Chloramphenicol 0.5% eye drops
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
06-09-2019
Summary of Product characteristics
(SPC)
06-09-2019
Public Assessment Report
(PAR)
20-04-2020
Active ingredient:
Chloramphenicol
Available from:
Kent Pharma (UK) Ltd
ATC code:
S01AA01
INN (International Name):
Chloramphenicol
Dosage:
5mg/1ml
Pharmaceutical form:
Eye drops
Administration route:
Ocular
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 11030100
Patient Information leaflet
INFORMATION FOR THE USER
CHLORAMPHENICOL 0.5% W/V EYE DROPS
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription to treat bacterial
conjunctivitis. However, you
still need to use it carefully to get the best results from it.
Keep this leaflet, you may need to read it again
Ask your pharmacist if you need more information or advice
You must contact a pharmacist or doctor if your symptoms worsen at
anytime, or do not
improve after 48 hours
WHAT THIS MEDICINE IS FOR
This medicine contains chloramphenicol, an antibiotic, which acts to
treat bacterial
infections.
It can be used for the treatment of acute bacterial conjunctivitis.
Conjunctivitis is an infection
of the lining that covers the front of the eye. When you have
bacterial conjunctivitis the white
part of one or both of your eyes will be red and/or your eyelids will
be red and swollen.
There will be a sticky discharge from the eye, which may make it hard
to open your eye
when you wake up, and your eye may feel “gritty” or
“irritated”.
These eye drops are not suitable for treating serious eye infections
(see “!Talk to your
doctor”).
BEFORE YOU USE THIS MEDICINE
This medicine can be used by adults and children aged 2 years and
over. However, some
people should not use this medicine or should seek the advice of their
pharmacist or doctor
first.
X
DO NOT USE:
IF YOU ARE ALLERGIC TO chloramphenicol or any of the ingredients
IF YOU HAVE EVER HAD PROBLEMS WITH YOUR BONE MARROW OR BLOOD when
using
chloramphenicol in the past (this includes capsules, injections and
eye drops) – your doctor
will have told you this
IF YOU HAVE A FAMILY HISTORY OF BLOOD “DYSCRASIAS” – a condition
which can cause
problems such as tiredness, fatigue, unusual bruising, or an increase
in the number of
infections that you get
IF YOU ARE PREGNANT OR BREASTFEEDING, unless your doctor tells you to
!
TALK TO YOUR DOCTOR:
If you have any of the following symptoms of a
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Boots Pharmacy Antibiotic Eye Drops
Boots Infected Eyes 0.5% w/v Eye Drops
Almus Chloramphenicol 0.5% w/v Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 0.5% w/v
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Eye drops, solution (Eye Drops). A clear, slightly yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute bacterial conjunctivitis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION ADULTS, CHILDREN AGED 2 YEARS AND OVER AND THE ELDERLY
One drop to be instilled into the infected eye every two hours for the
first 48
hours, and then every 4 hours thereafter. To be used during waking
hours only.
Treatment should continue for 5 days even if symptoms improve.
For ocular use.
4.3
CONTRAINDICATIONS
Chloramphenicol eye drops must not be administered to:
•
Patients who have a history of hypersensitivity to chloramphenicol or
to
any other ingredient of the drops
•
Patients who have experienced myelosuppression during previous
exposure to chloramphenicol
•
Patients with a family history of blood dyscrasias
4.4
SPECIAL WARNING 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.
The use of topical chloramphenicol may occasionally result in
overgrowth on
non-susceptible organisms including fungi. If any new infection
appears
during treatment, the patient should be referred to the doctor.
Patients should be referred to a doctor if any of the following apply:
•
Disturbed vision
•
Severe pain within the eye
•
Photophobia
•
Eye inflammation associated with a rash on the scalp or face
•
The eye looks cloudy
•
The pupil looks unusual
•
Suspected foreign body i
Read the complete document
