Dubine
ItalyF Package leaflet: Information for the user
Dubine 10 mg/g cream
Ozenoxacin
Please 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 questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Dubine is and what it is used for
- What you need to know before using Dubine
- How to use Dubine
- Possible side effects
- How to store Dubine
- Contents of the pack and other information
1. What Dubine is and what it is used for
Dubine contains the active substance ozenoxacin, which belongs 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 from six months of age. The infection, called non-bullous impetigo, initially presents with small blisters and gradually leads to the formation of a crust over the infected area.
2. What you need to know before using Dubine
Do not use Dubine:
- 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 Dubine is not recommended under the following circumstances:
- when blisters are large and affect an extensive area, and crust formation does not occur (bullous impetigo).
- in adults and adolescents: if the extent of lesions exceeds 100 cm².
- in children under 12 years of age: if the affected body surface area is greater than 2% of total body surface area or exceeds 100 cm².
If you notice worsening of the infection or increased redness, irritation, or other signs and symptoms at the application site, you must stop using Dubine and consult your doctor. See also section 4 of this leaflet.
Pay special attention if you have a pre-existing skin condition, such as rosacea or seborrheic dermatitis, as these skin conditions may worsen.
Avoid contact of Dubine with eyes and mucous membranes.
Avoid ingestion, taking particular care with 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 must not be used in children under six months of age.
Other medicines and Dubine
Inform your doctor if you are currently using, have recently used, or might use any other medicines.
Do not apply other ointments, creams, or lotions to the area treated with Dubine unless specifically instructed by your doctor.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Although clinical studies have not been conducted in pregnant women, ozenoxacin is not expected to cause effects during pregnancy, as absorption of ozenoxacin into the bloodstream is negligible. Dubine may be used during pregnancy.
Ozenoxacin is not expected to cause effects in breastfed infants, as systemic exposure to ozenoxacin in breastfeeding women is negligible. Dubine may be used during breastfeeding; however, as a precautionary measure, breastfeeding mothers should not apply ozenoxacin cream to the breast area to avoid accidental oral intake of the medicine by the infant.
Driving and using machines
Dubine is not expected to affect the ability to drive or use machinery.
Dubine contains propylene glycol, stearyl alcohol, and benzoic acid:
- This medicine contains 150 mg of propylene glycol in each gram of cream. Propylene glycol may 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 first consulting your doctor or pharmacist.
- Stearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
- This medicine contains 1 mg of benzoic acid in each gram of cream. Benzoic acid may cause local irritation and 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 exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of cream to the infected skin twice daily for five days. The treated area may be covered with a gauze or sterile dressing, if desired. Wash your hands before and after applying the cream.
Dubine is for external use only. 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, then continue with the next dose as usual.
If you stop using Dubine
If you stop treatment with Dubine too early, bacteria may start to grow again and the infection could return. Do not stop treatment with this medicine before talking to your doctor or pharmacist.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience a severe skin reaction or an allergic reaction:
- Stop using Dubine
- Gently remove the cream
- Contact your doctor or pharmacist immediately
The following side effects have occurred at the skin sites where Dubine was applied.
Uncommon side effects (occurring in up to 1 in 100 people) are:
- Itching or irritation at the application site.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at the following website:
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 stated on the tube and carton after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The cream can be used for up to 45 days after opening. The tube may be reused for a second treatment, provided that the above-mentioned 45-day period after opening is not exceeded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Dubine contains
- The active substance is ozenoxacin: each gram of Dubine contains 10 mg of ozenoxacin.
- The other components are macrogol stearate, ethylene glycol monopalmitostearate, oleic acid macrogol glycerides, octyldodecanol, stearyl alcohol, propylene glycol (E-1520), benzoic acid (E-210), purified water. Some of these components 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 aluminium tube with a white screw cap.
Pack:
Tubes containing 10 g of cream.
Marketing Authorisation Holder
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028 – Barcelona (Spain)
Selling Authorization Holder:
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 European Economic Area countries under the
following names:
Italy: Dubine
Portugal: Ozanex 10 mg/g cream
Spain: Ozanex 10 mg/g cream