Duspatalin retard

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Duspatalin retard
200 mg, prolonged-release hard capsules
Mebeverini hydrochloridum
Please read the following leaflet carefully before taking 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 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Duspatalin retard is and what it is used for
2. Important information before taking Duspatalin retard
3. How to take Duspatalin retard
4. Possible side effects
5. How to store Duspatalin retard
6. 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 as prolonged-release hard capsules. Duspatalin retard contains an active substance called mebeverine hydrochloride. It belongs to a group of medicines known as spasmolytics, which act on the intestine.
The intestine is part of the gastrointestinal tract. Its walls consist of muscles. Food passes through the intestine during digestion. When intestinal muscles contract strongly, pain may occur. Duspatalin retard acts by relaxing these muscles and relieving pain.
Why Duspatalin retard is used
Duspatalin retard is used to treat 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 stools in the form of pellets or ribbons

2. Important information before taking Duspatalin retard

When not to take Duspatalin retard

• if the patient is allergic to the active substance or 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 currently used medicines. However, inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.

Pregnancy, breastfeeding and fertility

During pregnancy, breastfeeding, if pregnancy is suspected, or when planning to become pregnant, 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 discontinuing Duspatalin retard or switching to 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 discontinuing breastfeeding or switching 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. If in
doubt, consult a doctor or pharmacist.
How to take the medicine

• Duspatalin retard can be taken by adults and children over 10 years of age.
• Capsules must be swallowed whole and taken 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.

Dosage
Adults and children over 10 years of age

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

Duspatalin retard must not be used in children under 10 years of age.
Taking more Duspatalin retard than recommended
If you take more than the recommended dose, contact a doctor immediately or go to hospital.
Take the medicine pack and the package leaflet with you.
If you forget to take Duspatalin retard

• If you miss a dose, take the next dose at the scheduled time. Missed doses should be skipped.
• Do not take a double dose to make up for a forgotten dose.

If you have any further doubts about 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.
The following adverse effects may occur after taking this medicine.
You must stop taking Duspatalin retard and contact your doctor immediately if you experience any of the following serious adverse reactions. Urgent medical care may be required:

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

Other adverse reactions

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

Reporting 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Duspatalin retard

• Keep this medicine out of sight and reach of children.
• Store below 25°C, in the original packaging. Do not freeze.
• Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the specified month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Packaging 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 (E 904), 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 cardboard boxes.
Pack sizes: 30 or 60 capsules.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Mylan IRE Healthcare Limited
Unit 35/36, Grange Parade
Baldoyle Industrial Estate
Dublin 13, Ireland

Manufacturer:
Mylan Laboratories S.A.S
Route de Belleville, Lieu dit Maillard
01400 Châtillon sur Chalaronne
France

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 73/624/99-C
Parallel Import Licence Number: 86/22