DUSPATALIN RETARD

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Duspatalin retard
200 mg, prolonged-release hard capsules
Mebeverini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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 pack and other information

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

What is Duspatalin retard
Duspatalin retard is available as prolonged-release hard capsules. Duspatalin retard 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 moves through the intestine. If the intestinal muscles contract strongly, this causes pain. Duspatalin retard acts by relaxing these muscles and relieving pain.
What Duspatalin retard is used for
Duspatalin retard is used to treat symptoms of irritable bowel syndrome. Symptoms of irritable bowel syndrome vary between individuals and may include:

• abdominal pain and cramps,
• bloating and flatulence,
• diarrhoea, constipation, or both,
• small, hard stools in the form of pellets 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 to any of the other ingredients of Duspatalin retard (listed in section 6).

Duspatalin retard should not be used if the patient is affected by the above condition.
In case of doubt, consult a doctor or pharmacist before using this medicine.

Duspatalin retard and other medicines
It is not expected that Duspatalin retard will affect the action of any other medicine being taken. However, you should inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.

Pregnancy, breastfeeding and fertility

During pregnancy, breastfeeding, or if pregnancy is suspected, or if a woman is planning to become pregnant, medical advice from a doctor or pharmacist should be sought before using this medicine.

• Inform your doctor if you are pregnant or suspect you may be pregnant. Duspatalin retard is not recommended during pregnancy. Your doctor may advise discontinuing Duspatalin retard or switching to another medicine.
• Inform your doctor if you are breastfeeding or intend to breastfeed. Duspatalin retard is not recommended for breastfeeding mothers. Your doctor may advise discontinuing breastfeeding or switching to another medicine if necessary.

Driving and operating machinery
It is unlikely that Duspatalin retard will affect the ability to drive or operate machinery.

3. How to take Duspatalin retard

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
How to take the medicine

• Duspatalin retard can be taken by adults and children above 10 years of age.
• The capsules should be swallowed whole with an adequate amount of water (at least 100 ml). Do not crush or chew the capsules.
• Try to take the capsules at the same time each day. This will help you remember to take them.

Dosage
Adults and children above 10 years of age

• The usual dose is 1 capsule of 200 mg twice daily.
• One capsule should be taken in the morning and one in the evening.

Duspatalin retard should not be used in children below 10 years of age.
If you take more Duspatalin retard than you should
If you take more than the recommended dose, contact your doctor or go to hospital immediately.
Take the medicine pack and the leaflet inside the pack with you.
If you forget to take 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur after taking this medicine.
You should stop taking Duspatalin retard and contact your doctor immediately if you experience any of the following serious adverse reactions. 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, 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.

Reporting of adverse reactions
If any adverse reactions occur, 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.: + 48 22 49 21 301, fax: + 48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Duspatalin retard

• Keep the medicine out of sight and reach of children.
• Store below 25°C. Keep in the original packaging. Do not freeze.
• Do not use this medicine after the expiry date stated on the packaging. 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 pack 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, iron oxide black (E 172), concentrated ammonium hydroxide, potassium hydroxide.

What Duspatalin retard looks like and contents of the pack
The capsules are opaque, white, hard gelatin capsules with the imprint "245".
The capsules are packed in PVC/Al blisters in a cardboard box.
The pack contains 30 or 60 prolonged-release hard capsules.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin, Ireland
Manufacturer:
Mylan Laboratories S.A.S.
Chatillon sur Chalaronne
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in the Czech Republic, country of export: 73/624/99-C
Parallel Import Authorisation Number: 447/19