OZANEX 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Ozanex 10mg/g cream

Ozenoxacin

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

• This medication has been prescribed to you only, and you should 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Ozanex is and what it is used for
2. What you need to know before using Ozanex
3. How to use Ozanex
4. Possible side effects

5 Storage of Ozanex

1. Contents of the pack and further information

1. What Ozanex is and what it is used for

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

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

2. What you need to know before using Ozanex

Do not use Ozanex:

• if you are allergic to ozenoxacin or any of the other ingredients of this medication (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 crust formation (bullous impetigo).
• In adults and adolescents: if the extent of the lesions is greater than 100 cm2.
• In children under 12 years of age: if the affected body surface area is greater than 2% of the total body surface area or if it is greater than 100 cm2.

If you notice a worsening of the infection or if the skin becomes red or irritated or shows other signs and symptoms at the application site, you should discontinue treatment with Ozanex and consult your doctor. See also section 4 of this package leaflet.

You should exercise special caution if you have any skin condition, e.g., rosacea or seborrheic dermatitis, as it may worsen pre-existing skin conditions.

contact of Ozanex with the eyes and mucous membranes should be avoided.

Ingestion should be avoided; be especially careful in children with lesions around the mouth.

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

Children and adolescents

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

Other medications and Ozanex

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

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

Pregnancy and breastfeeding

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

Although clinical studies have not been conducted in pregnant women, no effects are expected when this medication is administered during pregnancy, as the absorption of ozenoxacin into the bloodstream is negligible. Ozanex can be used during pregnancy.

No effects are expected in breastfed infants, as the systemic exposure to ozenoxacin in breastfeeding mothers is negligible. Ozanex can be used during breastfeeding, but as a precaution, breastfeeding mothers should not apply the ozenoxacin cream to the breast area to avoid the infant accidentally ingesting the medication.

Driving and using machines

Ozanex is not expected to affect your ability to drive or use machines.

Ozanex contains propylene glycol, stearic alcohol, benzoic acid:

• This medication contains 150 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation. Do not use this medication in infants under 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.
• Stearic alcohol may cause local skin reactions (such as contact dermatitis).
• This medication contains 1 mg of benzoic acid per gram of cream. Benzoic acid may cause local irritation and may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to use Ozanex

Follow your doctor's instructions for using this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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

Ozanex is for external use only. Do not apply it to the eyes, mouth, or lips, or to the inside of the nostrils or the female genital area. If these areas accidentally come into contact with the cream, wash them with water, and if you experience any discomfort, consult your doctor.

If you use more Ozanex than you should

Carefully remove the excess cream.

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 then apply the next dose at the usual time.

If you stop using 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 further questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience a severe skin reaction or an allergic reaction:

• Stop using Ozanex
• Carefully remove the cream
• Contact your doctor or pharmacist immediately

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

Uncommon side effects (may affect up to 1 in 100 people):

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System, Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ozanex

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

Do not use this medication after the expiration date stated on the tube and carton after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

You can use the cream for up to 45 days after first opening. The tube can be reused for a second treatment, as long as it has not been more than 45 days since the first opening.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medications in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ozanex

• The active ingredient is ozenoxacin. Each gram of Ozanex contains 10 mg of ozenoxacin.
• The other ingredients are macrogol stearate, ethylene glycol monopalmitostearate, oleoyl macroglycerides, octyldodecanol, stearic alcohol, propylene glycol (E-1520), benzoic acid (E-210), purified water. Some of these ingredients may cause skin irritation; see section 2 of this package leaflet.

Appearance of Ozanex and pack contents

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

Package size:

Tubes containing 10 g of cream.

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà 1-9

08173 Sant Cugat del Vallès, Barcelona (Spain)

This medication is authorized in the Member States of the European Economic Area under the following names:

Italy: Dubine

Spain: Ozanex 10 mg/g cream

Date of the last revision of this package leaflet:

January 2022