Debridat

Package leaflet: Information for the patient

Debridat 100 mg suppositories

trimebutine maleate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 using 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 substance trimebutine, a compound that regulates gastrointestinal motility.
Debridat is indicated for:

• irritable bowel syndrome
• disorders of esophageal and gastric motility.

2. What you should know before using Debridat

Do not use Debridat

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

Warnings and precautions
Talk to 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 between trimebutine and other medicines have been reported.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breast-feeding, ask your doctor for advice before using this medicine.
Do not use Debridat during the first trimester of pregnancy or while breast-feeding, unless advised by your
doctor.
Clinical studies on fertility with Debridat have not been conducted.
Driving and using machines
Debridat may cause dizziness, vertigo, and visual disturbances that could affect your ability to drive or operate machinery. If you experience or have previously experienced these symptoms, avoid driving or operating machinery.

3. How to use Debridat

Use this medicine exactly as directed by your doctor. 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
If you take an excessive dose of Debridat, contact your doctor immediately or go to the nearest hospital.
Cases of intentional abuse, suicide attempts or accidental overdose with Debridat have been reported.
Excessive oral doses of Debridat have caused loss of consciousness, coma, drowsiness, seizures, speech disorders, pupillary constriction, transient interruptions of breathing, profuse sweating, increased heart rate, high blood pressure, and changes in the electrocardiogram.
These effects have occurred within 3 hours after intake of trimebutine.
If you forget to use Debridat
Do not use a double dose to make up for a forgotten dose.
If you stop using Debridat
If you have any doubts about using 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
• Indigestion
• Nausea
• Vomiting
• Skin rash
• Fatigue

Side effects of unknown frequency (frequency cannot be estimated from the available data)

• Substance-related and addictive behavioural disorders
• Somnolence
• Dizziness
• Itching
• Urticaria

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after Exp.. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Debridat contains

• The active substance 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 package contains 10 suppositories.
It is possible that not all pack sizes are marketed.

Marketing Authorization 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).

Patient Information Leaflet

Debridat 150 mg soft capsules

trimebutine maleate
Debridat 72 mg/15 mL oral suspension granules
trimebutine base
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms seem identical to yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 taking Debridat
3. How to take Debridat
4. Possible side effects
5. How to store Debridat
6. Package contents and other information

1. What Debridat is and what it is used for

Debridat contains the active substance trimebutine, a compound that regulates gastrointestinal motility.
Debridat is indicated for:

• irritable bowel syndrome
• disorders of esophageal and gastric motility.

2. What you need to know before taking Debridat

Do not use Debridat

• if you are allergic to trimebutine or to any of the other ingredients of this medicine (listed in section 6)
• if you have intestinal obstruction caused by bowel paralysis (paralytic ileus) or other diseases characterized by gastrointestinal obstruction
• if you have ulcerative colitis, a chronic inflammatory and ulcerative disease of the colon
• if you have toxic megacolon, a condition characterized by marked 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
medicine.
No interactions between trimebutine and other medicines have been reported.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Do not use Debridat during the first trimester of pregnancy or while breastfeeding without first consulting your doctor.
Clinical studies on fertility with Debridat have not been conducted.
Driving and using machines
Debridat may cause dizziness and drowsiness that could affect your ability to drive or operate machinery. If you experience or have previously experienced these symptoms, avoid driving or operating machinery.
Debridat 150 mg soft capsules contain sodium ethylparahydroxybenzoate, sodium propylparahydroxybenzoate, and soybean oil
Sodium ethylparahydroxybenzoate and sodium propylparahydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains soy. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains soybean oil. Do not use it if you are allergic to peanuts or soy.
Debridat 72 mg/15 mL oral granules for suspension contains sodium methylparahydroxybenzoate and sucrose
Sodium methylparahydroxybenzoate may cause allergic reactions (including delayed reactions).
Debridat contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
This medicine contains 18 g of sucrose per dose (45 mL). This should be taken into account in patients with diabetes mellitus. It may be harmful to teeth.

3. How to take Debridat

Take this medicine exactly as directed by 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 for 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 tablespoonfuls).

Use in children

Children up to 6 months of age
The recommended dose of reconstituted suspension is 2.5 mL (i.e. half a teaspoonful) three times a day.

Children from 6 months to 1 year of age
The recommended dose of reconstituted suspension is 5 mL (i.e. 1 teaspoonful) twice a day.

Children from 1 to 5 years of age
The recommended dose of reconstituted suspension is 5 mL (i.e. 1 teaspoonful) three times a day.

Children over 5 years of age
The recommended dose of reconstituted suspension is 10 mL (i.e. 2 teaspoonfuls) three times a day.

