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Boots Infected Eyes 1% W/W Eye Ointment

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Document: leaflet BOOTS_PL 31103-0018 change

: PACKAGE LEAFLET: INFORMATION FOR THE USER ;

i    l

INFECTED EYES 1% w/w Eye Ointment (Chloramphenicol)



ReacTairof this leaflet carefully ~ before you start using this jmedicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your pharmacist has told you.

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

]• Ask your pharmacist if you need i more information or advice.

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

» You must talk to a doctor if you do | not feel better after 5 days or if you 1 feel worse at any time.

'In this leaflet you will find the following information:

[1. What your medicine is and what it i is used for

[2. Before you use your medicine

5.    How to use your medicine |4. Possible side effects

6.    How to store your medicine

[6. Contents of the pack and other | information


1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR


ilt is an eye ointment and each tube Contains 4 grams of the medicine. The active ingredient in this ointment is Chloramphenicol, which is an antibiotic (medicines used for infections caused py bacteria).

This ointment is used to treat acute bacterial conjunctivitis, which is an infection of the outer surface of the bye that causes redness, discomfort and discharge from the affected eye. however, this ointment is not suitable [for treating severe infections that have spread to the deeper layers of the eye.

This ointment is suitable for use in [children, adults and the elderly.


2. BEFORE YOU USE YOUR MEDICINE


[Do not use this ointment if:

* You are allergic to chloramphenicol [ or any of the other ingredients of 1 this medicine (listed in Section 6 for ! more details)

'• You or anyone in your family has i had blood problems such as a low [ white blood cell, red blood cell or i platelet count.


Warnings and-Precautions    i

Do not use this ointment and seek advice from a doctor if    i

•    Your eye sight is affected, for [ example, reduced or blurred vision i

•    You have pain within the eye [

•    Your eyes are sensitive to light i

•    Your eye is inflamed and you have a [

rash on the scalp or face    1

•    Your eye looks cloudy    [

•    The pupil of your eye looks unusual 1

•    You have or think you may have a !

foreign body in the eye    1

•    You have recently had an eye . infection

•    You have or have had glaucoma i

(raised pressure in the eye) or dry [ eyes    i

•    You have had eye surgery or laser j treatment in the last 6 months '

•    Your eye has had an injury    [

•    You are using any eye drops or eye 1

ointment    !

•    You wear contact lenses. If you 1

have been advised to use this ! ointment, do not wear your lenses [ during the course of treatment. Soft i contact lenses should not be    [

replaced for 24 hours after    i

completing the treatment.    [

•    Before using this ointment, tell your i

pharmacist if you suffer from any    [

other eye problems.    1

Other medicines and Infected Eyes 1 % w/w Eye Ointment    [

Tell your doctor or pharmacist if you ' are taking, have recently taken or might take any other medicines.    1

Do not use this ointment if you are    !

taking bone marrow depressant drugs1 (drugs which reduce bone marrow    .

activity resulting in low blood cell    [

counts) such as azathioprine or    i

receiving chemotherapy.    [

Pregnancy and breast-feeding    [

If you are pregnant or breast-feeding, ' think you may be pregnant or planning! to have a baby, ask your doctor or    1

pharmacist for advice before using this! ointment.

Driving and using machines    !

Do not drive or operate machines if i you have blurred vision after using this! ointment. You should wait until your i vision clears before driving or using    ]

machines.    '


3. HOWTO USE YOUR MEDICINE


•    Always use this ointment exactly as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    Use only in the eye, do not take it by mouth. The contents are sterile until the seal is broken. Do not use if the seal is broken before first opening.


Dose-

Children, adults and the elderly:

[The dose is about 1 cm of ointment to be put in the affected eye(s).

[If using just the eye ointment, use it 3 to 4 times a day.

[If using eye drops during the day and the ointment at night - put the Ointment in just before going to bed.

!rhe course of treatment is 5 days; so, keep using the ointment for 5 days even if you feel better.

