Active ingredients: Trimebutin maleate (trimebutin maleate)
DEBRIDAT 150 mg SOFT CAPSULES
DEBRIDAT 100 mg SUPPOSITORIES
DEBRIDAT 72 mg / 15 mL GRANULES FOR ORAL SUSPENSION
DEBRIDAT 50 mg / 5 mL SOLUTION FOR INJECTION
Why is Debridat used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Agonist of the encephalinergic receptors of the gastrointestinal tract.
THERAPEUTIC INDICATIONS
- irritable colon;
- functional disorders of gastroesophageal motility;
- post-operative intestinal atony and preparation for endoscopic examinations of the digestive tract (for the solution for injection).
Contraindications When Debridat should not be used
Hypersensitivity to the active substance or to any of the excipients.
Paralytic ileus and obstructive pathology of the gastrointestinal system.
Ulcerative colitis.
Toxic megacolon.
Children under 3 years (for solution for injection only) (see "Dose, method and time of administration" and "Special warnings").
Patients allergic to peanut or soy (for capsules only) (see "Special warnings").
Precautions for use What you need to know before taking Debridat
Cases of hypotension and lipothymias have been reported. These effects generally concern the intravenous route and occur when single doses greater than 100 mg are used and the injection is given too quickly (see "Undesirable Effects" and "Overdose").
The parenteral use of the product must take place under the direct supervision of the physician; in particular the intravenous injection must be performed slowly (see "Dose, method and time of administration").
There are no particular precautions to be observed in the use of oral trimebutin.
The use of the capsules is recommended in adults (see "Dose, method and time of administration").
Interactions Which drugs or foods may change the effect of Debridat
No interactions of trimebutin with other drugs specific to the individual diseases have been reported.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
The drug does not present any risk of addiction or dependence.
Injectable solution
Due to the presence of benzyl alcohol, the product should not be administered parenterally to children under 3 years of age (see "Contraindications" and "Dose, method and time of administration").
The solution for injection contains sodium chloride: to be taken into consideration in people with reduced kidney function or who follow a low sodium diet.
Granules for oral suspension
The suspension contains sucrose which should be taken into account in diabetic patients and in those subjected to low-calorie dietary regimes. In case of known intolerance to some sugars, contact your doctor before taking this medicine.
The sodium methyl parahydroxybenzoate contained in the suspension may cause allergic reactions (possibly delayed) (see "Undesirable effects").
Soft capsules
The sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate contained in the capsules may cause allergic reactions (even delayed) (see "Undesirable effects").
This medicinal product contains soy: do not administer to patients allergic to peanuts and soy (see "Contraindications").
Pregnancy and breastfeeding
It is not recommended to take DEBRIDAT in the first trimester of pregnancy and during breastfeeding.
Animal studies did not show teratogenic effects.
There are currently insufficient data to support a malformative or foetotoxic effect of trimebutin when administered during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
Effects on ability to drive and use machines
Trimebutin does not affect the ability to drive or use machines.
Dosage and method of use How to use Debridat: Dosage
Soft capsules
300-450 mg / day (equal to 2-3 capsules per day).
The use of the capsules is recommended in adults (see "Precautions for use").
SUPPOSITORIES
Adults: on average 2-3 suppositories per day.
Granules for oral suspension
Children
1mL of reconstituted suspension contains 4.8 mg of trimebutin. A teaspoon conventionally corresponds to 5 mL (equal to 24 mg of trimebutin).
Up to 6 months: 36 mg / day divided into three doses corresponding to 2.5 mL (1⁄2 teaspoon) 3 times a day.
From 6 months to 1 year: 48 mg / day divided into 2 doses corresponding to 5 mL (1 teaspoon) 2 times a day.
From 1 year to 5 years: 72 mg / day divided into 3 doses corresponding to 5 mL (1 teaspoon) 3 times a day.
Over 5 years: 144 mg / day divided into 3 doses corresponding to 10 mL (2 teaspoons) 3 times a day.
Adults
On average 2-3 soup spoons per day.
Method of preparation
For the extemporaneous preparation of the oral suspension, add spring water several times, until, when the granules are completely suspended, the level of the liquid reaches the guideline.
Shake the bottle before each administration.
Injectable solution
Surgery
100-150 mg / day (2 - 3 ampoules) intramuscularly or intravenously.
Diagnostics
50-100 mg / day (1-2 ampoules) by injection or by local instillation.
Intravenous administration should be done slowly (3-5 minutes) (see "Precautions for use").
The solution should not be given to children under 3 years of age (see "Contraindications" and "Special warnings").
Since incompatibilities with various drugs are known (dihydrostreptomycin, bipenicillin, pentosorbital sodium, etc.) which occur with a precipitate that makes the injectable solution unsuitable for administration, it is recommended not to add other drugs to the vial.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Debridat
Experience with deliberate overdose is very limited. However, there have been reports of hypotension and lipothymias following single doses above 100 mg intravenously and in cases where the injection is given too quickly (see "Precautions for use" and "Undesirable effects").
A specific antidote is not known. As in all cases of overdose, treatment should be symptomatic with generic supportive measures.
In case of accidental intake of an excessive dose of the medicine, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Debridat
Like all medicines, this can cause side effects, although not everybody gets them.
Cases of skin reactions have rarely been reported.
The sodium ethyl parahydroxybenzoate and the sodium propyl parahydroxybenzoate contained in the capsules, and the sodium methyl parahydroxybenzoate contained in the suspension, can cause allergic reactions (even delayed) (see "Special warnings").
Hypotension and lipothymias have been reported with intravenous administration (see "Precautions for use" and "Overdose").
Compliance with the instructions in this leaflet reduces the risk of side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Solution for injection: store between + 2 ° C and + 8 ° C.
The reconstituted suspension must be used within 20 days.
Expiry: see the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the product after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
Composition and pharmaceutical form
COMPOSITION
Soft capsules
One capsule contains:
Active ingredient: trimebutin maleate 150 mg.
Excipients: FU vegetable oil, partially hydrogenated vegetable oils, beeswax, soy lecithin, gelatin, glycerol, hydrogenated soybean oil, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, titanium dioxide.
SUPPOSITORIES
One suppository contains:
Active ingredient: trimebutin maleate
Excipients: semisynthetic glycerides. 100 mg
Granules for oral suspension
100 g of granules contain:
Active ingredient: 787 mg trimebutin base.
Excipients: sodium methyl parahydroxybenzoate, orange powder flavor, sucrose.
Injectable solution
One vial contains:
Active ingredient: trimebutin maleate 50 mg.
Excipients: benzyl alcohol, sodium chloride, water for injections.
PHARMACEUTICAL FORMS AND PACKAGING
DEBRIDAT 150 mg soft capsules - Box of 20 capsules
DEBRIDAT 100 mg SUPPOSITORIES, 10 suppositories of 10 mg
DEBRIDAT 50 mg / 5 mL solution for injection - Box of 5 vials of 5 mL
DEBRIDAT 72 mg / 15 mL granules for oral suspension - 250 mL bottle of extemporaneous suspension
Further information is available on: Summary of Characteristics on the Official Website of the Italian Medicines Agency Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
