Dubine 10 mg/g cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ozenoxacin

Available from:

Ferrer Internacional, S.A

ATC code:

D06AX

INN (International Name):

Ozenoxacin

Dosage:

10 milligram(s)/gram

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antibiotics for topical use

Authorization status:

Not marketed

Authorization date:

2017-06-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUBINE 10 MG/G CREAM
Ozenoxacin
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dubine is and what it is used for
2.
What you need to know before you use Dubine
3.
How to use Dubine
4.
Possible side effects
5.
How to store Dubine
6.
Contents of the pack and other information
1.
WHAT DUBINE IS AND WHAT IT IS USED FOR
Dubine contains the active substance Ozenoxacin, which belongs to the
group of antibiotics for
dermatological use.
Dubine is used to treat a bacterial infection, affecting small areas
of skin, in adults, adolescents, children,
and infants aged six months and older. The infection is called
non-bullous impetigo and starts with tiny
blisters and gradually a crust will cover the infected area.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DUBINE
_ _
DO NOT USE DUBINE:
-
if you are allergic to ozenoxacin or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Treatment with Dubine is not recommended in the following situations:

If the blisters are larger and affecting a larger area, without
formation of crust (bullous impetigo),

For adults and adolescents: if the extension of the lesions is higher
than 100 cm
2
.

For children under 12 years of age: if the a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Dubine 10 mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10 mg of ozenoxacin
Excipient(s) with known effect:
Each gram of cream contains 1mg of benzoic acid (E-210), 150 mg of
propylene glycol and 40 mg of stearyl alcohol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
Pale yellow, homogeneous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dubine is indicated for the short term treatment of non-bullous
impetigo in adults, adolescents, children, and infants
aged 6 months and older) (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial medicinal products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, adolescents, children, and infants aged 6 months and older
A thin layer of cream should be applied to the affected area twice
daily for five days. The treated area may be covered
by a sterile bandage or gauze dressing, if desired.
Patients not showing a clinical response within three days should be
re-evaluated and alternative therapy should be
considered.
_Special populations_
_Elderly_
No dosage adjustment is necessary.
_Renal impairment_
No dosage adjustment is necessary. See section 5.2.
_Hepatic impairment_
No dosage adjustment is necessary. See section 5.2.
_Paediatric population_
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