Active ingredients: Trimebutin (Trimebutin maleate)
Digerent Polifarma 50 mg hard capsules
Indications Why is Digerent used? What is it for?
Digerent Polifarma contains trimebutin maleate which belongs to a class of medicines called synthetic antispasmodics and used to treat functional intestinal disorders.
Digerent Polifarma is used in adults to treat the following disorders:
- irritable colon (inflammatory bowel disease)
- cramps and pains in the stomach and intestines
- changes in the motility of the esophagus (tube that connects the pharynx to the stomach)
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Digerent should not be used
Do not take Digerent Polifarma
- if you are allergic to trimebutin maleate or any of the other ingredients of this medicine (listed in section 6 "What Digerent Polifarma contains")
- in the first 3 months of pregnancy or if you are breastfeeding.
Precautions for use What you need to know before taking Digerent
Talk to your doctor or pharmacist before taking Digerent Polifarma.
Children and adolescents
Digerent Polifarma is not indicated for use in children and adolescents as safety and efficacy have not been established in this patient group.
Interactions Which drugs or foods can change the effect of Digerent
Other medicines and Digerent Polifarma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions of trimebutin maleate with other drugs have been reported during therapy with Digerent Polifarma.
Digerent Polifarma with food and drink
Digerent Polifarma can be taken on either an empty stomach or a full stomach.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine in the first three months of pregnancy and if you are breast-feeding.
Driving and using machines
The product does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Digerent: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose in adults is: one hard capsule 2-3 times a day, for oral use. If necessary, your doctor can increase the dose, up to double.
You can take Digerent Polifarma before or after meals (See Section 2 "Digerent Polifarma with food and drink").
Use in children and adolescents
It is not indicated for use in children and adolescents as safety and efficacy have not been established in this patient group.
Overdose What to do if you have taken too much Digerent
If you take more Digerent Polifarma than you should
If you take more Digerent Polifarma than you should, contact your doctor immediately, or go to the nearest hospital, where you will be given the most appropriate treatment.
If you forget to take Digerent Polifarma
Do not take a double dose to make up for a forgotten capsule.
If you stop taking Digerent Polifarma
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Digerent
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Skin reactions have been observed and reported rarely during treatment with Digerent Polifarma.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 safety. of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after "EXP."
The expiry date refers to the last day of that month.
Do not use this medicine if you notice changes in the color of the capsule.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Digerent Polifarma contains
- The active ingredient is: trimebutin maleate 150 mg
- The other ingredients are: Corn starch; Talc; Magnesium stearate; Titanium dioxide (E 171); Jelly.
Description of the appearance of Digerent Polifarma and contents of the pack
Hard white capsules.
Carton containing 30 hard capsules packed in three PVC blisters of 10 capsules
Carton containing 20 hard capsules packed in two PVC blisters of 10 capsules
Not all pack sizes may be marketed.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
DIGERENT POLIFARMA 150 MG HARD CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One hard capsule contains: Trimebutin maleate 150 mg
For excipients see section 6.1
03.0 PHARMACEUTICAL FORM
hard capsules
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Irritable colon. Spastic-painful manifestations of the gastrointestinal tract. Functional disorders of esophageal motility.
04.2 Posology and method of administration
Adults: one hard capsule 2-3 times a day. If necessary, the dose can be increased, in the opinion of the doctor, up to double.
The method of intake is independent of meals.
There is limited experience with the use of Digerent Polifarma 150 mg hard capsules in children.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Pregnancy and lactation (see par. 4.6).
04.4 Special warnings and appropriate precautions for use
The drug does not present any risk of addiction or dependence.
There are no particular precautions to be observed in the use of trimebutin for oral use.
04.5 Interactions with other medicinal products and other forms of interaction
During therapy with Digerent Polifarma 150 mg hard capsules, no interactions of trimebutin with other drugs specific to the individual conditions have been reported.
04.6 Pregnancy and lactation
Although animal studies have not shown direct or indirect harmful effects in relation to pregnancy, embryonic fetal development, parturition and postnatal development (see par. 5.3), its use is not recommended during the first three months of pregnancy and during breastfeeding.
04.7 Effects on ability to drive and use machines
The use of Digerent Polifarma 150 mg hard capsules does not affect the ability to drive and use machines.
04.8 Undesirable effects
Adverse reactions are rare: rare cases of skin reactions have been reported.
04.9 Overdose
In the event of an overdose, routine measures should be used to remove unabsorbed material from the gastrointestinal tract. Observe the patient.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for functional intestinal disorders
ATC code: A03AA05
Trimebutin maleate acts electively on the digestive system, both directly on smooth muscles, in the myolytic sense, and at the level of the intrinsic intramural nerve plexuses where, with a competitive mechanism towards acetylcholine, it interrupts the neurovegetative stimuli, thus freeing the intrinsic regulatory system gastrointestinal function.
This dual mechanism of action explains the spasmolytic effect of Digerent Polifarma 150 mg hard capsules and its simultaneous normalizing properties of intestinal motility.
05.2 "Pharmacokinetic properties
Trimebutin is rapidly and completely fixed in the digestive system from the esophagus to the sigmoid.
In particular, after one hour, 20% of the administered quantity is fixed in the esophageal wall, 30% in the gastric one, 10% in the small intestine. After 3 hours, 10% is found in the esophagus, in the stomach and in the 20% small and 15% in the large intestine.
6 hours after administration, 15% is found in the stomach, 20% in the small intestine, 30% in the large intestine.
Pharmacokinetic studies with labeled trimebutin have shown that the substance is fixed in all parts of the gastrointestinal tract, from the esophagus to the sigmoid, where the intramural nerve plexuses of Auerbach and Meissner are present.
85% of trimebutin is eliminated in the urine within 24 hours, in the form of metabolites, causing no accumulation phenomena.
05.3 Preclinical safety data
For acute administration
DL / 50 (albino mouse, per os)> 4000 mg / Kg
DL / 50 (albino mouse, for i.p.) 368.1 mg / Kg
DL / 50 (albino rat, per os)> 4000 mg / Kg
DL / 50 (albino rat for i.p.) 394.4 mg / Kg
For prolonged administration
Albino rat, per os (120 days): no alteration at 80 mg / kg / day Beagle dog, per os (120 days): no alteration at 40 mg / kg / day
Fetal toxicity
Trimebutin maleate, if administered to rats and rabbits during pregnancy, respectively at doses of 100 and 30 mg / kg, per os has no toxic effects on fetuses and during gestation.
Carcinogenic activity
Trimebutin maleate has no chemical analogy with compounds known to be carcinogenic and the evidence of prolonged administration (rat and dog) showed no histological changes or suspected biochemical activities.
Therefore carcinogenic activity is excluded.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Corn starch - Talc - Magnesium stearate - Titanium dioxide (E171) - Gelatin.
06.2 Incompatibility
There are no known incompatibilities with the use of the product.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Lithographed cardboard box containing 30 hard capsules in opaque white PVC blisters, welded on a semi-rigid aluminum support.
30 hard capsules of 150 mg
20 hard capsules of 150 mg
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
POLIFARMA S.p.A. - Viale dell "Arte, 69 00144 ROME.
08.0 MARKETING AUTHORIZATION NUMBER
30 hard capsules of 150 mg: A.I.C. 024493025
20 hard capsules of 150 mg: A.I.C. 024493013
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
30 hard capsules of 150 mg: 25-06-1981 / June 2010
20 hard capsules of 150 mg: 25-06-1981 / June 2010
10.0 DATE OF REVISION OF THE TEXT
April 2007
