Active ingredients: Ciprofloxacin, Hydrocortisone
MEDIFLOX 2 mg / ml + 10 mg / ml EAR DROPS, SUSPENSION
Why is Mediflox used? What is it for?
MEDIFLOX contains two active ingredients, a steroidal anti-inflammatory (hydrocortisone) and an antibiotic (ciprofloxacin); ciprofloxacin is an antibacterial agent that belongs to the group of fluoroquinolones and works by killing the bacteria that cause infections.
This medicine is used to treat acute otitis externa (infection of the ear canal) with unperforated eardrum in adults and children over 2 years of age.
Contraindications When Mediflox should not be used
Before prescribing this medicine, your doctor will need to examine your eardrums to make sure they are not perforated.
Do not use MEDIFLOX
- if you are allergic (hypersensitive) to ciprofloxacin or other drugs from the fluoroquinolone group
- if you are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of MEDIFLOX
- if your eardrum is punctured or damaged.
- if you have viral or fungal ear infections, including chickenpox or herpes simplex virus infections.
- If you have inflammation or infection of the middle ear. Symptoms include ear pain, high temperature (fever) and a plugged ear feeling.
Precautions for use What you need to know before taking Mediflox
- use MEDIFLOX only in the ears. Do not inject or swallow this medicine.
- and you experience a rash or notice the first signs of a rash or any other local allergic reaction, including hives, itching or trouble breathing, stop treatment immediately and consult your doctor.
- By using this medicine, you may become more susceptible to other infections. If any signs and symptoms persist after one week of therapy, consult your doctor.
- The dropper contains natural rubber (latex) which can cause severe allergic reactions.
Children
MEDIFLOX is not recommended in children below 2 years of age due to a lack of data in these patients.
Interactions Which drugs or foods can change the effect of Mediflox
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is recommended not to apply other medicines in the ear at the same time.
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 or pharmacist for advice before using this medicine.
Driving and using machines
Treatment with MEDIFLOX has no effect on the ability to drive and use machines.
The dropper cap contains latex rubber
The dropper cap contains latex rubber which can cause severe allergic reactions.
Dose, Method and Time of Administration How to use Mediflox: Posology
This medicine is for use in the ear only. Do not inject or swallow this medicine.
Always use MEDIFLOX exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Apply 3 drops into the ear canal of the affected ear twice a day, in the morning and in the evening.
The usual duration of treatment is 7 days. If symptoms persist after this time, consult your doctor.
For this medicine to be effective, apply it regularly at the prescribed doses and for the duration indicated by your doctor.
The disappearance of the symptoms does not mean that you are completely cured. Feelings of fatigue do not depend on the treatment but on the infection. Reducing the dose or discontinuing treatment has no influence on this feeling and only delays healing.
To apply the drops correctly, follow these instructions:
- Wash your hands well.
- Unscrew the bottle cap and insert the dropper into the bottle.
- Warm the bottle immediately before use by holding it in the palm of your hand for a few minutes to avoid the sensation of discomfort due to the contact between the cold suspension and the ears.
- Shake the bottle before use.
- With your head tilted to the opposite side of the affected ear so that the affected ear is facing upward, apply the drops into the affected ear by pulling the outer ear several times.
- Keeping your head tilted, gently pull the earlobe up and down. This will allow the ear drops to drain into the ear canal.
- Keep your head tilted to that side for about 5 minutes to make it easier for the drops to enter the outer ear canal. However, if you lift your head, some drops may come out of the ear. You can dry them with non-sterile absorbent paper.
- If necessary, repeat for the other ear.
It is especially important to follow these instructions for the medicine to work well in your ear. When putting the drops in your ear, holding your head up vertically or moving your head too fast could result in some of the medicine being lost because the drops would run down your face and would not go deep into the ear canal.
Be careful not to touch the dropper with your ears or fingers to limit the risk of contamination of the drops.
At the end of the treatment, what remains in the bottle should be discarded and not stored for later use.
If you forget to use MEDIFLOX, continue with your next dose as scheduled. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Mediflox
If you use more MEDIFLOX than you should, do not use any more drops until it is time for your next scheduled administration.
In case of overdose or accidental ingestion, contact the poison control center / emergency room.
Side Effects What are the side effects of Mediflox
Like all medicines, MEDIFLOX can cause side effects, although not everybody gets them.
The following side effects have been reported with MEDIFLOX.
Common (may affect up to 1 in 10 people)
Effects on the ear: ear itching
Uncommon (may affect up to 1 in 100 people)
Effects on the ear: ear pain, ear congestion, ear discomfort, redness of the ear canal.
