Duspatalin retard
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Duspatalin retard (Colofac retard)
200 mg, prolonged-release capsules
Mebeverini hydrochloridum
Duspatalin retard and Colofac retard are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
- Keep this leaflet so that you can read it again if necessary.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
- 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 is a medicine in the form of prolonged-release capsules. Duspatalin retard contains a substance called mebeverine hydrochloride. It belongs to a group of medicines known as spasmolytics, which act in 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 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 may vary between individuals and may include:
- abdominal pain and cramps
- bloating and flatulence
- diarrhoea, constipation, or both of these conditions
- small, hard stools in the shape 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 any of the other ingredients of Duspatalin retard (listed in section 6).
Duspatalin retard must 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
No interactions are expected between Duspatalin retard and any other currently used medicines. However, inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Pregnancy, breastfeeding and fertility
During pregnancy, breastfeeding, or 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 retard is not recommended during pregnancy. Your doctor may advise discontinuing Duspatalin retard or switching to an alternative treatment.
- 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 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.
Taking the medicine
- Duspatalin retard can 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
- The usual dose is one 200 mg capsule 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 medicine than recommended
If you take more than the recommended dose, contact your doctor immediately or go to the hospital. Take the medicine package and the package leaflet with you.
If you forget to take a dose of Duspatalin retard
- If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten 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 may cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur after taking this medicine.
You must stop taking Duspatalin retard and immediately contact your doctor 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 above symptoms 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 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.
Reporting adverse reactions helps to provide more information on the safety of this medicine.
5. How to store Duspatalin retard
- Keep this medicine out of sight and reach of children.
- Do not store above 25°C or below 5°C. Store in the original packaging to protect from light.
- 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.
- Translation of some information on the immediate packaging: Ch.-B.: Verwendbar bis: siehe Prägung - Batch number: Expiry date: see imprint
- 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 packaging and other information
What Duspatalin retard contains
- The active substance is mebeverine hydrochloride. Each capsule contains 200 mg of the active substance.
- 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, concentrated ammonium hydroxide, potassium hydroxide, black iron oxide (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/Al blisters within a cardboard box.
Pack sizes: 30 or 60 capsules.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorization Holder in Austria, the country of export:
Mylan Österreich GmbH
Guglgasse 15
1110 Vienna
Austria
Manufacturer:
Mylan Laboratories SAS
Route de Belleville, Lieu dit Maillard
01400 Châtillon-sur-Chalaronne, France
Parallel Importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorization number in Austria, the country of export: 1-23472
Parallel Import Authorization number: 217/24