Aceoto Plus 3 mg/ml + 0.25 mg/ml otic solution EFG

Spain
Brand name Aceoto Plus 3 mg/ml + 0.25 mg/ml otic solution EFG
Form drops, otic solution
Active substance / Dosage
FLUOCINOLONE ACETONIDE · 0,25 mg
CIPROFLOXACIN HYDROCHLORIDE · 3,49 mg
Prescription type Prescription Only Medicine
ATC code
S02C S02CA S02CA05
Registration number 64658
Manufacturer Zambon S.A.U.
Aceoto Plus 3 mg/ml + 0.25 mg/ml otic solution EFG drops, otic solution

Table of Contents

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aceoto Plus 3 mg/ml + 0.25 mg/ml ear drops solution

Ciprofloxacin / Fluocinolone acetonide

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Aceoto Plus is and what it is used for

Aceoto Plus is a solution for otic use (in the ear).

It contains:

  • Ciprofloxacin, which belongs to a group of antibiotics known as fluoroquinolones.

Ciprofloxacin works by eliminating bacteria that cause infections,

  • and fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties for the treatment of inflammation and pain.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dosage, dosing interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Aceoto Plus is an ear drop solution. It is used in adults and children aged 6 months and older to treat acute external otitis (infection of the outer ear) and bacterial middle ear infections (otitis media) with tympanostomy tubes (drainage tubes).

You should consult a doctor if symptoms worsen or do not improve after completing treatment.

2. What you need to know before using Aceoto Plus

Do not use Aceoto Plus

  • If you are allergic to ciprofloxacin, other quinolones, fluocinolone acetonide, or any of the other ingredients of this medicine (listed in section 6).

  • If you have an ear infection caused by a virus or a fungus.

Warnings and precautions

  • This medicine is for ear use only. It must not be swallowed, injected, or inhaled. It should not be applied to the eye.

  • If, after starting treatment, you develop symptoms of hives (itching) or skin rash, or any other allergic reaction (for example, sudden swelling of the face, throat, or eyelids, difficulty breathing), stop using the medicine immediately and consult your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.

  • Inform your doctor if your symptoms do not improve before completing the treatment.

As with other antibiotics, infections may sometimes be caused by organisms that are not susceptible to ciprofloxacin. In such cases, appropriate treatment must be prescribed by your doctor.

  • Contact your doctor if you experience blurred vision or other visual disturbances.

Use in children

Children: There is insufficient clinical experience regarding the use of Aceoto Plus in children under 6 months of age. Therefore, consult your doctor before administering this medicine to your child if they are in this age group.

Use of Aceoto Plus with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or might need to take/use any other medicines, including those obtained without a prescription.

The use of Aceoto Plus together with other otic (ear) medications is not recommended.

Pregnancy, breastfeeding, and fertility

There are no adequate and well-controlled studies in pregnant women on the teratogenic effects of fluocinolone acetonide.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Caution should be exercised when administering Aceoto Plus to a breastfeeding woman, as it is unknown whether Aceoto Plus is excreted in human milk.

Driving and using machines

Given the characteristics and route of administration of this medicine, Aceoto Plus does not affect the ability to drive or operate machinery.

Aceoto Plus contains Methyl parahydroxybenzoate and Propyl parahydroxybenzoate

Aceoto Plus may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

3. How to use Aceoto Plus

Aceoto Plus is intended for ear use only (otic use). Follow exactly the administration instructions provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and children is 6 to 8 drops twice daily into the affected ear for 7 days.

Administer Aceoto Plus in both ears only if your doctor has specifically instructed you to do so.

Your doctor will determine the duration of treatment with Aceoto Plus. To ensure the infection does not return, do not stop treatment early, even if you notice improvement in the ear(s).

Administration instructions

The person administering Aceoto Plus should wash their hands beforehand.

Two open hands holding a cylindrical vial with a cap on top and a flat base against a gray background with the number 1 in the upper left corner

  1. Warm the ear drops by holding the bottle in your hands for several minutes to avoid dizziness that may result from applying a cold solution into the ear.

