PATIENT INFORMATION LEAFLET

Aceoto Plus 3 mg/ml + 0.25 mg/ml Eye Drops in Solution

Ciprofloxacin / Fluocinolone Acetonide

Read this 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 you should not give it to others, even if they have the same symptoms, as it may harm them.

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

Aceoto Plus is an otic solution (for the ear).

Contains:

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

Ciprofloxacin acts by eliminating bacteria that cause infections,

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

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

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

No use Aceoto Plus

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

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

Warnings and precautions

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

Use in children

Children: There is not enough clinical experience on the use of Aceoto Plus in children under 6 months, so consult with your doctor before administering this medication to your child if they are this age.

Use of Aceoto Plus with other medications

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

The use of Aceoto Plus with other medications administered through the ear 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, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Care should be taken when administering Aceoto Plus to a breastfeeding woman, as it is not known whether Aceoto Plus is excreted through breast milk.

Driving and operating machinery

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

Aceoto Plus containsParahydroxybenzoate of methyl and Parahydroxybenzoate of propyl

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

Aceoto Plus is intended to be administered in the ear only (otic use). Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults and children is 6 to 8 drops twice a day in the affected ear for 7 days.

Only administer Aceoto Plus in both ears if your doctor recommends it.

Your doctor will indicate the duration of treatment with Aceoto Plus. To ensure that the infection does not recur, do not interrupt treatment prematurely, even if you notice improvement in the ear (s).

Administration Instructions

The person administering Aceoto Plus must wash their hands beforehand.

1. Keep your head inclined to the side of the affected ear for approximately 1 minute to allow the medication to enter the inner ear.

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

It is essential to follow these instructions to achieve a good outcome with this medication in your ear. Once the medication has been administered in the ear, keeping your head in a vertical position or moving your head too quickly may cause you to lose part of the administered medication, as the drops may fall down your face and not penetrate the inner part of the auditory canal.

Keep the bottle until the end of treatment. Do not store it for future use.

If you use more Aceoto Plus than you should

No symptoms related to overdose are known. In case of overdose or accidental ingestion, inform your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Aceoto Plus

Do not use a double dose to compensate for the missed doses. Simply continue with your next dose.

If you interrupt treatment with Aceoto Plus

Do not stop using Aceoto Plus without consulting your doctor or pharmacist. It is very important to use these ear drops for the time indicated by your doctor, even if your symptoms improve. If you stop using this medication prematurely, the infection may not disappear and symptoms may recur or worsen. Resistance to antibiotics may also occur.

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

Like all medications, Aceoto Plus may produce adverse effects, although not everyone will experience them.

If you experience a severe allergic reaction and any of the following symptoms appear, discontinue treatment with this medication and consult your doctor immediately:Swelling of 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

Ear effects:Discomfort,Pain,Itching.

General adverse effects:Alteration in taste.

Infrequent: may affect up to 1 in 100 people

Ear effects: Ringing, residual medication, blockage of the ear drainage tube, tingling, congestion, hearing loss, skin rash, redness, external ear fungal infection, discharge, inflammation, tympanic membrane disorder, granulation tissue, otitis media in the other ear.

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

Unknown frequency (cannot be estimated from available data):Blurred vision.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication must be discarded one month after opening.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aceoto Plus

The active principles are ciprofloxacin (as hydrochloride) and fluocinolone acetonide. Each milliliter 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, diethylglycol monoethyl ether, glycereth-26 (glycerin compound and ethylene oxide), hydrochloric acid (E507)/sodium hydroxide (E524) and purified water.

Appearance of the product and contents of the packaging

Aceoto Plus is a colorless or slightly yellowish aqueous solution in the form of ear drops for administration in the ear. It is presented in white opaque plastic bottles with a dropper. Each package contains 10 ml of solution.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

Zambon S.A.U.

Maresme, 5. Pol. Can Bernades-Subirà

08130 - Santa Perpètua de Mogoda

Barcelona (Spain)

Manufacturer responsible

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

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.