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PACKAGE LEAFLET: INFORMATION FOR THE USER    777151BMP/4J

KLORAFECT 1% w/w EYE OINTMENT

Chloramphenicol

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. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.

•    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.

What is in this leaflet:

1.    What Klorafect Eye Ointment is and what it is used for

2.    What you need to know before you use Klorafect Eye Ointment

3.    How to use Klorafect Eye Ointment

4.    Possible side effects

5.    How to store Klorafect Eye Ointment

6.    Contents of the pack and other information

1. WHAT KLORAFECT EYE OINTMENT IS AND WHAT IT IS USED FOR

It is an eye ointment and each tube contains 4 grams of the medicine. The active ingredient in Klorafect Eye Ointment is chloramphenicol, which is an antibiotic.

Klorafect Eye Ointment is used to treat acute bacterial conjunctivitis, which is an infection of the outer surface of eye that causes redness, discomfort and discharge from the affected eye. Your doctor can provide further advice about these symptoms.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE KLORAFECT EYE OINTMENT

Do not use Klorafect Eye Ointment if you:

•    Are sensitive or allergic to chloramphenicol or any of the ingredients in this product (see Section 6 for more details)

•    Are wearing contact lenses

•    Have previously had problems with your blood (in particular very low numbers of any type of blood cells) after taking chloramphenicol

•    Or anyone in your family, have had blood or bone marrow problems

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Klorafect Eye Ointment if you:

•    Are pregnant or intending to become pregnant

•    Are breast-feeding

•    Are taking other medicines

Before using Klorafect Eye Ointment, please tell your doctor, pharmacist or nurse if you have any other eye disorder. Also, if you are applying any other type of eye drops or eye ointment. Your medicine may affect their action and could alter their effect.

Other medicines and Klorafect Eye Ointment

Tell your doctor or pharmacist if you are using , have recently used or might use any other medicines for any condition, including medicines obtained without any prescription, or if the dose of any of your current medicines is changed.

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. Klorafect Eye Ointment should not be used by pregnant women or women who are breast-feeding unless necessary

Driving and using machines

Do not drive or operate machines if you have blurred vision after using Klorafect Eye Ointment. You should wait until your vision clears before driving or using machines.

3. HOW TO USE KLORAFECT EYE OINTMENT

•    Always use Klorafect Eye Ointment exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

•    Do not wear contact lenses whilst using Klorafect Eye Ointment

•    Do not use the product if the seal is broken.

The recommended dose for adults, children and infants of all age groups is as follows:

About 1cm of ointment to be applied into the affected eye (every three hours or more frequently if required), as directed by your doctor.

You should continue using this ointment for at least 48 hours after your eye has got better.

Apply your ointment in the following way:

1.    Always wash your hands before applying the eye ointment.

2.    Remove the cap.

3.    Take special care that the nozzle of the tube does not touch your eye, the skin around your eye or your fingers.

Continued overleaf

4.    You may use the mirror to help you to see what you are doing.

5.    Place the nozzle of the tube close to your eye and gently pull the lower eyelid downwards and look up.

6.    Squeeze the tube gently and apply about 1cm of ointment to the space between the lower lid and the eye.

7.    Close your eye for a moment.

8.    Where both eyes are to be treated, repeat steps from 3 to 6.

9.    Replace the cap securely after use.

If you use more Klorafect Eye Ointment than you should:

If you accidentally use too much or swallow your ointment, contact your doctor although it is unlikely to cause you any harm.

If you forget to use Klorafect Eye Ointment:

If you forget to take a dose, apply it as soon as possible, but if it is almost time for the next dose then miss the skipped dose and return to your normal dosing schedule.

If you stop using Klorafect Eye Ointment:

Do not stop using this ointment without talking to your doctor first.

If your symptoms are not getting better you should tell your doctor immediately. Chloramphenicol may not work against certain types of infections and other types of bacteria or fungi, which are not killed, may take over from the original infection.

This may seem as if the original infection has not cleared up or has got worse.

Your doctor may want to take blood samples to make sure the chloramphenicol has not affected your blood in any way.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Klorafect Eye Ointment can cause side effects, although not everybody gets them.

Stop using Klorafect Eye Ointment and immediately contact your doctor if

you get any of the following symptoms (general allergic reaction):

•    Breathing problems

•    Fever

•    Swelling of the face, lips or tongue

•    Rash with swelling of the skin Or, very rarely,

•    Bruising, bleeding, infections and weakness (symptoms of blood disorder)

As with other eye preparations, you may occasionally experience eye burning, stinging, sensitivity or visual blurring after initial application. If this persists or increases, stop using the ointment and contact your doctor or pharmacist immediately.

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 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 KLORAFECT EYE OINTMENT

Keep out of the reach and sight of children.

Do not store the tube at a temperature above 25"C.

Do not use this medicine for longer than 28 days after first opening the tube even if the tube is not empty.

Do not use Klorafect Eye Ointment after the expiry date which is stated on the tube and on the carton the tube is packed in.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Klorafect Eye Ointment contains

The active substance in Klorafect Eye Ointment is chloramphenicol 1% w/w which is equivalent to chloramphenicol 10 mg per gram. This product also contains liquid paraffin and white petroleum as excipients.

What Klorafect Eye Ointment looks like and contents of pack

Each tube of Klorafect Eye Ointment contains 4 grams of yellowish-white ointment.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Blumont Pharma Ltd, 23 Moortown Close, Grantham, NG31 9GG United Kingdom Manufacturer:

Tubilux Pharma S.p.A., Via Costarica 20/22, 00071 Pomezia (Rome), Italy PL Number: 31103/0009

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Call 01476 978568 for help.

This leaflet was last revised in 08/2015

777151BMP/4J

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