Chloramphenicol 0.5% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chloramphenicol

Available from:

Teva 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; GTIN: 5016192135319

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 0.5% Eye Drops
Vistaphenicol 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
Clear, colourless to slightly yellow solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chloramphenicol is a broad spectrum bacteriostatic antibiotic. It is
active
against a wide range of Gram-negative and Gram-positive organisms,
including Salmonella typhi, Haemophilus influenzae, Neisseria
meningitidis,
Streptococcus pneumoniae and Bacteroides fragilis. It has
antirickettsial and
antichlamydial activity. It is indicated for the topical treatment of
superficial
ocular infections caused by pathogens which are sensitive to it.
Chloramphenicol is indicated in adults and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (and the elderly) and children
One or two drops applied to each affected eye up to six times daily or
more
frequently if required. (Severe infections may require one to two
drops every
fifteen to twenty minutes initially, reducing the frequency of
instillation
gradually as the infection is controlled).
Paediatric population
Dosage adjustment may be necessary in newborn infants because of
reduced
systemic elimination due to immature metabolism and the risk of
dose-related
adverse effects. The maximum duration of treatment is 10-14 days.
Method of administration
For topical ocular use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
•
Myelosuprresssion during previous exposure to chloramphenicol.
•
Known personal or family history of blood dyscrasias including
aplastic anaemia
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Chloramphenicol is absorbed systemically from the eye and toxicity has
been
reported following chronic exposure.
Bone marrow hypoplasia, including aplastic anaemia and death, has been
reported following topical use of ch