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OZENOXACIN FERRER 10 MG/G CREAM

Active substance(s): OZENOXACIN / OZENOXACIN

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Package leaflet: Information for the user
Ozenoxacin Ferrer 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.

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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.
2.
3.
4.
5.
6.

What Ozenoxacin Ferrer is and what it is used for
What you need to know before you use Ozenoxacin Ferrer
How to use Ozenoxacin Ferrer
Possible side effects
How to store Ozenoxacin Ferrer
Contents of the pack and other information

1.

What Ozenoxacin Ferrer is and what it is used for

Ozenoxacin Ferrer contains the active substance Ozenoxacin, which belongs to the group of antibiotics for
dermatological use.
Ozenoxacin Ferrer is used to treat a bacterial infection, affecting small areas of skin, in adults and children
aged two years 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 Ozenoxacin Ferrer

Do not use Ozenoxacin Ferrer:
- if you are allergic to ozenoxacin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Treatment with Ozenoxacin Ferrer 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 cm2.
For children under 12 years of age: if the affected body surface is bigger than a 2% of all the skin
surface of the whole body or if it surpasses the 100cm2.

If you notice any worsening of the infection or develop increased redness, irritation or other signs and
symptoms at the site of application, you should stop using Ozenoxacin Ferrer and tell your doctor. See also
section 4 of this leaflet.

Take special care if you have a skin condition, e.g. rosacea or seborrhoeic dermatitis, since deterioration of
already present skin conditions may occur.
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Eye contact and contact with mucous membrane with Ozenoxacin Ferrer must be avoided.
Ingestion should be avoided, take special care with children who have lesions around the mouth.
Talk to your doctor if there is no improvement in your infection after three days of treatment.

Children and adolescents
Ozenoxacin Ferrer should not be used on children who are less than two years old.
Other medicines and Ozenoxacin Ferrer
Tell your doctor if you are using, have recently used or might use any other medicines.
Do not apply other ointments, creams or lotions to the area being treated with Ozenoxacin Ferrer unless
specifically instructed to do so by your doctor.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before using this medicine.
Although no clinical studies have been conducted in pregnant women, no effects during pregnancy are
anticipated, since uptake of ozenoxacin into the blood is negligible. Ozenoxacin Ferrer can be used during
pregnancy.
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to
ozenoxacin is negligible. Ozenoxacin Ferrer can be used during breast-feeding but, as a precaution, nursing
mothers should not apply ozenoxacin cream to the breast area to protect the suckling infant from
unintentional oral drug uptake.

Driving and using machines
Ozenoxacin Ferrer is not expected to affect your ability to drive or use machines.
Ozenoxacin Ferrer contains:
- Propylene glycol which may cause skin irritation.
- Stearyl Alcohol which may cause local skin reactions (e.g. contact dermatitis).
- 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
amount of Benzoic acid per each gram of cream is 1 mg.

3.

How to use Ozenoxacin Ferrer

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
Apply a thin layer of cream on the infected skin twice a day for five days. The treated area may be covered
by a sterile bandage or gauze dressing, if desired. Wash your hands before and after applying the cream.
Ozenoxacin Ferrer is for use on the skin only. It must not be put in the eyes, on the mouth or lips, inside the
nose or inside the female genital area. If the cream accidentally gets on to these areas, wash the area with
water and consult your doctor if you experience discomfort.

If you use more Ozenoxacin Ferrer than you should
Carefully wipe off the extra cream
If you accidentally swallow Ozenoxacin Ferrer
2

Contact your doctor or pharmacist for advice.
If you forget to use Ozenoxacin Ferrer
Apply the cream as soon as you remember, and apply the next dose at the usual time.
If you stop using Ozenoxacin Ferrer
If you stop using Ozenoxacin Ferrer too soon, the bacteria may start to grow again and your infection may
come back. Do not stop using this medicine before talking to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you develop a severe skin reaction or an allergy:
− Stop using Ozenoxacin Ferrer
− Carefully wipe off the cream
− Contact your doctor or pharmacist immediately
The following side effects have occurred on the skin where Ozenoxacin Ferrer has been applied.
Uncommon side effects (may affect up to 1 in 100 people):
• Itching (pruritus) or irritation at the application site.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

5.

How to store Ozenoxacin Ferrer

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and carton after “EXP”.The expiry
date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
You may use the cream for up to 45 days after opening. The tube can be re-used for a second treatment,
provided that those 45 days after opening are not exceeded.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Ozenoxacin Ferrer contains

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The active substance is ozenoxacin: Each gram of Ozenoxacin Ferrer contains 10 mg of ozenoxacin
The other ingredients are macrogol stearate ethylene glycol monopalmitostearate, , oleoyl macrogol
glycerides, octyldodecanol, stearyl alcohol, propylene glycol, benzoic acid (E-210), purified water.
Some of these ingredients can cause a skin reaction; see section 2 of this leaflet.

What Ozenoxacin Ferrer looks like and contents of the pack
Ozenoxacin Ferrer is a pale yellow cream, and is available in an aluminium tube with a white screw cap.
Pack size:
Tubes containing 10 g of cream.

Marketing Authorisation 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 Valles, Barcelona (Spain)
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium:
Finland:
Germany:
Greece:
Ireland:
Italy:
Poland:
Portugal:
The Netherlands:
Spain:
Sweden:
United Kingdom:

Ozenoxacin Ferrer 10 mg/g crème
Ozanex 10 mg/g emulsiovoide
Dubine 10 mg/g Creme
Dubine 10 mg/g kρέμα
Dubine 10 mg/g cream
Dubine
Dubine
Ozanex 10 mg/g creme
Ozanex 10 mg/g crème
Ozanex 10 mg/g crema
Ozanex 10 mg/g kräm
Ozenoxacin Ferrer 10 mg/g cream

This leaflet was last revised in
April 2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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