Package leaflet: Information for the user

CEXIDAL 3 mg/ml + 0,25 mg/ml ear drops, solution

Ciprofloxacin and fluocinolone acetonide
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CEXIDAL is and what it is used for
What you need to know before using CEXIDAL
How to use CEXIDAL
Possible side effects
How to store CEXIDAL
Contents of the pack and other information

1. What CEXIDAL is and what it is used for

CEXIDAL contains two active substances, ciprofloxacin and fluocinolone acetonide.
Ciprofloxacin belongs to a group of medicines called fluoroquinolone antibiotics,
used to treat infections caused by bacteria. Fluocinolone acetonide belongs to a
group of medicines called corticosteroids, used to relieve inflammation and allergies.
This medicine is indicated for the local treatment of ear inflammation (acute external otitis)
caused by bacteria, but without damage to the eardrum (tympanic membrane perforations).

2. What you should know before using CEXIDAL

Do not use CEXIDAL

if you are allergic to ciprofloxacin, fluocinolone acetonide, to medicines similar to ciprofloxacin (quinolones), or to any of the other ingredients of this medicine (listed in section 6);
if you have a viral ear infection (external auditory canal), including varicella or herpes simplex;
if the person using this medicine is a child under 7 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using CEXIDAL.
This medicine is for ear use only. It must not be swallowed, injected, or inhaled. Do not use it in the eyes.
Stop treatment and inform your doctor if you experience:

symptoms of skin irritation (urticaria) or any other sign of local or systemic (throughout the body) allergic reaction (hypersensitivity);
symptoms of light sensitivity (phototoxicity), such as skin problems (cutaneous hyperactivity) following exposure to sunlight. Therefore, avoid excessive exposure to sunlight during treatment with CEXIDAL;
if, after starting treatment, you develop urticaria, skin rash, or any other allergic symptom (e.g. sudden swelling of face, throat, or eyelids, difficulty breathing), you must

stop treatment immediately and consult your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.

In such cases, your doctor will determine appropriate therapy based on the severity of symptoms (adrenaline and other resuscitation measures: oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, vasopressor amines, and interventions to maintain airway patency). Contact your doctor if symptoms do not improve before the end of treatment. As with other antibiotic preparations, additional infections caused by organisms not affected by ciprofloxacin may occasionally occur. In case of such infection, your doctor will advise appropriate treatment.

Use this medicine with caution and inform your doctor if you have or suspect you have a damaged eardrum (perforation of the tympanic membrane) or if you are at risk, as the safety and efficacy of CEXIDAL have not been studied in these cases.
When applying the drops, avoid contact between the dropper tip and the ear or fingers to prevent possible contamination.
Do not use CEXIDAL if you are taking other medicines for ear disorders (otological medicines) (see section “Other medicines and CEXIDAL”).
During treatment with CEXIDAL, your doctor will closely monitor your condition to promptly identify any need for alternative therapies.
Contact your doctor if blurred vision or other visual disturbances occur.
Children
This medicine must not be used in children under 7 years of age (see section “Do not use CEXIDAL”).
Other medicines and CEXIDAL
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.
Do not use CEXIDAL if you are taking other medicines for ear disorders (otological medicines) (see section “Warnings and precautions”).
Use CEXIDAL with caution and inform your doctor if you are taking any of the following medicines, as ciprofloxacin may increase their effects, and monitoring of blood levels of these medicines may be necessary:

warfarin and other oral anticoagulants, medicines used to make blood less likely to clot;
ciclosporine, a medicine used after organ transplantation or to treat immune system disorders;
theophylline, a medicine used for respiratory obstruction and asthma;
clozapine, a medicine used to treat certain mental disorders;
tacrine, a medicine used to treat Alzheimer’s disease;
ropinirole, a medicine used to treat Parkinson’s disease;
tizanidine, a medicine used to treat multiple sclerosis;
ritonavir, cobicistat, medicines used for the treatment of HIV.

CEXIDAL and beverages
Be cautious with drinks containing caffeine during treatment with CEXIDAL, as ciprofloxacin may increase caffeine levels in the blood.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use CEXIDAL only if clearly necessary and under direct medical supervision.
Driving and using machines
Given the route of administration and intended use of this medicine, it is unlikely to affect your ability to drive or operate machinery.
CEXIDAL contains parahydroxybenzoates
This medicine contains parahydroxybenzoates (methylparahydroxybenzoate, propylparahydroxybenzoate), which may cause allergic reactions (including delayed reactions).

3. How to use CEXIDAL

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 4-6 drops of CEXIDAL to be applied into the ear every 8 hours.
Continue treatment for 7-8 days.
Method of administration
Before use, warm the bottle slightly by holding it in your hands, in order to reduce the sensation of
cold when applying the drops into the ear.
When applying the drops, tilt your head sideways and maintain this position for about 30 seconds
to help the drops flow into the ear (external auditory canal), gently pulling the ear upwards. This
will allow air to escape from the ear and facilitate entry of the liquid into the canal.
Use in children
Do not use this medicine in children under 7 years of age (see section “Do not use
CEXIDAL”).
If you use more CEXIDAL than you should
Cases of overdose are not known.
In case of accidental ingestion/overdose of an excessive amount of CEXIDAL, inform your
doctor immediately or go to the nearest hospital.
If you forget to use CEXIDAL
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience a severe allergic reaction and any of the following conditions, stop taking this medicine and inform your doctor immediately: swelling of hands, feet, ankles, face, lips, mouth or throat; difficulty swallowing or breathing; rash or hives; sores, ulcers.

The following side effects may occur:
Common: may affect up to 1 in 10 people
Ear-related effects: discomfort, pain, itching.

Uncommon: may affect up to 1 in 100 people
Ear-related effects: ringing in the ears, drug residue, blockage of the tube draining the ear, tingling, congestion, reduced hearing, skin rash, redness, itching, fungal infection of the outer ear, discharge, swelling, increased skin sensitivity (hyperesthesia) at the application site.
General side effects: Candida infection, irritability, crying, dizziness, skin redness, headache, vomiting, fatigue.

Not known (frequency cannot be estimated from available data):
Eye disorders: blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEXIDAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store below 30°C.
Use the medicine within 30 days of first opening the container and store it below 25°C.
Remember to write the date of first opening on the packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What CEXIDAL contains

The active substances are ciprofloxacin and fluocinolone acetonide. Each ml of solution contains 3.49 mg of ciprofloxacin hydrochloride monohydrate (equivalent to 3 mg of ciprofloxacin) and 0.25 mg of fluocinolone acetonide.
The other components are: methylparahydroxybenzoate, propylparahydroxybenzoate, povidone, diethylene glycol monoethyl ether, Glycereth-26 (a compound of glycerin and ethylene oxide), hydrochloric acid / sodium hydroxide (to maintain acidity levels within normal range), and purified water.

Description of the appearance of CEXIDAL and contents of the pack
White opaque 10 ml bottle with dropper and cap.
Marketing Authorization Holder
Holder
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany
Selling Concessionaire
Bruno Farmaceutici S.p.A.
Via delle Ande, 15
00144 Rome
Italy
Manufacturer
Laboratorios SALVAT SA – C/. Gall, 30-36 – 08950 Esplugues de Llobregat – Barcelona – Spain
Pharmaloop S.L - C/Bolivia, 15 - Polig Industrial Azque 28806 Alcalá de Henares, Madrid – Spain