Duspatalin retard

Package Leaflet: Information for the Patient

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

Duspatalin retard (Duspatal Retard)

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

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.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not give it to others. The medicine may harm another person, even if their 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, pharmacist, or nurse. 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 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

Do not take Duspatalin retard if the above statement applies to you. If in doubt, consult your doctor or pharmacist before taking the medicine.
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Duspatalin retard and other medicines

It is not expected that Duspatalin retard will affect the action of any other medicine you are taking. 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

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

• Tell 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.
• 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 your ability to drive or use 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 old.
• 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.

Dose

Adults and children over 10 years old

• 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 old.

Taking a higher dose of Duspatalin retard than recommended

If you take more than the recommended dose, contact your doctor or go to the hospital immediately. Take the medicine 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 a missed dose.

If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

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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, pharmacist, or nurse. 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
Phone: +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 30°C. Do not store in a temperature below 5°C. Store in the original packaging.
• Do not use the 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. 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, polyacrylate dispersion 30%, hypromellose, talc, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, triacetin. Capsule shell: gelatin, titanium dioxide (E 171). Printing ink: shellac (E 904), propylene glycol (E 1520), ammonia solution, potassium hydroxide, iron oxide black (E 172).

What Duspatalin retard looks like and what the pack 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.
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The packaging contains 30 or 60 capsules.
For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, Nº. 44C – 7.3 e 7.4
1990-095 Lisbon
Portugal

Manufacturer:

Mylan Laboratories SAS
Route de Belleville
Lieu-dit Maillard
01400 Châtillon sur Chalaronne
France
Abbott Biologicals, B.V.
Veerweg 12
8121 AA Olst, Netherlands

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portuguese marketing authorization number: 8354845

Parallel import authorization number: 784/12 Date of approval of the leaflet: 04.11.2022

[Information about the trademark]
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