Clorogen Eye Drops 0.5% W/V
Package leaflet: Information for the user
CLOROGEN EYE DROPS
0.5% w/v
(Chloramphenicol)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist told you.
• Keep this leaflet. You may need to read it again.
• Askyour pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 48 hours.
• This medicine is foryou. Never give it to other people. It may harm them, even if theirsymptomsappearto be the same.
What is in this leaflet:
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. How to 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 contain an antibiotic called chloramphenicol. It is used in both adults and children 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 your eyelids 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 ‘gritty1 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. A child below the age of 2 years with an eye infection should see a doctor, due to necessary dosage adjustment.
Do not use this product if you
• are allergic to chloramphenicol or any of the ingredients shown under section 6 'Contents of the pack and other information'
• have ever had problems with your blood (in particular very low numbers of blood cells) during previous treatment with chloramphenicol
• have a family history of blood problems such as low white blood cell, red blood cell, or platelet counts
Do not use this product and seek advice from your doctor 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
• youreye is inflamed and you have a rash on the scalp or face
• the pupil of youreye looks unusual oryoureye looks cloudy
• youreyesaresensitivetolight
• you have (or think you have)aforeign body in youreye, 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. If 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. Wearyourglasses 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.
Tell your pharmacist before using this product if you
• are taking any other medicines
• sufferfrom any other eye problems.
Other medicines and Clorogen Eye Drops
Tell your doctor or pharmacist if your 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, thinkyou 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
After using the drops, you may temporarily get blurred vision, Do not drive or operate machinery until yourvision is clear. If in doubt, talkto your pharmacist or doctor.
Clorogen Eye Drops contains _ _
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
• First wash your hands
• These drops are supplied as a sealed bottle with spiked cap. When using the bottle for the first
time, screw the cap down tightly in order to pierce the tip of the bottle
• Tilt your head back and look at the ceiling
• 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 corner of the closed eye, and hold for 1 minute
• When both eyes are to be treated, repeat for the other eye
• 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 (or any other surface) with the tip of the bottle
• share youreyedrops with anyoneelse.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Use in children
Dosage adjustment may be necessary in newborn infants because of reduced systemic elimination due to immature metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days.
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 the therapy
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 the therapy
Do not use Clorogen Eye Drops for more than 5 days without consulting your doctor. Discard any remaining eye drops afterthe 5 days 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.
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 oreasy bruising. If you experience these effects, stop using the drops immediately and tell your doctor.
• Discolouration or clouding 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 your doctor or 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 www.mhra.aov.uk/vellowcard. 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 PACKAND OTHER INFORMATION
The active substance is chloramphenicol 0.5% w/v. It also contains Borax, Boric acid, Phenyl mercuric nitrate (as preservative) 0.002% w/v and purified water.
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, Hampshire, P015 7FE PL number: 15872/0015
Hard to see or read the leaflet? Call + 44(0) 1489 565222 for help.
This leaflet was last revised in: 09/2016
Version 05 Colour: CMYK