Anauran - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life

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.

Further information on Anauran can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

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.


System and organ classification Adverse reactions Skin and subcutaneous tissue disorders Allergic dermatitis, itching General disorders and administration site conditions Application site irritation Injury, poisoning and procedural complications Ototoxicity (see section 4.4)

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

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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