SYNALOTIC 3 mg/ml + 0.25 mg/ml OTIC SOLUTION DROPS

Introduction

Package Leaflet: Information for the User

Synalotic 3mg/ml + 0.25 mg/ml Ear Drops Solution

Ciprofloxacin / Fluocinolone Acetonide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Synalotic and what is it used for
2. What you need to know before you use Synalotic
3. How to use Synalotic
4. Possible side effects
5. Storage of Synalotic
6. Contents of the pack and further information

1. What is Synalotic and what is it used for

Synalotic is a solution for otic use (in the ear). It contains:

• Ciprofloxacin, which belongs to the group of antibiotics called fluoroquinolones. Ciprofloxacin acts by eliminating bacteria that cause infections,
• 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 the flu or the common cold.

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

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or into the trash.

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

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

2. What you need to know before you use Synalotic

Do not use Synalotic

• 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 a viral or fungal ear infection.

Warnings and Precautions

• This medication should only be applied in the ear. It should not be ingested, injected, or inhaled. It should not be applied to the eye.
• If you experience symptoms of urticaria (itching) or skin rash or any other allergic symptom (such as sudden swelling of the face, throat, or eyelids, difficulty breathing) after starting treatment, discontinue the medication immediately and consult your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.
• Tell your doctor if your symptoms do not improve before completing treatment.
• Consult your doctor if you experience blurred vision or other visual disturbances.

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

Children:

There is not enough clinical experience with the use of Synalotic in children under 6 months of age, so you should consult your doctor before administering this medication to your child if they are of this age.

Using Synalotic with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

The use of Synalotic with other ear medications is not recommended.

Pregnancy, Breast-feeding, 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 breast-feeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Caution should be exercised when administering Synalotic to a breast-feeding woman, as it is not known whether Synalotic is excreted in breast milk.

Driving and Using Machines

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

Synalotic contains

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

3. How to use Synalotic

Synalotic is intended for otic use (in the ear) only. Follow your doctor's instructions for administering this medication exactly. If in 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 Synalotic in both ears if your doctor recommends it.

Your doctor will indicate the duration of treatment with Synalotic. 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 Synalotic should wash their hands beforehand.

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

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

It is important that you follow these instructions to achieve a good result 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 part of the administered medication to be lost because the drops may fall down your face and not penetrate the inner part of the ear canal.

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

If you use more Synalotic than you should

The symptoms related to overdose are not known.

In case of overdose or accidental ingestion, inform your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Synalotic

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

If you stop using Synalotic

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

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

4. Possible side effects

Like all medicines, Synalotic can cause side effects, although not everybody gets them.

If you experience a severe allergic reaction and get any of the following symptoms, stop using this medication and consult your doctor immediately: swelling of hands, feet, ankles, face, lips, mouth, or throat, difficulty swallowing or breathing, rash, or hives.

Common: may affect up to 1 in 10 people

Ear effects:Discomfort, pain, itching.

General side effects:Alteration in taste.

Uncommon: may affect up to 1 in 100 people

Ear effects: Ringing in the ears, residue of medication, blockage of the ear drainage tube, tingling, congestion, reduced hearing, skin rash, redness, external ear fungal infection, discharge, inflammation, eardrum disorder, granulation tissue, otitis media in the other ear.

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

Not known: frequency cannot be estimated from the available data

Eye effects:Blurred vision.

Reporting of side effects

If you experience 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 through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Synalotic

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine must be discarded 1 month after opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Synalotic

• The active substances are ciprofloxacin (as hydrochloride) and fluocinolone acetonide. Each milliliter of Synalotic contains 3 mg of ciprofloxacin (as hydrochloride) and 0.25 mg of fluocinolone acetonide.
• The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), povidone, diethylene glycol monoethyl ether, glycereth-26 (a compound of glycerin and ethylene oxide), hydrochloric acid (E507)/sodium hydroxide (E524), and purified water.

Appearance of the product and pack contents

Synalotic is a clear solution in the form of ear drops for administration in the ear. It comes in white opaque plastic bottles with a dropper. Each pack contains 10 ml of solution.

Marketing Authorization Holder and Manufacturer

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo, s/n

39011 Santander – Spain

This leaflet was approved in August 2019.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es/