DEBRIDAT 50 mg /5 Ml Injectable Solution

Зміст інструкції

1. Debridat 100 mg suppositories
   1. What Debridat is and what it is used for
   2. What you need to know before you use Debridat
   3. How to use Debridat
   4. Possible side effects
   5. How to store Debridat
   6. Contents of the pack and other information
2. Debridat 150 mg soft capsules
   1. What Debridat is and what it is used for
   2. What you need to know before you take Debridat
   3. How to take Debridat
   4. Possible side effects
   5. How to store Debridat
   6. Contents of the pack and other information
3. Debridat 50 mg injectable solution
   1. What Debridat is and what it is used for
   2. What you need to know before using Debridat
   3. How to use Debridat
   4. Possible side effects
   5. How to store Debridat
   6. Contents of the pack and other information

Debridat 100 mg suppositories

trimebutine maleate

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Debridat is and what it is used for
• 2. What you need to know before you use Debridat
• 3. How to use Debridat
• 4. Possible side effects
• 5. How to store Debridat
• 6. Contents of the pack and other information

1. What Debridat is and what it is used for

Debridat contains the active ingredient trimebutine, a substance that regulates the motility of the
gastrointestinal tract.
Debridat is indicated in case of:

• irritable bowel syndrome
• alteration of the motility of the esophagus and stomach.

2. What you need to know before you use Debridat

Do not use Debridat

• if you are allergic to trimebutine or any of the other ingredients of this medicine (listed in section 6)
• if you have an intestinal obstruction caused by paralysis of the intestine (paralytic ileus) or other diseases characterized by an obstruction of the gastrointestinal tract
• if you have ulcerative colitis, a chronic inflammatory and ulcerative disease of the colon
• if you have toxic megacolon, a disease characterized by a considerable dilation of the colon.

Warnings and precautions
Consult your doctor or pharmacist before using Debridat.

Other medicines and Debridat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions of trimebutine with other medicines have been reported.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.
Do not use Debridat in the first trimester of pregnancy and during breastfeeding, without first consulting your
doctor.
Clinical studies with Debridat on fertility have not been conducted.

Driving and using machines
Debridat may cause dizziness, vertigo and visual disturbances that may affect the ability to drive
vehicles and use machinery. If you have experienced or have experienced these symptoms in the past, avoid driving a vehicle or
using machinery. .

3. How to use Debridat

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2-3 suppositories per day.

If you take more Debridat than you should
In case of administration of an excessive dose of Debridat, immediately inform your doctor or go to the nearest hospital.
Cases of intentional abuse, suicide attempt or accidental overdose of Debridat have been reported.
Excessive doses of Debridat, taken orally, have caused loss of consciousness, coma, drowsiness, convulsions, speech disorders, pupillary constriction, transient respiratory interruptions, profuse sweating, rapid heartbeat, high blood pressure, electrocardiogram changes.
These effects appeared within 3 hours of taking trimebutine.

If you forget to use Debridat
Do not use a double dose to make up for a missed dose.

If you stop using Debridat
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)

• Headache
• Abdominal pain
• Constipation
• Diarrhea
• Dry mouth
• Difficulty in digestion
• Nausea
• Vomiting
• Skin rash
• Fatigue

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• Psychiatric disorders related to substance use and dependence
• Drowsiness
• Dizziness
• Itching
• Urticaria

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Debridat

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after Scad.. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Debridat contains

• The active ingredient is trimebutine maleate. Each suppository contains 100 mg of trimebutine maleate.
• The other ingredients are semi-synthetic glycerides.

Description of the appearance of Debridat and contents of the pack
Each pack contains 10 suppositories.
It is possible that not all packs are marketed

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM).

Debridat 150 mg soft capsules

trimebutine maleate
Debridat 72 mg/15 mL granules for oral suspension
trimebutine base

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Debridat is and what it is used for
• 2. What you need to know before you take Debridat
• 3. How to take Debridat
• 4. Possible side effects
• 5. How to store Debridat
• 6. Contents of the pack and other information

1. What Debridat is and what it is used for

Debridat contains the active ingredient trimebutine, a substance that regulates the motility of the
gastrointestinal tract.
Debridat is indicated in cases of:

• irritable bowel syndrome
• alteration of the motility of the esophagus and stomach.

2. What you need to know before you take Debridat

Do not use Debridat

• if you are allergic to trimebutine or any of the other ingredients of this medicine (listed in section 6)
• if you have an intestinal obstruction caused by paralysis of the intestine (paralytic ileus) or other diseases characterized by an obstruction of the gastrointestinal tract
• if you have ulcerative colitis, a chronic inflammatory and ulcerative disease of the colon
• if you have toxic megacolon, a disease characterized by a considerable dilation of the colon
• if you are allergic to peanuts or soy (see section “Debridat contains sodium ethylparahydroxybenzoate, sodium propylparahydroxybenzoate, soy and peanut oil”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Debridat.

