ANTALGENTA

PACKAGE LEAFLET

ANTALGENTA 0.1% cream

Generic medicine
COMPOSITION
100 g of cream contain:
Active substance: gentamicin 0.1 g (as gentamicin sulfate 0.166 g)
Excipients: Cetostearyl alcohol, cetomacrogol, white soft paraffin, liquid paraffin, monobasic sodium phosphate, chlorocresol, purified water.
PHARMACEUTICAL FORM AND CONTENT
Cream. 30 g tube.
THERAPEUTIC PHARMACOLOGICAL CATEGORY
Antibiotics and chemotherapeutic agents for dermatological use.
MARKETING AUTHORISATION HOLDER
SF GROUP Srl – via Tiburtina 1143, 00156 Rome (Italy)
MANUFACTURER AND FINAL CONTROLLER
LACHIFARMA Srl - SS 16 Zona Industriale, Zollino (Lecce)
THERAPEUTIC INDICATIONS
Bacterial skin inflammatory conditions, such as pyodermitis of varying severity and extent, including ecthyma, folliculitis, sycosis, furunculosis, microbial eczema, as well as secondarily infected conditions such as impetiginized dermatitis and eczema, stasis ulcers, traumatic wounds, burns and infected excoriations.
Other skin conditions that benefit from the application of gentamicin include acne and pustular psoriasis, intertriginous lesions and bacterial perionyxitis.
Gentamicin is ineffective against fungal infections, since it has no activity against any fungal strains; however, the drug is useful in treating bacterial superinfections of fungal or viral infections.
Particular efficacy of the preparation has been demonstrated in burns of various degrees and extent, where the "devitalization of the tissue" caused by the intense thermal injury promotes the development of particularly virulent bacterial flora.
CONTRAINDICATIONS
Hypersensitivity to the active substance (gentamicin), to substances closely related from a chemical standpoint, or to any of the excipients.
PRECAUTIONS FOR USE
Prolonged use, especially, of topical products may lead to sensitization phenomena. In such cases, treatment must be discontinued and appropriate therapy initiated.
This preparation must not be used for ophthalmic purposes. As with all antibiotics, treatment with gentamicin may lead to overgrowth of insensitive microorganisms; in such cases, treatment must be suspended and appropriate therapy initiated. Cross-allergenicity among aminoglycosides has been demonstrated.
INTERACTIONS
None known so far.
SPECIAL WARNINGS
The product contains chlorocresol, which may cause allergic reactions.
The product also contains cetostearyl alcohol, which may cause local skin reactions such as contact dermatitis.
PREGNANCY AND BREAST-FEEDING
In pregnant women and in early infancy, the product should be administered only when strictly necessary and under direct medical supervision.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Apply the cream 3–4 times daily until initial improvement is observed; thereafter, the number of applications may be reduced to 1–2 times per day. After application, it is advisable to protect the treated area with sterile gauze.
OVERDOSE
No cases of overdose have been reported.
UNDESIRABLE EFFECTS
Treatment with gentamicin may occasionally cause transient irritation (erythema or pruritus), which usually does not require discontinuation of therapy. In such cases, subsequent patch testing has not demonstrated irritation or sensitization phenomena.
Following the instructions provided in this leaflet reduces the risk of adverse effects.
Patients should inform their physician or pharmacist of any adverse effects observed.
EXPIRY DATE AND STORAGE
See the expiry date stated on the packaging. This date refers to the product stored unopened and correctly preserved.
Warning: do not use the medicine after the expiry date stated on the packaging.
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: March 2015