Medine.co.uk

Chloramphenicol 1%W/W Eye Ointment

Document: leaflet OPTREX_PL 18956-0009 change

Area riservata cod. deca Reserved area for deca code



RB204J35 CREAMS

BACTERIAL CONJUNCTIVITIS 1 % W/W EYE OINTMENT

_ Chbmmphen[coL


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

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.

•    Ask your 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.

•    You must talk to a doctor if you do not feel better or if you feel worse after 48 hours.


What is in this leaflet

1.    What Optrex Bacterial Conjunctivitis i% w/w Eye Ointment is and what it is used for

2.    What you need to know before you use Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

3.    How to use Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

4.    Possible side effects

5.    How to store Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

6.    Contents of the pack and other information

1.    What Optrex Bacterial Conjunctivitis i% w/w Eye Ointment is and what is it used for

Optrex Bacterial Conjunctivitis i% w/w Eye Ointment is a topical ointment for administration to the eye only. It contains an antibiotic called chloramphenicol and is used to treat bacterial infections that affect the outer surface of the eye.

The most common type of infection in this area is called acute bacterial conjunctivitis. When you have acute bacterial conjunctivitis 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’.

Chloramphenicol eye ointment is 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 and more serious infections.

2.    What you need to know before you use Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

Optrex Bacterial Conjunctivitis i% w/w Eye Ointment is recommended for children over 2 years, adults and the elderly It is recommended that any child below the age of two years with an eye infection should be seen by a doctor.


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 Gn particular with low numbers of blood cells) during previous treatments with chloramphenicol

•    have a family history of blood problems such as low white blood cell, red blood cell or platelet count.

Do not use this product and seek advice from a doctor if

•    your eyesight is affected Goss of sight, reduced vision, blurred vision or halos around lights)

•    you have pain within the eye

•    your eye nas 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 or your eye looks cloudy

•    your eyes are sensitive to light

•    you have (orthinkyou 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. 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 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.

Tell your pharmacist before using this product if you

•    suffer from any other eye problems.

•    are taking any other medicines

Other medicines and Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

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

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant or breastfeeding tell your doctor or pharmacist before usingthis product.

Driving and operating machinery

After using the eye ointment, 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.

Please turn over


BIANCA FRONT PANEL


3.    Howto use Optrex Bacterial Conjunctivitis p%w/w Eye Ointment

Applying the ointment

To be used in the eye(s) only.

I 1. Check the tube seal is not broken before first | using the eye ointment, i 2. Wash and dry your hands | 3. Remove the cap. Take special care that the '    nozzle of the tube does not touch your eye,

I    the skin around your eye or your fingers.

] 4. Use a mirror, this will help you see what you i    are doing

| 5. Place the nozzle of the tube close to your eye. i    Gently pull the lower eyelid downwards and

|    lookup.

] 6. Squeeze the tube gently and apply about 1 cm !    of the ointment to the space between the

]    lower eyelid and the eye.

i 7. Close for a moment | 8. When both eyes are to be treated, repeat 1    steps 5-7.

! 9. Replace the cap securely after use.

VVhilst applying the ointment, do not [• Breathe on or touch the nozzle of the tube '• Touch the eyes or eyelids with the nozzle of the tube

» Share your ointment with anyone else

[For external use only

Dose

The dose is a small amount of ointment (approx |1 cm) to be applied to the affected eye(s) if you are using drops during the day and the ointment at night - apply the ointment at night, |before going to bed.

if you are using just the ointment - apply 3 to 4 Idmesaday.

Length of treatment

[The course of treatment is 5 days. Keep using the ^ye ointment Ibr5 days, do not stop just because you feel better - this could make your condition (vorse.

If your symptoms do not improve within 48 hours,

/consult your doctor. If your symptoms get worse, seek medical advice at once. iDo not use Optrex Bacterial Conjunctivitis i% w/w |Eye Ointment for more than 5 days without consultingyour doctor. Discard any remaining /ointment after the 5 day course of treatment.

(see section 5).

