Debretin Forte

Leaflet attached to the packaging: patient information

Debretin Forte, 200 mg, coated tablets

Trimebutine maleate

Please read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

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

• motility disorders referred to as irritable bowel syndrome and gastrointestinal disorders associated with functional gastrointestinal disorders;
• pain associated with functional gastrointestinal disorders and biliary tract disorders.

2. Important information before taking Debretin Forte

When not to take 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 take Debretin Forte, the patient should discuss it with their doctor or pharmacist.

Debretin Forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Concomitant administration of trimebutine maleate with zotepine (used in the treatment of schizophrenia) may enhance anticholinergic effects.
Synergism of trimebutine action in combination with rizatriptan (another medicine used in the treatment of migraine) has been reported in the treatment of migraine headaches.

Debretin Forte with food and drink

See section 3.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Debretin Forte should not be taken during the first trimester of pregnancy. The medicine may be taken during the second and third trimesters of pregnancy only if necessary.
Breastfeeding
The safety of Debretin Forte in breastfeeding women has not been established.

Driving and using machines

Debretin Forte does not affect the ability to drive or operate machinery.

Debretin Forte contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Debretin Forte

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for use in adults only.

Adults: 100 mg - 200 mg (half or 1 tablet) 3 times a day.

Usually, 100 mg (half a tablet) is taken 3 times a day. In exceptional cases, the dose may be increased to 600 mg per day in divided doses, i.e., 200 mg (1 tablet) taken 3 times a day.

Method of administration

The tablet should be swallowed with a glass of water.

Taking a higher dose of Debretin Forte than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
In case of overdose, symptomatic treatment is recommended.

Missing a dose of Debretin Forte

The patient should not take a double dose to make up for a missed dose.
The patient should return to the dosage schedule established by their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Debretin Forte can cause side effects, although not everybody gets them.
Uncommon side effects(occurring in less than 1 in 100 patients):

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

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

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

* Side effects mainly observed after intravenous administration of trimebutine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Debretin Forte

The medicine should be stored out of 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 stated on the packaging is the last day of the given 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 containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Debretin Forte contains

• The active substance of the medicine is trimebutine maleate. Each tablet contains 200 mg of trimebutine maleate.
• The other ingredients are: mannitol; microcrystalline cellulose; corn starch; sodium carboxymethylcellulose (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 flavor.

What Debretin Forte looks like and what the packaging contains

Debretin Forte is a prolonged, oblong, biconvex, white or almost white coated tablet with a dividing line (14.9 mm - 15.4 mm x 7.2 mm - 7.7 mm). The tablet can be divided into equal doses.
Aluminum/PVC/PVDC blisters in a cardboard box.
60 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Polpharma S.A.
Production Plant in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: