belongs to a group of medicines known as spasmolytics, which act in the intestine.
The intestine is part of the gastrointestinal tract. Its walls are made of muscle. Digested food moves through the intestine. If the intestinal muscles contract strongly, this causes pain. Duspatalin retard acts by relaxing these muscles and relieving pain.

What Duspatalin retard is used for
Duspatalin retard is used in the treatment of symptoms of irritable bowel syndrome. Symptoms of irritable bowel syndrome vary between individuals and may include:

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

2. Important information before taking Duspatalin retard

When not to take Duspatalin retard

if the patient is allergic to the active substance or to any of the other ingredients of Duspatalin retard (listed in section 6).

Duspatalin retard must not be used if the patient is affected by the above condition. In case of doubt, consult a doctor or pharmacist before using the medicine.

Duspatalin retard and other medicines

No interactions are expected between Duspatalin retard and any other concomitantly administered medicines. However, you should inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.

Pregnancy, breastfeeding and fertility

During pregnancy, breastfeeding, if pregnancy is suspected, or when planning a pregnancy, consult a doctor or pharmacist before using this medicine.

Inform your doctor if you are pregnant or suspect you may be pregnant. Duspatalin retard is not recommended during pregnancy. Your doctor may advise you to discontinue treatment with Duspatalin retard or to use an alternative medicine.
Inform your doctor if you are breastfeeding or intend to breastfeed. Duspatalin retard is not recommended for breastfeeding mothers. Your doctor may advise you to discontinue breastfeeding or to switch to another medicine if breastfeeding.

Driving and operating machinery

It is unlikely that Duspatalin retard affects the ability to drive or operate machinery.

3. How to take Duspatalin retard

This medicine should always be taken as directed by a doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
How to take the medicine

Duspatalin retard may be taken by adults and children above 10 years of age.
Capsules should be swallowed whole with an adequate amount of water (at least 100 ml). Do not crush or chew the capsules.
Try to take the capsules at the same time each day. This will help you remember to take them.

Recommended dosage
Adults and children above 10 years of age

The usual dose is 1 capsule of 200 mg twice daily.
One capsule should be taken in the morning and one in the evening.

Duspatalin retard should not be used in children below 10 years of age.
If you take more Duspatalin retard than recommended

If you take more than the recommended dose of this medicine, contact your doctor immediately or go to hospital. Take the medicine package and the leaflet included in the package with you.
If you forget to take Duspatalin retard

If you miss a dose, take the next dose at the scheduled time. Miss the forgotten dose.
Do not take a double dose to make up for a missed dose.

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 experiences them.
The following undesirable effects may occur after taking this medicine.
You must stop taking Duspatalin retard and contact your doctor immediately if any of the following serious adverse reactions occur. Immediate medical attention may be required:

Difficulty breathing, swelling of the face, neck, lips, tongue or throat. This may be a severe allergic reaction (hypersensitivity) to the medicine. If any of the above symptoms occur, stop taking the medicine and contact your doctor immediately.

Other adverse reactions

Milder allergic reactions (hypersensitivity) to the medicine may occur, such as rash, red, itchy skin lesions.

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.
Reporting adverse reactions allows additional information on the safety of the medicine to be collected.

5. How to store Duspatalin retard

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 Duspatalin retard contains

The active substance is mebeverine hydrochloride. Each capsule contains 200 mg of the active substance.
The other ingredients are: magnesium stearate, talc, polyacrylate dispersion 30%, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triacetin. Capsule shell composition: gelatin, titanium dioxide (E 171). Printing ink: shellac, propylene glycol, concentrated ammonium hydroxide, potassium hydroxide, black iron oxide (E 172).

What Duspatalin retard looks like and contents of the pack
The capsules are opaque, white, hard gelatin capsules of size 1, printed with "245".
The capsules are packed in PVC/Al blisters in a cardboard box.
Pack sizes contain 30 or 60 capsules.
For further detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Greece, country of export:
BGP PRODUCTS LTD
Ag. Dimitriou 63
174 56 Alimos, Greece
Manufacturer:
Mylan Laboratories SAS
Route de Belleville
Lieu-dit Maillard
01400 Châtillon-sur-Chalaronne
France
Parallel Importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Repackaged by:
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Greece, country of export: 45598/14-09-2009
92996/14/04-11-2016
Parallel Import Licence Number: 366/19