Black and white drawing of a person lying on their back with closed eyes and face turned upward

  1. Tilt the head to one side so that the affected ear is facing upward.

Black and white technical drawing showing the cross-section of a

  1. Instill the drops into the affected ear canal using the dropper. Avoid contact between the dropper tip and the ear or fingers to prevent possible contamination.

Black and white drawing showing a hand holding a vertical object above a curved and wavy surface with the

Black and white technical drawing showing a hand holding a medical device above a curved surface with dashed reference lines

  1. After instillation of the drops, follow the instructions below depending on the patient's specific type of ear infection.

For patients with middle ear infection with drainage tubes:

While the patient remains lying on their side, the person administering Aceoto Plus should gently press the skin fold at the entrance of the ear canal (figure 4a) 4 times using a pumping motion. This will help the drops pass through the eardrum and reach the middle ear.

For patients with outer ear infection:

While the patient remains lying on their side, the person administering Aceoto Plus should gently pull the earlobe forward and backward (figure 4b). This will help the drops penetrate into the ear canal.

  1. Keep your head tilted toward the affected ear for about one minute to allow the medication time to enter the ear canal.

  2. Repeat the procedure in the other ear, if necessary.

It is important that you follow these instructions to achieve the best results with this medication in your ear. Once the medication has been administered into the ear, keeping your head upright or moving your head too quickly may cause some of the administered dose to be lost, as the drops may run out onto the face and not penetrate into the inner part of the ear canal.

Keep the bottle until the end of treatment. Do not save it for later use.

If you use more Aceeto Plus than you should

Symptoms related to overdose are unknown. In case of overdose or accidental ingestion, inform your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Aceeto Plus

Do not use a double dose to make up for missed doses. Simply continue with your next scheduled dose.

If you stop using Aceeto Plus

Do not stop using Aceeto Plus without consulting your doctor or pharmacist. It is very important to use these ear drops for the full duration prescribed by your doctor, even if symptoms improve. Stopping the medication early may result in the infection not being completely cleared, and symptoms may return or even worsen. Additionally, antibiotic resistance may develop.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Aceoto Plus can cause adverse effects, although not everyone will experience them.

If you experience a severe allergic reaction and develop any of the following symptoms, stop treatment with this medicine and consult your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty swallowing or breathing, rashes or hives, sores, ulcers.

Frequent: may affect up to 1 in 10 people

Effects on the ear: Discomfort, pain, itching.

General adverse effects: Taste disturbance.

Uncommon: may affect up to 1 in 100 people

Effects on the ear: Tinnitus (ringing in the ears), drug residue, ear drainage tube blockage, tingling, congestion, reduced hearing, skin rash, redness, fungal infection of the outer ear, discharge, inflammation, tympanic membrane disorder, granulation tissue, middle ear infection in the other ear.

General adverse effects: Fungal infection (Candida), irritability, crying, dizziness, flushing, headache, vomiting, fatigue.

Frequency not known (cannot be estimated from available data): Blurred vision.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aceoto Plus

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

This medicine must be discarded one month after opening.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aceoto Plus

The active substances are ciprofloxacin (as hydrochloride) and fluocinolone acetonide. Each millilitre of Aceoto Plus contains 3 mg of ciprofloxacin (as hydrochloride) and 0.25 mg of fluocinolone acetonide.

The other components are methylparaben (E218), propylparaben (E216), povidone-K-90-F, diethylene glycol monoethyl ether, glycereth-26 (a compound of glycerin and ethylene oxide), hydrochloric acid (E507)/sodium hydroxide (E524), and purified water.

Nature of the product and contents of the container

Aceoto Plus is a colourless or slightly yellow aqueous solution in the form of ear drops. It is supplied in opaque white plastic bottles with a dropper. Each container holds 10 ml of solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zambon S.A.U.

Maresme, 5. Pol. Can Bernades-Subirà

08130 - Santa Perpètua de Mogoda

Barcelona (Spain)

Manufacturer

Laboratorios Salvat, S.A.

C/ Gall 30-36

08950 - Esplugues de Llobregat

Barcelona (Spain)

or

Pharmaloop, S.L.

C/Bolivia, 15 – Polig.Industrial Azque

28806 Alcalá de Henares,

Madrid (Spain)

This leaflet was approved in November 2020.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.