Ciloxan 0.3% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ciprofloxacin hydrochloride

Available from:

Waymade Healthcare Plc

ATC code:

S01AE03

INN (International Name):

Ciprofloxacin hydrochloride

Dosage:

3mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11030100

Patient Information leaflet


DO NOT SQUEEZE THE BOTTLE, only a gentle press on the
bottom is needed.

If you use drops in both eyes, repeat the steps for your
other eye. Put the bottle cap firmly back on immediately
after use.

IF A DROP MISSES YOUR EYE, try again.

IF YOU FORGET TO USE CILOXAN, do not worry, just use it
when it is next due. DO NOT TAKE A DOUBLE DOSE TO MAKE UP.

IF YOU USE MORE CILOXAN THAN YOU SHOULD it can be
washed out of your eye with lukewarm water.

IF THIS MEDICINE IS ACCIDENTALLY SWALLOWED, it is NOT LIKELY
to cause any serious problems, but contact your doctor.
IF YOU HAVE ANY FURTHER QUESTIONS on the use of Ciloxan,
ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Ciloxan can cause side effects, although not
everybody gets them.

YOU MAY EXPERIENCE SOME OR ALL OF THE FOLLOWING EFFECTS
IN YOUR EYE(S):
_Common (1 to 10 users in 100): _White deposits on the eye
surface (cornea), discomfort (stinging or burning, gritty feeling in
the eye, irritation), redness.
_Uncommon (1 to 10 users in 1,000): _Damage to the eye surface
(cornea), sensitivity to light, blurred vision, swelling of the eye or
eyelid, pain, dry eye, itchiness, eye discharge, eyelid crusting,
eyelids scales, eyelid redness, poor vision, watery eyes, red
eyes.
_Rare (1 to 10 users in 10,000): _Damage of the eye,
inflammation, double vision, decreased eye sensation, tired
eyes, stye.
IF YOU NOTICE WHITE PARTICLES in your eyes, continue to use
Ciloxan but tell your doctor immediately.

YOU MAY ALSO EXPERIENCE EFFECTS IN OTHER AREAS OF YOUR
BODY INCLUDING:
_Common: _Bad taste.
_Uncommon: _Headache, nausea.
_Rare: _Hypersensitivity, dizziness, ear pain, inflammation inside
the nose, nasal sinus discharge, diarrhoea, abdominal pain,
skin inflammation, tendon disorder.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CILOXAN 0.3% w/v eye drops, solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ciprofloxacin 0.3% w/v (as hydrochloride)
Excipients with known effect: One ml of solution contains 0.06mg of
benzalkonium chloride
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, solution.
A clear and colourless to pale yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults, newborn infants (0-27 days), infants and toddlers (28 days to
23
months), children (2-11 years) and adolescents (12 – 16 years)
CILOXAN is indicated for the treatment of corneal ulcers and
superficial
infections of the eye and adnexa caused by susceptible strains of
bacteria.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, newborn infants (0-27 days), infants and toddlers (28 days to
23
months), children (2-11 years) and adolescents (12 – 16 years)
Corneal Ulcers:
CILOXAN must be administered in the following intervals, even during
night
time:
On the first day, instil 2 drops into the affected eye every 15
minutes for the
first six hours and then 2 drops into the affected eye every 30
minutes for the
remainder of the day.
On the second day, instil 2 drops in the affected eye hourly.
On the third through the fourteenth day, place two drops in the
affected eye
every 4 hours. If the patient needs to be treated longer than 14 days,
the dosing
regimen is at the discretion of the attending physician.
Superficial Ocular Infection:
The usual dose is one or two drops in the affected eye(s) four times a
day. In
severe infections, the dosage for the first two days may be one or two
drops
every two hours during waking hours.
For either indication a maximum duration of therapy of 21 days is
recommended.
The dosage in children above the age of 1 year is the same as for
adults.
Use in children
Safety and effectiveness of CILOXAN Eye Drops were determined in