Trimebutin - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Trimebutin (Trimebutin maleate)

Trimebutina Angenerico 150 mg soft capsules

Why is Trimebutin used? What is it for?

Trimebutina Angenerico contains the active ingredient trimebutin maleate, belonging to the class of medicines called synthetic antispasmodics (anticholinergics), which act directly on the muscles of the stomach and intestine, normalizing their motility and function when it is altered

This medicine is used to treat a particular inflammatory state of the intestine called irritable bowel and functional disorders of the motility of the esophagus and stomach.

Contraindications When Trimebutin should not be used

Do not take Trimebutina Angenerico

  • if you are allergic to trimebutin maleate or any of the other ingredients of this medicine (listed in section 6), especially if you are allergic to peanut or soya;
  • if you suffer from blockage of the intestinal muscles (paralytic ileus) and other obstructive intestinal motility disorders;
  • if you have "inflammation of the gut" accompanied by lesions (ulcerative colitis);
  • if you have been diagnosed with an increase in the size of your colon (toxic megacolon);

Precautions for use What you need to know before taking Trimebutin

Talk to your doctor or pharmacist before taking Trimebutin.

Interactions Which drugs or foods can modify the effect of Trimebutin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

No interactions with other medicinal products have been reported.

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.

It is not recommended to use this medicine during the first three months of pregnancy and while breastfeeding.

Driving and using machines

The use of this medicine does not affect the ability to drive and use machines.

Trimebutina Angenerico contains parahydroxybenzoates and soybean oil

This medicinal product contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which can cause allergic reactions (including delayed).

This medicine contains soy. If you are allergic to peanuts or soy, do not use this medicine.

Dose, Method and Time of Administration How to use Trimebutin: Posology

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor.

The recommended dose is 2-3 capsules per day. The medicine is indicated in adults.

Overdose What to do if you have taken too much trimebutin

If you take more trimebutin than you should

In case of accidental intake of an excessive dose of the medicine, notify your doctor immediately or contact the nearest hospital

If you forget to take Trimebutina Angenerico

Do not take a double dose to make up for a forgotten dose.

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 Trimebutin

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

Cases of skin irritation (skin reactions) have been reported.

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 through the "Agenzia Italiana del Farmaco" 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.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date refers to the last day of that month.

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.

What Trimebutina Angenerico contains

  • The active ingredient is trimebutin maleate. Each capsule contains 150 mg of trimebutin maleate.
  • The other ingredients are: FU vegetable oil, partially hydrogenated vegetable oils, beeswax, soy lecithin, hydrogenated soybean oil, gelatin, glycerol, sodium ethyl p-oxybenzoate (E215), propyl sodium possibenzoate (E217), titanium dioxide (E171).

What Trimebutin looks like and contents of the pack

The medicine comes in the form of soft capsules. Pack of 20 soft capsules.

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.

Further information on Trimebutin is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

TRIMEBUTINA ANGENERICO 150 MG SOFT CAPSULES

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Soft capsules

One capsule contains:

Active principle

Trimebutin maleate 150 mg.

For a full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Soft capsules.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Irritable colon.

Functional disorders of gastroesophageal motility.


04.2 Posology and method of administration

Capsules

2-3 capsules per day

The use of the capsules is recommended in adults (see 4.4)


04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Paralytic ileus and obstructive pathology of the gastrointestinal system.

Ulcerative colitis.

Toxic megacolon.

Patients allergic to peanut or soy (see 4.4)


04.4 Special warnings and appropriate precautions for use

The drug does not present any risk of addiction or dependence.

Cases of hypotension and lipothymias have been reported. These effects generally concern intravenous administration.

There are no special precautions to be observed when using oral trimebutin. Keep the medicine out of reach of children.

The use of the capsules is recommended in adults (see 4.2)

The sodium ethyl parahydroxybenzoate and the sodium propyl parahydroxybenzoate contained in the capsules may cause allergic reactions (including delayed) (see 4.8).

This medicine contains soy: do not administer in patients allergic to peanuts and soy (see 4.3)


04.5 Interactions with other medicinal products and other forms of interaction

No interactions of trimebutin with other drugs specific to the individual diseases have been reported.


04.6 Pregnancy and breastfeeding

Animal studies have shown no teratogenic effects (see 5.3).

There are currently insufficient data to support a malformative or foetotoxic effect of trimebutin when administered during pregnancy.

It is not recommended to take trimebutin in the first trimester of pregnancy and during breastfeeding.


04.7 Effects on ability to drive and use machines

Trimebutin has no negative effect on the ability to drive or use machines.


04.8 Undesirable effects

Cases of skin reactions have been reported.

The sodium ethyl parahydroxybenzoate and the sodium propyl parahydroxybenzoate contained in the capsules may cause allergic reactions (including delayed) (see 4.4).


04.9 Overdose

No overdose symptoms have ever been reported due to the drug.

A specific antidote is not known. Like all cases of overdose, treatment should be symptomatic with general supportive measures.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Trimebutin: agonist of the encephalinergic receptors of the gastrointestinal tract.

ATC: A03AA05.

Trimebutin is a synthetic molecule with a regulating action on the motility of the digestive tract. The investigations on the mechanism of action have shown that the fundamental effect of trimebutin consists in the normalization of the modalities and speed of gastrointestinal transit. TRIMEBUTINA ANGENERICO is, therefore, indicated in functional pathological conditions in which it is necessary to bring an "altered motility back to the norm. The drug is normally devoid of anticholinergic effects."


05.2 "Pharmacokinetic properties

Studies with the labeled molecule have shown an "elective impregnation in those areas of the gastro-enteric apparatus in which the autonomic nervous plexuses of Meissner and Auerbach are present.

Distribution

The impregnation is rapid and lasting (after one hour it is maximum at the esophageal level, after three hours at the gastric level and after six hours at the intestinal level, small and large).

Elimination

The molecule is eliminated, in the form of various metabolites, through the urine in the ratio of 85% within 24 hours of administration.


05.3 Preclinical safety data

Experimental animal data reveal no special hazard for humans based on conventional studies of safety, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Soft capsules: FU vegetable oil, partially hydrogenated vegetable oils, beeswax, soy lecithin, hydrogenated soybean oil, gelatin, glycerol, sodium ethyl p-oxybenzoate (E215), sodium propyl p-oxybenzoate (E217), titanium dioxide (E171).


06.2 Incompatibility

None.


06.3 Period of validity

Capsules: 5 years.


06.4 Special precautions for storage

They are not necessary.


06.5 Nature of the immediate packaging and contents of the package

Box of 20 capsules of 150mg of trimebutin maleate.


06.6 Instructions for use and handling

07.0 MARKETING AUTHORIZATION HOLDER

ANGENERICO S.p.A.

Via Nocera Umbra, 75

00181 Rome

08.0 MARKETING AUTHORIZATION NUMBER

TRIMEBUTINA ANGENERICO, 150mg capsules A.I.C. n ° 034324032

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

12/01/2000-12/01/2005

10.0 DATE OF REVISION OF THE TEXT

AIFA Determination of 15 July 2009

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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