If you forget to use your ointment

Ilf 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 ointment straight away. If it is nearly time (or your next dose, just put in the next dose of ointment at the usual time. Do not take a double [dose to make up for a forgotten dose.

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 jlong - others may only happen after several days of use.

Possible side effects include:

!• alleigic 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. Stop using the i treatment and consult your doctor if you | experience these effects.

•    The use of topical chloramphenicol may I occasionally result in the overgrowth of other non [ susceptible organisms including funghi. If any new i infection appears during treatment you should tell [ your doctor.

•    bluned vision or mild burning or stinging when |

you put the ointment in. These should subside | quickly.    i

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, j 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 mor^ information on the safety of this medicine. '

5.    How to store Optrex Bacterial    [

Conjunctivitis i% w/w Eye Ointment

Replace the cap securely after use. Store below i 25“C.    !

Keep all medicines out of the sight and reach of ; children. Do not use after the ‘use by’ date shown ! on the tube and end of the carton.    [

Discard any unused ointment after completing your 5 day course of treatment    j

Do not throw away any medicines via wastewater 1 or household waste. Ask your pharmacist how to ! throw away medicines you no longer use. These [ measures will help protect the environment.

6. Contentsofthepackandother    ;

information    i

What Optrex Bacterial Conjunctivitis i% w/w Eye ! Ointment contains    [

The active substance is chloramphenicol. One (1) [ gram of ointment contains 10 mg of    '

chloramphenicol. The other ingredients are liquid j paraffin and white petroleum.

What Optrex Bacterial Conjunctivitis i% w/w Eye [ Ointment looks like and contents of the pack '

Each pack contains one tube with 4g of ointment. '

Marketing Authorisation Holder

Medicom Healthcare Ltd., 235 Hunts Pond Road, 1 Titchfield Common, Fareham, Hants    j

PO144PJ.UK

Manufacturer

TUBILUX PHARMAS.PA via Costarica 20/22,

00071 Pomezia (RM), Italy    j

Distributed by    !

Optrex Limited, Slough, SL13UH    [

PL number: 18956/0009    !

Leaflet revised January 2016.

9-COLOP-36-GB-PV1


_EB2Q4435_ CRE_9Q440


VOLTA BACK PANEL



BACTERIAL CONJUNCTIVITIS 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.

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.

•    Ask your 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.

•    You must talk to a doctor if you do not feel better or if you feel worse after 48 hours.


Do not use this product if you

•    are allergic to chloramphenicol or any of the ingredients shown under section 6 “Contents of the packand other information”

•    have ever had problems with your blood (in particular with low numbers of blood cells) during previous treatments with chloramphenicol

•    have a family history of blood problems such as low white blood cell, red blood cell or platelet count.


;What is in this leaflet

il. What Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment is land what it is used for

[2. What you need to know before you use Optrex Bacterial IConjunctivitis 1% w/w Eye Ointment [3. How to use Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment 4. Possible side effects

|5. Howto store Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment [6. Contents of the pack and other information

|1. What Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment is and what is it used for

[Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment is a topical lointment for administration to the eye only. It contains an [antibiotic called chloramphenicol and is used to treat bacterial ■infections that affect the outer surface of the eye.

■The most common type of infection in this area is called acute [bacterial conjunctivitis. When you have acute bacterial [conjunctivitis the white part of one or both of your eyes will be red land /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’.

'Chloramphenicol eye ointment is 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 and more serious [infections.


Do not use this product and seek advice from a doctor if

•    your eyesight is affected floss 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 or your eye looks cloudy

•    your eyes are sensitive to light

•    you have (or thinkyou 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. 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 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 eyesuigeryorlasertreatment in the last 6 months.


Tell your pharmacist before using this product if you

•    suffer from any other eye problems.

•    are taking any other medicines


Other medicines and Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

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



Pharmacode Reads This Way


2. What you need to know before you use Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

Optrex Bacterial Conjunctivitis i% w/w Eye Ointment is recommended for children over 2years, adults and the elderly It is recommended that any child below the age of two years with an eye infection should be seen by a doctor.


