Leaflet: information for the user

Ozanex 10mg/g cream

Ozenoxacin

This medicine is subject to additional monitoring, which will speed up the detection of any new information about its safety. You can contribute by reporting any side effects you may experience. The final part of section 4 includes information on how to report these side effects.

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Ozanex and what it is used for

2.What you need to know before starting to use Ozanex

3.How to use Ozanex

4.Possible side effects

5Storage of Ozanex

6.Contents of the pack and additional information

Ozanex contains the active ingredient ozenoxacin, which belongs to the group of dermatological antibiotics.

Ozanex is used to treat a bacterial infection that affects small areas of the skin in adults, adolescents, children, and infants six months of age and older. The infection is called non-bullous impetigo, which begins with small blisters and gradually develops a crust that covers the infected area.

Do not use Ozanex:

• if you are allergic to ozenoxacin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Ozanex treatment is not recommended in the following situations:

• if the blisters are larger and affect a larger area, without the formation of a scab (impetigo blisters).
• in adults and adolescents: if the extent of the lesions is greater than 100cm2.
• in children under 12 years: if the affected skin surface is greater than 2% of the total body surface area or greater than 100cm2.

If you notice an aggravation of the infection or if the skin becomes red, irritated, or shows other signs and symptoms at the application site, you must interrupt the treatment with Ozanex and consult your doctor. See also section 4 of this leaflet.

You must have special caution if you have any skin condition, e.g., rosacea or seborrheic dermatitis, as it could lead to the deterioration of pre-existing skin conditions.

Avoid contact of Ozanex with the eyes and mucous membranes.

Avoid ingestion, be especially careful in children with lesions around the mouth.

Consult your doctor if the infection does not improve after 3days of treatment.

Children and adolescents

Ozanex should not be used in children under six months of age.

Other medicines and Ozanex

Inform your doctor if you are using, have used recently, or may have to use any other medicine.

Do not apply other creams, ointments, or lotions to the area being treated with Ozanex, unless your doctor instructs you to do so explicitly.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Although no clinical studies have been conducted in pregnant women, no effects are anticipated when this medicine is administered during pregnancy sincethe absorption of ozenoxacin in the blood is insignificant. Ozanex can be used during pregnancy.

No effects are anticipated in breastfeeding infants since the systemic exposure to ozenoxacin in lactating mothers is insignificant. Ozanex can be used during breastfeeding, but, as a precaution, lactating mothers should not apply the ozenoxacin cream to the breast area to avoid the infant ingesting the medicine involuntarily.

Driving and operating machines

Ozanex is not expected to affect the ability to drive or operate machines.

Ozanex contains propylenglycol, stearic acid, benzoic acid:

• This medicine contains 150 mg of propylenglycol in each gram of cream. Propylenglycol may cause skin irritation. Do not use this medicine in babies under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.
• Stearic acid may cause local skin reactions (such as contact dermatitis).
• This medicine contains 1 mg of benzoic acid in each gram of cream. Benzoic acid may cause local irritation, may increase the risk of jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks of age).

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Apply a thin layer of cream to the infected skin, twice a day for 5 days. If desired, cover the treated area with a sterile bandage or gauze. Wash your hands before and after applying the cream.

Ozanex is for exclusive use on the skin. Do not apply it to the eyes, mouth, or lips, or inside the nasal passages or female genital area. If these areas come into contact with the cream by accident, wash them with water and, if you experience any discomfort, consult your doctor.

If you use more Ozanex than you should

Remove the excess cream carefully.

If you accidentally ingest Ozanex

Seek advice from your doctor or pharmacist.

If you forget to use Ozanex

Apply the cream as soon as you remember and resume the next dose at the usual time.

If you interrupt treatment with Ozanex

If you stop using Ozanex too soon, the bacteria may start growing again and the infection may recur. Do not stop using this medication without consulting your doctor or pharmacist first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If you experience a severe skin reaction or an allergy:

The following adverse effects may occur on the skin where Ozanex has been applied.

Less common effects (may affect up to 1 in 100 people):

• Itching (pruritus) or irritation at the application site.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use,Website:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the tube and the box after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

You can use the cream up to 45 days after the first opening. The tube can be reused for a second treatment, as long as 45 days have not passed after the first opening.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.In case of doubtask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Ozanex

• The active ingredient is ozenoxacin.Each gram of Ozanex contains 10mg of ozenoxacin
• The other components are macrogol stearate, monopalmito stearate of ethylene glycol, macrogol glycerides of oleic oil, octyldodecanol, stearyl alcohol, propylene glycol (E-1520), benzoic acid (E-210), purified water. Some of these components may cause skin irritation; see section 2 of this leaflet.

Appearance of Ozanex and contents of the packaging

Ozanex is a light yellow cream that is presented in an aluminum tube with a white screw cap.

Package size:

Tubes containing 10g of cream.

Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

Ferrer Internacional, S.A.

Joan Buscallà 1-9

08173 Sant Cugat del Vallès, Barcelona (Spain)

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Italy:Dubine

Spain:Ozanex 10 mg/g cream

Last review date of this leaflet:

January 2022.