DUBINE <10 mg/g Cream

Зміст інструкції

1. Dubine 10 mg/g cream
   1. What is Dubine and what is it used for
   2. What you need to know before using Dubine
   3. How to use Dubine
   4. Possible side effects
   5. How to store Dubine
   6. Contents of the pack and other information

F olio illustrativo: information for the user

Dubine 10 mg/g cream

Ozenoxacina

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Dubine is and what it is used for
• 2. What you need to know before you use Dubine
• 3. How to use Dubine
• 4. Possible side effects
• 5. How to store Dubine
• 6. Contents of the pack and other information

1. What is Dubine and what is it used for

Dubine contains the active ingredient ozenoxacin, belonging to the group of antibiotics for dermatological use.
Dubine is used to treat a bacterial infection affecting small areas of the skin in adults, adolescents, children and infants six months of age and older. The infection, called non-bullous impetigo, is initially associated with small blisters and, gradually, with the formation of a crust on the infected area.

2. What you need to know before using Dubine

Do not use Dubine:

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

Warnings and precautions
Treatment with Dubine is not recommended in the following circumstances:

• When the blisters are larger in size and affect a wider area, and crust formation does not occur (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 entire body skin surface or if it exceeds 100 cm².

If you notice any worsening of the infection or further redness, irritation or other signs and symptoms
at the application site, you should stop using Dubine and consult your doctor. See also section
4 of this leaflet.
Pay particular attention if you suffer from a skin condition, such as rosacea or seborrheic
dermatitis, as pre-existing skin conditions may worsen.
Avoid contact of Dubine with the eyes and mucous membranes.
Avoid ingestion, paying particular attention to children who have lesions around the
mouth.
If the infection does not improve after three days of treatment, contact your doctor.

Children and adolescents
Dubine should not be used in children under six months of age.

Other medicines and Dubine
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not apply any other ointments, creams or lotions to the area treated with Dubine unless specifically
advised by your doctor.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Although clinical studies have not been conducted in pregnant women, it is not believed that ozenoxacine
can cause effects during pregnancy, since the absorption of ozenoxacine into the
blood is negligible. Dubine can be used during pregnancy.
It is not believed that ozenoxacine can cause effects on infants, since systemic exposure to ozenoxacine in
breastfeeding women is negligible. Dubine can be
used during breastfeeding, but, as a precaution, breastfeeding mothers should not apply
ozenoxacine cream to the breast area in order to avoid accidental oral intake of the drug
by the infant.

Driving and using machines
Dubine is not expected to interfere with the ability to drive vehicles or operate machinery.

Dubine contains propylene glycol, stearyl alcohol and benzoic acid:

• This medicine contains 150 mg of propylene glycol per gram of cream. Propylene glycol can cause skin irritation. Do not use this medicine in children under 4 weeks of age with open wounds or extensive areas of damaged skin (such as burns) without talking to your doctor or pharmacist.
• Stearyl alcohol may cause localised skin reactions (e.g. contact dermatitis).
• This medicine contains 1 mg of benzoic acid per gram of cream. Benzoic acid may cause local irritation, may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to use Dubine

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Apply a thin layer of cream to the infected skin twice a day for five days. The treated area
may be covered with a gauze or sterile bandage, if desired. Wash your hands
before and after applying the cream.
Dubine must be used only on the skin. It must not be applied to the eyes, mouth or lips, inside the
nose or inside the female genital area. If the cream accidentally comes
into contact with these areas, wash the area with water and consult your doctor if you
experience any discomfort.

If you use more Dubine than you should
Gently remove any excess cream.

If you accidentally swallow Dubine
Contact your doctor or pharmacist for advice.

If you forget to use Dubine
Apply the cream as soon as you remember and apply the next dose as usual.

If you stop using Dubine
If you stop treatment with Dubine too early, bacteria may begin to multiply again
and the infection may reappear. Do not stop treatment with this medicine before you have
spoken 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 everyone will experience them.
If you experience a severe skin reaction or an allergy:

• Stop using Dubine
• Gently remove the cream
• Contact your doctor or pharmacist immediately. The following side effects have occurred in the skin areas where Dubine has been applied. Uncommon side effects (up to 1 in 100 people) are:
• Itching or irritation at the application site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at:
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Dubine

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 the package after
“Scad.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
The cream can be used for up to 45 days after opening. The tube can be reused for a
second treatment, provided that the aforementioned 45 days after opening are not exceeded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dubine contains

• The active ingredient is ozonoxacin: each gram of Dubine contains 10 mg of ozonoxacin.
• The other ingredients are macrogol stearate, ethylene glycol monopalmitostearate, macrogol glycerides oleate, octyldodecanol, stearyl alcohol, propylene glycol (E-1520), benzoic acid (E-210), purified water. Some of these ingredients may cause a skin reaction; see section 2 of this leaflet.

Description of the appearance of Dubine and contents of the pack
Dubine is a light yellow cream available in an aluminum tube with a white screw cap
white.
Pack:
Tubes containing 10 g of cream.

Marketing Authorisation Holder
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94

• 08028 – Barcelona (Spain)

Distributor for sale:
Angelini S.p.A. – Viale Amelia, 70 – 00181 ROME

Manufacturer
Ferrer Internacional, S.A.
Joan Buscallà 1-9
08173-Sant Cugat del Vallès, Barcelona (Spain)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: Dubine
Portugal: Ozanex 10 mg/g cream
Spain: Ozanex 10 mg/g cream