Trimonase - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Tinidazole

Trimonase, 500 mg tablets

Why is Trimonase used? What is it for?

Pharmacotherapeutic group

Antiprotozoars

Therapeutic indications

Trichomonas vaginalis infections of the urogenital tract in patients of both sexes. Simultaneous treatment of the partner is recommended in order to avoid reinfection. Infections with Lamblia intestinalis (Giardia Lamblia), entamoeba histolica.

Contraindications When Trimonase should not be used

Like all similar medicaments, Trimonase is contraindicated in patients with previous blood dyscrasias or organic affections of the central nervous system.

Precautions for use What you need to know before taking Trimonase

Not known.

Interactions Which drugs or foods can modify the effect of Trimonase

In the days of treatment with Trimonase and in the following days, the consumption of alcoholic beverages should be reduced to avoid possible abdominal cramps, vomiting and facial redness.

Warnings It is important to know that:

There is no evidence that Trimonase is harmful during pregnancy; however, it should be used during pregnancy when in the physician's opinion the benefits outweigh the potential repercussions for the mother and fetus.

Drugs of similar chemical structure are present in milk when administered to women during breastfeeding and, although it is not known whether these drugs are harmful to the newborn, Trimonase should not be administered during breastfeeding.

KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.

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

Tricomonas Vaginalis infections: 4 tablets taken at once with a little liquid. A single administration is usually enough. In case of reinfection repeat the treatment after 8 days.

Amebiasis and lambliasis: 1-3 tablets per day according to the nature of the infection and according to medical judgment. Generally the treatment is 5 days.

The posology described above is only indicative: it is in any case in relation to the severity of the infection and therefore can vary according to medical indication.

Overdose What to do if you have taken too much Trimonase

There are no known cases of overdose. In case of accidental or deliberate overdose, perform gastric lavage as soon as possible and keep the patient under observation in a suitable hospital setting.

Side Effects What are the side effects of Trimonase

Mild side effects affecting the gastrointestinal tract have been reported without serious patient discomfort. Nausea and vomiting in particular occur only rarely.

In one patient, biochemical changes indicative of a drug allergy were reported; in patients showing such changes, Trimonase should be discontinued.

As drugs of similar chemical structure, it can produce mild and transient leukopenia when administered by mouth. Also drugs of similar chemical structure have also produced neurological disorders such as: dizziness, in coordination, ataxia and drowsiness. If abnormal neurological signs occur during therapy with Trimonase, the drug should be promptly discontinued.

In the event of undesirable effects other than those described, the patient is expressly invited to communicate them to their doctor or pharmacist.

Expiry and Retention

The expiry date is shown on the package and refers to the product in intact packaging, correctly stored.

CAUTION: DO NOT USE THE MEDICINAL PRODUCT AFTER THE EXPIRY DATE INDICATED ON THE PACKAGE

Composition and pharmaceutical form

Composition

Each tablet contains:

Active ingredient: Tinidazole 500 mg

Excipients: Lactose monohydrate - Anhydrous lactose - Microcrystalline cellulose - Povidone - Croscarmellose sodium - Magnesium stearate.

Pharmaceutical form

500 mg tablets

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 Trimonase 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 interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 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 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER 09 .0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS AND QUALITY CONTROLS

01.0 NAME OF THE MEDICINAL PRODUCT

TRIMONASE 500 MG TABLETS

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 500 mg tablet contains:

active ingredient: tinidazole 500 mg.

03.0 PHARMACEUTICAL FORM

Tablets.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Trichomonas vaginalis infections of the urogenital tract in patients of both sexes. Simultaneous treatment of the partner is recommended to avoid infections.


04.2 Posology and method of administration

Trichomonas vaginalis infections: 4 tablets taken at once with a little liquid.

A single administration is usually enough. In case of reinfection repeat the treatment after 8 days.

Amebiasis and lambliasis: 1-3 tablets per day according to the nature of the infection and according to medical judgment. Generally the treatment is 5 days.