Other medicines and Debridat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions of trimebutine with other medicines have been reported.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
Do not use Debridat in the first trimester of pregnancy and during breastfeeding, without first consulting your
doctor.
No clinical studies have been conducted with Debridat on fertility.

Driving and using machines
Debridat can cause dizziness and drowsiness that can affect your ability to drive vehicles and use
machinery. If you have experienced or have experienced these symptoms in the past, avoid driving a vehicle or using
machinery. .

Debridat150mgsoftcapsulescontainsodiumethylparahydroxybenzoate,sodium
propylparahydroxybenzoate, soy oil
Sodium ethylparahydroxybenzoate and sodium propylparahydroxybenzoate may cause allergic
reactions (even delayed).
This medicine contains soy. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains soy oil. Do not use it if you are allergic to peanuts or soy.

Debridat 72 mg/15 mL granules for oral suspension contains sodium methylparahydroxybenzoate and
sucrose
Sodium methylparahydroxybenzoate may cause allergic reactions (even delayed).
Debridat contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him
before taking this medicine.
This medicine contains 18 g of sucrose per dose (45 mL). To be taken into consideration in people
affected by diabetes mellitus. It may be harmful to teeth.

3. How to take Debridat

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Debridat 150 mg soft capsules
The recommended dose is 2-3 capsules per day (equivalent to 300-450 mg per day). The use of capsules is recommended
in adults.
Debridat 72 mg/15 mL granules for oral suspension

Use in adults
The recommended dose of reconstituted suspension is 30 to 45 mL per day (i.e. 2-3 tablespoons).

Use in children
Children up to 6 months of age
The recommended dose of reconstituted suspension is 2.5 mL (i.e. half a teaspoon) 3 times a day.
Children from 6 months to 1 year of age
The recommended dose of reconstituted suspension is 5 mL (i.e. 1 teaspoon) 2 times a day.
Children from 1 year to 5 years of age
The recommended dose of reconstituted suspension is 5 mL (i.e. 1 teaspoon) 3 times a day.
Children over 5 years of age
The recommended dose of reconstituted suspension is 10 mL (i.e. 2 teaspoons) 3 times a day.

How to prepare the oral suspension of Debridat

• Add spring water to the bottle little by little, until the water reaches the raised line on the container
• Shake the bottle well before taking Debridat

1 mL of reconstituted suspension contains 4.8 mg of trimebutine. A teaspoon conventionally
corresponds to 5 mL (equal to 24 mg of trimebutine) and a tablespoon conventionally corresponds to
15 mL (equal to 72 mg of trimebutine).

If you take more Debridat than you should
In case of accidental ingestion of an excessive dose of Debridat, inform your doctor immediately or
go to the nearest hospital.
Cases of intentional abuse, suicide attempt or accidental overdose of Debridat have been reported. Excessive doses of Debridat have caused loss of consciousness, coma, drowsiness, convulsions,
speech disorders, pupillary constriction, transient respiratory interruptions, profuse sweating,
rapid heartbeat, high blood pressure, electrocardiogram changes. These effects
appeared within 3 hours of taking an excessive dose of trimebutine.

If you forget to take Debridat
Do not take a double dose to make up for a missed dose.

If you stop taking Debridat
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)

• Headache
• Abdominal pain
• Constipation
• Diarrhoea
• Dry mouth
• Difficulty in digestion
• Nausea
• Vomiting
• Skin rash
• Fatigue

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• Psychiatric disorders related to substance use and dependence
• Drowsiness
• Dizziness
• Itching
• Urticaria

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Debridat

Keep this medicine out of the sight and reach of children.
Debridat 72 mg/15 mL granules for oral suspension
Use the reconstituted suspension within 20 days of reconstitution.
Do not use this medicine after the expiry date which is stated on the packaging after Scad.. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What Debridat contains
Debridat 150 mg soft capsules

• The active ingredient is trimebutine maleate. Each soft capsule contains 150 mg of trimebutine maleate. The other ingredients are soybean oil, hydrogenated vegetable oils, beeswax, soybean lecithin, hydrogenated soybean oil, gelatin, glycerol, sodium ethylparahydroxybenzoate, sodium propylparahydroxybenzoate, titanium dioxide. Debridat 72 mg/15 mL granules for oral suspension
• The active ingredient is trimebutine base. 100 g of granules for oral suspension contains 787 mg of trimebutine base.
• The other ingredients are sodium methylparahydroxybenzoate, orange flavour powder, sucrose.

Description of the appearance of Debridat and contents of the pack
Debridat 150 mg soft capsules
Each pack of Debridat 150 mg soft capsules contains 1 blister of 20 soft capsules.
Debridat 72 mg/15 mL granules for oral suspension
Each pack of Debridat 72 mg/15 mL granules for oral suspension contains 1 bottle of 250 mL of
extemporaneous suspension.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM).

