Package leaflet: Information for the patient

Debretin Forte, 200 mg, coated tablets
Trimebutini maleas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further 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 other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Contents of the leaflet

What Debretin Forte is and what it is used for
What you need to know before taking Debretin Forte
How to take Debretin Forte
Possible side effects
How to store Debretin Forte
Contents of the pack and other information

1. What Debretin Forte is and what it is used for

Debretin Forte contains as the active substance trimebutine maleate. Trimebutine acts directly on the smooth muscles of the gastrointestinal tract and regulates gastrointestinal motility. It does not affect the central nervous system.
Debretin Forte is indicated in adults for symptomatic treatment of:

motility disorders known as irritable bowel syndrome and intestinal disorders associated with functional gastrointestinal disturbances;
pain associated with functional disorders of the gastrointestinal tract and biliary ducts.

2. Important information before using Debretin Forte

When not to use Debretin Forte:

if the patient is allergic to trimebutine maleate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Debretin Forte, please discuss this with your doctor or pharmacist.
Debretin Forte and other medicines
You must 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 maleate with zotepine (used in the treatment of schizophrenia) may enhance anticholinergic effects.
A synergistic effect of trimebutine in combination with rizatriptan (another medicine used in the treatment of migraine) in the treatment of migraine attacks has been reported.
Debretin Forte with food and drink
See section 3.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Administration of Debretin Forte is not recommended during the first trimester of pregnancy. The medicine may be used during the second and third trimesters of pregnancy only if clearly necessary.
Breastfeeding
The safety of using Debretin Forte in breastfeeding women has not been established.
Driving and operating machinery
Debretin Forte has no influence on the ability to drive vehicles or operate machinery.
Debretin Forte contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Debretin Forte

This medicine should always be used as directed by a physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is intended for use in adults only.
Adults: 100 mg - 200 mg (half or 1 tablet) 3 times daily.
Typically, 100 mg (half a tablet) 3 times daily is used. In exceptional cases, the dose
may be increased up to 600 mg per day in divided doses, i.e. 200 mg (1 tablet) administered
3 times daily.
Method of administration
The tablet should be swallowed with a glass of water.
Use of a higher than recommended dose of Debretin Forte
If more than the recommended dose of the medicine is taken, seek immediate advice from a doctor or
pharmacist.
In case of overdose, symptomatic treatment is recommended.
Missed dose of Debretin Forte
Do not take a double dose to make up for a missed dose.
Resume the dosing schedule prescribed by the doctor.
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Uncommon adverse reactions (occurring no more frequently than in 1 out of 100 patients):

pre-syncopal states and (or) syncope*
rash.

Frequency not known (cannot be estimated from available data):

hypersensitivity
contact dermatitis, dermatitis, erythema, pruritus, and urticaria
severe skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, toxic skin eruptions, exfoliative dermatitis.

* Adverse reactions observed mainly after intravenous administration of trimebutine.
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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further collection of information on the safety of the medicine.

5. How to store Debretin Forte

Keep this medicine out of the sight and reach of children.
Do not store above 25°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.
The marking on the packaging following "EXP" indicates the expiry date, and following "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. Such measures help protect the environment.

6. Contents of the pack and other information

What Debretin Forte contains

The active substance is trimebutine maleate. Each tablet contains 200 mg of trimebutine maleate.
The other ingredients are: mannitol; microcrystalline cellulose; pregelatinized corn starch; sodium carboxymethyl starch (type A); hypromellose 2910 (5 mPa·s); tartaric acid; colloidal anhydrous silica; zinc stearate; hypromellose (6 mPa·s); hypromellose (15 mPa·s); titanium dioxide (E 171); talc; triacetin; peppermint flavour.

What Debretin Forte looks like and contents of the pack
Debretin Forte is an elongated, biconvex, white or almost white coated tablet with a division line
(14.9 mm - 15.4 mm x 7.2 mm - 7.7 mm). The tablet can be divided into equal doses.
Aluminium/PVC/PVDC blisters in a cardboard box.
60 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba