Active ingredients: Polymyxin B sulfate, Neomycin sulfate, Lidocaine hydrochloride
Anauran ear drops, solution
Why is Anauran used? What is it 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 ear infections.
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Anauran should not be used
Do not use Anauran:
- if you are allergic (hypersensitive) to polymyxin B sulphate, neomycin sulphate and lidocaine hydrochloride or any of the other ingredients of this medicine
- if you have a perforated tympanic membrane, due to the risk of ear damage
Precautions for use What you need to know before taking Anauran
Talk to your doctor or pharmacist before using Anauran.
The use, especially if prolonged, of topical products such as Anauran can give rise to sensitization phenomena. In this case, stop the treatment and consult your doctor to institute suitable therapy.
In the presence of deep or resistant infections it is advisable to integrate the local dressing with appropriate antibiotic treatments by general route.
As with other antibiotic medicines, prolonged treatments can lead to further infections (called "superinfections") with 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 damage to the ear is greater in case of prolonged use, therefore a duration of therapy limited to 10 consecutive days is recommended.
If you have experienced allergic reactions or resistance to other antibiotics similar to neomycin (aminoglycosides), these can also occur with the use of Anauran.
Interactions Which drugs or foods can modify the effect of Anauran
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
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.
Pregnancy
Use this medicine only when clearly needed and under direct medical supervision.
Feeding time
If you are breast-feeding, use this medicine with caution.
Driving and using machines
Anauran does not affect the ability to drive and use machines.
Anauran contains benzalkonium chloride and propylene glycol
Benzalkonium chloride
Irritating, may cause local skin reactions.
Propylene glycol
It can cause skin irritation.
Dose, Method and Time of Administration How to use Anauran: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, 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 treatment period 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
Pour the drops, using the appropriate dropper, directly into the ear, keeping the head tilted to the side for a few minutes.
ANAURAN is for otological use only (= in the ear); applications in other sites are inappropriate.
Overdose What to do if you have taken an overdose of Anauran
No cases of overdose have been reported.
If you forget to use Anauran
Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Anauran
Like all medicines, this medicine can cause side effects, although not everybody gets them
The following undesirable effects have been reported following the administration of Anauran:
Frequency not known (frequency cannot be estimated from the available data)
- Allergic skin reaction (allergic dermatitis), itching
- Application site irritation
- Damage to the ear (ototoxicity)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.
Expiry and Retention
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 package after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
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.
What Anauran looks like and contents of the pack
Anauran is presented as a solution contained in a glass bottle with dropper placed inside a cardboard box.
It is available in a 25 ml bottle.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ANAURAN EARPHONE DROPS, SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of solution contain:
Active principles
Polymyxin B sulphate U.I. 1,000,000
Neomycin sulfate 0.500 g
(equal to neomycin base g 0.375)
Lidocaine hydrochloride g 4
03.0 PHARMACEUTICAL FORM
Ear drops.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Acute and chronic otitis.
04.2 Posology and method of administration
- Adults 4-5 drops, 2-4 times a day
- Children 2-3 drops, 3-4 times a day
Instill, using the special dropper, into the ear canal, keeping the head bent to the side for a few minutes.
The treatment period is variable in relation to the rapidity of the therapeutic response, it is recommended not to use the medicine for more than 10 consecutive days.
04.3 Contraindications
ANAURAN is contraindicated:
- in patients with hypersensitivity to Polymyxin B sulfate, Neomycin sulphate and Lidocaine hydrochloride and to closely related compounds from a chemical point of view or to any of the excipients
- in patients with perforated tympanic membrane, due to the risk of ototoxicity
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, interrupt the treatment and consult the doctor to institute suitable therapy.
In the presence of deep or resistant infections it is advisable to integrate the local dressing with appropriate antibiotic treatments by general route.
As with other antibiotic preparations, prolonged treatments can result in superinfections with resistant germs.
Neomycin can induce permanent sensorineural hearing loss following damage to the cochlea, especially with the destruction of the hair cells of the organ of Corti. The risk of ototoxicity is greater in case of prolonged use, therefore a duration of therapy limited to 10 consecutive days is recommended.
Cross-allergy and cross-resistance with other aminoglycoside derivatives may occur.
ANAURAN is to be used exclusively in the otological field; applications in other locations are inappropriate.
Important information about some of the ingredients
The medicine contains benzalkonium chloride, an irritant that can cause skin reactions.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interaction studies with the active ingredients present in the medicinal product.
04.6 Pregnancy and lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women.
The medicine should be used during pregnancy only in cases of real need and under direct medical supervision.
Feeding time
Caution should be used when the medicine is used by breastfeeding women.
04.7 Effects on ability to drive and use machines
Anauran does not affect the ability to drive and use machines.
04.8 Undesirable effects
Following administration of Anauran, the following adverse reactions have been reported. Frequency cannot be estimated from the available data.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ANAURAN, based on chemo-antibiotic factors with the addition of an anesthetic, is a preparation particularly suitable for the treatment of many otological diseases.
The antibiotic association therefore acts effectively on all the germs commonly responsible for the various infectious forms of otological localization, also due to the marked synergy between the components. Furthermore, since polymyxin B is also endowed with an antifungal action, ANAURAN can find useful application in the field otomycosis.
Lidocaine, due to its anesthetic action, allows to dominate the painful symptoms often present in most otological affections.
ANAURAN is therefore able to rapidly attenuate, until their disappearance, the inflammatory signs and mucopurulent secretions, to promptly relieve painful or itchy subjective symptoms; the preparation also carries out a preventive action against any complications of the pathological form in progress (fungal superinfections, wound infections, etc.).
05.2 Pharmacokinetic properties
The individual components of the medicinal product are not absorbed systemically at active doses.
05.3 Preclinical safety data
Studies, conducted to highlight possible local and / or systemic toxic effects, have demonstrated the good tolerability of the drug.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Benzalkonium chloride, propylene glycol, glycerol, purified water
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years (three)
The expiry date indicated refers to the product in intact and correctly stored packaging.
06.4 Special precautions for storage
No particular precautions.
06.5 Nature of the immediate packaging and contents of the package
Cardboard box, containing a glass bottle with a rubber pump dropper, closed with a polythene cap + safety cap and a leaflet.
06.6 Instructions for use and handling
No particular precautions.
07.0 MARKETING AUTHORIZATION HOLDER
ZAMBON Italia s.r.l.
Via Lillo del Duca, 10 "." 20091 Bresso (MI)
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. n. 014302032
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: 3 July 1961
Renewal: 1 June 2010
10.0 DATE OF REVISION OF THE TEXT
Determination of 28 August 2012