General side effects: dizziness, headache, nausea, peeling of the skin, mycosis of the skin, hives, rash, itching, reduced or unusual skin sensitivity and presence of drug residue in or around the ear.
Additional reported side effects for which the frequency is not known (frequency cannot be estimated from the available data) include:
Effects on the ear: reduced hearing, ringing in the ears.
General side effects: allergy
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicinal.
Expiry and Retention
Keep MEDIFLOX out of the sight and reach of children.
Do not use MEDIFLOX after the expiry date which is stated on the carton and carton (indicated as EXP). The expiry date refers to the last day of that month.
Do not store above 25 ° C
Do not refrigerate or freeze.
Keep the container in the outer packaging to protect it from light.
Keep the container tightly closed to protect it from moisture.
Once the bottle is opened and the dropper inserted, the drops must be used within 14 days.
At the end of the treatment, discard the solution left in the bottle. Do not keep it for use at a later date.
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.
Deadline "> Other information
What MEDIFLOX contains
- The active ingredients are ciprofloxacin 2 mg / ml and hydrocortisone 10 mg / ml.
- The other ingredients are polysorbate 20, sodium acetate, glacial acetic acid, benzyl alcohol, lecithin, sodium chloride, polyvinyl alcohol and purified water.
Description of what MEDIFLOX looks like and contents of the pack
MEDIFLOX is a white to off-white liquid (suspension). It is supplied in a pack containing a 10 ml glass bottle with a polypropylene screw cap.Packaged separately, a dropper is included (polyethylene pipette, polypropylene cap and latex rubber cap).
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.
01.0 NAME OF THE MEDICINAL PRODUCT -
MEDIFLOX®
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
One ml of ear drops, ear suspension contains 2.329 mg of ciprofloxacin hydrochloride monohydrate, (equivalent to 2,000 mg of ciprofloxacin), and 10.00 mg of hydrocortisone.
For excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Ear drops, suspension.
The suspension is opaque white to off-white in color.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Local treatment of acute external otitis of bacterial origin, in the absence of perforation of the eardrum.
Pay particular attention to official guidelines relating to the use of antibiotics.
04.2 Posology and method of administration -
Dosage:
Adults and children over 2 years of age: instill three drops of suspension in the affected ear, twice a day. Duration of treatment: 7 days
Method of administration:
Topical use: otological instillation. Warm the bottle immediately before use by holding it in the palm of your hand for a few minutes. This will avoid unpleasant sensations due to ear contact with the cold suspension. Shake well before use. Keeping the head tilted, instill the drops in the affected ear. Keep the head tilted sideways for at least 30 seconds to allow the drops to penetrate the external ear canal. Repeat, if necessary, in the other ear.
Shake before use. Immediately before use, remove the cap from the bottle and replace it with the appropriate dropper dispenser. The ciprofloxacin and hydrocortisone-based ear suspension is ready for use as soon as the dropper dispenser has been inserted. At the end of the treatment period, discard the amount of leftover drug that must not be retained for reuse.
04.3 Contraindications -
This product MUST NEVER BE USED in patients with:
hypersensitivity to ciprofloxacin or other quinolones
hypersensitivity to hydrocortisone or to any of the other components of the suspension
Known or suspected perforation of the eardrum
acute or chronic otitis media.
The use of the product is contraindicated in viral infections of the external auditory canal, including chicken pox and herpes simplex infection.
04.4 Special warnings and appropriate precautions for use -
Always make sure the eardrum is not perforated before prescribing the product.
Discontinue treatment immediately if any signs of rash or any other signs of local or systemic hypersensitivity appear.
Do not inject. Do not swallow.
During administration avoid contact between the dropper and the ear or fingers to limit the risk of contamination.
There is no clinical experience on use in children under 2 years of age.
It is recommended not to administer this product concurrently with other topical medicinal products.
04.5 Interactions with other medicinal products and other forms of interaction -
Not relevant.
04.6 Pregnancy and breastfeeding -
No clinical data are available.
Based on the pharmaceutical form, route of administration and normal conditions of use, a systemic shift is unlikely to occur.
Consequently, this medicine can, if necessary, be administered during pregnancy or breastfeeding, under normal conditions of use.
04.7 Effects on ability to drive and use machines -
Not relevant.
04.8 Undesirable effects -
The only undesirable effects reported with an incidence ranging from 0.1 to 1% were the following local reactions: hypoesthesia, paraesthesia, pruritus, rash, urticaria and a feeling of fullness in the ear.
