Synalotic 3 mg/ml + 0.25 mg/ml otic solution drops
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Synalotic 3mg/ml + 0.25 mg/ml ear drops solution
Ciprofloxacin / Fluocinolone acetonide
Read the 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 only and must not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Synalotic is and what it is used for
- What you need to know before using Synalotic
- How to use Synalotic
- Possible side effects
- How to store Synalotic
- Contents of the pack and other information
1. What Synalotic is and what it is used for
Synalotic is a solution for otic use (in the ear). It contains:
- Ciprofloxacin, which belongs to a group of antibiotics called fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections,
- fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties used to treat inflammation and pain.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.
It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
Synalotic is a solution in the form of ear drops. It is used in adults and children aged 6 months and older to treat acute otitis externa (infection of the outer ear) and otitis media (infection of the middle ear) with tympanostomy tubes (drainage tubes) of bacterial origin.
You should consult a doctor if your condition worsens or does not improve after completing the treatment.
2. What you need to know before using Synalotic
Do not use Synalotic
- If you are allergic to ciprofloxacin, other quinolones, fluocinolone acetonide, or any of the other components 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 such as hives (itching) or skin rash, or any other allergic symptoms (for example, sudden swelling of the face, throat, or eyelids, difficulty breathing), stop using the medicine immediately and contact your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.
- Inform your doctor if your symptoms do not improve before completing the treatment.
- Contact 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 must be prescribed by your doctor.
Children:
There is insufficient clinical experience regarding the use of Synalotic in children under 6 months of age; therefore, you should consult your doctor before administering this medicine to your child if they are this age.
Use of Synalotic 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 Synalotic 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 Synalotic to a breastfeeding woman, as it is not known whether Synalotic is excreted in human milk.
Driving and using machines
Given the characteristics and route of administration of this medicine, Synalotic does not affect the ability to drive vehicles or operate 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 ear use only (otic use). Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose in adults and children is 6 to 8 drops twice daily into the affected ear for 7 days.
Administer Synalotic in both ears only if your doctor has instructed you to do so.
Your doctor will determine the duration of treatment with Synalotic. 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 Synalotic should wash their hands beforehand.
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For patients with middle ear infection with drainage tubes: While the patient remains lying on their side, the person administering Synalotic 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 external ear infection: While the patient remains lying on their side, the person administering Synalotic should gently pull the earlobe forward and backward (Figure 4b). This will help the drops penetrate into the ear canal. |
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Keep your head tilted toward the side of the affected ear for approximately one minute to allow time for the medication to enter the ear.
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Repeat the procedure, if necessary, in the other ear.
It is important to follow these instructions to achieve an optimal outcome 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 completion of treatment. Do not save it for future use.
If you use more Synalotic than you should
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, telephone: 91 562 04 20, stating 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 scheduled 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 length of time indicated by your doctor, even if symptoms improve. If you stop using this medicine too early, the infection may not clear 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, Synalotic may 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 immediately and consult your doctor without delay: swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty swallowing or breathing, rashes or hives, sores, ulcers.
Common: may affect up to 1 in 10 people
Ear-related effects: Discomfort, pain, itching.
General adverse effects: Taste disturbance.
Uncommon: may affect up to 1 in 100 people
Ear-related effects: Tinnitus, 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, 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
Eye-related effects: 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse 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.
Store below 30°C.
Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.
This medicine must be discarded one month after opening.
Medicines should not be disposed of via wastewater or household waste. Return unused or expired medicines and their containers to your pharmacist. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Synalotic
- The active substances are ciprofloxacin (as hydrochloride) and fluocinolone acetonide. Each millilitre of Synalotic contains 3 mg of ciprofloxacin (as hydrochloride) and 0.25 mg of fluocinolone acetonide.
- The other components are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), povidone, diethylene glycol monoethyl ether, glycereth-26 (a compound of glycerine and ethylene oxide), hydrochloric acid (E507)/sodium hydroxide (E524), and purified water.
Appearance of the product and contents of the container
Synalotic is a clear solution in the form of ear drops. It is supplied in opaque white plastic bottles with a dropper. Each package 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 up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/