Patient Information Leaflet

Duspatalin Gastro, 135 mg, tablets
Mebeverini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
You should always take this medicine exactly as described in this patient leaflet or as your
doctor or pharmacist has advised.

Keep this leaflet so that you can read it again if needed.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Table of contents

What Duspatalin Gastro is and what it is used for
Important information before taking Duspatalin Gastro
How to take Duspatalin Gastro
Possible side effects
How to store Duspatalin Gastro
Contents of the pack and other information

1. What Duspatalin Gastro is and what it is used for

What is Duspatalin Gastro
Duspatalin Gastro comes in the form of tablets. Duspatalin Gastro contains a medicine called mebeverine hydrochloride. It belongs to a group of medicines known as spasmolytics, which act on the intestine. The intestine is part of the digestive tract. Its walls are made of muscle. Digested food passes through the intestine. If the intestinal muscles contract strongly, this causes pain. Duspatalin Gastro acts by relaxing these muscles and relieving pain.

What Duspatalin Gastro is used for
Duspatalin Gastro is used in adults and children over 10 years of age for the treatment of abdominal pain or discomfort (e.g. bloating, feeling of distension) in the abdominal cavity, which may be associated with disturbances in bowel rhythm and changes in stool consistency, including diarrhoea and/or constipation, caused by abnormal gastrointestinal function.
Duspatalin Gastro should not be used for longer than 5 days without consulting a doctor. If there is no improvement after 5 days, or if you feel worse, you should consult your doctor.

2. Important information before using Duspatalin Gastro

When not to use Duspatalin Gastro

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

Do not use Duspatalin Gastro if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before using this medicine.
Warnings and precautions
Before starting to take this medicine, discuss with your doctor if:

the patient is over 40 years old
if someone in the patient's family has been diagnosed with colorectal cancer, coeliac disease, or inflammatory bowel disease
abdominal pain occurs at night
there is blood in the stool
nausea or vomiting occur
the patient has lost appetite or has rapidly and unexpectedly lost weight
the patient is pale and feels tired (anaemia)
the patient has severe constipation
the patient has a fever, which may be a sign of inflammation or infection
the patient has recently travelled abroad
the patient has recently taken antibiotics
there is difficulty or pain when passing urine
the female patient has abnormal vaginal bleeding or discharge
the patient is pregnant or suspects she may be pregnant If any of the above apply to the patient (or if in doubt), contact a doctor before taking Duspatalin Gastro.

Duspatalin Gastro and other medicines
No interaction is expected between Duspatalin Gastro and any other medicines currently being taken. However, inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to use.
Pregnancy, breastfeeding and fertility
During pregnancy, while breastfeeding, if pregnancy is suspected, or when planning a pregnancy, consult a doctor or pharmacist before using this medicine.

Inform your doctor if you are pregnant or suspect you may be pregnant. Duspatalin Gastro is not recommended during pregnancy. Your doctor may advise stopping treatment with Duspatalin Gastro or switching to an alternative medicine.
Inform your doctor if you are breastfeeding or intend to breastfeed. Duspatalin Gastro is not recommended for breastfeeding mothers. Your doctor may advise stopping breastfeeding or switching to another medicine if you are breastfeeding.

Driving and operating machinery
It is unlikely that Duspatalin Gastro affects the ability to drive or operate machinery.
Duspatalin Gastro contains lactose and sucrose (types of sugars). If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before using this medicine.
3. How to take Duspatalin Gastro
This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
How to take the medicine

Duspatalin Gastro may be taken by adults and children over 10 years of age.
Tablets should be swallowed whole with sufficient water (at least 100 ml). Do not crush or chew the tablets.
Try to take the tablets at the same time each day. This will help remember to take them.

Dosage
Adults and children over 10 years of age

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

Do not use Duspatalin Gastro in children under 10 years of age.
If more Duspatalin Gastro has been taken than recommended
If more than the recommended dose has been taken, contact a doctor immediately or go to hospital. Take the medicine packaging and the enclosed leaflet with you.
If a dose of Duspatalin Gastro has been missed

If a dose has been missed, take the next dose at the usual time. Do not take the missed dose.
Do not take a double dose to make up for a forgotten dose.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur after taking this medicine:
You must stop taking Duspatalin Gastro and immediately contact your doctor if any of the following serious adverse reactions occur. Urgent medical attention may be required:

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 symptoms listed above occur, you must stop taking the medicine and contact your doctor immediately.

Other adverse reactions

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

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Duspatalin Gastro

Keep this medicine out of sight and reach of children.
Store in a dry place, at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date stated on the carton following: EXP. The expiry date refers to the last day of the stated month.
Medicines must 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 package and other information

What Duspatalin Gastro contains

The active substance is mebeverine hydrochloride. Each tablet contains 135 mg of active substance.
Other ingredients are: monohydrate lactose, starch (corn or potato), povidone (K25), talc, magnesium stearate. Coating: talc, sucrose, gelatin, gum arabic, Carnauba wax.

What Duspatalin Gastro looks like and contents of the pack
Tablets are round and white.
Tablets are packed in PVC/Al blisters in a cardboard box.
Pack contains 15 tablets.
Marketing Authorisation 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, contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00