Debridat 50 mg injectable solution

trimebutine maleate

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Debridat is and what it is used for
• 2. What you need to know before you use Debridat
• 3. How to use Debridat
• 4. Possible side effects
• 5. How to store Debridat
• 6. Contents of the pack and other information

1. What Debridat is and what it is used for

Debridat contains the active ingredient trimebutine, a substance that regulates the motility of the
gastrointestinal tract.
Debridat is indicated in cases of:

• irritable bowel syndrome
• altered motility of the esophagus and stomach
• loss of tone of the intestinal muscles with consequent alteration of intestinal motility, after surgical operation
• preparation for an endoscopy of the gastrointestinal tract.

2. What you need to know before using Debridat

Do not use Debridat

• if you are allergic to trimebutine or any of the other ingredients of this medicine (listed in section 6)
• if you have an intestinal obstruction caused by paralysis of the intestine (paralytic ileus) or other diseases characterized by an obstruction of the gastrointestinal tract
• if you have ulcerative colitis, a chronic inflammatory and ulcerative disease of the colon
• if you have toxic megacolon, a disease characterized by considerable dilation of the colon
• in children under 3 years of age. (see section “Debridat contains benzyl alcohol and sodium”).

Warnings and precautions
Consult your doctor or pharmacist before using Debridat.
Be careful because the use of the injectable solution must occur under the direct supervision of the
doctor.

Other medicines and Debridat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions of trimebutine with other medicines have been reported.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine
Do not use Debridat in the first trimester of pregnancy and during breastfeeding, without first consulting your
doctor.
Clinical studies on fertility with Debridat have not been conducted

Driving and operating machinery
Debridat can cause dizziness and drowsiness that can affect the ability to drive vehicles and operate
machinery. If you have or have had these symptoms in the past, avoid driving a vehicle or operating
machinery.

Debridat contains benzyl alcohol and sodium
Debridat contains benzyl alcohol (25 mg/5 mL). Benzyl alcohol can cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious side effects including breathing problems
(agonal respiratory syndrome) in young children.
Do not administer to infants under 4 weeks of age unless otherwise recommended by your doctor. Do not use
for more than one week in young children (under 3 years of age) unless otherwise recommended by your
doctor or pharmacist. See section “Do not use Debridat”.
Ask your doctor or pharmacist for advice if you are pregnant, suspect you are pregnant or are planning a
pregnancy, or if you are breastfeeding with breast milk as benzyl alcohol, contained in the vials, can accumulate in
your body and cause side effects (such as metabolic acidosis).
Ask your doctor or pharmacist for advice if you have liver or kidney diseases as benzyl alcohol, contained in the vials, can accumulate in your body and cause side effects (such as
metabolic acidosis).
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially ‘sodium-free’.

3. How to use Debridat

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.
The doctor or other healthcare professional will administer Debridat to you.

Use of Debridat in surgery
The recommended dose is 2-3 vials (100-150 mg) per day, which can be injected into the muscle or into a vein.

Use of Debridat during endoscopy of the gastrointestinal tract
The recommended dose is 1-2 vials (50-100 mg) per day, which can be injected or administered locally.

If you take more Debridat than you should
In case of an overdose of Debridat, immediately inform your doctor or go to the nearest
hospital.
Cases of intentional abuse, suicide attempt or accidental overdose of
Debridat have been reported. Cases of low blood pressure and loss of consciousness (syncope) have been reported following
intravenous administration of single doses greater than 100 mg and in cases where the injection was
performed too quickly.
Furthermore, excessive doses of Debridat, taken orally, have caused loss of consciousness, coma,
drowsiness, convulsions, speech disorders, pupillary constriction, transient interruptions of
breathing, profuse sweating, rapid heartbeat, high blood pressure, changes
in the electrocardiogram. These effects appeared within 3 hours of taking trimebutine.

If you forget to use Debridat
Do not use a double dose to make up for a missed dose.

If you stop using Debridat
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)

• Headache
• Abdominal pain
• Constipation
• Diarrhoea
• Dry mouth
• Difficulty in digestion
• Nausea
• Vomiting
• Skin rash
• Fatigue

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• Psychiatric disorders related to substance use and dependence
• Drowsiness
• Dizziness
• Itching
• Urticaria

Following the use of the intravenous solution, low blood pressure and loss of consciousness
(syncope) have been reported.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Debridat

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C-8°C).
Do not use this medicine after the expiry date which is stated on the packaging after Scad.. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Debridat contains

• The active ingredient is trimebutine maleate. Each vial contains 50 mg of trimebutine maleate.
• The other ingredients are benzyl alcohol, sodium chloride, water for injections.

Description of the appearance of Debridat and contents of the pack
Each pack contains 5 vials of 5 mL.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)