Anauren

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ANAURAN

Composition:

Active substances: 100 ml of the preparation contains: polymyxin B sulfate – 1000000 IU, neomycin sulfate – 0.5 g (equivalent to 375000 IU), lidocaine hydrochloride – 4.0 g;

Excipients: benzalkonium chloride, propylene glycol, glycerin, purified water.

Pharmaceutical form. Ear drops.

Main physicochemical properties: clear, slightly viscous, odorless liquid.

Pharmacotherapeutic group. Agents acting on the sensory organs. Preparations used in otology. Antimicrobial agents, combinations.

ATC code S02AA30.

Pharmacological Properties

Pharmacodynamics.

The medicinal product Anauran has antibacterial and anesthetic properties due to its active ingredients.

The components, neomycin sulfate and polymyxin B sulfate, are effective against etiological agents of infectious inflammations of the hearing organs.

Lidocaine, due to its anesthetic effect, suppresses pain symptoms typical for most otological diseases.

When using the medicinal product Anauran, inflammatory signs such as pain and itching are reduced, mucopurulent discharge ceases, and the drug prevents the development of possible complications of existing inflammation (fungal superinfections, wound infection, etc.).

Pharmacokinetics.

The active ingredients of the medicinal product are not absorbed into the systemic circulation in active amounts.

Clinical characteristics.

Indications.

Acute or chronic otitis.

Contraindications.

• Hypersensitivity to any component of the medicinal product and to other compounds with a related chemical structure.
• Perforation of the tympanic membrane (risk of developing ototoxicity).
• Hypersensitivity to amide-type local anesthetics.

Interaction with other medicinal products and other forms of interaction.

There are no known studies on interactions with active substances present in the medicinal product.

Special precautions for use.

The use of topical preparations, especially prolonged use, may lead to sensitization. In such cases, treatment should be discontinued and medical advice should be sought.

In severe and persistent infections, local treatment should be supplemented with appropriate systemic antibacterial therapy.

Prolonged use of this medicinal product, as with other antibiotics, may result in superinfection with microorganisms resistant to the drug, including fungi.

Neomycin may cause permanent sensorineural hearing loss, particularly if the hair cells of the organ of Corti are affected. The risk of ototoxicity increases with prolonged use; therefore, treatment should be limited to 10 consecutive days.

Cross-allergy and cross-resistance with other aminoglycoside derivatives may occur.

Neomycin and polymyxin B sulfate are potentially nephrotoxic substances.

Auraran is intended for otological use only; application of the product to other areas of the body is not permitted.

Before prescribing the medicinal product, the integrity of the tympanic membrane should be checked.

Important information about the excipients

The product contains benzalkonium chloride and propylene glycol, which may cause skin reactions and skin irritation.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding, as adequate and well-controlled studies in pregnant women have not been conducted.

Ability to influence reaction speed when driving or operating machinery.

Auraran does not affect the ability to drive or operate machinery.

Method of administration and dosage.

Apply locally into the external auditory canal using the provided dropper. After instillation, keep the head tilted for several minutes.

For adults: 4–5 drops 2–4 times daily. For children aged 6 years and older: 2–3 drops 3–4 times daily, depending on the severity of the condition.

The duration of treatment is determined by the physician and depends on the response to therapy. The treatment course should not exceed 10 days.

Children.

There is insufficient experience with the use of Anauran in children under 6 years of age; therefore, the medication is not recommended for this age group.

Overdose.

Cases of overdose have not been reported.

Adverse reactions.

The following adverse reactions have been reported with the use of the drug Anauran (frequency of adverse reactions cannot be estimated from available data).

Reporting of Adverse Reactions

Reporting adverse reactions after the medicinal product has been registered is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua/.

Shelf life.

3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

After opening the bottle, the product can be used for up to 3 months.

Packaging.

25 ml in a bottle with a dropper cap; 1 bottle per carton.

Prescription status.

Prescription only.

Manufacturer/Marketing Authorization Holder.

Zambon S.P.A.

Address of manufacturer and location of its operations.

Via della Chimica, 9 - 36100 Vicenza (VI), Italy.