Golamixin - Package Leaflet

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

Active ingredients: Tyrotricin, Cetrimonio bromide, Benzocaine

GOLAMIXIN® spray for oral mucosa

Why is Golamixin used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Prepared for the oropharyngeal cavity - ATC R02A

THERAPEUTIC INDICATIONS

Topical therapy of bacterial stomatitis sensitive to thyrotricin.

Contraindications When Golamixin should not be used

Subjects with known hypersensitivity to the components, especially thyrotricin.

Subjects whose marked predisposition to allergies is known.

Precautions for use What you need to know before taking Golamixin

In pregnant women and in very early childhood, the product should be administered in cases of real need and under the direct supervision of the doctor.

In case of no response within two days from the beginning of the administration, interrupt the treatment for the possible colonization of bacterial strains or fungi (especially Candida) resistant to thyrotricin. The use, especially if prolonged, of topical products can give rise to sensitization phenomena. In this case, therapy must be interrupted and appropriate therapy instituted.

Similar behavior must be observed in the event of the development of non-sensitive microorganisms.

Interactions Which drugs or foods can modify the effect of Golamixin

In view of the low doses administered, no serious interactions with other drugs are expected.

Warnings It is important to know that:

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

For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.

Dosage and method of use How to use Golamixin: Dosage

Adults: 2-3 applications at a time, 3-4 times a day.

Children: 1-2 applications at a time, 3-4 times a day.

The dispensing is exactly metered by a particular metering valve. Press the down button to obtain metered dispensing.

Overdose What to do if you have taken too much Golamixin

There are no known manifestations of overdose toxicity.

Side Effects What are the side effects of Golamixin

With the use of thyrotricin, blackening of the tongue, rarely glossitis and sensitization reactions have been reported which, however, regress with the interruption of treatment. More relevant may be the sensitization symptoms of anesthetics, including muscle disorders, convulsions.

The patient is invited to communicate to his doctor or pharmacist any undesirable effect other than those indicated above.

Expiry and Retention

Golamixin must be kept in a cool place.

Validity: 36 months.

Warning: do not use the medicine after the expiry date indicated on the package.

Deadline "> Other information

COMPOSITION

100 ml contain:

  • ACTIVE INGREDIENTS: Thyrotricin 0.02 g; Cetrimony bromide 0.05 g; Benzocaine g 0.05.
  • EXCIPIENTS: Peppermint essential oil; Alcohol.

PHARMACEUTICAL FORM

"oral mucosal spray" bottle 10 ml.

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 Golamixin can be found 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 the 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 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 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 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

GOLAMIXIN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

100 ml contain:

Active ingredients: thyrotricin 0.02 g; cetrimony bromide 0.05 g; benzocaine g 0.05.

03.0 PHARMACEUTICAL FORM -

Oral mucosal spray.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Topical therapy of bacterial stomatitis sensitive to thyrotricin.

04.2 Posology and method of administration -

Adults: 2-3 applications at a time, 3-4 times a day.

Children: 1-2 applications at a time, 3-4 times a day.

04.3 Contraindications -

Subjects with known hypersensitivity to the individual components, especially thyrotricin. Subjects whose marked predisposition to allergies is known.

04.4 Special warnings and appropriate precautions for use -

In very early childhood, the product should be administered in cases of real need and under the direct supervision of the doctor.

If there is no response within two days from the start of administration, interrupt the treatment for the possible colonization of strains or fungi (especially Candida) resistant to thyrotricin. The use, especially if prolonged, of topical products can give rise to sensitization phenomena. In this case, therapy must be interrupted and appropriate therapy instituted. Similar behavior must be observed in the event of the development of non-sensitive microorganisms.

Keep out of reach of children.

04.5 Interactions with other medicinal products and other forms of interaction -

In view of the low doses administered, no serious interactions with other drugs are expected.

04.6 Pregnancy and breastfeeding -

In pregnant women, the product should be administered in cases of real need, and under the direct supervision of the doctor.

04.7 Effects on ability to drive and use machines -

The administration of Golamixin does not affect the attention span, so there is no impediment to driving and using precision machines.

04.8 Undesirable effects -

With the use of thyrotricin, blackening of the tongue, rarely glossitis and sensitization reactions have been reported which, however, regress with the interruption of treatment. More relevant may be the sensitization symptoms of anesthetics, including muscle disorders, convulsions.

04.9 Overdose -

There are no known manifestations of overdose toxicity.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Golamixin is constituted by the association of an antibiotic, thyrotricin, with a disinfectant, cetrimide, and a local anesthetic, benzocaine. The pharmacological tests conducted using Golamixin have confirmed that the specialty possesses and carries out the already known activities carried out by the individual active ingredients in it. contents.

05.2 "Pharmacokinetic properties -

The active ingredients contained in Golamixin do not interfere with the intestinal bacterial flora and are not absorbed by the body in such concentrations as to determine a systemic microbial activity.

05.3 Preclinical safety data -

Acute toxicity tests carried out in rats and mice by the oral and subcutaneous route provided LD50 values ​​higher than 50 mg / kg and 20 mg / kg, respectively, giving the product a large safety margin. Chronic treatment for 24 weeks was well tolerated by the organism of orally treated rats and dogs. Golamixin treatment did not affect the fertility of orally treated rats and rabbits, nor was it shown to have maternal toxicity and teratogenic activity The product was also found to have no appreciable acute circulatory effects in the anesthetized rabbit.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Peppermint essential oil ml 0.25; alcohol to taste at 100 ml.

06.2 Incompatibility "-

There are no known incompatibilities with other drugs.

06.3 Period of validity "-

3 years in intact packaging.

06.4 Special precautions for storage -

None.

06.5 Nature of the immediate packaging and contents of the package -

Neutral glass bottle, type III, closed with dosing pump and equipped with oral dispenser.

Spray 10 ml

06.6 Instructions for use and handling -

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

Teofarma S.r.l. - via F.lli Cervi, 8 -27010 Valle Salimbene (PV)

08.0 MARKETING AUTHORIZATION NUMBER -

Oromucosal spray 10 ml bottle - A.I.C. 016703035 -

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

October 1960 / June 2010

10.0 DATE OF REVISION OF THE TEXT -

June 2010

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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