Debretin

Package Leaflet: Information for the Patient

Debretin, 100 mg, Film-Coated Tablets

Trimebutine Maleate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Debretin and what is it used for

Trimebutine stimulates intestinal motility. The action of the medicine depends on the functional state of the gastrointestinal tract. Regulation of peristalsis includes the entire gastrointestinal tract: the tension of the lower esophageal sphincter, the process of gastric emptying, the peristalsis of the small and large intestines. Trimebutine stimulates the muscles of the intestine with reduced function and acts spasmolytically on muscles with increased motor excitability. Maximum blood concentration occurs after 1 to 2 hours. The medicine is excreted mainly with urine.

Indications

Debretin is used to treat:

• motility disorders of the gastrointestinal tract, referred to as irritable bowel syndrome;
• functional disorders of the gastrointestinal tract: diarrhea, constipation, abdominal pain, intestinal spasm.

2. Important information before taking Debretin

When not to take Debretin:

Warnings and precautions

Before taking Debretin, discuss it with your doctor or pharmacist.

Debretin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take. Concomitant administration of trimebutine with zotepine may enhance anticholinergic effects. Synergism of trimebutine action in combination with rizatriptan in the treatment of migraine headaches has been reported.

Debretin with food and drink

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There are no sufficient data to confirm the safety of trimebutine during pregnancy. The medicine should not be given to women in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the medicine can be used only in cases of absolute necessity. During breastfeeding, taking the medicine is not contraindicated.

Driving and using machines

Debretin does not affect the ability to drive and use machines.

3. How to take Debretin

Take this medicine always as directed by your doctor. If you are not sure, ask your doctor or pharmacist. The medicine is intended for use in adults only. Adults: 1 tablet 3 times a day. In exceptional cases, the dose can be increased to 6 tablets a day in divided doses.

Method of administration

Swallow the tablet whole with a glass of water.

Overdose of Debretin

If you have taken more than the recommended dose of the medicine, seek medical advice immediately. In case of overdose, symptomatic treatment is recommended.

Missed dose of Debretin

Do not take a double dose to make up for a forgotten dose. Return to the dosage schedule prescribed by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Debretin can cause side effects, although not everybody gets them. Rare (≥1/10 000 to <1>

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Debretin

Keep the medicine out of the sight and reach of children. Store in a temperature below 25 ° C. Store in a dry place, 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 month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. Medicines should 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 Debretin contains

• The active substance is trimebutine maleate. Each tablet contains 100 mg of trimebutine maleate.
• The other ingredients are: core: microcrystalline cellulose, crospovidone, magnesium stearate; coating: hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide (E171).

What Debretin looks like and contents of the pack

Debretin is white, spherical tablets with a dividing line. The pack contains 20, 30, 40, 60 or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. + 48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., Medana Division in Sieradz, ul. Władysława Łokietka 10, 98-200 Sieradz, Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Zakłady Farmaceutyczne POLPHARMA S.A., Production Division in Nowa Dęba, ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: