CILOXANT 5ml.

STATEMENT OF ACTIVE SUBSTANCE (CONTAINING THE MEDICINAL PRODUCT):
Each milliliter of Ciloxan contains:
Medicinal product: Ciprofloxacin (as hydrochloride) - 3 mg. Preservatives: Benzalkonium chloride.
Other excipients: Sodium acetate, acetic acid, mannitol, sodium edetate, hydrochloric acid and / or sodium hydroxide (to achieve the required pH) and purified water.

PHARMACEUTICAL FORM AND CONTENTS:
Ciloxan is eye drop and eyelid solution and is supplied in 5 ml plastic vials.
Pharmacotherapeutic group: Antibacterial drug suitable for infections in the eye and ear.

The marketing authorization holder for Ciloxan is: Alcon Pharmaceuticals Ltd.,
CH-6331 Hunenberg, Switzerland.
Ciloxan is manufactured by: S.A. Alcon - Couvreur N. V., Rijskweg 14, B-2870 Puurs, Belgium.

INDICATIONS (What is the use of the medicinal product?):
Eye application:
Ciloxan is indicated for the treatment of corneal ulceration and superficial infections of the eye and its appendages caused by ciprofloxacin-susceptible micro-organisms.
Ocular use: Ciloxan is also indicated for: auditory canal infections accompanied by severe inflammatory reactions caused by ciprofloxacin-susceptible micro-organisms, as well as acute chronic inflammation of the middle ear.

CONTRAINDICATIONS (When should the use of the medicine be avoided?):
Hypersensitivity to ciprofloxacin or any other component of the medicinal product. The use of Ciloxan should be avoided with proven hypersensitivity to other medicinal substances of the same pharmacological group - quinolones.

ATTENTION:
If the inflammation does not respond, please consult your doctor.

Special warnings and precautions

• Ciprofloxacin (Ciloxan) should be discontinued at the first onset of skin rash or other signs of allergic reaction and consultation with the treating physician.
• Serious and in some cases fatal hypersensitivity reactions sometimes occur immediately after the first dose as a consequence of concomitant use of medicinal products of the same group administered by other routes of administration (oral, intramuscular or intravenous).
• Serious hypersensitivity reactions require immediate treatment. Immediate consultation with your doctor is required!
• If you wear soft contact lenses and use Ciloxan eye drops - it is necessary to remove the lens from your eyes when using the medicine! Ciloxan contains as a preservative benzalkonium chloride, an ingredient that can damage your lenses!
• For use in the ears (Ciloxan ear drops), special monitoring is required.
• In the case of exacerbated chronic inflammation of the middle ear, fever secretion can occur due to perforated eardrum.
• In the case of other ear infections (eg Eustachian tube inflammation) caused by ciprofloxacin susceptible micro-organisms, Ciloxan may be used only with the express eye of an eye specialist.

INCOMPATIBILITIES:
The medicinal product is incompatible with alkaline solutions.

USE IN PRAYER AND BREAST:
Ciloxan (both for ocular and for oral use) should be used after consultation and at the discretion of the treating physician.

CHILD USE
Ciloxan (both for ocular and otic use) is not suitable for use in children below 1 year of age.
The safety and efficacy of the medicinal product in patients under this age has not been established.

EFFECTS ON ABILITY TO DRIVE AND WORK WITH MACHINES:
So far there is no evidence of a likely effect of Ciloxan under these circumstances, therefore more caution is recommended.

DOSAGE AND ROUTE OF ADMINISTRATION
Use in the eye - adults and children over 1 year of age
Corneal ulcer:
For the treatment of corneal ulcer, Ciloxan should be used following the following intervals (even at night):
First day: two drops every 15 minutes during the first 6 hours, then - by the end of the first day - two drops every 30 minutes.
Day two: Two drops every hour in the affected eye.
Day 3 to Day 14: Two drops in the affected eye / eyes every four hours.
* If the treating physician has determined that you need additional treatment after the 14th day, the dosage is at his discretion.
Surface infections of the eye:
The usual dose is 1-2 drops in the affected eye / eyes - 4 times a day.
For severe infections, the dosage for the first two days is: 1 - 2 drops every two hours (through
day).
Both cases, as a maximum duration of treatment, are recommended for a 21-day period.
Ocular use - adults and children over 1 year old
Before using Ciloxan in the ear, it is necessary to clean the ear canal gently. It is advisable to warm the drops to a temperature close to the body before dropping the vestibular stimulation.
Ciloxan is used in the ear canal, with the usual dose being: 3-4 drops - 2 to 4 times a day (physician's discretion may be more frequent).
For better penetration, the patient has to lie down with the affected ear up and put the drops in it. It is necessary to stay in this position for at least 5-10 minutes to facilitate the penetration of the drops into the ear canal.
After local cleaning of the ear canal, a swab (cotton or gauze) can be placed in the ear for one to two days. The tampon should be irrigated with Ciloxan twice a day. The duration of treatment is usually 5 to 10 days. In some cases, treatment may be continued - by medical judgment, but it is necessary to demonstrate the sensitivity of the local flora.
As with any anti-bacterial drug, prolonged use may cause over-growth of non-susceptible micro-organisms or fungi.
Remember - dosage and duration of treatment are determined by your doctor!

OCCURRENCE:
Overdosed Ciloxan for topical ocular administration can be removed with warm, tap water.
The overdose of the medicinal product after dropping it into the ears, especially in the presence of perforation of the tympanic membrane, is removed by aspiration (from an otorhinolaryngologist).

UNDESIRABLE MEDICINAL REACTIONS:
Eye contact: Burning and discomfort may occur immediately after use in the eye. It is possible that itching, foreign body sensation, eyelid sticking, conjunctival flushing, unpleasant taste after dripping may also be seen as undesirable effects.
Less often, keratitis (corneal inflammation), allergic reactions, eyelid edema, lacrimation, light sensitivity (photophobia), corneal edema, decreased vision may occur.
The frequent, local use of Ciloxan in corneal ulcer patients may lead to the appearance of white precipitates resolving upon cessation of treatment. If any of these or other unusual symptoms occur, your doctor or pharmacist should be consulted for more information.
When used in the ear: The use of Ciloxan in the ear rarely leads to hypersensitivity reactions. If any allergic reactions (to any of the components of the medicinal product) occur during the use of Ciloxan, consult your doctor or pharmacist.

STORAGE:
• No special storage conditions are required.
• Keep the vial tightly closed when not in use.
• Four weeks after first opening the vial - discard unused remainder of the contents.
When used in the eye:
• Do not touch the tip of the applicator-dropper to avoid contaminating the contents of the vial.
For use in the ear:
• To avoid contamination of the applicator-dropper with material from the ears, hands and other sources.
• The solution should be warmed to room temperature before administration to the ear.
• Ciloxan should be used either for use in the eye or for use only in the ear!
• Never use the same Ciloxan vial for use in the eye and ear!
• Keep out of reach of children!

TIME LIMIT:
Do not use after the expiry date stated on the package.

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