PACKAGE LEAFLET: INFORMATION FOR THE USER

Chloramphenicol Eye Drops BP 0.5% w/v

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness symptoms are the same as yours.

•    If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:

1.    What Chloramphenicol is and what it is used for

2.    What you need to know before you use Chloramphenicol

3.    How to use Chloramphenicol

4.    Possible side effects

5.    How to store Chloramphenicol

6.    Contents of the pack and other information

1.    WHAT CHLORAMPHENICOL IS AND WHAT IT IS USED FOR

Chloramphenicol Eye Drops are used to treat bacterial infections of the eye.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORAMPHENICOL

DO NOT use Chloramphenicol

•    if you have ever had a bad reaction to any of the ingredients listed in section 6

•    if you suffer from very dry eyes

•    if you are about to have an operation to remove a cataract (chloramphenicol may interfere with one of the drugs which could be used to help the operation)

•    if you have ever had problems with your bone marrow or blood when using chloramphenicol in the past

•    if you have a family history of “dyscrasias”, a condition which can cause tiredness, bruising and an increased risk of infections.

Warnings and precautions

Talk to your doctor or pharmacist before taking Chloramphenicol

Chloramphenicol Eye Drops also contain phenylmercuric nitrate which may cause infection in the corner of the eye. It may also discolour the front part of the lens, if Chloramphenicol is used for a long time so prolonged usage of products containing phenylmercuric nitrate is to be avoided.

If you normally wear contact lenses, do not wear them while you are having treatment with Chloramphenicol. If your infection is severe, you may have to take antibiotics as well as using your eye drops.

Prolonged use is not recommended, if you are unsure contact your doctor.

These eye drops are sterile while the bottle is sealed. Do not use them if the bottle is open or the seal is broken when you get them.

Other medicines and Chloramphenicol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Talk to your doctor if you are taking any of the following:

•    chymotrypsin used as digestive enzyme

•    bone marrow suppressant drugs such as azathioprine

Pregnancy, breast-feeding and fertility

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

Driving and using machines

You may find that your vision is blurred after you put the eye drops into your eyes. Do not drive or use machinery until your vision is completely normal.

3. HOW TO USE CHLORAMPHENICOL

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults, children aged 2 years and over and elderly

The label will tell you how many drops to use and how often to use them. The usual treatment is one or two drops every two hours at first, but less frequently as the infection becomes controlled. You should carry on using the drops for at least 48 hours after the eye appears normal. The correct way to put eye drops into your eye is as follows.

•    first, wash your hands.

•    twist off the protective cap from the bottle.

•    tilt your head backwards.

•    pull your bottom eyelid downwards to make a pocket.

•    hold the bottle in your other hand between your thumb and first finger, with the tip close to your bottom eyelid.

•    squeeze the bottle gently until one drop of the solution falls into your eye.

•    blink a few times to spread the eye drop.

•    repeat the process with the other eye if you need to treat both eyes.

•    do not breathe on or touch the dropper nozzle and do not let the dropper touch the eye.

•    put the cap back on the bottle.

•    wash your hands again.

Close the bottle tightly after you have used your eye drops. Use your eye drops for as long as your doctor has told you to but do not carry on using them longer than this.

Use in children and adolescents:

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 1014 days.

If you forget to use Chloramphenicol

If you forget to use your drops at the right time, use them as soon as you remember. However, if it is almost time for the next dose, wait until then and then carry on as before.

If you use more Chloramphenicol than you should

If you use too many eye drops, rinse your eyes with clean water. Contact your nearest hospital casualty department or a doctor for advice if you swallowed the eye drops or if you think a child has swallowed any. Take this leaflet, and any eye drops that are left to show the doctor.

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

4.    POSSIBLE SIDE EFFECTS

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

Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:

• an allergic reaction (difficulty in breathing, closing of the throat, swelling of the lips, tongue, face or hives).

Please tell your doctor if you notice any of the following side effects:

Your eyes may be sensitive to the drops. This may cause transient irritation, burning, itching, dermatitis, stinging or redness when the drops are put in.

Rarely the optic nerve behind the eye can become inflamed, causing blurred vision. Your bone marrow may not produce enough blood forming cells and leukaemia and anaemia may occur very rarely.

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.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE CHLORAMPHENICOL

Keep this medicine out of the sight and reach of children.

You should keep your eye drops between 2°C and 8°C (in a refrigerator) and away from light.

Do not use the eye drops after the ‘use by’ date, after the bottle has been open for a month or if the drops have become cloudy or discoloured. Get a new bottle.

You should take any eye drops that are out of date or which you no longer need back to your pharmacist. These eye drops are only for you. Only a doctor can prescribe them for you. Never give them to anyone else.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Chloramphenicol Eye Drops contain:

Your eye drops are called Chloramphenicol Eye Drops BP. Chloramphenicol is an anti-bacterial agent.

Each bottle contains:

•    10ml of a clear colourless solution containing 0.5% w/v Chloramphenicol Ph Eur (active ingredient); and

•    Borax, boric acid, phenylmercuric nitrate and purified water (inactive ingredients).

Marketing Authorisation Holder and Manufacturer

Your eye drops are made by Medeva Pharma Ltd, Vale of Bardsley, Ashton-under-Lyne, Lancashire OL7 9RR.

The marketing authorisation holder is Teva UK Limited, Eastbourne, BN22 9AG PL 00289/1806

This leaflet was last revised in May 2016