If you are pregnant, planning to become pregnant or breastfeeding tell your doctor or pharmacist before using this product

Driving and operating machinery

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


3. How to use Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment [Applying the ointment

[To be used in the eye (s) only.

' 1. Check the tube seal is not broken before first using the eye [    ointment.

[ 2. Wash and dry your hands 1 3. Remove the cap. Take special care that the nozzle of the [    tube does not touch your eye, the skin around your eye or

your fingers.

[ 4. Use a mirror, this will help you see what you are doing ] 5. Place the nozzle of the tube close to your eye. Gently pull [    the lower eyelid downwards and look up.

[ 6. Squeeze the tube gently and apply about 1 cm of the i ointment to the space between the lower eyelid and the eye. [ 7. Close for a moment

' 8. When both eyes are to be treated, repeat steps 5-7.

! 9. Replace the cap securely after use.

[Whilst applying the ointment, do not

[• Breathe on or touch the nozzle of the tube

'• Touch the eyes or eyelids with the nozzle of the tube

[•Share your ointment with anyone else

[For external use only

[Dose

[The dose is a small amount of ointment (approx 1 cm) to be applied to the affected eye(s)

[If you are using drops during the day and the ointment at night -apply the ointment at night, before going to bed.

[if you are using just the ointment - apply 3 to 4 times a day [Length of treatment

The course of treatment is 5 days. Keep using the eye ointment [for S 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. iDo not use Optrex Bacterial Conjunctivitis i% w/w Eye Ointment [for more than 5 days without consulting your doctor. Discard any 'remaining ointment after the 5 day course of treatment.

[(see section 5).

[If you forget to use your ointment

jlf you have only just missed a dose and it is a longtime before [the next dose is due, put in the missed dose of ointment straight [away. If it is nearly time for your next dose, just put in the next idose of ointment at the usual time. Do not take a double dose to [make up for a forgotten dose.

l4. Possible side effects iLike 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 ■ others may only happen after several days of use. [Possible side effects include:

[• allergic reactions such as itching or rashes. If you get a severe 'reaction, with swelling or breathing problems get medical help [straightaway.

•    changes in the blood (anaemia) leading to severe tiredness or easy biuising. Stop using the treatment and consult your doctor if you experience these effects.

•    The use of topical chloramphenicol may occasionally result in the overgrowth of other non susceptible organisms including funghi. If any new infection appears during treatment you should tell your doctor.

•    blurred vision or mild bumingor stinging when you put the

ointment in. These should subside quickly.

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, 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 Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

Replace the cap securely after use. Store below 25°C.

Keep all medicines out of the sight and reach of children. Do not use after the ‘use by1 date shown on the tube and end of the carton.

Discard any unused ointment after completing your 5 day course of treatment

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

6.    Contents ofthe packand other information

What Optrex Bacterial Conjunctivitis i% w/w Eye Ointment contains

The active substance is chloramphenicol. One (1) gram of ointment contains 10 mg of chloramphenicol. The other ingredients are liquid paraffin and white petroleum.

What Optrex Bacterial Conjunctivitis i% w/w Eye Ointment looks like and contents ofthe pack

Each pack contains one tube with 4g of ointment.

Marketing Authorisation Holder

Medicom Healthcare Ltd., 235 Hunts Pond Road,

Titchfield Common, Fareham, Hants PO144PJ.UK

Manufacturer

Excelvision, 27, Rue de la Lombardiere, BP 131,07100 Annonay, France

Distributed by

Optrex Limited, Slough, SLi 3UH PL number: 18956/0009 Leaflet revised January 2016.

1-COLOP-36-GB-PV2



II



"8249303 777131MED0571K

BACTERIAL CONJUNCTIVITIS 1 % W/W EYE OINTMENT

_ Chlommphenicol.



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.

•    Ask your 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.

•    You must talk to a doctor if you do not feel better or if you feel worse after 48 hours.


