Chloramphenicol Antibiotic 0.5% eye drops

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Chloramphenicol

Disponibbli minn:

Numark Ltd

Kodiċi ATC:

S01AA01

INN (Isem Internazzjonali):

Chloramphenicol

Dożaġġ:

5mg/1ml

Għamla farmaċewtika:

Eye drops

Rotta amministrattiva:

Ocular

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 11030100; GTIN: 5010441012352

Fuljett ta 'informazzjoni

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 Chloramphenicol Eye Drops are and what they
are used for
2. What you need to know before you use
Chloramphenicol Eye Drops
3. How to use Chloramphenicol Eye Drops
4. Possible side effects
5. How to store Chloramphenicol Eye Drops
6. Contents of the pack and other information
1.
WHAT CHLORAMPHENICOL EYE DROPS ARE
AND WHAT THEY ARE USED FOR
Chloramphenicol Eye Drops contain an antibiotic called
chloramphenicol. It is used 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 ‘gritty’ or ‘irritated’.
Chloramphenicol 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 CHLORAMPHENICOL EYE DROPS
Chloramphenicol 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 be seen by a doctor.
DO NOT USE THIS PRODUCT IF YOU:
• are ALLERGIC TO CHLO

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 0.5% w/v Antibiotic Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 0.5% w/v
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Eye Drops, solution
Clear, colourless to slightly yellow solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chloramphenicol is broad spectrum antibiotic indicated in both adults
and children
aged 2 years and over for the treatment of acute bacterial
conjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (including the elderly) and children aged 2 years and over:
•
Put one drop into the affected eye(s) every 2 hours for the first 48
hours and 4
hourly thereafter.
•
To be used during waking hours only
•
The course of treatment should be 5 days.
Method of administration
For ocular use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1
•
Myelosuppression during previous exposure to chloramphenicol.
•
Family or personal history of blood dyscrasias including aplastic
anaemia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Chloramphenicol is absorbed systemically from the eye and systemic
toxicity has
been reported (see section 4.8).
In severe bacterial conjunctivitis and in cases where infection is not
confined to the
conjunctivae,
the
topical
use
of
chloramphenicol
should
be
supplemented
by
appropriate systemic treatment. Therefore, the patient should be
referred to seek
medical advice.
Prolonged use of chloramphenicol eye drops is not advisable. Prolonged
or frequent
intermittent topical application of chloramphenicol should be avoided
since it may
increase the likelihood of sensitisation and emergence of resistant
organisms.
Do not use for more than 5 days without consulting your doctor.
The use of topical chloramphenicol may occasionally result in
overgrowth of
non-susceptible organisms including fungi. If any new infection
appears
during treatment, the patient shoul