Ozanex 10 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ozanex 10mg/g cream
Ozenoxacin
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor, pharmacist, or nurse.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
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What Ozanex is and what it is used for
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What you need to know before using Ozanex
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How to use Ozanex
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Possible side effects
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Storage of Ozanex
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Contents of the pack and other information
1. What Ozanex is and what it is used for
Ozanex contains the active substance ozenoxacin, which belongs to the group of antibiotics for dermatological use.
Ozanex is used to treat a bacterial infection affecting small areas of the skin in adults, adolescents, children, and infants from six months of age. The infection is called non-bullous impetigo; it starts with small blisters and gradually develops a crust that eventually covers the infected area.
2. What you need to know before using Ozanex
Do not use Ozanex:
- if you are allergic to ozenoxacin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Treatment with Ozanex is not recommended in the following situations:
- If the blisters are large and affect a larger area without crusting (bullous impetigo).
- In adults and adolescents: if the extent of the lesions exceeds 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 exceeds 100 cm².
If you notice worsening of the infection, or if the skin becomes red, irritated, or shows other signs and symptoms at the application site, you must stop treatment with Ozanex and consult your doctor. See also section 4 of this leaflet.
You should take special care if you have any skin condition, e.g., rosacea or seborrheic dermatitis, as pre-existing skin conditions may worsen.
Avoid contact of Ozanex with the eyes and mucous membranes.
Ingestion must be avoided; take particular care 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 must not be used in children under six months of age.
Other medicines and Ozanex
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
Do not apply other ointments, creams, or lotions to the area being treated with Ozanex unless specifically instructed by your doctor.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Although clinical studies have not been conducted in pregnant women, no adverse effects are expected when this medicine is used during pregnancy, as systemic absorption of ozenoxacin into the blood is negligible. Ozanex may be used during pregnancy.
No effects on breastfed infants are expected, as systemic exposure to ozenoxacin in breastfeeding mothers is negligible. Ozanex may be used during breastfeeding; however, as a precaution, breastfeeding mothers should not apply ozenoxacin cream to the breast area to avoid inadvertent ingestion of the drug by the infant.
Driving and using machines
Ozanex is not expected to affect the ability to drive or operate machinery.
Ozanex contains propylene glycol, stearyl alcohol, and benzoic acid:
- This medicine contains 150 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation. Do not use this medicine in infants under 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.
- Stearyl alcohol may cause local skin reactions (such as contact dermatitis).
- This medicine 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 exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Apply a thin layer of cream to the infected skin area, twice daily for 5 days. If desired, you may cover the treated area with a sterile dressing or gauze. Wash your hands before and after applying the cream.
Ozanex is for cutaneous use only. It must not be applied to the eyes, mouth, lips, inside the nostrils, or the female genital area. If these areas come into accidental 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 any 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 continue with the next dose at the usual time.
If you stop treatment with Ozanex
If you stop using Ozanex too soon, bacteria may start growing again and the infection may recur. Do not discontinue using this medicine without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse 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 adverse effects may occur on the skin where Ozanex has been applied.
Uncommon effects (may affect up to 1 in 100 people):
- Itching (pruritus) or irritation at the application site.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ozanex
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the carton after "EXP". The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
The cream may be used for up to 45 days after first opening. The tube may be reused for a second treatment, provided that no more than 45 days have passed since the first opening.
Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ozanex
- The active substance is ozenoxacin. Each gram of Ozanex contains 10 mg of ozenoxacin.
- The other components are macrogol stearate, ethylene glycol monopalmitostearate, oleoyl macrogol glycerides, 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 pack
Ozanex is a light yellow cream supplied in an aluminum tube with a white screw cap.
Pack 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 medicinal product 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 most recent review of this leaflet:
January 2022