CEPROLEN EYE DROPS

WHAT CEPROLEN CONTAINS:

CEPROLEN EYE DROPS contains ciprofloxacin hydrochloride monohydrate equivalent to ciprofloxacin 0.003 g per ml (0.3 % w/v).
It is preserved with 0.02 % v/v Benzalkonium chloride solution (50 % w/v) equivalent to 0.0001 g per ml (0.01

% w / v) of benzalkonium chloride.

Other ingredients contained in CEPROLEN EYE DROPS include: boric acid and disodium edetate.

WHAT CEPROLEN EYE DROPS IS USED FOR:

CEPROLEN EYE DROPS is used to treat bacterial infection of the eye and corneal ulcers in the eye. CEPROLEN is only available with a doctor’s prescription.

BEFORE YOU USE CEPROLEN EYE DROPS:

ALLERGIES:

f you have any allergies to any foods, or if you experienced any allergies such as red itchy skin, or severe skin rash or swelling of the skin when you have taken a similar medicine before e.g. ciprofloxacin, nalidixic acid, norfloxacin and ofloxacin, or if you are allergic to any of the ingredients contained in this medicine tell your doctor or healthcare professional.

PREGNANCY:

The use of CEPROLEN EYE DROPS has not been established in pregnant women.

BREAST-FEEDING:

It is not known whether CEPROLEN EYE DROPS passes into breast milk. Therefore mothers using CEPROLEN and who wish to breast-feed should first consult with their doctors.
CHILDREN:

The use of CEPROLEN EYE DROPS is not recommended in infants and children up to 1 year of age.

ELDERLY PATIENTS:

There is no specific information comparing the use of CEPROLEN EYE DROPS in the elderly with use in other age groups.
OTHER MEDICINES:

Tell your doctor or health care profession if you are using any other medicine while you are taking CEPROLEN as it may interact with CEPROLEN EYE DROPS.

Take special care with CEPROLEN EYE DROPS:

If your infection does not improve within a few days or if it becomes worse, consult with your doctor.

If you develop severe swelling, itching of the eye or a skin rash while using CEPROLEN, stop using CEPROLEN and consult your doctor immediately.

CEPROLEN EYE DROPS may cause your eyes to become more sensitive to light than they are normally. Therefore to lessen the discomfort, you may wear sunglasses and also try and avoid too much exposure to bright light.

You should not wear contact lenses while you are using CEPROLEN EYE DROPS. The preservative contained in CEPROLEN, will be absorbed by your contact lens, damaging it.

Important information about ingredients contained in CEPROLEN EYE DROPS:

The preservative contained in this eye drop (benzalkonium chloride solution) can cause damage to the cornea of your eye if used for long periods. If you are prescribed to use CEPROLEN EYE DROPS for more than 14 days, it is important to consult your ophthalmologist (eye specialist) for regular check up.

HOW TO USE CEPROLEN EYE DROPS

Remove the plastic wrapping around the bottle and turn the lid to tighten it on the bottle. This will pierce a hole at the tip of the bottle.
To use CEPROLEN eye drop:

Wash your hands.

It is important that you keep CEPROLEN EYE DROPS as germ-free as possible. Therefore do not touch the tip of the bottle with your finger or even touch the tip to your infected eye.

Tilt your head back or lie down and pull the lower eyelid down to form a pouch.

Drop CEPROLEN EYE DROPS as directed by your doctor or pharmacist into the pouch and gently close your eyes and release the lower lid slowly.

Do not blink. Keep your eyes closed for 1 – 2 minutes to allow the medicine to come into contact with the infection.

If you did not get the drop of the medicine into your eye properly, use another drop.

Dosing:

Please note that the dose for Ceprolen Eye Drops will be different for different patients. The dosing information given below is only the average doses of Ceprolen Eye Drops. It is therefore important to follow your doctor’s, or pharmacist’s instructions or the directions on CEPROLEN EYE DROPS label. If you are unsure on how to use CEPROLEN, please contact your doctor or pharmacist.
Corneal ulcers or abscesses:

Instill 2 drops into the affected eye every 15 minutes for 6 hours, then instill 2 drops every 30 minutes while you are awake for the rest of day 1. On day 2, instill 2 drops every hour while you are awake. On day 3 through to day 14, instill 2 drops every 4 hours while you are awake.
If treatment is required for more than 14 days, the dosage regimen is at the discretion of the doctor.

Bacterial Conjunctivitis:

Instill 1 drop into the conjunctiva sac of the infected eye every 2 hours, while you are awake for 2 days, then 1 drop every 4 hours, while you are awake, for the next 5 days.

If you use more Ceprolen eye drops than you should:

In the event of overdosage, the Ceprolen eye drop may be flushed out of your eye with warm water. Consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison center.

If you forget to use Ceprolen Eye Drops:

If you miss a dose of CEPROLEN EYE DROPS, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not double the dose.

POSSIBLE SIDE EFFECTS

CEPROLEN may cause unwanted effects. Although not all the effects listed below may occur, if they do occur, they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur: Incidence less frequent:

Ophthalmic Disorder

• Allergic reactions such as skin rash, hives or itching
• Blurred vision or any other change in vision
• Eye pain or irritation (severe), or redness of eye

Gastro-Intestinal Disorder

• Nausea

The following side effects need medical attention only if they continue or are bothersome Incidence common – Ophthalmic Disorder:

• Burning or other discomfort of the eye
• Crusting or crystals in corner of eye

Incidence less common: Ophthalmic Disorder

• Feeling of something in the eye
• Itching of eye
• Redness of the lining of the eyelid
• Dryness of eye
• Swelling of the eyelid
• Increased sensitivity of the eyes to light
• Tearing of eye

Gastro-intestinal Disorder:

• Bad taste after instillation in eye

Not all side effects reported for CEPROLEN EYE DROPS are included in this leaflet. Should your general health worsen while taking CEPROLEN, please consult your doctor, pharmacist or other health care professional for advice

STORAGE & DISPOSAL INORMATION FOR CEPROLEN EYE DROPS:

Store CEPROLEN EYE DROPS away from heat and direct light at or below 25 C

Do not use CEPROLEN for more than 30 days after first opening CEPROLEN EYE DROPS. Do not refrigerate or freeze CEPROLEN EYE DROPS.

Any expired or outdated medicines and unused medicines can be returned to your nearest pharmacy.

Store all medicines out of reach and sight of children.

PRESENTATION:

The product is contained in a translucent (clear), 5 ml LDPE (low density polyethylene) bottle, with a translucent (clear) LDPE nozzle, which is enclosed by an ivory yellow HDPE (high density polyethylene) cap

IDENTIFICATION:

A light yellow to yellow, clear solution, which is free from visible particulate matter

REGISTRATION NUMBER:

A40/15.1/0048

NAME AND BUSINESS ADDRESS OF HOLDER OF THE CERTIFICATE OF REGISTRATION:

Epiglo Pharmaceuticals (Pty) Ltd
Allandale Building First Floor
23 Magwa Crescent
Waterfall City
Gauteng
1685

DATE OF PUBLICATION THE PATIENT INFORMATION LEAFLET:

07/06/2012