Debretin
Poland
Table of Contents
Package leaflet: Information for the patient
Debretin, 100 mg, coated tablets
Trimebutini maleas
Please read this leaflet carefully before using 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 doubts, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are identical.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.
Table of contents
- What Debretin is and what it is used for
- Important information before taking Debretin
- How to take Debretin
- Possible side effects
- How to store Debretin
- Contents of the pack and other information
1. What Debretin is and what it is used for
Trimebutine stimulates intestinal motility. The drug's action depends on the functional state of the gastrointestinal tract. It regulates peristalsis throughout the gastrointestinal system, including the tone of the lower esophageal sphincter, gastric emptying, and peristalsis of the small intestine and colon.
Trimebutine enhances muscle activity in underactive intestinal segments and exerts a spasmolytic effect on overactive muscles.
Maximum blood concentration is reached within 1 to 2 hours. The drug is primarily excreted in urine.
Indications
Debretin is used in the treatment of:
- Gastrointestinal motility disorders defined as irritable bowel syndrome;
- Functional gastrointestinal disorders: diarrhea, constipation, abdominal pain, intestinal spasms.
2. Important information before using Debretin
When not to use Debretin:
- if the patient is allergic to trimebutine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Debretin, discuss this with your doctor or pharmacist.
Debretin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant administration of trimebutine with zotepine may enhance anticholinergic effects.
A synergistic effect of trimebutine in combination with rizatriptan in the treatment of migraine attacks has been reported.
Debretin with food and drink
See section 3.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data to confirm the safety of trimebutine during pregnancy. The medicine should not be given to women during the first trimester of pregnancy.
During the second and third trimesters of pregnancy, the medicine may be used only if clearly necessary.
During breastfeeding, taking this medicine is not contraindicated.
Driving and operating machinery
Debretin has no effect on the ability to drive or operate machinery.
3. How to use Debretin
This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
This medicine is intended for use in adults only.
Adults: 1 tablet three times daily. In exceptional cases, the dose may be increased to 6 tablets daily in divided doses.
Method of administration
The tablet should be swallowed whole with a glass of water.
Taking more Debretin than recommended
If you have taken more than the recommended dose of this medicine, seek immediate advice from a doctor or pharmacist.
In case of overdose, symptomatic treatment is recommended.
Missed dose of Debretin
Do not take a double dose to make up for a missed dose.
Resume the dosing schedule as prescribed by your doctor.
If you have any further questions 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 everyone will experience them.
Rarely (≥1/10,000 to <1/1,000): skin allergic reactions, fatigue, nausea.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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
Tel.: +48 22 49 21 301
Fax: +48 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 this medicine.
5. How to store Debretin
Keep this medicine out of sight and reach of children.
Store below 25 °C. Keep in a dry place and 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.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
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. Package contents and other information
What Debretin contains
- The active substance is trimebutine maleate. Each tablet contains 100 mg of trimebutine maleate.
- 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 coated tablets with a score line.
Packs contain 20, 30, 40, 60 or 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 Branch 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 Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba