Package Insert: Information for the User

Synalotic 3mg/ml + 0.25 mg/ml Eye Drops in Solution

Ciprofloxacin / Fluocinolone Acetonide

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, 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 not listed in this package insert. See section 4.

1. What is Synalotic and for what it is used

2. What you need to know before starting to use Synalotic

3. How to use Synalotic

4. Possible adverse effects

5. Storage of Synalotic

6. Contents of the package and additional information

Synalotic is an otic solution (for 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 for treating viral infections such as the flu or a cold.

It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or re-use this medication. If there is leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Synalotic is an ear drop solution. It is used in adults and in children 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 symptoms worsen or do not improve after completing treatment.

No use Synalotic

• If you are allergic to ciprofloxacin, other quinolones, acetonide fluocinolone 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

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

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

Children:

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

Use of Synalotic 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 acquired without a prescription.

The use of Synalotic with other medications 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 acetonide fluocinolone.

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

Care should be taken when administering Synalotic to a breastfeeding woman since Synalotic is known to be excreted through breast milk.

Driving and operating machinery

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.

Synalotic 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 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 must wash their hands beforehand.

1. Keep your head inclined to the side of the affected ear for approximately one 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 because 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 Synalotic 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 Synalotic

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

If you interrupt treatment with Synalotic

Do not stop using Synalotic 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, Synalotic 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 that cannot be estimated from available data

Eye effects: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 to 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 below30°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 away through drains or in the trash. Dispose of packaging and medications you no longer need atthe pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Synalotic

• The active principles are ciprofloxacin (as hydrochloride) and acetonide of fluocinolone.Each milliliter of Synalotic contains 3 mg of ciprofloxacin (as hydrochloride) and 0.25 mg of acetonide of fluocinolone.
• The other components are methylparaben (E218), propylparaben (E216), povidone, 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

Synalotic is a transparent solution in drop form 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 responsible for manufacturing

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo, s/n

39011 Santander – Spain

This leaflet was approved in August 2019

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