Duspatalin retard

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Duspatalin retard (Colofac retard)

200 mg, prolonged-release capsules
Mebeverine hydrochloride
Duspatalin retard and Colofac retard are different trade names for the same medicine.

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

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 Duspatalin retard and what is it 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 packaging and other information

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

What is Duspatalin retard

Duspatalin retard is in the form of prolonged-release capsules. Duspatalin retard contains a medicine called mebeverine hydrochloride. It belongs to a group of medicines called antispasmodics, which act on the intestine.
The intestine is part of the digestive tract. Its walls are made of muscles. Digested food passes through the intestine. If the muscles of the intestine contract strongly, it causes pain. Duspatalin retard acts to relax the muscles and relieve pain.

What is Duspatalin retard used for

Duspatalin retard is used to treat the symptoms of irritable bowel syndrome. The symptoms of irritable bowel syndrome vary from person to person and may include:

• abdominal pain and cramps
• bloating and gas
• diarrhea, constipation, or both
• small, hard stools in the shape of balls 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 should not be taken if the patient has the above condition. In case of doubts, the patient should consult a doctor or pharmacist before taking the medicine.

Duspatalin retard and other medicines

It is not expected that Duspatalin retard will affect the action of any other medicine taken. However, the patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

In pregnancy, breastfeeding, or if the patient suspects they are pregnant, or plans to become pregnant, they should consult a doctor or pharmacist before taking this medicine.

• The patient should inform their doctor about pregnancy or suspected pregnancy. Duspatalin retard is not recommended during pregnancy. The doctor may advise stopping Duspatalin retard or taking a different medicine instead of Duspatalin retard.
• The patient should inform their doctor about breastfeeding or plans to breastfeed. Duspatalin retard is not recommended for breastfeeding mothers. The doctor may advise stopping breastfeeding or taking a different medicine while breastfeeding.

Driving and using machines

It is unlikely that Duspatalin retard will affect driving or using machines.

3. How to take Duspatalin retard

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.

Using the medicine

• Duspatalin retard can be taken by adults and children over 10 years old.
• The capsules should be swallowed whole and washed down with a sufficient amount of water (at least 100 ml). The capsules should not be crushed or chewed.
• The patient should try to take the capsules at the same time every day. This will help them remember to take them.

Dose

Adults and children over 10 years old

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

Duspatalin retard should not be taken by children under 10 years old.

Taking a higher dose of Duspatalin retard than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately contact a doctor or go to the hospital. They should take the packaging and the leaflet with them.

Missing a dose of Duspatalin retard

• If a dose is missed, the patient should take the next dose at the scheduled time. They should skip the missed dose.
• The patient should not take a double dose to make up for the missed dose.

In case of any further doubts about taking the medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Duspatalin retard can cause side effects, although not everybody gets them.
After taking this medicine, the following side effects may occur.

The patient should stop taking Duspatalin retard and immediately contact a doctor if they experience any of the following serious side effects. Urgent 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, the patient should stop taking the medicine and immediately contact a doctor.

Other side effects

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

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. 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Duspatalin retard

• The medicine should be stored out of sight and reach of children.
• It should not be stored at temperatures above 25°C or below 5°C. It should be stored in the original packaging to protect it from light.
• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Translation of some information on the immediate packaging: Ch.-B.: Usable until: see embossing - Batch number: Expiry date: see embossing
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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, and ethyl acrylate copolymer (1:1) dispersion 30%, triacetin. The ingredients of the capsule shell are: gelatin, titanium dioxide (E 171). The ink used for printing: shellac (E 904), propylene glycol, ammonia solution, potassium hydroxide, iron oxide black (E 172).

What Duspatalin retard looks like and what the packaging contains

The capsules are opaque, white, hard gelatin capsules, size 1, with the imprint "245".
The capsules are packaged in PVC/Al blisters in a cardboard box.
The packaging contains 30 or 60 capsules.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Austria, the country of export:

Mylan Österreich GmbH
Guglgasse 15
1110 Vienna
Austria

Manufacturer:

Mylan Laboratories SAS
Route de Belleville, Lieu dit Maillard
01400 Châtillon-sur-Chalaronne, France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number:1-23472

Parallel import authorization number: 217/24

Date of leaflet approval: 29.05.2024

[Information about the trademark]