Golamixin

GOLAMIXIN®
"oral mucosa spray"
COMPOSITION
100 ml contains: ACTIVE SUBSTANCES: Tyrothricin 0.02 g; Cetrimide bromide 0.05 g;
Benzocaine 0.05 g. EXCIPIENTS: Peppermint essential oil; Alcohol.
PHARMACEUTICAL FORM
"oral mucosa spray" bottle 10 ml.
THERAPEUTIC PHARMACOLOGICAL CATEGORY
Preparation for the oropharyngeal cavity – ATC R02A
MARKETING AUTHORISATION HOLDER
TEOFARMA S.R.L.
Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
PRODUCED, PACKAGED AND CONTROLLED BY:
TEOFARMA S.R.L.
Viale Certosa, 8/A - 27100 Pavia
THERAPEUTIC INDICATIONS
Topical treatment of bacterial stomatitis sensitive to tyrothricin.
CONTRAINDICATIONS
Hypersensitivity to the components, especially tyrothricin.
Subjects known to have a marked predisposition to allergies.
SUITABLE PRECAUTIONS FOR USE
In pregnant women and very young infants, the product should be administered only
when clearly necessary and under direct medical supervision.
If no response occurs within two days of starting treatment, discontinue therapy due to the possible colonization by bacterial strains or fungi (especially Candida) resistant to tyrothricin.
The use, especially prolonged, of topical products may lead to sensitization phenomena. In such cases, treatment must be discontinued and appropriate therapy initiated. The same approach should be followed if non-sensitive microorganisms develop.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER TYPES OF INTERACTIONS
Given the low dosages administered, no severe interactions with other drugs are expected.
SPECIAL WARNINGS
Keep the medicine out of the reach and sight of children.
For individuals engaged in sports, the use of medicinal products containing ethyl alcohol may result in a positive outcome in anti-doping tests, depending on the alcohol concentration limits established by certain sports federations.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Adults: 2–3 sprays per application, 3–4 times daily.
Children: 1–2 sprays per application, 3–4 times daily.
The spray is precisely metered by a special dosing valve. Press the button downward to deliver the measured dose.
MANAGEMENT IN CASE OF OVERDOSAGE
No toxicity symptoms from overdose have been reported.
UNDESIRABLE EFFECTS
With the use of tyrothricin, black discoloration of the tongue has been reported, rarely glossitis and sensitization reactions, which however resolve upon discontinuation of treatment. More significant may be sensitization symptoms related to anesthetics, including muscular disorders and convulsions.
Patients are advised to inform their doctor or pharmacist of any adverse effect not listed above.
STORAGE
Golamixin must be stored in a cool place.
Shelf life: 36 months
Caution: do not use the medicine after the expiry date stated on the packaging.
Last update: March 2009