Duspatalin

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

135 mg effervescent tablets
Mebeverine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform the doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Duspatalin and what is it used for
• 2. Important information before taking Duspatalin
• 3. How to take Duspatalin
• 4. Possible side effects
• 5. How to store Duspatalin
• 6. Contents of the packaging and other information

1. What is Duspatalin and what is it used for

What is Duspatalin

Duspatalin is a tablet. Duspatalin contains a medicine called mebeverine hydrochloride.
It belongs to a group of medicines called antispasmodics, which work in 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 in the intestine contract too much, it causes pain. Duspatalin works to relax the muscles and relieve pain.

What is Duspatalin used for

Duspatalin is used in adults and children over 10 years old to treat symptoms of abdominal pain
or discomfort (e.g., bloating, feeling of fullness) in the abdominal cavity, which may be accompanied
by disturbances in bowel habits and changes in stool consistency, including diarrhea and/or constipation,
caused by abnormal bowel function. Duspatalin should not be taken for more than 5 days without consulting a doctor. If there is no improvement after 5 days or the patient feels worse, they should consult a doctor.

2. Important information before taking Duspatalin

When not to take Duspatalin

• in children under 10 years old
• in pregnant or breastfeeding women
• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Duspatalin should not be taken if the patient has any of the above conditions. In case of doubt, the patient should consult a doctor or pharmacist before taking the medicine.

Warnings and precautions

Before taking this medicine, the patient should discuss it with their doctor if:

• the patient is over 40 years old
• a family member of the patient has been diagnosed with colon cancer, celiac disease, or inflammatory bowel disease
• abdominal pain occurs at night
• there is blood in the stool
• there are nausea or vomiting
• the patient has lost appetite or has lost weight quickly and unexpectedly
• the patient is pale and feels tired (anemia)
• the patient has severe constipation
• the patient has a fever, which may be a sign of inflammation
• the patient has recently traveled abroad
• the patient has recently taken an antibiotic
• there is difficulty or pain when urinating
• the patient has abnormal vaginal bleeding or discharge
• the patient is pregnant or suspects they may be pregnant If any of the above applies to the patient (or in case of doubt), they should consult a doctor before taking Duspatalin.

Duspatalin and other medicines

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

Pregnancy, breastfeeding, and fertility

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

• The patient should inform their doctor if they are pregnant or suspect they may be pregnant. Duspatalin is not recommended during pregnancy. The doctor may advise the patient to stop taking Duspatalin or take a different medicine instead of Duspatalin.
• The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Duspatalin is not recommended for breastfeeding mothers. The doctor may advise the patient to stop breastfeeding or take a different medicine while breastfeeding.

Driving and using machines

It is unlikely that Duspatalin will affect driving or using machines.
Duspatalin contains lactose monohydrate and sucrose(types of sugars). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Duspatalin

This medicine should always be taken exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions. If in doubt, the patient should consult a doctor or pharmacist.

How to take the medicine

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

How much to take

Adults and children over 10 years old

• The usual dose is 1 tablet of 135 mg 3 times a day.
• The medicine should be taken 20 minutes before meals at regular intervals throughout the day.

Duspatalin should not be taken in children under 10 years old.

Taking more than the recommended dose of Duspatalin

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

Missing a dose of Duspatalin

• If a dose is missed, the next dose should be taken at the scheduled time. The missed dose should be skipped.
• A double dose should not be taken to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Duspatalin 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 and immediately consult a doctor if they experience any of the following serious side effects.

Emergency medical help may be necessary:

• 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 consult a doctor.

Other side effects

• Milder allergic reactions (hypersensitivity) to the medicine may occur, such as rash, red, itchy skin redness. If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should consult a doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 gather more information on the safety of the medicine.

5. How to store Duspatalin

• The medicine should be stored out of sight and reach of children.
• Store in a temperature below 25°C.
• 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. 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 contains

• The active substance is mebeverine hydrochloride. Each tablet contains 135 mg of the active substance.
• The other ingredients are: lactose monohydrate, sodium carboxymethyl cellulose (type A), povidone, talc, magnesium stearate. Coating: talc, sucrose, arabic gum, gelatin, and carnauba wax.

What Duspatalin looks like and what the pack contains

The tablets are round and white.
The tablets are packaged in PVC/Al blisters in a cardboard box.
The packaging contains 15 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Mylan IRE Healthcare Limited
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate, Dublin 13
Ireland

Manufacturer

Recipharm Parets S.L.U.
C/Ramón y Cajal, 2
08150
Parets del Vallès
Barcelona, Spain

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
Marketing authorization number in Spain, the country of export: 779678.7
Parallel import authorization number: 206/19

Date of leaflet approval: 28.05.2024

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