Duspatalin retard

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Duspatalin retard

200 mg, prolonged-release hard capsules, Mebeverine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness 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 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 hard capsule. Duspatalin retard contains the active substance 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).

Do not take Duspatalin retard if the above statement applies to you. In case of doubts, 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, tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, consult a doctor or pharmacist before taking this medicine.

• Tell your doctor if you are pregnant or suspect you are 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.
• Tell 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 driving or using machines.

3. How to take Duspatalin retard

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

Using the medicine

• Duspatalin retard can be taken by adults and children over 10 years of age.
• Swallow the capsules whole with a sufficient amount of water (at least 100 ml). Do not crush or chew the capsules.
• 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 of age

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

Do not give Duspatalin retard to children under 10 years of age.

Taking more than the recommended dose of Duspatalin retard

If you have taken more than the recommended dose of the medicine, contact your doctor or go to the hospital immediately. Take the packaging and the leaflet with you.

Missing a dose of 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 the forgotten dose.

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

Stop taking Duspatalin retard and contact your 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, stop taking the medicine and contact your doctor immediately.

Other side effects

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. You can report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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

• Keep the medicine out of the sight and reach of children.
• Store in a temperature 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. The expiry date refers to the last day of the month stated.
• Medicines should 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, and ethyl acrylate copolymer (1:1) dispersion 30%, triacetin. Capsule shell: gelatin, titanium dioxide (E 171). Printing ink: 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, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the 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

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa, Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa, Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, Marketing authorization number in the Czech Republic, the country of export: 73/624/99-C, Parallel import authorization number: 86/22, Date of leaflet approval: 16.02.2022
[Information about the trademark]