'It may be necessary to adjust the dose for newborn infants as, due to their immature metabolism, they may be at risk of dose-related adverse effects. 'Please seek advice from your doctor or pharmacist before using this medicine pn a newborn infant.

(Jse your ointment in the following way:

!1. Always wash and dry your hands ' before you put the eye ointment in ! the eye.

2.    Remove the cap.

3.    Take special care that the nozzle of [ the tube does not touch your eye,

i the skin around your eye or your [ fingers.

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

6.    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 put ' about 1 cm of ointment in the space ! between the lower lid and the eye.

7.    Close your eye for a moment.

l8. Where both eyes are to be treated,

[ repeat steps from 3 to 7.

0. Replace the cap securely after use.

Do not

!• Use this ointment for more than ' 5 days without consulting your doctor !• Share your ointment with anyone [ else

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

If you forget to use a dose of this ointment, put it in as soon as possible, but if it is almost time for the next dose then miss the skipped dose fcnd return to your normal dosing schedule. Do not use a double dose fo make up for a missed dose.

!ralk to your doctor if your eyes do not jmprove within 48 hours.

[If your symptoms get worse seek medical advice immediately.

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


As with other eye preparations, you may occasionally experience eye burning, stinging, sensitivity or visual blurring after initial application. If this continues or increases, stop using the ointment.

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.

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


5. HOW TO STORE YOUR MEDICINE


Keep out of the sight and reach of i children.    '

Do not store the tube above 25°C.    [

Do not use this ointment after the [ expiry date which is stated on the tube and the carton.    [

After 5 days throw away any eye [ ointment left. Medicines should not be i disposed of via wastewater or    [

household waste. Ask your    i

pharmacist how to dispose of    [

medicines that are no longer required.i These measures will help to protect [ the environment.    '


6. CONTENTS OF THE PACK AND OTHER INFORMATION


ARTWORK TEXT SIZE


ARTWORK ONLY


4. POSSIBLE SIDE EFFECTS


Like all medicines, this ointment can pause side effects, although not everybody gets them.

Stop using this ointment and immediately contact your doctor

jf you get any of the following symptoms (general allergic reaction): joreathing problems, fever, swelling of the face, lips or tongue or rash with pwelling of the skin.

Pr, very rarely, bruising, bleeding, infections and weakness (symptoms pf blood disorder).


The active ingredient in Infected Eyes 1 % w/w 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.

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

Marketing Authorisation Holder:

Blumont Pharma Ltd.

23 Moortown Close, Grantham,

United Kingdom NG31 9GG

Manufacturer:

Tubilux Pharma, Via Costarica 20/22, 00071 Pomezia (Rome), Italy

Distributor:

The Boots Company PLC,

Nottingham, NG2 3AA

PL Number: 31103/0018

This leaflet was last revised in 08/2016

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Infected Eyes 1 % w/w Eye Ointment Reference number: 31103/0018 This is a service provided by the Royal National Institute of Blind People.


Main Headings: Sub Headings: Body Copy:

PACK MOCK LIP

Product Name: Infected Eyes 1% w/w Eye Ointment

Product Licence No.: 31103/0018

WordingRef: Intemally approved dated v1 14/04/2016

Status: Internally approved

Pack Details: Pre-printed collapsible aluminium tube with

integral nozzle and a tamper evident membrane. Polyethylene closure. Each tube is packed into a carton

Pack Size: 4g

Version No.

Date Issued

Reason For Change


Category:

Healthcare

Sub-Category:

Eye Care

Brand:

Core

Pack Type:

Leaflet

Variant:

Infected Eyes 1% w/w Eye Ointment 4g

Action:

E

Date:

15/08/16

Country:

UK

Component Code:

N/A

Item Code:

18-25-410

CAD Ref No:

120 mm width x 276 mm height

Printer:

Substrate:

White Paper

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: N/A

(smallest bar)

Edgemark Position:

n/a

Pharmacode No/NE:

Technical ft Non Printing Items Cutter | Guides


Colours

PANTONE 280 C

1


STUDIO USE ONLY    v1.0