Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Duspatalin retard (Duspatal Retard)
200 mg, prolonged-release hard capsules
Mebeverini hydrochloridum
Duspatalin retard and Duspatal Retard are different trade names for the same medicine.
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 pass it on to others. It may harm other people, even if their symptoms are identical.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

What Duspatalin retard is
Duspatalin retard comes in the form of prolonged-release hard capsules. Duspatalin retard contains a medicinal substance 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. Food passes through the intestine during digestion. If the intestinal muscles contract strongly, this causes pain.
Duspatalin retard acts by relaxing the intestinal muscles and relieving pain.
What Duspatalin retard is used for
Duspatalin retard is used in the treatment of symptoms of irritable bowel syndrome. Symptoms of irritable bowel syndrome vary between individuals and may include:
abdominal pain and cramps
bloating and flatulence
diarrhea, constipation, or both
small, hard, pellet-shaped or ribbon-like stools.

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 meets the above condition.
If in doubt, consult a doctor or pharmacist before using the medicine.

Duspatalin retard and other medicines
No interactions are expected between Duspatalin retard and any other medicines being taken. However, you should inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

Pregnancy, breastfeeding and fertility
During pregnancy, when breastfeeding, or when suspecting pregnancy or 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 retard is not recommended during pregnancy. Your doctor may advise discontinuing Duspatalin retard or switching to an alternative medicine.
Inform your doctor if you are breastfeeding or intend to breastfeed. Duspatalin retard is not recommended for nursing mothers. Your doctor may recommend stopping breastfeeding or switching to another medicine if breastfeeding.

Driving and operating machinery
It is unlikely that Duspatalin retard affects 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 in doubt, consult your doctor or pharmacist.
How to take the medicine
Duspatalin retard may be taken by adults and children over 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 over 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 under 10 years of age.
If you take more Duspatalin retard than recommended
If you take more than the recommended dose, contact your doctor immediately or go to hospital.
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 concerning 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 gets them.
The following adverse reactions may occur after taking this medicine.
You must stop taking Duspatalin retard and contact your doctor immediately if you experience any of
the following serious adverse reactions. Urgent medical help may be required:
Difficulty breathing, swelling of the face, neck, lips, tongue or throat. This may be a severe allergic
(hypersensitivity) reaction to the medicine.
If any of the above symptoms occur, stop taking the medicine and contact your doctor immediately.
Other adverse reactions
Milder allergic (hypersensitivity) reactions to the medicine may occur, such as rash, red, itchy skin lesions.
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 Reactions of Medicinal Products at 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 adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Duspatalin retard

Keep the medicine out of sight and reach of children.
Store below 30°C. Do not store below 5°C.
Keep in the original packaging.
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 in use. 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 composition: gelatin, titanium dioxide (E 171).
Printing ink: shellac (E 904), propylene glycol (E 1520), ammonium hydroxide, potassium hydroxide, iron oxide black (E 172).

What Duspatalin retard looks like and contents of the pack
The capsules are opaque, white, hard gelatin capsules of size 1, printed with "245".
The capsules are packed in PVC/aluminum blisters and placed in a cardboard box.
The pack contains 30 or 60 capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, No. 44C – 7.3 and 7.4
1990-095 Lisbon, Portugal

Manufacturer:
Mylan Laboratories SAS
Route de Belleville
Lieu-dit Maillard
01400 Châtillon sur Chalaronne
France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Relabelled and repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Portugal, country of export: 8354845
Parallel Import Licence Number: 491/13