Debretin Neo

Package Leaflet: Information for the Patient

Debretin Neo, 100 mg, 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

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

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

2. Important information before taking Debretin Neo

When not to take Debretin Neo:

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

Warnings and precautions

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

Debretin Neo and other medicines

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

Debretin Neo 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.
Pregnancy
Debretin Neo should not be taken during the first trimester of pregnancy. The medicine may be used in the second and third trimesters of pregnancy only if strictly necessary.
Breastfeeding
The safety of Debretin Neo in breastfeeding women has not been established.

Driving and using machines

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

Debretin Neo contains sodium

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

3. How to take Debretin Neo

Take this medicine always as directed by your doctor. If you are not sure, ask your doctor or pharmacist.
This medicine is for use in adults only.
Adults: 100 mg, 200 mg (1-2 tablets), 3 times a day.
Usually, 100 mg (1 tablet) is taken 3 times a day. In exceptional cases, the dose can be increased to 600 mg per day in divided doses (6 tablets).

Method of administration

Swallow the tablet whole with a glass of water.

Overdose of Debretin Neo

If you take more than you should, contact your doctor or pharmacist immediately.
In case of overdose, symptomatic treatment is recommended.

Missed dose of Debretin Neo

Do not take a double dose to make up for a forgotten dose.
Return to the dose 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 Neo 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 you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Debretin Neo

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package 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 month.
The notation 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 Neo contains

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

What Debretin Neo looks like and contents of the pack

Debretin Neo is a round, biconvex, white or almost white coated tablet with a diameter of:
7.9 mm - 8.4 mm.
Aluminium/PVC/PVDC blisters in a cardboard box.
30 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: