CLOROGEN EYE DROPS 0.5% W/V - patient leaflet, side effects, dosage

1. What Clorogen Eye Drops is and what it is used for

2. What you need to know before you use Clorogen Eye Drops

• 3. Howto use Clorogen Eye Drops

4. Possible side effects

• 5. Howto Store Clorogen Eye Drops

6. Contents of the pack and other information

1. what clorogen eye drops is and what it is used for

Clorogen Eye Drops contains an antibiotic called chloramphenicol. It is used in both adults and children aged 2 years and over to treat bacterial infections that affect the front surfaces of the eye.

The most common type of infection in this area is called acute bacterial conjunctivitis. When you have this condition, the white part of one or both of your eyes will be red and/or youreyelids will be red or swollen. There will be a sticky discharge, which can make the eye difficult to open in the morning and the eye may feel “gritty' or irritated”.

Clorogen Eye Drops are not suitable for treating eye infections that have spread to the deeper layers of the eye coverings or into the fluid within the eyeball. Antibiotic tablets or injections are needed to treat these deeper, more serious infections.

2. what you need to know before you use clorogen eye drops

Clorogen Eye Drops are recommended for use in children aged 2 years and over, in adults and the elderly. Achild below the age of 2 years with an eye infection should see a doctor, due to necessary dosage adjustment.

Do not use Clorogen eye drops

• if you are allergic to chloramphenicol or any of the ingredients shown under section 6 ‚Contents of the pack and other information‘
• if you have ever had problems with your blood (in particular very low numbers of blood cells) during previous treatment with chloramphenicol
• if you have a family history of blood problems such as low white blood cell, red blood cell, or platelet counts

Warnings and precautions

Talk to your doctor or pharmacist before using Clorogen eye drops if

• your eyesight is affected (loss of sight, reduced vision, blurred vision or halos around lights)
• you have pain within the eye
• your eye has suffered a blow or other injury
• your eye is inflamed and you have a rash on the scalp or face
• the pupil of your eye looks unusual oryoureye looks cloudy
• your eyes are sensitive to light
• you have (or think you have) a foreign body in your eye, which has not been removed
• you have recently had an eye infection
• you suffer from or have ever suffered from glaucoma or dry eye syndrome
• you wear contact lenses and your contact lens practitioner or doctor has advised you to use this product, do not wear your lenses during the course of treatment. Wear your glasses instead. Soft contact lenses should not be replaced for 24 hours after completing the treatment.
• you are using any other eye drops or eye ointment
• you have had eye surgery or laser treatment in the last 6 months.

• ■ you suffer from any other eye problems.

Other medicines and Clorogen Eye Drops

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

If you are taking bone marrow depressant drugs (drugs which decrease the activity of the bone marrow, causing low blood cell counts) such as azathioprine or are receiving chemotherapy, seek the advice of your pharmacist or your doctor before using this product.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyourdoctor or pharmacist for advice before using this medicine.

Driving and using machines

After using the drops, you may temporarily get blurred vision, Do not drive or operate machinery until your vision is clear. If in doubt, talk to your pharmacist or doctor.

Clorogen eye drops contains phenyl mercuric nitrate

Clorogen Eye Drops contains phenylmercuric nitrate which may cause allergic reactions.

• 3. Howto use clorogen eye drops

Instructions for use:

To be used in the eye(s) only

(Please also referto pictograms at the end of the leaflet)

• First wash your hands
• Avoid touching the eye (or any other surface) with the tip of the bottle
• These drops are supplied in a low density polyethylene (LDPE) bottle with LDPE dropper nozzle, white coloured HDPE screw cap and tamper-evident LDPE dust cover. When using the bottle for the first time, snap off the dust cover by turning it clockwise to break the seal. Unscrew the inner cap.
• Tiltyourhead backand lookattheceiling
• Pull the lower eyelid gently downwards
• Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye
• Keep the affected eye closed and press yourfingertip against the inside comer of the closed eye, and hold for 1 minute
• Repeatfortheot­hereyeif necessary
• Replace and tighten the cap immediately after use.

Whilst applying the drops, do not

• breathe on ortouch the tip of the bottle

• ■ touch the eyes or eyelids (oranyothersurface) with the tip of the bottle

• share your eye drops with anyone else.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist

has told you. Check with yourdoctoror pharmacist if you are not sure.

= Use this medicine only in your eyes.

The recommended dose is one drop to the affected eye(s) every 2 hours for the first two days and 4 hourly thereafter. Use during waking hours only.

---- The usual duration of thetherapy

The course of treatment is 5 days. Keep using these eye drops for

5 days. Do not stop just because you feel better, this could make your condition worse.

If your symptoms do not improve within 48 hours, consult your doctor. If your symptoms get worse seek medical advice at once.

The maximum duration of thetherapy

Do not use Clorogen Eye Drops for more than 5 days without consulting your doctor. Discard any remaining eye drops after the 5 day course of treatement.

If you forget to use your Clorogen Eye Drops

If you have only just missed a dose and it is a long time before the next dose is due, put in the missed dose of drops straight away. If you missed the dose some time ago and it is nearly time for your next dose, just put in the next dose of drops at the right time. Never double up on a dose to make up for the one you have missed.

If you have any further questions on the use of this medicine, ask yourdoctoror pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some people may get one or more of these side effects. Some effects happen straight away but do not last long, other may only happen after several days of use.

• allergic reactions such as itching or rashes. If you get a severe reaction, with swelling or breathing problems get medical help straight away.
• changes in the blood (anaemia) leading to severe tiredness or easy bruising. If you experience these effects, stop using the drops immediately and tell your doctor.
• Discolourationn or cloudig of the eye surface (cornea) or lens due to the preservative.
• The use of topical chloramphenicol may occasionally result in the overgrowth of other non susceptible organisms including fungi. If any new infection appears during treatment you should tell yourdoctor.
• blurred vision or mild burning or stinging when you put the drops in. These should subside quickly.
• irritation of the skin around the eyes, mercurialentis (brown discolouration of the lens) and a typical band keratopathy (appearance of calcium on the cornea). These may be due to the preservative in the drops called phenylmercuric nitrate.

If you do not feel well or are worried about your health, talk to a pharmacist or doctor.

If any of the side effects get serious or if you experience any side effect not listed in this leaflet please tell yourdoctoror pharmacist.

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 via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• 5. Howto store clorogen eye drops

Replace the cap securely after use. Store at 2°C to 8°C.

This is the temperature of most domestic refrigerators.

Protect from light.

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.

Throw away any medicine left at the end of the 5 days course.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

• 6. Content of the pack and other information

What Clorogen Eye Drops look like and contents of the pack

Each bottle contains 10ml of the drops.

Clorogen Eye Drops is a bright, colourless to faint yellow aqueous solution.

Marketing Authorisation Holder and Manufacturer

FDC International Ltd,

Unit 6, Fulcrum 1,

Solent Way, Whiteley,

Fareham,

pressure. Do not touch dropper tip to the surface of the eye.

to break the seal.

Pull off the dust cover

Replace the bottle in the outer carton after every use