Duspatalin retard

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Duspatalin Retard (Duspatalin)

200 mg, prolonged-release capsules
Mebeverine hydrochloride
Duspatalin retard and Duspatalin 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 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 a prolonged-release capsule. 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 too much, 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

You should not take Duspatalin retard if you are affected by the above statement. In case of doubt, you 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 you are taking. However, you should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or if you are planning to become pregnant, you should consult a doctor or pharmacist before taking this medicine.

• You should inform your doctor if you are pregnant or think you may be pregnant. Duspatalin retard is not recommended during pregnancy. Your doctor may advise you to stop taking Duspatalin retard or take a different medicine instead of Duspatalin retard.
• You should inform your doctor if you are breastfeeding or plan to breastfeed. Duspatalin retard is not recommended for breastfeeding mothers. Your doctor may advise you to stop breastfeeding or take a different medicine while breastfeeding.

Driving and using machines

It is unlikely that Duspatalin retard will affect your ability to drive or use machines.

3. How to take Duspatalin retard

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.

How to take the medicine

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

Dosage

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.

Overdose

If you take more than the recommended dose, you should immediately contact a doctor or go to the hospital. You should take the packaging and the leaflet with you.

Missed dose

• If you miss a dose, you should take the next dose at the scheduled time. You should skip the missed dose.
• You should not take a double dose to make up for a missed dose.

If you have any further doubts about taking the medicine, you 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:

You should stop taking Duspatalin retard and contact a doctor immediately if you experience any of the following serious side effects. You may need urgent medical attention:

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

Other side effects

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Duspatalin retard

• The medicine should be stored 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 month stated.
• Medicines should not be disposed of via wastewater or household waste. You should 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, and ethyl acrylate copolymer (1:1), dispersion 30%, triacetin. The capsule shell contains: gelatin, titanium dioxide (E 171). The printing ink contains: shellac, propylene glycol, ammonia solution, potassium hydroxide, iron oxide black (E 172).

What Duspatalin retard looks like and contents of the packaging

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, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

BGP PRODUCTS LTD
Ag. Dimitríou 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.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Greece, the country of export:45598/14-09-2009
92996/14/04-11-2016
Parallel import authorization number:366/19

Date of leaflet approval: 20.09.2024

[Information about the trademark]