Active ingredients: Ciprofloxacin, Dexamethasone
CILODEX 3 mg / ml / 1 mg / ml ear drops, suspension
Indications Why is Cilodex used? What is it for?
CILODEX is a suspension for use in the ear (in the ear). Contains:
- ciprofloxacin, an antibiotic belonging to the fluoroquinolone group. Ciprofloxacin works by killing the bacteria responsible for infections;
- dexamethasone, a corticosteroid or anti-inflammatory agent that helps relieve inflammation and redness.
CILODEX is in the form of ear drops. This medicine is used to treat acute middle ear infections (otitis media) in patients with otological drainage catheters (tympanostomy or "Grommets" catheters) or to treat an "infection of the external ear" (acute otitis It has been shown to be safe and effective in pediatric patients 6 months of age, or older, for the treatment of middle ear infections (AOMT) and in patients 1 year of age, or older, for the treatment of external ear infections (AOE).
Contraindications When Cilodex should not be used
Do not use CILODEX:
- If you are allergic to ciprofloxacin, dexamethasone or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to medicines called quinolone antibiotics, as this medicine could cause the same type of allergic reaction
- if the ear infection is caused by a virus or fungus
Precautions for use What you need to know before taking Cilodex
Talk to your doctor or pharmacist before using CILODEX
- This preparation should only be applied in the ear. It is not suitable for ocular use and should not be ingested, injected or inhaled.
- Once treatment has started, if you notice the first signs of a "rash or any other allergic symptoms (eg hives (hives), sudden swelling of the face, throat or eyelids, trouble breathing), you should stop immediately use the medicine and should consult your doctor. Severe allergic reactions may require immediate emergency treatment.
- Tell your doctor if your symptoms do not improve within a week of starting treatment, worsen or suddenly reappear. As with all antibiotics, sometimes additional infections caused by organisms that are not sensitive to ciprofloxacin may occur. In case of such infections, appropriate treatment should be initiated under the guidance of your physician.
- If you experience pain, swelling or inflammation of the tendons during or shortly after using this medicine, stop the treatment and contact your doctor.Pay special attention if you are over 65 or are on corticosteroid treatment.
- Use in children: There is insufficient clinical experience on the use of CILODEX for the treatment of middle ear infections in children less than 6 months of age and for the treatment of external ear infections in children less than 1 year of age. ; therefore, talk to your doctor before giving this medicine to your child if he or she is within the specified age groups.
If these situations concern you, ask your doctor for advice
Interactions Which drugs or foods can change the effect of Cilodex
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
There are no known effects of CILODEX on the ability to drive or use machines.
This medicine contains benzalkonium chloride which is a known irritant that can cause local skin reactions.
Dose, Method and Time of Administration How to use Cilodex: Posology
Always use this medicine exactly as your doctor has told you. If in doubt, consult your doctor.
The recommended dose for adults and children is 4 drops in the ear canal, twice a day - morning and evening for 7 days. This medicine is intended to be administered in the ear only (earphone use).
Remove the movable protective ring from the cap when opening the bottle for the first time.
Your doctor will inform you about the duration of treatment with this medicine. To prevent the infection from returning, do not stop treatment early, even if you notice improvements in the health of your ear (s).
Only use this medicine for both ears if your doctor has advised you to do so.
Instructions for Use
It is preferable that another person put the drops in their place. Children should never be allowed to administer the drops themselves.
1. Wash your hands
The person administering CILODEX will need to wash their hands with soap and water.
2. Heat and shake the bottle
The person administering CILODEX must hold the bottle in their hands for a few minutes in order to warm the contents (figure 1) to avoid dizziness resulting from the instillation of a cold solution into the ear canal, then shake the bottle well before "use.
3. Administer the drops
The patient should be lying down with the infected ear pointing upwards (Figure 2).
Put 4 drops of CILODEX into the infected ear (figure 3). Do not touch your fingers or ear or any other surface with the tip of the bottle as this may infect the drops.
CILODEX After putting the drops follow the instructions below related to the specific ear infection of the patient.
4. For patients with middle ear infection with otological drainage catheters (tympanostomy or "Grommets" catheters): while the patient lies on their side, the person administering CILODEX must gently press the skin flap at the entrance to the canal. auditory (figure 4) 5 times with a pumping motion. This will allow the drops to pass through the tube to the eardrum and middle ear.
5. For patients with external ear infection. While the patient is lying on their side, the person administering CILODEX should gently pull the outer ear lobe up and down (figure 5). This will allow the drops earphones to drain into the ear canal.
6. Remain lying on your side
The patient is advised to lie on his side for about 5 minutes in order to facilitate the penetration of the drops into the ear.
When he lifts his head again, a few drops may come out. You can dry them with non-sterile absorbent paper.
It is imperative that you follow these instructions in order to get the medicine to work well in your ear. Keeping your head upright or moving your head too quickly while instilling the ear drops could result in partial loss of the medicine as the drops, rather than penetrating deep into the ear canal, they would glide over the face.
Keep the bottle tightly closed when not in use.
Keep the bottle until the treatment is finished. Do not keep it for future use.
When applying the medicine, take care that the dropper does not come into contact with the ear or fingers to avoid contamination.
Repeat steps 2 to 5 for the other ear if both ears have infections.
Overdose What to do if you have taken too much Cilodex
If you use more medicine than you should, tell your doctor or pharmacist.
If you forget to use this medicine don't worry, just continue with the next dose. Do not use a double dose to make up for a forgotten dose.
If you stop taking CILODEX
Do not stop giving your medicine without telling your doctor or pharmacist. If the health of your ear does not improve after 1 week of treatment, please go back to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Cilodex
Like all medicines, CILODEX can cause side effects, although not everybody gets them.
If you experience a severe allergic reaction and any of the following, stop taking the medicine and tell your doctor immediately: swelling of hands, feet, ankles, face, lips, mouth or throat, difficulty in swallowing or breathing, rash or hives, sores, ulcers
Common: affects up to 1 in 10 people
Effects in the ear: ear pain.
Uncommon: affects up to 1 in 100 people
Effects in the earEar discomfort, ear drainage catheter obstruction, tingling, ear congestion, itchy ear, fungal infection of the outer ear, ear discharge, ear enlargement.
General side effects: candida infection, irritability, crying, redness of the skin, vomiting, feeling of bad taste, tiredness.
Rare side effects: affect up to 1 in 1000 people
Effects in the ear: reduced hearing, ringing in the ears, drug residues.
General side effects: dizziness, headache, redness of the ear.
The following side effects have been reported with Cilodex ear drops. Frequency cannot be estimated from the available data:
Effects in the ear: inflammation of the ear
General side effects: allergy
Reporting of side effects
If you get 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 "Agenzia Italiana del Farmaco" at 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.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton. The expiry date refers to the last day of that month.
Do not freeze.
Keep the bottle in the outer carton to protect the medicine from light.
Discard the bottle 4 weeks after first opening.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What CILODEX contains
The active ingredients are ciprofloxacin and dexamethasone.
Each ml of suspension contains 3 mg of ciprofloxacin as hydrochloride and 1 mg of dexamethasone. The other ingredients are benzalkonium chloride, hydroxyethylcellulose, sodium acetate trihydrate, acetic acid, sodium chloride, disodium edetate, tyloxapol, boric acid, hydrochloric acid / sodium hydroxide (for pH adjustment), purified water.
Description of what CILODEX looks like and contents of the pack
CILODEX is a uniform suspension whose color ranges from white to off-white; it is supplied in a pack containing a 5 ml bottle (LPDE) with a white cap (PP).
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
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