The posology described above is only indicative: it is in any case in relation to the severity of the infection and therefore goes according to medical indication.


04.3 Contraindications

Like all similar medicaments, Trimonase is contraindicated in patients with previous blood dyscrasias or organic affections of the central nervous system. Since these drugs cross the placental barrier, Trimonase is contraindicated in the first trimester of pregnancy; in the second and third trimester it must be used only in case of absolute necessity under the direct supervision of the doctor. Since similar products administered during lactation were found in breast milk and evidence of their harmlessness to the newborn is lacking, Trimonase is contraindicated for breastfeeding women.


04.4 Special warnings and appropriate precautions for use

Trimonase is generally well tolerated and secondary effects affecting the gastrointestinal tract are rare, however always minor and such as not to disturb the patient.

Nausea and vomiting are observed only exceptionally. Like other similar drugs, Trimonase can cause a slight transient leukopenia. On the day of treatment with Trimonase and in the following days, the consumption of alcoholic beverages should be reduced to avoid possible abdominal cramps, vomiting and facial redness.

Chemically similar drugs can sometimes lead to neurological disorders such as clouding, dizziness, incoordination and ataxia.

Keep this medicine out of the reach of children.


04.5 Interactions with other medicinal products and other forms of interaction

There are no known drug interactions and incompatibilities.


04.6 Pregnancy and breastfeeding

There is no evidence that Trimonase is harmful during pregnancy; however, it should be used during pregnancy when in the physician's opinion the benefits outweigh the potential repercussions for the mother and fetus. Drugs of similar chemical structure are present in milk when given to women during breastfeeding and, although not if these drugs are known to be harmful to the newborn, Trimonase should not be given while breastfeeding.


04.7 Effects on ability to drive and use machines

No effect of Trimonase on the ability to drive and use machines has been reported.


04.8 Undesirable effects

Mild side effects affecting the gastrointestinal tract have been reported without serious disturbances for the patient.Nausea and vomiting in particular occur only rarely.

Biochemical changes indicative of a drug allergy were reported in one patient; in patients showing such changes, Trimonase should be discontinued.

As drugs of similar chemical structure, it can produce a mild and transient leukopenia when administered by mouth. In addition, drugs of similar chemical structure have also produced abnormal neurological disorders during therapy with Trimonase, the drug must be promptly discontinued.


04.9 Overdose

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Trimonase provides a truly effective oral therapy in Trichomonas vaginalis infections in both women and men. The spectrum of activity of Trimonase also extends to other protozoa such as Entamoeba histolitica and Lamblia intestinalis (Giardia Lamblia).

In human infections, the usefulness of Trimonase has been confirmed by a large clinical trial.


05.2 "Pharmacokinetic properties

After oral administration the active principle is rapidly assimilated, reaches high serum concentrations in a short time and remains in the organism for a long time.


05.3 Preclinical safety data

Trimonase, whose active ingredient is Tinidazole, proved to be a very active drug, both in vitro, in the test with Trichomonas fetus and Trichomonas vaginalis, and in vivo in animals infected with Trichomonas fetus.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Lactose monohydrate, anhydrous lactose, microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate.


06.2 Incompatibility

There are no known drug interactions and incompatibilities.


06.3 Period of validity

3 years.


06.4 Special precautions for storage

There are no special storage precautions


06.5 Nature of the immediate packaging and contents of the package

Carton with non-toxic PVC blister pack of 8 tablets.


06.6 Instructions for use and handling

None.

07.0 MARKETING AUTHORIZATION HOLDER

Farmitalia s.r.l.

Viale Alcide De Gasperi 165 / B - 95127 Catania

08.0 MARKETING AUTHORIZATION NUMBER

A.I.C. n. 024860025

Pack of 8 tablets

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

01/05/2010

10.0 DATE OF REVISION OF THE TEXT

June 2007

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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