What is in this leaflet

]1. What Optrex Bacterial Conjunctivitis 1% w/w Eye

lOintment is and what it is used for

[2. What you need to know before you use Optrex

'Bacterial Conjunctivitis 1% w/w Eye Ointment

[3. How to use Optrex Bacterial Conjunctivitis 1%

jw/w Eye Ointment

'A. Possible side effects

|5. How to store Optrex Bacterial Conjunctivitis 1% iw/w Eye Ointment

[6. Contents of the pack and other information

'l. What Optrex Bacterial Conjunctivitis 1% [w/w Eye Ointment is and what is it used for

jOptrex Bacterial Conjunctivitis 1% w/w Eye [Ointment is a topical ointment for administration to ithe eye only. It contains an antibiotic called [chloramphenicol and is used to treat bacterial 'infections that affect the outer surface of the eye.

'The most common type of infection in this area is leaded acute bacterial conjunctivitis. When you [have acute bacterial conjunctivitis the white part of lone 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’.

[Chloramphenicol eye ointment is 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 and more serious 'infections.

[2. What you need to know before you use [Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

[Optrex Bacterial Conjunctivitis i% w/w Eye [Ointment is recommended for children over 2 years, adults and the elderty.

[It is recommended that any child below the age of [two years with an eye infection should be seen by [a doctor.


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 On particular with low numbers of blood cells) during previous treatments with chloramphenicol

•    have a family history of blood problems such as low white blood cell, red blood cell or platelet count.

Do not use this product and seek advice from a doctor if

•    your eyesight is affected floss 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 or your eye 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. 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 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.

Tell your pharmacist before using this product if you

•    suffer from any other eye problems.

•    are taking any other medicines

Other medicines and Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

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

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant

or breastfeeding tell your doctor or pharmacist

before using this product

Driving and operating machinery

After using the eye ointment you may temporarily

get blurred vision. Do not drive or operate

machinery untilyourvision is clear.

If in doubt, talk to your pharmacist or doctor.

_ _P!ease turn over


3. Howto use Optrex Bacterial Conjunctivitis ji%w/w Eye Ointment Applying the ointment

|To be used in the eye(s) only, i 1. Check the tube seal is not broken before first !    using the eye ointment.

1 2. Wash and dry your hands ! 3. Remove the cap. Take special care that the |    nozzle of the tube does not touch your eye,

the skin around your eye or your fingers.

| 4. Use a mirror, this will help you see what you '    are doing

I 5. Place the nozzle of the tube close to your eye.

| Gently pull the lower eyelid downwards and !    lookup.

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

1 7. Close for a moment ! 8. When both eyes are to be treated, repeat |    steps 5-7.

i 9. Replace the cap securely after use.

Iwhilst applying the ointment, do not !• Breathe on or touch the nozzle of the tube ;• Touch the eyes or eyelids with the nozzle of the Itube

j» Share your ointment with anyone else

jFor external use only

jDose

The dose is a small amount of ointment (approx !l cm) to be applied to the affected eye(s) jlfyou are using drops during the day and the ointment at night - apply the ointment at night, [before going to bed.

jlfyou are using just the ointment - apply 3 to 4 [times a day. jLength of treatment

The course of treatment is 5 days. Keep using the jeye ointment Ibr5 days, do not stop just because you feel better - this could make your condition iworse.

jlf your symptoms do not improve within 48 hours,

.consult your doctor. If your symptoms get worse, jseek medical advice at once.

.Do not use Optrex Bacterial Conjunctivitis i% w/w |Eye Ointment for more than 5 days without jconsultingyour doctor. Discard any remaining iointment after the 5 day course of treatment. j(see section 5).

jlfyou forget to use your ointment

.If you have only just missed a dose and it is a long jtime before the next dose is due, put in the missed 'dose of ointment straight away. If it is nearly time ifor your next dose, just put in the next dose of jointment at the usual time. Do not take a double .dose to make up for a forgotten dose.

j4. Possible side effects

jLike all medicines, this medicine can cause side .effects, although not everybody gets them. Some jpeople may get one or more of these side effects. .Some effects happen straight away but do not last jlong - others may only happen after several days of juse.

