ANAURAN
ItalyThis medicinal product is indicated for the treatment of acute and chronic otitis in adults and children.
Frequently asked questions
When should you not use Anauran?
It must not be used if you are allergic to any of the components of the medicinal product or if you have a perforated eardrum, to avoid the risk of ear damage.
How should Anauran be administered?
The drops should be poured directly into the ear using the appropriate dropper, keeping the head tilted to the side for a few minutes. For adults, the dose is 4-5 drops, 2-4 times a day; for children, it is 2-3 drops, 3-4 times a day.
How long can the medicinal product be used?
Treatment may last for a variable period depending on the patient's response, but must not exceed 10 consecutive days.
What are the possible side effects of Anauran?
Skin allergic reactions (allergic dermatitis), itching, irritation at the site of application, or ear damage (ototoxicity) may occur.
What should you do if you do not notice any improvement?
It is necessary to consult a doctor if symptoms do not improve or if they worsen after three days of treatment.
Are there any special warnings for pregnancy or breastfeeding?
In case of pregnancy, the medicinal product should be used only if strictly necessary and under medical supervision. If breastfeeding, the product must be used with caution and a doctor or pharmacist should be consulted.
How long can the bottle be stored after opening?
Once the bottle is opened, the medicinal product must be used within 3 months.
Instructions for use
Package leaflet: Information for the user
Anauran ear drops, solution
Polymyxin B sulfate, Neomycin sulfate, Lidocaine hydrochloride
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
- Keep this leaflet. You may need to read it again.
- If you need more advice or information, consult your doctor or pharmacist.
- If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement, or if your symptoms worsen after three days.
Contents of this leaflet:
- What Anauran is and what it is used for
- What you need to know before using Anauran
- How to use Anauran
- Possible side effects
- How to store Anauran
- Contents of the pack and other information
1. What Anauran is and what it is used for
Anauran contains the active substances polymyxin B sulfate, neomycin sulfate, and lidocaine hydrochloride.
The medicine is a combination of antibiotics and a local anaesthetic.
Anauran is indicated in adults and children for the treatment of acute and chronic otitis.
Consult your doctor if you do not feel better or if you feel worse after three days.
2. What you need to know before using Anauran
Do not use Anauran:
- if you are allergic (hypersensitive) to polymyxin B sulfate, neomycin sulfate, and lidocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
- if you have a perforated eardrum, due to the risk of ear damage
Warnings and precautions
Talk to your doctor or pharmacist before using Anauran.
The use, especially if prolonged, of topical products such as Anauran may lead to sensitization reactions.
If this occurs, discontinue treatment and consult your doctor to establish appropriate therapy.
In the presence of deep or resistant infections, it is advisable to combine local treatment with appropriate systemic antibiotic therapy.
As with other antibiotic medicines, prolonged treatment may lead to additional infections (so-called "superinfections") caused by germs resistant to the same antibiotic treatments.
Neomycin, one of the active substances in this medicine, may cause permanent hearing loss. The risk of ear damage is higher with prolonged use; therefore, treatment duration should be limited to 10 consecutive days.
If you have previously experienced allergic reactions or resistance to antibiotics similar to neomycin (aminoglycosides), these may also occur with the use of Anauran.
Other medicines and Anauran
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Use this medicine only if strictly necessary and under direct medical supervision.
Breastfeeding
If you are breastfeeding, use this medicine with caution.
Driving and using machines
Anauran does not affect the ability to drive vehicles or operate machinery.
Anauran contains benzalkonium chloride and propylene glycol
The medicine contains 0.001 mg of benzalkonium chloride per drop, which may cause skin irritation.
The medicine contains 11.6 mg of propylene glycol per drop, which may cause skin irritation.
3. How to use Anauran
Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.
Adults
The recommended dose is 4-5 drops, 2-4 times daily.
Children
The recommended dose is 2-3 drops, 3-4 times daily.
The duration of treatment may vary and depends on your response to therapy. In any case, do not use the medicine for longer than 10 consecutive days.
Method of administration
Using the provided dropper, instill the drops directly into the ear, keeping the head tilted to the side for a few minutes.
ANAURAN is for otic use only (=in the ear); application to other sites is inappropriate.
If you use more Anauran than you should
Cases of overdose have not been reported.
If you forget to use Anauran
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects have been reported after administration of Anauran:
Frequency not known (frequency cannot be estimated from the available data)
- Allergic skin reaction (allergic dermatitis), itching
- Application site irritation
- Ear damage (ototoxicity)
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Anauran
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
After the first opening of the bottle, the medicine should be used within 3 months; after this period, any remaining medicine must be discarded.
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 Anauran contains
25 ml contain:
- The active substances are Polymyxin B sulfate 250,000 IU, Neomycin sulfate 0.125 g, Lidocaine hydrochloride 1 g.
- The other components are benzalkonium chloride, propylene glycol, glycerol, purified water.
Description of Anauran's appearance and contents of the pack
Anauran is a solution contained in a glass bottle with a dropper, placed inside a cardboard carton.
It is available in 25 ml bottles.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ZAMBON ITALIA s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI)
Manufacturer
ZAMBON S.p.A. - Via della Chimica 9 - Vicenza
The original data is available in the language of the country of manufacture.
Data source: Italian Medicines Agency (AIFA)
Data last verified: September 21, 2026