Minims Chloramphenicol 0.5% Eye Drops, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chloramphenicol

Available from:

Bausch Health Ireland Limited

ATC code:

S01AA; S01AA01

INN (International Name):

Chloramphenicol

Dosage:

0.5 percent

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Antibiotics; chloramphenicol

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

Minims ® Chloramphenicol 0.5
Eye Drops, solution
Chloramphenicol
Read all this leaflet carefully before you start using your medicine. It contains a summary of the
information available on your medicine.
If you have any questions or are not sure about any thing, ask your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone else.
In this leaflet:
1. What Minims ® Chloramphenicol eye drops are and what they are used for
2. Before y ou use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information
1. What Minims ® Chloramphenicol eye drops are and what are they used for
Minims ® Chloramphenicol contains an antibiotic. It is used to treat infections of your eyes.
Sometimes parts of the outer surface of the eye, such as the cornea (the transparent membrane
covering the surface of the eye) or the conjunctiva (the lining of the inside of the eyelids and part of
the eye), may bec ome infected with bacteria. These eye drops can be used to treat this infection and
are effective against many different types of bacteria.
If the eye infection is very severe, your doctor may give you antibiotic tablets as well as this
antibiotic eye drop s. This medicine is indicated for children (abov e 2 years old) , adults and the
elderly.
2. Before you use your eye drops
Do not use these drops if
• you are allergic to the active substance (chloramphenicol) or any of the ingredients (refer to the
end of this leaflet).
Take s pecial care
If you use the se eye drops over a long period of time they could possibly become less effective or
produce allergic reactions.
In order to prevent this, make sure that you stop using this medicine as soon as your doctor tells you
to.
Do you use any of these medicines?
Chymotrypsin (solution used during cataract surgery) may not work properly when used at the same
time as Minims ® Chloramphenicol.
Pregnancy, breast -feeding and fertility
If you are pregnant, may be pregnant, or are breastfeeding tell your doc

Summary of Product characteristics

Health Products Regulatory Authority
26 January 2021
CRN009ZYG
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Chloramphenicol 0.5% Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 0.5% w/v.
Excipients with known effect
Minims Chloramphenicol contains borax and boric acid.
_For a full listof excipients,seesection 6.1._
3 PHARMACEUTICAL FORM
Clear, colourless, sterile single use eye drops solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chloramphenicol is indicated for the topical treatment of infections
due to micro-organisms sensitive to the anti-infective.
Chloramphenicol is indicated in adults and children (above 2 years
old).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults(includingtheElderly)
One to two drops applied topically 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).
Paediatricpopulation (children above 2 years old)
As for adults. The maximum duration of treatment is 10 - 14 days.
4.3 CONTRAINDICATIONS
Use in patients with a history of hypersensitivity or toxicity to
chloramphenicol or any other component of the preparation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In severe infections topical use of chloramphenicol should be
supplemented with appropriate systemic treatment.
Aplastic anaemia has, very rarely, followed topical use of
chloramphenicol eye drops and, whilst this hazard is an uncommon
one, it should be borne in mind when the benefits of the use of
chloramphenicol are assessed.
Prolonged use should be avoided as it may increase the likelihood of
sensitisation and the emergence of resistant organisms.
Chloramphenicol should be reserved for use only in infections for
which it is specifically indicated. Contact lenses should be
removed during the period of treatment.
Systemic absorption may be reduced by compressi