Since the marketing of the product has been reported, in very rare cases, the presence of residues of the product in the auditory canal with or without manifestation of symptoms such as ear discomfort, hearing disorders, ear pain.
04.9 Overdose -
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: otological drug; association of corticosteroid and antibacterial; hydrocortisone and antibacterial. ATC code: S02CA03.
Hydrocortisone is a corticosteroid with anti-inflammatory and analgesic properties.
Ciprofloxacin is a synthetic antibiotic belonging to the fluoroquinolone group. Its activity is strongly bactericidal, thanks to the inhibition of bacterial DNA-gyrase, which prevents the synthesis of bacterial chromosomal DNA.
The MIC values (breakpoints) that separate susceptible organisms from those with intermediate susceptibility and the latter from resistant ones are as follows:
S ≤1 mg / l and R> 2 mg / l
The prevalence of acquired resistance may vary in different geographic areas and over time for selected species. It is therefore useful to have local information on resistance, particularly for the treatment of severe infections. This information provides only indicative guidance on the likelihood that microorganisms are sensitive to this antibiotic.
The cases for which it is known, for certain species, that the resistance varies within the European Union, are indicated in the following table:
* Clinical efficacy demonstrated for susceptible strains and for the approved clinical indication.
** The frequency of methicillin resistance ranges from approximately 30% to 50% for all Staphylococci and is mainly observed in hospitals.
*** A study conducted using the experimental model of anthrax bacterial infection showed that antibiotic therapy is established quickly after exposure and prevents the disease from occurring if the treatment is continued until the number of spores present in the body decreases. below the infection threshold.
Atypical mycobacteria: ciprofloxacin shows moderate in vitro activity against some species of mycobacteria: Mycobacterium tuberculosis, Mycobacterium fortuitum, lower against Mycobacterium kansasii and even lower against Mycobacterium avium.
Cross resistance
There is in vitro cross-resistance between ciprofloxacin and other fluoroquinolones. Due to its mechanism of action, there is generally no cross-resistance between ciprofloxacin and other classes of antibacterial agents.
NB: this spectrum corresponds to that of the systemic forms of ciprofloxacin. With local pharmaceutical forms, concentrations achieved in situ are much higher than plasma concentrations. Some doubts remain regarding the kinetics of in situ concentrations, the local physical and chemical conditions that can modify the activity of the antibiotic and the stability of the product in situ.
05.2 "Pharmacokinetic properties -
Based on the data available for oral administration, if absorption of the locally administered doses were complete, steady state peak ciprofloxacin concentrations of approximately 3mg / L should be expected. Since the analytical detection limit is 5mg / L, not Clinical pharmacokinetic studies have been conducted with the 0.2% ciprofloxacin-hydrocortisone ear suspension in otitis externa.
In 7 children with chronic purulent otitis media treated locally with 0.3% ciprofloxacin there were no circulating plasma concentrations of ciprofloxacin in the blood samples.
Under normal conditions of use, a significant systemic passage of ciprofloxacin or corticosteroid is not expected.
05.3 Preclinical safety data -
Studies conducted in guinea pigs for periods of 30 days did not reveal functional or morphological ototoxicity. 14-day skin safety studies performed in rabbits revealed mild skin reactions (erythema) with no histological related inflammatory type; the suspension may be considered mildly irritating to the skin.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Polysorbate 20, sodium acetate, glacial acetic acid, benzyl alcohol, (soy) lecithin, sodium chloride, polyvinyl alcohol, purified water.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
2 years
After opening the bottle and inserting the dropper: 14 days.
06.4 Special precautions for storage -
Do not store above 25 ° C.
Do not store in the refrigerator. Do not freeze.
Keep the bottle in the original package in order to protect it from light.
Keep the bottle tightly closed to protect it from moisture.
06.5 Nature of the immediate packaging and contents of the package -
10 ml bottle (type I glass), with polypropylene screw cap and dropper packaged separately, consisting of polyethylene pipette, polypropylene cap and rubber bulb, single pack.
06.6 Instructions for use and handling -
No particular instruction.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Alcon Italia S.p.A., Viale Giulio Richard 1 / B, 20143 Milan
08.0 MARKETING AUTHORIZATION NUMBER -
AIC 035271016 / M
10 ml in bottle (glass) with dropper (PE).
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
25/11/2002
10.0 DATE OF REVISION OF THE TEXT -
01/02/2006
