ANAURAN 25 ML Ear drops, solution

Зміст інструкції

1. Anauran ear drops, solution
   1. What is Anauran and what is it used for?
   2. What you need to know before you use Anauran
   3. How to use Anauran
   4. Possible side effects
   5. How to store Anauran
   6. Contents of the pack and other information

Anauran ear drops, solution

Polymyxin B sulfate, Neomycin sulfate, Lidocaine hydrochloride
Read this leaflet carefully before using this medicine as 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 do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after three days.

Contents of this leaflet:

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

1. What is Anauran and what is it used for?

Anauran contains the active ingredients polymyxin B sulfate, neomycin sulfate and lidocaine hydrochloride.
The medicine consists of a combination of antibiotics and a local anesthetic.
Anauran is indicated in adults and children for the treatment of acute and chronic otitis.
See your doctor if you do not feel better or if you feel worse after three days.

2. What you need to know before you use 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 can give rise to phenomena of
sensitization. In this case, stop treatment and consult your doctor to establish appropriate therapy.
In the presence of deep or resistant infections, it is appropriate to integrate local medication with appropriate
antibiotic treatments for general use.
As with other antibiotic medicines, prolonged treatments can lead to further infections (so-called
“superinfections”) from germs that are resistant to the same antibiotic therapies.
Neomycin, one of the active ingredients of this medicine, can induce permanent hearing loss. The risk
of ear damage is greater in case of prolonged use, therefore a limited duration of therapy is recommended
to 10 consecutive days.
If you have experienced allergic reactions or resistance with other antibiotics similar to neomycin (aminoglycosides),
these may also occur with the use of Anauran.

Other medicines and Anauran
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Use this medicine only if absolutely necessary and under direct medical supervision.

Breastfeeding
If you are breastfeeding, use this medicine with caution.

Driving and using machines
Anauran does not alter the ability to drive vehicles and use machines.

Anauran contains benzalkonium chloride and propylene glycol
The medicine contains in each drop 0.001 mg of benzalkonium chloridewhich may irritate the skin.
The medicine contains in each drop 11.6 mg of propylene glycolwhich may cause skin irritation.

3. How to use Anauran

Use this medicine following 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 a day.

Children
The recommended dose is 2-3 drops, 3-4 times a day.
The duration of treatment is variable and depends on your response to therapy. In any case, do not use the
medicine for more than 10 consecutive days.

Method of administration
Administer the drops, using the appropriate dropper, directly into the ear, keeping your head tilted to the side for
a few minutes.
ANAURAN is only for otological use (=in the ear); applications in other areas are inappropriate.

If you use more Anauran than you should
No cases of overdose have been reported.

If you forget to use Anauran
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with the administration of Anauran:

Not known frequency (frequency cannot be estimated from available data)

• Allergic skin reaction (allergic dermatitis), itching
• Irritation at the application site
• Ear damage (ototoxicity)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 that is reported on the packaging after EXP. The expiry
date refers to the last day of that month.
After the first opening of the bottle, the medicine must be used within 3 months; after this period, the
remaining medicine must be disposed of.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Anauran contains
25 ml contain:

• The active ingredients are polymyxin B sulfate 250,000 I.U., neomycin sulfate 0.125 g, lidocaine hydrochloride 1 g.
• The other ingredients are benzalkonium chloride, propylene glycol, glycerol, purified water.

Description of the appearance of Anauran and contents of the pack
Anauran is presented as a solution contained in a glass bottle with a dropper placed inside
a cardboard box.
It is available in 25 ml bottles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ZAMBON ITALIA s.r.l. - via Lillo del Duca 10 - 20091 Bresso (MI)

Manufacturer
ZAMBON S.p.A. - via della Chimica 9 - Vicenza