'Possible side effects include:

!• allergic reactions such as itching or rashes. If you jget a severe reaction, with swelling or breathing 'problems get medical help straight away.


•    changes in the blood (anaemia) leading to severe j

tiredness or easy bruising. Stop using the treatment and consult your doctor if you    j

experience these effects.    .

• The use of topical chloramphenicol may    !

occasionally result in the overgrowth of other non j susceptible organisms including fonghi. If any new! infection appears during treatment you should tell j your doctor.    .

•    blurred vision or mild burning or stinging when j

you put the ointment in. These should subside 1 quickly.    !

If you do not feel well or are worried about your    j

health, talk to a pharmacist or doctor.    .

If any of the side effects get serious or if you    j

experience any side effect not listed in this leaflet ' please tell your doctor or pharmacist.    !

Reporting of side effects    j

If you get any side effects, talk to your doctor,    j

pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also j report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard    !

By reporting side effects you can help provide morej information on the safety of this medicine.

5.    How to store Optrex Bacterial    j

Conjunctivitis i% w/w Eye Ointment    .

Replace the cap securely after use. Store below    !

25“C.    j

Keep all medicines out of the sight and reach of    '

children. Do not use after the ‘use by’ date shown ! on the tube and end of the carton.    j

Discard any unused ointment after completing your! 5 day course of treatment    j

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

6.    Contents of the pack and other

information    !

What Optrex Bacterial Conjunctivitis i% w/w Eye I Ointment contains    j

The active substance is chloramphenicol. One (1) j gram of ointment contains 10 mg of    .

chloramphenicol. The other ingredients are liquid j paraffin and white petroleum.    '

What Optrex Bacterial Conjunctivitis i% w/w Eye j Ointment looks like and contents of the pack

Each pack contains one tube with 4g of ointment. !

Marketing Authorisation Holder

Medicom Healthcare Ltd., 235 Hunts Pond Road, ! Titchfield Common, Fareham, Hants    j

PO144PJ.UK

Manufacturer    1

TUBILUX PHARMAS.PA via Costarica 20/22,    !

00071 Pomezia (RM), Italy    j

Distributed by    I

Optrex Limited, Slough, SL13UH    j

PL number: 18956/0009

Leaflet revised January 2016.

9-COLOP-36-GB-PV1    !


8249605.777] 5] MED05/1k!



BACTERIAL CONJUNCTIVITIS 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.

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.

•    Ask your 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.

•    You must talk to a doctor if you do not feel better or if you feel worse after 48 hours.


Do not use this product if you

•    are allergic to chloramphenicol or any of the ingredients shown under section 6 “Contents of the packand other information”

•    have ever had problems with your blood (in particular with low numbers of blood cells) during previous treatments with chloramphenicol

•    have a family history of blood problems such as low white blood cell, red blood cell or platelet count.


;What is in this leaflet

il. What Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment is land what it is used for

[2. What you need to know before you use Optrex Bacterial IConjunctivitis 1% w/w Eye Ointment [3. How to use Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment 4. Possible side effects

|5. Howto store Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment [6. Contents of the pack and other information

|1. What Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment is and what is it used for

[Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment is a topical lointment for administration to the eye only. It contains an [antibiotic called chloramphenicol and is used to treat bacterial ■infections that affect the outer surface of the eye.

■The most common type of infection in this area is called acute [bacterial conjunctivitis. When you have acute bacterial [conjunctivitis the white part of one or both of your eyes will be red land /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’.

'Chloramphenicol eye ointment is 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 and more serious [infections.


Do not use this product and seek advice from a doctor if

•    your eyesight is affected floss 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 or your eye looks cloudy

•    your eyes are sensitive to light

•    you have (or thinkyou 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. 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 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 eyesuigeryorlasertreatment in the last 6 months.


Tell your pharmacist before using this product if you

•    suffer from any other eye problems.

