SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Klorafect 1% w/w Eye Ointment

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Chloramphenicol 1% w/w

For a full list of excipients, see Section 6.1

3    PHARMACEUTICAL FORM

Eye Ointment

Homogeneous, yellowish-white ointment

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Treatment of bacterial conjunctivitis caused by the organisms Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus haemolyticus, Morax-Axenfeld and others.

4.2    Posology and method of administration

The recommended dosage for adults, children and infants of all age groups is a small amount of ointment to be applied to the affected eye every three hours or more frequently if required. Treatment should be continued for at least 48 hours after eye appears normal.

4.3    Contra-indications

Known hypersensitivity to chloramphenicol or to any of the excipients. Family or personal history of blood dyscrasias including myelosuppression and 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 the use of the compound. Where chloramphenicol eye ointment is used on a long-term or intermittent basis, it may be advisable to perform a routine blood profile before therapy and at appropriate intervals thereafter to detect haemopoietic abnormalities.

In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. The prolonged use of antibiotics may occasionally result in overgrowth of non-susceptible organisms, including fungi. If any new infection appears during the treatment, the antibiotic should be discontinued and appropriate measures taken. Chloramphenicol should be reserved for use only for infections for which it is specifically indicated. Contact lenses should be removed during treatment.

Chloramphenicol does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

It is recommended that all types of contact lenses are avoided during ocular infections. Chloramphenicol eye ointment may smear over the surface of contact lenses.

4.5 Interaction with other medicinal products and other forms of interactions

The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.

4.6 Fertility, pregnancy and lactation

Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physician. In view of the fact that chloramphenicol may appear in breast milk, use of the product during lactation should be avoided.

4.7 Effects on ability to drive and use machines

Transient blurring of vision may occur immediately after use and driving or using machinery should not occur until the vision is clear.

4.8 Undesirable effects

Transient burning or stinging sensations may occur. Serious side effects include hypersensitivity reactions that may manifest as angioneurotic oedema, anaphylaxis, urticaria, fever, and vesicular and maculopapular dermatitis and are causes for immediate discontinuation. Bone marrow depression, including the idiosyncratic type of irreversible and fatal aplastic anaemia that is recognised to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard

4.9 Overdose

Accidental ingestion of the ointment is unlikely to cause systemic toxicity due to the low content of the antibiotic in the product. If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after this, an ophthalmological examination should be considered.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

ATC Code: S01AA01

Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of gram-negative and gram-positive organisms.

5.2    Pharmacokinetic properties

Not applicable to topical (ophthalmic) preparations.

5.3    Preclinical safety data

Nothing of relevance which is not included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Liquid paraffin White petroleum

6.2    Incompatibilities

None known

6.3    Shelf life

Unopened:    48 months

Opened:    28 days

6.4    Special precautions for storage

Do not store above 25°C

6.5    Nature and contents of container

Aluminium tube and polyethylene cap containing 4g of homogeneous, yellowish-white ointment.

6.6    Special precautions for disposal

None stated

7 MARKETING AUTHORISATION HOLDER

Blumont Pharma Ltd 23 Moortown Close Grantham United Kingdom NG31 9GG

8    MARKETING AUTHORISATION NUMBER(S)

PL 31103/0009

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16/09/2011

10 DATE OF REVISION OF THE TEXT

04/12/2013