Package leaflet: Information for the patient

Debretin Neo, 100 mg, coated tablets
Trimebutini maleas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Debretin Neo is and what it is used for
Important information before taking Debretin Neo
How to take Debretin Neo
Possible side effects
How to store Debretin Neo
Contents of the package and other information

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

Debretin Neo 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 Neo is used in adults for symptomatic treatment of:

motility disorders defined as irritable bowel syndrome and intestinal disorders associated with functional gastrointestinal disturbances;
pain associated with functional disorders of the gastrointestinal and biliary tracts.

2. Important information before using Debretin Neo

When not to use Debretin Neo:

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 treatment with Debretin Neo, discuss this with your doctor or pharmacist.
Debretin Neo 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 use.
Concomitant administration of trimebutine maleate with zotepine (used in the treatment of schizophrenia) may enhance anticholinergic effects.
Synergistic action of trimebutine maleate in combination with rizatriptan (another medicine used in migraine treatment) in the treatment of migraine attacks has been reported.
Debretin Neo 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 child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Administration of Debretin Neo 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 Debretin Neo in breastfeeding women has not been established.
Driving and operating machinery
Debretin Neo has no influence on the ability to drive vehicles or operate machinery.
Debretin Neo contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Debretin Neo

This medicine should always be used exactly as directed by the physician. If in doubt, consult
your doctor or pharmacist.
This medicine is intended for use in adults only.
Adults: 100 mg – 200 mg (1–2 tablets) three times daily.
Typically, 100 mg (1 tablet) three times daily is recommended. In exceptional cases, the dose may be
increased up to 600 mg per day in divided doses (6 tablets).
Method of administration
The tablet should be swallowed whole with a glass of water.
Taking more Debretin Neo than recommended
If you take more than the recommended dose of this medicine, seek immediate advice from your
doctor or pharmacist.
In case of overdose, symptomatic treatment is recommended.
Missed dose of Debretin Neo
Do not take a double dose to make up for a missed dose.
Resume the dosing regimen 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 experiences them.
Uncommon adverse reactions (occurring in not more than 1 in 100 patients):

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

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

hypersensitivity
contact dermatitis, dermatitis, erythema, pruritus, and urticaria
severe skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, toxic skin eruptions, and 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Debretin Neo

Keep this medicine 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 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. This will help protect the environment.

6. Contents of the packaging and other information

What Debretin Neo contains

The active substance is trimebutine maleate. Each tablet contains 100 mg of trimebutine maleate.
The other ingredients are: mannitol; microcrystalline cellulose; pregelatinized maize 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); macrogol 3350; talc; peppermint flavour.

What Debretin Neo looks like and contents of the pack
Debretin Neo is a round, biconvex, white or almost white film-coated tablet with a diameter of:
7.9 mm – 8.4 mm.
Aluminium/PVC/PVDC blisters in a cardboard box.
30 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA Pharmaceuticals Plants S.A.
Pelplińska Street 19, 83-200 Starogard Gdanski
tel. + 48 22 364 61 01

Manufacturer
POLPHARMA Pharmaceuticals Plants S.A.
Pelplińska Street 19, 83-200 Starogard Gdanski
POLPHARMA Pharmaceuticals Plants S.A.
Production Branch in Nowa Dęba
Metalowca Street 2, 39-460 Nowa Dęba