Chloramphenicol 1% eye ointment

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Chloramphenicol

Saatavilla:

Martindale Pharmaceuticals Ltd

ATC-koodi:

S01AA01

INN (Kansainvälinen yleisnimi):

Chloramphenicol

Annos:

10mg/1gram

Lääkemuoto:

Eye ointment

Antoreitti:

Ocular

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 11030100; GTIN: 5014124334021

Pakkausseloste

CHLORAMPHENICOL 1%W/W EYE OINTMENT
WHAT IS IN THIS LEAFLET:
1. What Chloramphenicol Eye Ointment is and
what it is used for
2. What you need to know before you use
Chloramphenicol Eye Ointment
3. How to use Chloramphenicol Eye Ointment
4. Possible side effects
5. How to store Chloramphenicol Eye Ointment
6. Contents of the pack and other information
1. WHAT CHLORAMPHENICOL EYE OINTMENT
IS AND WHAT IT IS USED FOR
Chloramphenicol belongs to a group of medicines
called antibiotics.
An antibiotic is a medicine which is used for the
treatment of a variety of infections caused by
bacteria.
Chloramphenicol Eye Ointment is used in both
adults and children for the treatment of eye
infections caused by bacteria.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE CHLORAMPHENICOL EYE OINTMENT
DO NOT USE CHLORAMPHENICOL EYE OINTMENT IF:
• if you are allergic to chloramphenicol or any of
the other ingredients of this medicine listed in
section 6
• you or a member of your family has had problems
with their blood or bone marrow. These problems
can include a severe reduction in red blood cells
or lower than normal blood count
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Chloramphenicol Eye Ointment if:
• you have visual disturbances
• you have severe pain in the eye
• you are sensitive to light
• your eye is inflamed and you have a rash on the
scalp or face
• your eye looks cloudy
• your black or coloured part of the eye looks
unusual
• you have a foreign body in the eye
• you have an eye infection that keeps coming
back
• you have glaucoma (raised pressure in the eye)
• you have dry eyes
• you have eye injury or eye surgery
• you are currently using any other eye drops or
eye ointment
OTHER MEDICINES AND CHLORAMPHENICOL
EYE OINTMENT
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking any of
the following:
• medicines for cancer such as methotrexate
• medicines for the immune syste

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 1%w/w Eye Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 1% w/w
For the full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Sterile Eye Ointment
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, including the elderly and children
The eye ointment is to be applied every 3 hours or more frequently, if
required. Alternatively, the ointment may be applied at night with
appropriate
eye drops used during the day.
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. A thin line of ointment to be placed along the
inside of
the lower eye lid.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to chloramphenicol or to any of the excipients listed
in
section 6.1.
•
Patients with a 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
chloramphenicol.
Whilst the hazard is a rare one, it should be borne in mind when
assessing the benefits
expected from