•    are taking any other medicines


Other medicines and Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

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



Pharmacode Reads This Way


2. What you need to know before you use Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

Optrex Bacterial Conjunctivitis i% w/w Eye Ointment is recommended for children over 2years, adults and the elderly It is recommended that any child below the age of two years with an eye infection should be seen by a doctor.


If you are pregnant, planning to become pregnant or breastfeeding tell your doctor or pharmacist before using this product

Driving and operating machinery

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


3. How to use Optrex Bacterial Conjunctivitis 1% w/w Eye Ointment [Applying the ointment

[To be used in the eye (s) only.

' 1. Check the tube seal is not broken before first using the eye [    ointment.

[ 2. Wash and dry your hands 1 3. Remove the cap. Take special care that the nozzle of the [    tube does not touch your eye, the skin around your eye or

your fingers.

[ 4. Use a mirror, this will help you see what you are doing ] 5. Place the nozzle of the tube close to your eye. Gently pull [    the lower eyelid downwards and look up.

[ 6. Squeeze the tube gently and apply about 1 cm of the i ointment to the space between the lower eyelid and the eye. [ 7. Close for a moment

' 8. When both eyes are to be treated, repeat steps 5-7.

! 9. Replace the cap securely after use.

[Whilst applying the ointment, do not

[• Breathe on or touch the nozzle of the tube

'• Touch the eyes or eyelids with the nozzle of the tube

[•Share your ointment with anyone else

[For external use only

[Dose

[The dose is a small amount of ointment (approx 1 cm) to be applied to the affected eye(s)

[If you are using drops during the day and the ointment at night -apply the ointment at night, before going to bed.

[if you are using just the ointment - apply 3 to 4 times a day [Length of treatment

The course of treatment is 5 days. Keep using the eye ointment [for S 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. iDo not use Optrex Bacterial Conjunctivitis i% w/w Eye Ointment [for more than 5 days without consulting your doctor. Discard any 'remaining ointment after the 5 day course of treatment.

[(see section 5).

[If you forget to use your ointment

jlf you have only just missed a dose and it is a longtime before [the next dose is due, put in the missed dose of ointment straight [away. If it is nearly time for your next dose, just put in the next idose of ointment at the usual time. Do not take a double dose to [make up for a forgotten dose.

l4. Possible side effects iLike 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 ■ others may only happen after several days of use. [Possible side effects include:

[• allergic reactions such as itching or rashes. If you get a severe 'reaction, with swelling or breathing problems get medical help [straightaway.

•    changes in the blood (anaemia) leading to severe tiredness or easy biuising. Stop using the treatment and consult your doctor if you experience these effects.

•    The use of topical chloramphenicol may occasionally result in the overgrowth of other non susceptible organisms including funghi. If any new infection appears during treatment you should tell your doctor.

•    blurred vision or mild bumingor stinging when you put the

ointment in. These should subside quickly.

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, 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 Optrex Bacterial Conjunctivitis i% w/w Eye Ointment

Replace the cap securely after use. Store below 25°C.

Keep all medicines out of the sight and reach of children. Do not use after the ‘use by1 date shown on the tube and end of the carton.

Discard any unused ointment after completing your 5 day course of treatment

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

6.    Contents ofthe packand other information

What Optrex Bacterial Conjunctivitis i% w/w Eye Ointment contains

The active substance is chloramphenicol. One (1) gram of ointment contains 10 mg of chloramphenicol. The other ingredients are liquid paraffin and white petroleum.

What Optrex Bacterial Conjunctivitis i% w/w Eye Ointment looks like and contents ofthe pack

Each pack contains one tube with 4g of ointment.

Marketing Authorisation Holder

Medicom Healthcare Ltd., 235 Hunts Pond Road,

Titchfield Common, Fareham, Hants PO144PJ.UK

Manufacturer

Excelvision, 27, Rue de la Lombardiere, BP 131,07100 Annonay, France

Distributed by

Optrex Limited, Slough, SLi 3UH PL number: 18956/0009 Leaflet revised January 2016.

1-COLOP-36-GB-PV2



1B76087 £RE 90440'