How to prepare the Debridat oral suspension

• Gradually add tap water to the bottle until the water reaches the raised line on the container.
• Shake the bottle well before taking Debridat.

Each 1 mL of reconstituted suspension contains 4.8 mg of trimebutine. A standard teaspoon corresponds to 5 mL (equivalent to 24 mg of trimebutine), and a standard tablespoon corresponds to 15 mL (equivalent to 72 mg of trimebutine).

If you take more Debridat than you should
In case of accidental overdose, inform your doctor immediately or go to the nearest hospital.
Cases of intentional abuse, suicide attempts, or accidental overdose with Debridat have been reported. Overdoses of Debridat have caused loss of consciousness, coma, drowsiness, seizures, speech disorders, pupil constriction, transient interruptions of breathing, profuse sweating, rapid heartbeat, high blood pressure, and changes in the electrocardiogram. These effects have occurred within 3 hours after ingestion of an excessive dose of trimebutine.

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

If you stop taking Debridat
If you have any questions 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
• Indigestion
• Nausea
• Vomiting
• Skin rash
• Fatigue

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Substance-related and addictive behavioural disorders
• Somnolence
• Dizziness
• Itching
• Urticaria

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 after reconstitution.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Debridat contains
Debridat 150 mg soft capsules

• The active substance is trimebutine maleate. Each soft capsule contains 150 mg of trimebutine maleate. The other components 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 substance is trimebutine base. 100 g of granules for oral suspension contains 787 mg of trimebutine base.
• The other components are sodium methylparahydroxybenzoate, orange flavour powder, sucrose.

Description of the appearance of Debridat and the contents of the pack
Debridat 150 mg soft capsules
Each pack of Debridat 150 mg soft capsules contains 1 blister with 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 1 250 mL bottle of extemporaneous suspension.
It is possible that not all pack sizes 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).

Package leaflet: information for the patient

Debridat 50 mg injectable solution

trimebutine maleate
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 using Debridat
3. How to use Debridat
4. Possible side effects
5. How to store Debridat
6. Package contents and other information

1. What Debridat is and what it is used for

Debridat contains the active substance trimebutine, a compound that regulates gastrointestinal tract motility.
Debridat is indicated for:

• irritable bowel syndrome
• altered motility of the esophagus and stomach
• loss of intestinal muscle tone resulting in altered intestinal motility following surgical procedures
• preparation for gastrointestinal endoscopy.

2. What you need to know before taking Debridat

Do not use Debridat

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

Warnings and precautions
Talk to your doctor or pharmacist before using Debridat.
Be careful because the injectable solution must be administered under direct medical supervision.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
Do not use Debridat during the first trimester of pregnancy or while breastfeeding, unless advised by your doctor.
Clinical studies with Debridat on fertility have not been conducted.

Driving and using machines
Debridat may cause dizziness and drowsiness, which could affect your ability to drive or operate machinery. If you experience or have previously experienced these symptoms, avoid driving or operating machinery.

Debridat contains benzyl alcohol and sodium
Debridat contains benzyl alcohol (25 mg/5 mL). Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with a risk of serious adverse effects, including respiratory problems (gasping syndrome), in young children.
Do not administer to neonates up to 4 weeks of age unless otherwise recommended by the doctor. Do not use for more than one week in young children (less than 3 years of age) unless otherwise recommended by the doctor or pharmacist. See section “Do not use Debridat”.
Consult your doctor or pharmacist if you are pregnant, suspect you may be pregnant, or are breastfeeding, as benzyl alcohol contained in the vials may accumulate in your body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease, as benzyl alcohol contained in the vials may accumulate in your body and cause adverse 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 exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Debridat will be administered to you by a doctor or other healthcare professional.

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

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

If you use more Debridat than you should
If you have used an excessive dose of Debridat, inform your doctor immediately or go to the nearest hospital.
Cases of intentional abuse, suicide attempts or accidental overdose with Debridat have been reported. Cases of low blood pressure and loss of consciousness (syncope) have been reported following intravenous administration of single doses exceeding 100 mg, or when the injection was administered too rapidly.

Furthermore, excessive oral doses of Debridat have caused loss of consciousness, coma, drowsiness, convulsions, speech disturbances, constricted pupils, transient interruptions of breathing, profuse sweating, rapid heartbeat, high blood pressure, and changes in the electrocardiogram. These effects occurred within 3 hours after ingestion of trimebutine.

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

If you stop treatment with Debridat
If you have any questions 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 will get them.

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

• Headache
• Abdominal pain
• Constipation
• Diarrhoea
• Dry mouth
• Indigestion
• Nausea
• Vomiting
• Skin rash
• Fatigue

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

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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.
Store in the refrigerator (2°C-8°C).
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Debridat contains

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

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

Marketing Authorization 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)