Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Ferrer Internacional, S.A., Gran Vía Carlos III, 94, 08028, Barcelona, Spain
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Treatment of bullous impetigo with ozenoxacin is not recommended (see section 5.1).
Safety and efficacy have not been established in the following:
The efficacy of ozenoxacin in the treatment of impetigo in patients with pre- existing skin conditions has not been evaluated in clinical studies.
In the event of a sensitisation or severe local irritation from the use of ozenoxacin cream, treatment should be discontinued, the cream carefully wiped off, and appropriate alternative therapy for the infection instituted.
Caution should be exercised when used on patients with increased skin sensitivity, e.g. rosacea or seborrhoeic dermatitis, since deterioration of already present skin conditions have been observed.
Ozenoxacin cream must be kept away from the eyes and mucous membranes.
Care must be taken to avoid ingestion which is especially important in children who has lesions around the mouth.
Dubine contains propylene glycol which may cause skin irritation.
Dubine contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Dubine contains benzoic acid which may be irritant to the skin, eyes and mucous membranes and may increase the jaundice in pre-term and full-term jaundiced neonates because of its absorption through the skin.
The effect of concurrent application of ozenoxacin and other topical medicinal products to the same area of skin has not been studied, and it is not recommended.
In human liver microsomes, ozenoxacin showed to cause mild direct competitive inhibition of CYP3A4 at high concentrations (100µM), and possibly cause very mild time-dependent inhibition of CYP2C9 at high concentrations (200µM). However, since systemic exposure to ozenoxacin was not observed following topical application of 10 mg/g cream in adult and paediatric patients aged 6 months and older (see section 5.2), it is not expected that concurrent systemic administration of CYP3A4 or CYP2C9 substrates will result in clinically important inhibition of their metabolism by ozenoxacin.
Ozenoxacin does not induce cytochrome P450 enzymes in vitro.
In vitro data, very strongly suggest that the use of ozenoxacin in combination with commonly used antimicrobial agents should not represent a risk to clinical outcome.
There are no data from the use of ozenoxacin in pregnant women. Studies in animals have shown reproductive toxicity after oral exposure (see section 5.3).
No effects during pregnancy are anticipated, since systemic exposure to ozenoxacin is negligible. Dubine can be used during pregnancy.
It is unknown whether ozenoxacin is excreted in human breast milk. The excretion of ozenoxacin in milk has not been studied in animals. No effects on the breastfed infant are anticipated since the systemic exposure of the breast-feeding woman to ozenoxacin is negligible. Dubine cream can be used during breast-feeding. As a precaution, it is recommended to avoid applying Dubine cream to the breast area to protect the suckling infant from unintentional oral drug uptake.
There are no data on the effects of ozenoxacin on human fertility. No treatment-related effects on male or female fertility have been shown in animal studies (see section 5.3).
Dubine has no or negligible influence on the ability to drive and use machines.
In clinical studies in which 559 patients with superficial skin infections applied ozenoxacin cream, the most commonly reported adverse reaction was application site irritation, which affected less than 1% of patients.
No significant safety issues were reported during the clinical studies.
The following convention has been used for the classification of frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
Uncommon: Application site irritation, Application site pruritus
During the clinical development program no adverse drug reactions were reported in the paediatric population. Frequency, type and severity of adverse reactions in the paediatric population are expected to be the same as in adults.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
Not applicable.
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