Duspatalin retard

Leaflet attached to the packaging: patient information

Duspatalin retard

200 mg, prolonged-release capsules
Mebeverine hydrochloride

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on 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 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 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 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. In case of doubt, consult your 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, please 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 your 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 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, consult 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 packaging and 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 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 the above 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. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder.
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.
• Do not store below 5°C. Store in the original packaging.
• Do not use this medicine after the expiry date stated on the carton after: Expiry date. 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-ethyl acrylate copolymer (1:1) dispersion 30%, glycerol triacetate. Capsule shell: gelatin, titanium dioxide (E171). Printing ink: shellac (E904), propylene glycol, ammonia solution, potassium hydroxide, iron oxide black (E172).

What Duspatalin retard looks like and contents of the pack

The capsules are opaque, white, hard gelatin capsules, size 1, with the imprint "245".
The capsules are packed in PVC/Al blisters in a cardboard box.
The pack contains 30 or 60 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Manufacturer

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

For further information, please contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel. 22 546 64 00
Date of last revision of the leaflet:02/2024